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CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefits of provisional patent application, the content of which is incorporated by referenced: Varroa Mite Control Entrance (VMCE). REFERENCE CITED UNITED STATES PATENTS [0002] Application of Provisional Utility Patent: 60/,928,104 [0003] Application Filing Date: May 8, 2007 UNITED STATES PATENT DOCUMENTS SEARCH [0004] [0000] Patent Filing Number Date Inventor Relationship of 4,876,731 19SEP89 Willard Process for detecting parasite infestion for package bees 5,069,651 03DEC91 Arndt Method and Apparatus for removing parasites from honeybee using heat and electric fan 6,468,129 22OCT02 Griffith Bottom board reducing parasite infestation 6,702,645 09MAR04 Vanderpool Separating parasites from honeybees using compressed air to dislodge parasites STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OF DEVELOPMENT [0005] The request for this patent is not sponsored by any federal sponsored research or development program. REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIX [0006] No Computer Program Listing or Compact Disc is submitted with this patent application. BACKGROUND OF THE INVENTION [0007] Over the past three decades, ever since Varroa Mites (also known as Varroa Jacobsoni, Varroa Destructor, Varroa mellifera) were discovered in the United States, they have plagued Apiary honey production. This infestation has affected the commercial, hobbyist and sideliner apiaries through out the United States. Varroa Mites are very destructive to the hive. They enter the hive by attaching themselves to adult Honeybees and are thereby carried into the hive. Adult Varroa Mites lay eggs in brood cells with new, unhatched bee larva, causing deformities to new bees and eventually causing death to the young bee and to the adult host bees. There are numerous research articles on current methods of combating the Varroa Mites populations and methods for detecting Varroa Mite infestation. These methods include non-organic and organic methods for detection and removal of the Varroa Mites. [0008] Some of the non-organic methods include “Api-guard” and “Mite Away” chemicals, which cause the Honeybees to go into their cleaning hygiene mode. Through this method, the Honeybees will dislodge the Varroa Mites causing them to fall off the bee and land in the bottom of the hive. Varroa Mites like any other pest/insect can and will eventually become immune to these chemicals according to research. The Varroa Mites that are dislodged and land in the bottom of the hive have the ability to climb back up in the brood frames and lay eggs in brood cells. These chemicals used in conjunction with screen bottoms have some reduction of re-infestation of the hive. [0009] Organic methods include confectioned/powered sugar sprinkled onto the Honeybee while they are in the frames inside of the hive. Similarly, Honeybees go into their cleaning hygiene mode to remove the powered sugar from their bodies, causing the Varroa Mites to be dislodged and fall off the Honeybee and into the bottom of the hive. Again, the Varroa Mites can re-infest the hive by climbing back up on to the frame of brood. The powdered sugar methods used with a screen bottom board also have some reduction of re-infestation of the hive and frames of brood. [0010] Both of these methods are more effective when used with a screen bottom board and Westel Small Hive Beetle trap or Sticky Bottom Board. Using with screen bottom board, the Varroa Mites that fall through the screen bottom board and land in the Westel Small Hive Beetle trap greatly reduces the re-infestation of the hive. The Sticky Bottom Board fits through the hive opening with a plastic mesh screen to prevent bees from becoming stuck onto the sticky adhesive. The Varroa Mites fall off the Honeybee and through the mesh screen becoming stuck to the sticky board preventing re-infestation of the hive. The draw back to Sticky Bottom Board is it has to be replaced at regular intervals and especially after it has rained. Rain reduces the effectiveness of the sticky bottom board and the corners have known to curl up making the removal of the board more difficult. [0000] Current method for detecting Varroa Mites infestation is: [0011] Ether/Alcohol Roll Test—The beekeeper pours ether/alcohol into ajar with fifty to a hundred Honeybees then rolls the jar. The Varroa Mites stick onto the side of the jar and the beekeeper counts the number of Varroa Mites in the sample. Of course, this method kills the Honeybees in the sample as well as the Varroa Mites. [0012] The Powdered Sugar Roll Test—The beekeeper puts fifty to a hundred Honeybees in jar with a screen mesh lid. The beekeeper adds powdered sugar and rolls the jar covering the honey bees with powered sugar. After the bees finish their cleaning, the beekeeper shakes the powdered sugar onto a piece of white paper or white poster board and counts the number of Varroa Mites. The Honeybees are not harmed and are returned to the hive. [0013] The Powdered Sugar Frames Test—The beekeeper sprinkles powdered sugar on frames with a piece of poster board and inserts them through the hive entrance to catch the Varroa Mites that have fallen off of the Honeybees. The beekeeper waits approximately fifteen minutes, removes the poster board, and counts the number of Varroa Mites that have fallen onto the poster board. [0014] The pathogens being passed on to the Honeybees from Varroa Mites is recognized as one possible cause for the Colony Collapse Disorder in Apiary yards across the country. The need to remove the Varroa Mites from Honeybees to ensure a healthy hive for pollination and honey production is clear. OTHER SELECTED REFERENCES [0000] Aratanakul P, Burgett M. 1975. Varroa jacobsoni: A prospective pest of Honeybees in many parts of the world. Bee World 56: 119-121. Crane E. 1979. Fresh news on the Varroa Mites. Bee World. 608: 8. Cromroy H L. 1984. The Asian Honeybee Mites, a new threat to American beekeepers. Florida Extension Service. EYN-48. 4 p. Kevan P G, Laverty T M, Denmark H A. 1990. Association of Varroa jacobsoni with organisms other than honey bees and implications for its dispersal. Bee World 7: 119-121. Popa A. 1980. Agriculture in Lebanon. American Bee Journal 120: 336-367. Ritter W. 1981. Varroa disease of the Honeybee Varroa mellifera. Bee World 62: 141-153. Sanford M T. 2001. Introduction, spread and economic impact of Varroa Mites in North America. In: Mites of the Honey Bee. Hamilton, Ill.: Dadant & Sons. pp. 149-162. Sanford M T. (1997). A history of varroa Mites in Florida, with discussion of controls. APIS http://apis.ufl.edu/threads/varroa.htm (May 2000). BRIEF SUMMARY OF THE INVENTION [0023] A method and apparatus for removing of Varroa Mites from Honeybees. The device consists of two primary components: a brush and a metal receiving tray. The assembly is placed in front of the hive entrance. Honeybees past between the brush and the over a wire mesh screen cover on top of the metal receiving tray. Soft nylon bristles of the brush gently dislodge the Varroa Mites from the Honeybees. Varroa Mites fall off the Honeybees; pass through a wire mesh screen in the metal receiving tray and land onto contact paper with the adhesive side facing upward. This invention prevents the Varroa Mites from re-infesting the Honeybees or the hive. Over a prolonged period of time the Varroa Mite Control Entrance (VMCE) in place reduces the total population of Varroa Mites from the hive body. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0024] This invention is designed to greatly reduce Varroa Mites on Honeybees using no chemicals. [0025] This invention has two main parts: [0026] First, the Brush that is used to dislodge the Varroa mites from the Honeybees. [0027] Second, the metal tray which the mite's fall into, preventing the Varroa Mites from crawling back up onto their hosts. [0028] Together, they act to reduce or prevent the Varroa Mites from entering the hive body which reduces the parasitic effect on Honeybee larva that causes deformities in their young. [0029] FIG. 1 : The wire mesh screen that separates the Honeybees from coming in contact with the adhesive side of the contact paper. The wire mesh screen has approximately 2 mm-4 mm openings in the mesh. The overall size of the wire mesh screen is 12¼″ long by 2/¼″ wide by ¼″ deep. [0030] FIG. 2 : The metal receiving tray that is 12½′″ long by 2½″ wide and ¼″ deep. The metal receiving tray holds the contact paper with the adhesive side facing upwards. [0031] FIG. 3 : Shows FIGS. 1 and 2 assembled together. To assemble, place a strip of contact paper 12½″ in long by 2½″ wide into the bottom of the metal receiving tray ( FIG. 2 ) with the adhesive side facing upwards. Then place the wire mesh screen ( FIG. 1 ) into the metal receiving tray. [0032] FIG. 4 : The brush portion of the Varroa Mite Control Entrance (VMCE). The center section of the brush consists of five strips of wood that are 12¼″ in length and 7/16″ in width and ¾″ in height. In between each of these five strips of wood are ¾″ soft nylon polyester bristles. A ¼″ of the soft nylon polyester bristles is glued between the strips of wood with ½″ of bristles sticking below the bottom of the wood. On each end of the strips of wood is 7/16″ length by 2¼″ wide by ¾″ height. At the very end is piece of wood that is ¾″ in length by 2¼″ wide and 1¾″ tall. The overall dimension of the brush is 14¾″ [0033] FIG. 5 : The metal top that fits over the top of the brush to protect the glue and polyester bristles from rain. This piece is 14¾″ long, by 2¼″ wide and ¾″ deep. It is glued onto the brush portion of the apparatus. [0034] FIG. 6 : Shows the completed assembly of the brush and tray of Varroa Mite Control Entrance (VMCE). [0035] FIG. 7 : Shows the Varroa Mite Control Entrance (VMCE) placed on the bottom board of the beehive in front of the entrance for the bee to enter and exit the hive. [0036] Method of Operation: As the Honeybees pass through the Varroa Mite Control Entrance (VMCE) the soft polyester bristles gentle dislodge the Varroa Mites from the top and back portions of the Honeybee. The Varroa Mites fall through the small wire mess into either oil or a sticky substance preventing the Varroa Mites from re-entering the hive body. [0037] Goal of Invention: Reduction of Varroa Mite infestation in the hive body which reduces the infestation in Honeybee larva thereby reducing deformities in their young and increasing overall hive health and honey production. DETAILED DESCRIPTION OF THE INVENTION [0038] The Varroa Mite Control Entrance (VMCE) is lightweight, easy to clean and can be left in place year around. The Varroa Mite Control Entrance does not require any electric or harmful chemicals making it environmentally friendly. Other inventions and methods are heavy; require electricity, heat, compressed air, or harmful chemicals. The Varroa Mite Control Entrance (VMCE), compared to other inventions, is more cost effect for large commercial Apiaries and is affordable for the hobbyist and sideliner Apiary yards as well. [0039] Constructing FIG. 1 —The wire mesh screen that fits into the metal receiving tray: Using 2 mm-4 mm wire mesh screen cut to the length of 12¼″ by 2¾″ wide rectangle. Then bend the wire mesh screen down ¼″ on the two sides that are 12¼″ long. This makes the overall dimension of wire mesh screen 12¼ long by 2¼″ wide and ¼″ high. [0040] Constructing FIG. 2 —The metal receiving tray: This piece is cut from a piece of galvanized aluminum into rectangle shape with the length of 13″ by 3″ wide. Down the long side of the Aluminum rectangle, bend the galvanized aluminum upward ¼″ along each of the sides. Cut a ¼″ slit into the side ¼″ from ends, then bend ¼″ of the galvanized aluminum upward at each end. Fold the galvanized aluminum to create the corners of the metal tray. [0041] Constructing FIG. 4 —The brush used to dislodge the Varroa Mites: [0000] The following items are needed: Five strips of wood that are each 12¼″ in length and 7/16″ wide and ¾″ deep. Two strips of wood 7/16″ in length by 2¼″ in width by ¾″ in height. Two pieces of wood that are ¾″ by 2¼″ by 1¾″ Wood glue ¼″ wide double sided tape Soft nylon polyester paintbrush Two C-clamps Sheet metal bending jig First cut four pieces of the double sided tape 12¼″ long and cut ¾″ of the bristles off the soft nylon polyester paintbrush. Align the bristles from the paintbrush onto the tape, leaving ½″ of the bristle sticking past the adhesive portion of the tape. Repeat this process for the other three pieces of the double-sided tape. Now peel off the back side of the double sided tape and affix it to the lower portion of strip of wood that is 12¼″ long, add a bead of wood glue down the length of the strip of wood, place another strip of 12¼″ wood on top of the glue. Repeat this process until you have four rows of bristles between the five strips of 12¼″ strips of wood. Use C-clamps to hold the strips of wood together until the glue dries. Once the glue has dried remove the c-clamps and glue the 7/16″×2¼×¾″ pieces of wood to each end of the 12¼″ piece of wood, clamp until glue is dry. Finally, glue the last two-pieces of wood ( 3/4″×2¼″×1¾″). [0050] Constructing FIG. 5 : Cut a piece of galvanized aluminum into a rectangle 16¼″ long by 4″ wide. Down the long side of the Aluminum rectangle, bend the galvanized aluminum downward ¾″ along each of the sides. Cut a ¾″ slit into the side ¾″ from ends then bend ¾″ of the galvanized aluminum downward at each end. Fold the galvanized aluminum to create the corners of the metal cover. Put beads of wood glue on the top and sides of the brush assembly and place the metal cover over the top of the brush. [0051] Final assembly: Line the metal tray with contact paper with adhesive side face upward. Place the wire mesh screen into the tray. Place the brush and metal tray in front of the hive opening, pushing against the hive not to allow the Honeybees access between the hive and the brush.

1a

CROSS-REFERENCE TO RELATED APPLICATION The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/040,836, filed on Mar. 31, 2008, the entire content of which is incorporated herein by reference. BACKGROUND 1. Technical Field The present disclosure relates generally to electrosurgical instruments and, more particularly, to an electrosurgical pencil having a plurality of hand-accessible variable controls. 2. Background of Related Art Electrosurgical instruments have become widely used by surgeons in recent years. Accordingly, a need has developed for equipment and instruments which are easy to handle, are reliable and are safe in an operating environment. By and large, most electrosurgical instruments are hand-held instruments, e.g., an electrosurgical pencil, which transfer radio-frequency (RF) electrical or electrosurgical energy to a tissue site. The electrosurgical energy is returned to the electrosurgical source via a return electrode pad positioned under a patient (i.e., a monopolar system configuration) or a smaller return electrode positionable in bodily contact with or immediately adjacent to the surgical site (i.e., a bipolar system configuration). The waveforms produced by the RF source yield a predetermined electrosurgical effect known generally as electrosurgical cutting and fulguration. As used herein the term “electrosurgical pencil” is intended to include instruments which have a handpiece which is attached to an active electrode and which is used to cauterize, coagulate and/or cut tissue. Typically, the electrosurgical pencil may be operated by a handswitch or a foot switch. The active electrode is an electrically conducting element which is usually elongated and may be in the form of a thin flat blade with a pointed or rounded distal end. Alternatively, the active electrode may include an elongated narrow cylindrical needle which is solid or hollow with a flat, rounded, pointed or slanted distal end. Typically electrodes of this sort are known in the art as “blade”, “loop” or “snare”, “needle” or “ball” electrodes. As mentioned above, the handpiece of the electrosurgical pencil is connected to a suitable electrosurgical energy source (i.e., generator) which produces the radio-frequency electrical energy necessary for the operation of the electrosurgical pencil. In general, when an operation is performed on a patient with an electrosurgical pencil, electrical energy from the electrosurgical generator is conducted through the active electrode to the tissue at the site of the operation and then through the patient to a return electrode. The return electrode is typically placed at a convenient place on the patient's body and is attached to the generator by a conductive material. Typically, the surgeon activates the controls on the electrosurgical pencil to select the modes/waveforms to achieve a desired surgical effect. The power or energy parameters are typically controlled from outside the sterile field which requires an intermediary like a circulating nurse to make such adjustment. A typical electrosurgical generator has numerous controls for selecting an electrosurgical output. For example, the surgeon can select various surgical “modes” to treat tissue: cut, blend (blend levels 1-3), low cut, desiccate, fulgurate, spray, etc. The surgeon also has the option of selecting a range of power settings typically ranging from 1-300 W. As can be appreciated, this gives the surgeon a great deal of variety when treating tissue. However, so many options also tend to complicate simple surgical procedures and may lead to confusion. Moreover, surgeons typically follow preset control parameters and stay within known modes and power settings. Therefore, there exists a need to allow the surgeon to selectively control and easily select and regulate the various modes and power settings utilizing simple and ergonomically friendly controls associated with the electrosurgical pencil. Existing electrosurgical instrument systems allow the surgeon to change between two pre-configured settings (i.e., coagulation and cutting) via two discrete switches disposed on the electrosurgical pencil itself. Other electrosurgical instrument systems allow the surgeon to increment the power applied when the coagulating or cutting switch of the instrument is depressed by adjusting or closing a switch on the electrosurgical generator. The surgeon then needs to visually verify the change in the power being applied by looking at various displays and/or meters on the electrosurgical generator. In other words, all of the adjustments to the electrosurgical instrument and parameters being monitored during the use of the electrosurgical instrument are typically located on the electrosurgical generator. As such, the surgeon must continually monitor the electrosurgical generator during the surgical procedure. Furthermore, someone outside the sterile field must continually adjust the parameters of the electrical instrument, which prolongs the duration of the procedure. Accordingly, the need exists for electrosurgical instruments which do not require the surgeon to continually monitor the electrosurgical generator during the surgical procedure. Further, a need exists for electrosurgical instruments, which permit the surgeon to accurately self-adjust the electrical parameters of the instrument from within the sterile field. In addition, the need exists for electrosurgical instruments which may be configured such that the power output can be adjusted without the surgeon having to turn his/her vision away from the operating site and toward the electrosurgical generator. SUMMARY The present disclosure relates to electrosurgical pencils having a plurality of hand-accessible variable controls. According to an aspect of the present disclosure, an electrosurgical pencil is provided including an elongated housing configured to support an electrocautery electrode extending distally therefrom; at least one voltage divider network supported on the housing, the at least one voltage divider network operable to electrically connect to a source of electrosurgical energy for controlling at least one of an intensity and a mode of electrosurgical energy being delivered to the electrocautery electrode; and an intensity controller slidably supported on the housing. The intensity controller is configured to exert a force on the at least one voltage divider network and to provide a tactile feedback to a user of the electrosurgical pencil as the intensity controller is moved relative to the housing. The intensity controller may include a nub extending from a surface thereof. The nub may be configured to contact the at least one voltage divider network and affect the at least one voltage divider network as the intensity controller is moved relative to the housing. The intensity controller may include a spring plunger assembly configured to operatively engage a tactile feature formed in the housing. The spring plunger assembly may include a stem and a biasing member. The stem may be disposed on a side opposite to the nub and is configured to retain an actuator. The biasing member may be configured to maintain the actuator in contact with the tactile feature formed in the housing. The actuator may be disposed at one of a distal, a proximal and a substantially aligned location with respect to the nub. The intensity controller may include a spring lever assembly configured to operatively engage a tactile feature formed in the housing. The spring lever assembly may include a lever and a biasing member for maintaining the lever in contact with the tactile feature. The lever may be pivotally connected to a body portion of the intensity controller, on a side opposite to the nub. The biasing member may be a spring. A tip of the lever may be disposed at one of a distal, a proximal and a substantially aligned location with respect to the nub. According to another aspect of the present disclosure, an electrosurgical device configured for connection to a source of electrosurgical energy is provided. The electrosurgical device includes a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on the electrical circuit to affect a change in the electrical circuit and to provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing. The controller may include a nub extending from a surface thereof and being dimensioned to contact the electrical circuit. The electrical circuit may be a voltage divider network capable of controlling at least one of an intensity and a mode of electrosurgical energy being delivered, and wherein the nub is configured to contact the voltage divider network and affect a change in at least one of the intensity and the mode of electrosurgical energy being delivered as the controller is moved relative to the housing. The controller may include a spring plunger assembly configured to operatively engage a tactile feature formed in the housing. The spring plunger assembly may include a stem and a biasing member. The stem may be disposed on a side opposite to the nub and is configured to retain an actuator. The biasing member may be configured to maintain the actuator in contact with the tactile feature formed in the housing. The actuator may be disposed at one of a distal, a proximal and a substantially aligned location with respect to the nub. The controller may include a spring lever assembly configured to operatively engage a tactile feature formed in the housing. The spring lever assembly may include a lever and a biasing member for maintaining the lever in contact with the tactile feature. The lever may be pivotally connected to a body portion of the intensity controller, on a side opposite to the nub. The biasing member may be a spring. A tip of the lever may be disposed at one of a distal, a proximal and a substantially aligned location with respect to the nub. According to a further aspect of the present disclosure, an electrosurgical pencil is provided including an elongated housing configured to support an electrocautery electrode extending distally therefrom; at least one voltage divider network supported on the housing, the at least one voltage divider network operable to electrically connect to the source of electrosurgical energy for controlling at least one of an intensity and a mode of electrosurgical energy being delivered to the electrocautery electrode; and an intensity controller slidably supported on the housing, wherein the intensity controller is configured to exert a force on the at least one voltage divider network and provide a tactile feedback to a user of the electrosurgical pencil as the intensity controller is moved relative to the housing. The intensity controller may include a lever pivotally connected to a body portion thereof and contactable with the housing and the at least one voltage divider network. The lever may include a first end configured for engagement with a tactile feature formed in the housing. The lever may include a second end configured for engagement with the at least one voltage divider network. The intensity controller may include a biasing member configured to maintain a first end of the lever in contact with the tactile feature formed in the housing. The intensity controller may include a biasing member configured to maintain a second end of the lever in contact with the at least one voltage divider network. The intensity controller may include a biasing member configured to maintain a first end of the lever in contact with the tactile feature formed in the housing and to maintain a second end of the lever in contact with the at least one voltage divider network. The biasing members may be one of a coil spring, a tension spring and a compression spring. The tactile feature may include one or more adjacent detents. In use, movement of the first end of the lever into the one or more adjacent detents may cause the second end of the lever to substantially strike the at least one voltage divider network. According to yet another aspect of the present disclosure, an electrosurgical device configured for connection to a source of electrosurgical energy is provided. The electrosurgical device includes a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on the electrical circuit to affect a change in the electrical circuit and to exert a force on a surface of the housing to provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing. The electrical circuit may comprise at least one voltage divider network capable of controlling at least one of an intensity and a mode of electrosurgical energy being delivered, and wherein the controller may include a lever pivotally connected to a body portion thereof and contactable with the housing and the at least one voltage divider network. The lever may include a first end configured for engagement with a tactile feature formed in the housing. The lever may include a second end configured for engagement with the at least one voltage divider network. The controller may include a biasing member configured to maintain a first end of the lever in contact with the tactile feature formed in the housing. The controller may include a biasing member configured to maintain a second end of the lever in contact with the at least one voltage divider network. The controller may include a biasing member configured to maintain a first end of the lever in contact with the tactile feature formed in the housing and to maintain a second end of the lever in contact with the at least one voltage divider network. The biasing members may be one of a coil spring, a tension spring and a compression spring. The tactile feature may include one or more adjacent detents. In use, movement of the first end of the lever into the one or more adjacent detents may cause the second end of the lever to substantially strike the at least one voltage divider network. According to still another aspect of the present disclosure, an electrosurgical pencil is provided including an elongated housing configured to support an electrocautery electrode extending distally therefrom; at least one voltage divider network supported on the housing, the at least one voltage divider network operable to electrically connect to the source of electrosurgical energy for controlling at least one of an intensity and a mode of electrosurgical energy being delivered to the electrocautery electrode, wherein the at least one voltage divider network defines a plurality of tactile enhancement features; and an intensity controller slidably supported on the housing, wherein the intensity controller is configured to exert a force on the at least one voltage divider network and engage the tactile enhancement feature and provide a tactile feedback to a user of the electrosurgical pencil as the intensity controller is moved relative to the housing. The electrosurgical pencil may further include a tactile mask overlying at least a portion of the at least one voltage divider network, wherein the tactile mask defines the plurality of tactile enhancement regions. The tactile enhancement features of the tactile mask may include at least one aperture formed therein. The intensity controller may include a tactile feedback transmitting feature configured to project through the at least one aperture formed in the tactile mask to selectively engage the at least one voltage divider network. The tactile feedback transmitting feature may include at least one of an actuator and a nub selectively positionable within the aperture of the tactile mask. At least one of an actuator and a nub may extend from a surface of the intensity controller, in a direction toward the tactile mask. The tactile feedback transmitting feature may further comprise a spring plunger assembly including a biasing member for maintaining the tactile feedback transmitting feature in contact with at least one of the voltage divider network and the tactile mask. The tactile feedback transmitting feature may be configured to selectively strike the at least one voltage divider network. According to yet another aspect of the present disclosure, an electrosurgical device, configured for connection to a source of electrosurgical energy, is provided. The electrosurgical device comprises a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy, wherein the electrical circuit is provided with at least one tactile enhancement feature; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on the electrical circuit to affect a change in the electrical circuit and to exert a force on a surface of the housing to engage the tactile enhancement feature and provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing. The electrosurgical device may further include a tactile mask overlying at least a portion of electrical circuit, wherein the tactile mask defines the plurality of tactile enhancement regions. The tactile enhancement features of the tactile mask may include at least one aperture formed therein. The controller may include a tactile feedback transmitting feature configured to project through the at least one aperture formed in the tactile mask to selectively engage the electrical circuit. The tactile feedback transmitting feature may include at least one of an actuator and a nub selectively positionable within the aperture of the tactile mask. At least one of an actuator and a nub may extend from a surface of the controller, in a direction toward the tactile mask. The tactile feedback transmitting feature may further include a spring plunger assembly including a biasing member for maintaining the tactile feedback transmitting feature in contact with at least one of the electrical circuit and the tactile mask. The tactile feedback transmitting feature may be configured to selectively strike the electrical circuit. The electrical circuit may include at least one voltage divider network. According to still another aspect of the present disclosure, an electrosurgical pencil is provided including an elongated housing configured to support an electrocautery electrode extending distally therefrom; at least one voltage divider network supported on the housing, the at least one voltage divider network operable to electrically connect to the source of electrosurgical energy for controlling at least one of an intensity and a mode of electrosurgical energy being delivered to the electrocautery electrode; and an intensity controller slidably supported on the housing, wherein the intensity controller is configured to exert a force on each of the housing and the at least one voltage divider network, wherein the intensity controller provides a tactile feedback to a user of the electrosurgical pencil as the intensity controller is moved relative to the housing. The intensity controller may include a torsion spring pivotally supported on a body portion thereof, wherein the torsion spring is in contact with at least one of the housing and the electrical circuit. The torsion spring may include a first leg configured for engagement with a tactile feature formed in the housing. The torsion spring may include a second leg configured for engagement with the at least one voltage divider network. The torsion spring may include a first leg configured for engagement with a tactile feature formed in the housing and a second leg configured for engagement with the at least one voltage divider network. The intensity controller may include a link assembly pivotally supported on a body portion. The link assembly may include a first leg configured for engagement with a tactile feature formed in the housing; and a second leg configured for engagement with the at least one voltage divider network. The link assembly may further include a biasing member interposed between the first leg and the second leg for maintaining the first leg in engagement with the tactile feature formed in the housing and for maintaining the second leg in engagement with the at least one voltage divider network. The biasing member may be configured for maintaining the first leg in engagement with the tactile feature formed in the housing. The biasing member may be configured for maintaining the second leg in engagement with the at least one voltage divider network. According to still another aspect of the present disclosure, an electrosurgical device, configured for connection to a source of electrosurgical energy, is provided. The electrosurgical device comprises a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on each of the housing and the electrical circuit to affect a change in the electrical circuit and to provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing. The controller may include a torsion spring pivotally supported on a body portion thereof, wherein the torsion spring is in contact with at least one of the housing and the electrical circuit. The torsion spring may include a first leg configured for engagement with a tactile feature formed in the housing. The torsion spring may include a second leg configured for engagement with the electrical circuit. The torsion spring may include a first leg configured for engagement with a tactile feature formed in the housing and a second leg configured for engagement with the electrical circuit. The controller may include a link assembly pivotally supported on a body portion. The link assembly may include a first leg configured for engagement with a tactile feature formed in the housing; and a second leg configured for engagement with the electrical circuit. The link assembly may further include a biasing member interposed between the first leg and the second leg for maintaining the first leg in engagement with the tactile feature formed in the housing and for maintaining the second leg in engagement with the electrical circuit. The biasing member may be configured for maintaining the first leg in engagement with the tactile feature formed in the housing. The biasing member may be configured for maintaining the second leg in engagement with the electrical circuit. The electrical circuit may include at least one voltage divider network supported on the housing, the at least one voltage divider network operable to electrically connect to the source of electrosurgical energy for controlling at least one of an intensity and a mode of electrosurgical energy being delivered to the electrocautery electrode. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention. FIG. 1 is a perspective view of a prior art electrosurgical system including an electrosurgical generator and an electrosurgical pencil; FIG. 2 is an exploded perspective view of the electrosurgical pencil of FIG. 1 ; FIG. 3 is a longitudinal, cross-sectional, side elevational view of the electrosurgical pencil of FIGS. 1 and 2 ; FIG. 4 is an enlarged view of the indicated area of detail of FIG. 3 ; FIG. 5 is an exploded perspective view of a voltage divider network; FIG. 6A is a schematic side elevational view of a slider according to an embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 6B is a schematic side elevational view of a slider according to another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 6C is a schematic side elevational view of a slider according to yet another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 6D is a schematic perspective view, with parts separated, of a slider according to a further embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 7A is a schematic side elevational view of an alternate slider according to an embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 7B is a schematic side elevational view of the alternate slider according to another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 7C is a schematic side elevational view of the alternate slider according to yet another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 8A is a schematic illustration of a further alternate slider and a tactile mask according to an embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 8B is a schematic illustration of the further alternate slider according and a tactile mask to another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; FIG. 9A is a schematic side elevational view of an alternate slider according to an embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 ; and FIG. 9B is a schematic side elevational view of a further alternate slider according to another embodiment of the present disclosure, for use in an electrosurgical pencil as shown in FIGS. 1-4 . DETAILED DESCRIPTION Preferred embodiments of the presently disclosed electrosurgical pencil will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to that portion which is further from the user while the term “proximal” refers to that portion which is closer to the user or surgeon. FIG. 1 sets forth a perspective view of an electrosurgical system including an electrosurgical pencil 100 constructed in accordance with a prior art embodiment. While the following description will be directed towards electrosurgical pencils it is envisioned that the features and concepts (or portions thereof) of the present disclosure can be applied to any electrosurgical type instrument, e.g., forceps, suction coagulators, vessel sealers, wands, etc. As seen in FIGS. 1-5 , electrosurgical pencil 100 includes an elongated housing 102 having a right-half shell section 102 a and a left-half shell section 102 b . As seen in FIGS. 1 and 2 , when right and left-half shell sections 102 a , 102 b are connected to one another, a distal opening 103 a is defined therebetween, through which an electrode 106 extends, and a proximal opening 103 b (see FIG. 2 ) is defined therebetween, through which connecting cable 224 (see FIG. 1 ) extends. As seen in FIG. 1 , electrosurgical pencil 100 is coupled to an electrosurgical generator “G” via a plug assembly 200 connected to connecting cable 224 . As seen in FIG. 2 , electrosurgical pencil 100 further includes an electrode receptacle 104 disposed at a distal end of housing 102 , and a replaceable electrode 106 operatively and removably connectable to electrode receptacle 104 . With continued reference to FIGS. 1-3 , electrosurgical pencil 100 includes three activation buttons 120 a - 120 c , each of which is reciprocally supported in a carrier 121 (see FIG. 2 ) of a controller unit which is supported in housing 102 . Each activation button 120 a - 120 c includes a portion which extends through an upper surface of housing 102 . As seen in FIGS. 2 and 3 , each activation button 120 a - 120 c is operatively supported on a respective tactile element 122 a - 122 c formed in a switch plate 124 . Each activation button 120 a - 120 c controls the transmission of RF electrical energy supplied from generator “G” to electrode 106 . Switch plate 124 is positioned over the top of a voltage divider network 127 (hereinafter “VDN 127 ”) such that tactile elements 122 a - 122 c are in operative association therewith. As seen in FIGS. 1-4 , electrosurgical pencil 100 includes an intensity controller 128 slidingly supported in housing 102 . Intensity controller 128 includes a pair of nubs 129 a , 129 b which are slidingly supported, one each, in respective guide channels 130 a , 130 b (see FIG. 1 ). As seen in FIGS. 3 and 4 , intensity controller 128 includes a third nub 129 c extending from a bottom surface thereof which contacts and presses into or against VDN 127 . As seen in FIG. 5 , VDN 127 includes electrical contacts 144 a provided on upper layer 140 a and resistive element 144 b on lower layer 140 b . In this manner, as intensity controller 128 is displaced in a distal and proximal direction relative to housing 102 , third nub 129 c moves along VDN 127 , thereby pressing electrical contact 144 a from upper layer 140 a of VDN 127 against resistance element 144 b of lower layer 140 b of VDN 127 . In so doing, a resistance value of resistance element 144 b is changed thereby changing the value of the voltage measured by electrosurgical generator “G”. The electrosurgical generator “G” in turn varies the intensity of the waveform being transmitted to electrode 106 . Slidable manipulation or movement of intensity controller 128 adjusts the power parameters (e.g., voltage, power and/or current intensity) and/or the power verses impedance curve shape to affect the output intensity of the waveform. In order to vary the intensity of the power parameters of electrosurgical pencil 100 , the surgeon displaces intensity controller 128 , by manipulating at least one of nubs 129 a , 129 b , in either of the directions indicated by double-headed arrow “X” (see FIG. 3 ). Intensity controller 128 is also operable to provide a degree of tactile feedback by the inter-engagement of resilient finger 128 a of intensity controller 128 in detents 131 formed along an inner surface of right-half shell section 102 a (see FIGS. 3 and 4 ). As seen in FIG. 5 , VDN 127 includes a pair of layers 140 a , 140 b of resilient material each supporting a plurality of electrical contacts 142 a , 142 b thereon. Electrical contacts 142 a from an upper layer 140 a of VDN 127 are in juxtaposed electrical relation with respect to electrical contacts 142 b from a lower layer 140 b of VDN 127 . The electrical contacts 142 a , 142 b of the upper and the lower layers 140 a , 140 b of VDN 127 are in juxtaposed relation with respective tactile elements 122 a - 122 c. Upper and lower layers 140 a , 140 b of VDN 127 are separated by a dividing layer 140 c . Dividing layer 140 c includes a first series of apertures 142 c formed therein which are in vertical registration with electrical contacts 142 a , 142 b . Dividing layer 140 c includes a second aperture 144 c formed therein which is in vertical registration between electrical contacts 144 a provided on upper layer 140 a and a variable resistance element 144 d provided on lower layer 140 b . Upper layer 140 a , lower layer 140 b , and dividing layer 140 c are supported on a support layer 140 d. In operation, and depending on the particular electrosurgical function desired, the surgeon depresses one of activation buttons 120 a - 120 c , in the direction indicated by arrow “Y” (see FIG. 3 ) thereby urging and/or deflecting a corresponding tactile element 122 a - 122 c against VDN 127 and thereby causing the respective electrical contact 142 a of upper layer 140 a to electrically engage the respective electrical contact 142 b of the lower layer 140 b . In so doing, a respective characteristic voltage is generated and measured by electrosurgical generator “G”. In turn, depending on the characteristic voltage generated, generator “G” selects and transmits an appropriate waveform output to electrocautery blade 106 . Reference may be made to U.S. application Ser. No. 11/337,990 filed on Jan. 24, 2006, the entire content of which is incorporated herein by reference, for a more detailed discussion of the construction and operation of electrosurgical pencil 100 . Turning now to FIGS. 6A-6D , a series of sliders or intensity controllers 228 according to an embodiment of the present disclosure is shown. Sliders 228 are configured to increase a contact force exerted on VDN 127 while maintaining a degree of facility for an end user to move slider 228 relative to housing 102 of electrosurgical pencil 100 . As seen in FIG. 6A , a slider 228 a may include a body portion 228 a 1 and at least one arm 228 a 2 extending from body portion 228 a 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 228 a includes a nub 228 a 3 extending or projecting from a bottom surface thereof, such as, for example, from a bottom surface of body portion 228 a 1 . Slider 228 a further includes a spring plunger assembly having a stem 228 a 4 extending from body portion 228 a 1 , on a side opposite nub 228 a 3 , and defining a recess configured to retain a biasing member 228 a 5 and an actuator 228 a 6 therein. The spring plunger assembly is located distal or proximal of nub 228 a 3 . In use, as slider 228 a is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , nub 228 a 3 moves along VDN 127 thereby affecting VDN 127 while actuator 228 a 6 of the spring plunger assembly inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . Biasing member 228 a 5 functions to maintain nub 228 a 3 in contact with VDN 127 and actuator 228 a 6 of the spring plunger assembly in contact with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 . As seen in FIG. 6B , a slider 228 b may include a body portion 228 b 1 and at least one arm 228 b 2 extending from body portion 228 b 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 228 b includes a nub 228 b 3 extending or projecting from a bottom surface thereof, such as, for example, from a bottom surface of body portion 228 b 1 . Slider 228 b further includes a spring lever assembly having a stem 228 b 4 extending from body portion 228 b 1 , on a side opposite nub 228 b 3 , and defining a recess configured to retain a biasing member 228 b 5 therein. The spring lever assembly further includes a lever 228 b 6 pivotally connected to body portion 228 b 1 and having a tip 228 b 7 configured to extend over or overlie biasing member 228 b 5 . The spring lever assembly is configured such that stem 228 b 4 is located distal or proximal of nub 228 b 3 and such that lever 228 b 6 extends away from nub 228 b 3 . In use, as slider 228 b is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , nub 228 b 3 moves along VDN 127 thereby affecting VDN 127 while tip 228 b 7 of lever 228 b 6 of the spring lever assembly inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . Biasing member 228 b 5 functions to maintain nub 228 b 3 in contact with VDN 127 and tip 228 b 7 of lever 228 b 6 of the spring lever assembly in contact with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 . As seen in FIG. 6C , a slider 228 c may include a body portion 228 c 1 and at least one arm 228 c 2 extending from body portion 228 c 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 228 c includes a nub 228 c 3 extending or projecting from a bottom surface thereof, such as, for example, from a bottom surface of body portion 228 c 1 . Slider 228 c further includes a spring lever assembly having a biasing member 228 c 5 supported on body portion 228 c 1 , on a side opposite nub 228 c 3 , and a lever 228 c 6 pivotally connected to body portion 228 c 1 and having a tip 228 c 7 configured to extend over or overlie biasing member 228 c 5 . The spring lever assembly is configured such that biasing member 228 c 5 is located distal or proximal of nub 228 c 3 and such that lever 228 c 6 extends away from nub 228 c 3 . In use, as slider 228 c is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , nub 228 c 3 moves along VDN 127 thereby affecting VDN 127 while tip 228 c 7 of lever 228 c 6 of the spring lever assembly inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . Biasing member 228 c 5 functions to maintain nub 228 c 3 in contact with VDN 127 and tip 228 c 7 of lever 228 c 6 of the spring lever assembly in contact with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 . In each of sliders 228 a - 228 c shown in FIGS. 6A-6C and described above, it is contemplated that in some embodiments that actuator 228 a 6 , or tips 228 b 7 , 228 c 7 of levers 228 b 6 , 228 c 6 may axially overlie respective nubs 228 a 3 - 228 c 3 . In this manner, the force of the biasing member 228 a 5 - 228 c 5 acts directly in line with respective nubs 228 a 3 - 228 c 3 . Although the embodiment in FIGS. 6B-6C is shown to a use coil spring as the biasing member, it is contemplated that these slider designs may alternatively incorporate torsion springs of the type shown in FIG. 6D . As seen in FIG. 6D , a slider 228 d may include a body portion 228 d 1 and at least one arm 228 d 2 extending from body portion 228 d 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 228 d includes a nub 228 d 3 extending or projecting from a bottom surface thereof, such as, for example, from a bottom surface of body portion 228 d 1 . Slider 228 d further includes a torsion spring lever assembly supported on body portion 228 d 1 having a biasing member 228 d 5 and a connector rod 228 d 8 pivotally connecting lever 228 d 6 to body portion 228 d 1 on a side adjacent nub 228 d 3 . Lever 228 d 6 includes a tip 228 d 7 configured such that biasing member 228 d 5 is located distal or proximal of nub 228 d 3 . In use, as slider 228 d is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , nub 228 d 3 moves along VDN 127 thereby affecting VDN 127 while tip 228 d 7 of lever 228 d 6 of the spring lever assembly inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . Biasing member 228 d 5 functions to maintain nub 228 d 3 in contact with VDN 127 and tip 228 d 7 of lever 228 d 6 of the torsion spring lever assembly in contact with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 . One advantage to using a torsion spring lever assembly configuration as set forth in FIG. 6D is that such a configuration provides greater spring deflections with smaller spring constants, thus making the delivered force less sensitive to dimensional variations in slider 228 d. Turning now to FIGS. 7A-7C , a series of sliders or intensity controllers 328 according to an embodiment of the present disclosure is shown. Sliders 328 are configured to increase a contact force excited on VDN 127 while maintaining a degree of facility for an end user to move slider 328 relative to housing 102 of electrosurgical pencil 100 . As seen in FIGS. 7A-7C , a slider 328 a may include a body portion 328 a 1 and at least one arm 328 a 2 extending from body portion 328 a 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 328 a includes a lever 328 a 3 pivotally connected to body portion 328 a 1 . Lever 328 a 3 includes a first end 328 a 4 configured to extend above body portion 328 a 1 and a second end 328 a 5 configured to extend below body portion 328 a 1 . First end 328 a 4 of lever 328 a 3 is configured to selectively engage detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 and second end 328 a 5 of lever 328 a 3 is configured to selectively engage VDN 127 . As seen in FIG. 7A , slider 328 a may include a biasing member in the form of a coil or constant force spring 329 a , or as seen in FIG. 7B slider 328 a may include a biasing member in the form of a tensile spring 329 b , or as seen in FIG. 7C slider 328 a may include a biasing member in the form of a compression spring 329 c . Biasing members 329 a - 329 c are each configured or arranged so as to maintain first end 328 a 4 of lever 328 a 3 in contact with or in engagement with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 and to maintain second end 328 a 5 of lever 328 a 3 in engagement with VDN 127 . Biasing members 329 a - 329 c may be secured to and extend between a suitable location on lever 328 a 3 and a suitable location on body portion 328 a 1 . In use, as slider 328 a is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , first end 328 a 4 of lever 328 a 3 inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 while second end 328 a 5 of lever 328 a 3 moves along VDN 127 thereby affecting VDN 127 . In particular, as first end 328 a 4 of lever 328 a 3 moves from one detent or tactile features 131 to an adjacent detent or tactile features 131 , first end 328 a 4 of lever 328 a 3 is moved towards body portion 328 a 1 and second end 328 a 5 of lever 328 a 3 moves off of or reduces a pressure on VDN 127 and also is moved towards body portion 328 a 1 . As first end 328 a 4 of lever 328 a 3 is moved into the adjacent detent or tactile features 131 second end 328 a 5 of lever 328 a 3 substantially strikes down onto, imparts or otherwise increases a pressure on VDN 127 . Turning now to FIGS. 8A and 8B , a series of sliders or intensity controllers 428 and a tactile mask 429 according to an embodiment of the present disclosure are shown. Sliders 428 are configured to increase a contact force exerted on VDN 127 while maintaining a degree of facility for an end user to move slider 428 relative to housing 102 of electrosurgical pencil 100 . Tactile mask 429 is configured to cause slider 428 to impact or strike against VDN 127 . As seen in FIG. 8A , a slider 428 a may include a body portion 428 a 1 and at least one arm 428 a 2 extending from body portion 428 a 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 428 a includes a spring plunger assembly having a stem 428 a 4 extending from body portion 428 a 1 and defining a recess configured to retain a biasing member 428 a 5 and a tactile feedback transmitting feature in the form of an actuator 428 a 6 therein. The spring plunger assembly is configured such that actuator 428 a 6 extends from a bottom surface of body portion 428 a 1 , in the direction of VDN 127 . Tactile mask 429 includes an elongate body portion 429 a configured to overlie VDN 127 . Body portion 429 a defines a plurality of apertures or windows 429 b formed therein along a length thereof. Tactile mask 429 is positioned over VDN 127 at a location such that apertures 429 b may align or register with variable resistance elements 144 d provided on lower layer 140 b of VDN 127 (see FIG. 5 ). In use, as slider 428 a is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , actuator 428 a 6 of spring plunger assembly moves over and between apertures 429 b formed in tactile mask 429 . In so doing, actuator 428 a 6 of spring plunger assembly impacts or strikes against VDN 127 . Additionally, the inter-engagement of actuator 428 a 6 of spring plunger assembly with apertures 429 b formed in tactile mask 429 provides a degree of tactile feedback to the user of electrosurgical pencil 100 . As seen in FIG. 8B , a slider 428 b may include a body portion 428 b 1 and at least one arm 428 b 2 extending from body portion 428 b 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 428 b includes a tactile feedback transmitting feature in the form of a nub 428 b 3 extending or projecting from a bottom surface thereof, such as, for example, from a bottom surface of body portion 428 b 1 . Slider 428 b further includes a spring lever assembly having a stem 428 b 4 extending from body portion 428 b 1 , on a side opposite nub 428 b 3 , and defining a recess configured to retain a biasing member 428 b 5 therein. The spring lever assembly further includes a lever 428 b 6 pivotally connected to body portion 428 b 1 and having a tip 428 b 7 configured to extend over or overlie biasing member 428 b 5 . The spring lever assembly is configured such that stem 428 b 4 is located distal or proximal of nub 428 b 3 and such that lever 428 b 6 extends away from nub 428 b 3 . In use, as slider 428 b is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , nub 428 b 3 of slider 428 b moves over and between apertures 429 b formed in tactile mask 429 . In so doing, nub 428 b 3 of slider 428 b contacts VDN 127 . Additionally, the inter-engagement of nub 428 b 3 of slider 428 b with apertures 429 b formed in tactile mask 429 provides a degree of tactile feedback to the user of electrosurgical pencil 100 . Moreover, tip 428 b 7 of lever 428 b 6 rides against an inner surface of housing 102 of pencil 100 and biasing member 428 b 5 act on tip 428 b 7 of lever 428 b 6 to exert a force on body portion 428 b 1 and thereby press nub 428 b 3 of slider 428 b against tactile mask 429 . Tactile mask 429 may be constructed from a rigid, semi-rigid or non-rigid material, from a resilient or non-resilient material, from a conductive or non-conductive material, from any combination thereof, or from any material suitable for the intended purpose of defining apertures and transmitting forces through said apertures. Turning now to FIGS. 9A and 9B , a series of sliders or intensity controllers 528 according to an embodiment of the present disclosure is shown. Sliders 528 are configured to increase a contact force exerted on VDN 127 while maintaining a degree of facility for an end user to move slider 528 relative to housing 102 of electrosurgical pencil 100 . As seen in FIG. 9A , a slider 528 a may include a body portion 528 a 1 and at least one arm 528 a 2 extending from body portion 528 a 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 528 a includes a biasing member, in the form of a torsion spring 528 a 3 pivotally supported on body portion 528 a 1 at pivot point “P”. Torsion spring 528 a 3 includes a first leg 528 a 4 extending from pivot point “P” and configured to engage a surface of housing 102 of electrosurgical pencil 100 , and a second leg 528 a 5 extending from pivot point “P” and configured to engage VDN 127 . As seen in FIG. 9A , first leg 528 a 4 of torsion spring 528 a 3 extends above body portion 528 a 1 and second leg 528 a 5 of torsion spring 528 a 3 extends below body portion 528 a 1 . In use, as slider 528 a is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , second leg 528 a 5 of torsion spring 528 a 3 moves along VDN 127 thereby affecting VDN 127 while first leg 528 a 4 of torsion spring 528 a 3 inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . As first leg 528 a 4 of torsion spring 528 a 3 is flexed downwardly, in the direction of body portion 528 a 1 , as slider 528 a is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , second leg 528 a 5 of torsion spring 528 a 3 is pressed more or less into the surface of VDN 127 . As seen in FIG. 9B , a slider 528 b may include a body portion 528 b 1 and at least one arm 528 b 2 extending from body portion 528 b 1 and configured for slidable engagement in guide channels 130 a , 130 b (see FIG. 1 ) of electrosurgical pencil 100 . Slider 528 b includes a link assembly 528 b 3 pivotally supported on body portion 528 b 1 at pivot point “P”. Link assembly 528 b 3 includes a first leg 528 b 4 extending from pivot point “P” and configured to engage a surface of housing 102 of electrosurgical pencil 100 , a second leg 528 b 5 extending from pivot point “P” and configured to engage VDN 127 , and a biasing member 528 b 6 interposed between first leg 528 b 4 a second leg 528 b 5 . As seen in FIG. 9B , first leg 528 b 4 of link assembly 528 b 3 is in registration with or extends above second leg 528 b 5 of link assembly 528 b 3 . In use, as slider 528 b is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , second leg 528 b 5 of link assembly 528 b 3 moves along VDN 127 thereby affecting VDN 127 while first leg 528 b 4 of link assembly 528 b 3 inter-engages with detents or tactile features 131 formed in housing 102 of electrosurgical pencil 100 to thereby provide a degree of tactile feedback to the user of electrosurgical pencil 100 . As first leg 528 b 4 of link assembly 528 b 3 is moved downwardly, in the direction of body portion 528 b 1 , as slider 528 b is moved distally and proximally relative to housing 102 of electrosurgical pencil 100 , biasing member 528 b 6 transmits forces to second leg 528 b 5 of link assembly 528 b 3 to press more or less into the surface of VDN 127 . Although the subject apparatus has been described with respect to preferred embodiments, it will be readily apparent, to those having ordinary skill in the art to which it appertains, that changes and modifications may be made thereto without departing from the spirit or scope of the subject apparatus.

1a

BACKGROUND OF THE INVENTION 1. FIELD OF THE INVENTION This invention relates to a bracket that hooks into store uprights and more particularly a universal upright interface bracket used to support a variety of different shelving. signs, peg hooks, and other various point-of-sale elements in display case uprights. 2. DESCRIPTION OF THE RELATED ART Upright interface brackets are used in standard store gondola, dairy case, and frozen food display case uprights. Uprights from different manufacturers have different slot configurations into which shelving is affixed by means of different sized brackets. This is due to proprietary and evolutionary design processes, as well as varying design trends, which have been introduced to meet customer requirements for hook prices and functions. A continuing and strong need exists to vastly improve the functionality of standard store shelving. This is being driven by the desire to increase shelf space utilization, to alter existing spaces to handle new and different packaging, and to embellish sections of shelf space, setting them apart from other areas of the store, all while maintaining efficiency and cost effectiveness. Because of this need, upgrade and retrofit point-of-sale programs are growing in importance and, as a result, many different types of display cases, each with its own slot configuration, must be used together. This causes an obvious problem, namely the need to keep many different shelf brackets in stock. This is both financially and temporally inefficient. SUMMARY OF THE INVENTION This problem is solved by the use of a universal upright interface bracket which can be fitted to the wide variety of differing slot configurations present in a given store. The invention is composed of three interlocking components--a fixed bracket member, a sliding bracket member, and a sliding shim--held together by a locking assembly. The fixed and sliding bracket members each have a vertical tab which are vertically aligned when the brackets are fitted together. The tabs interface with slots in a slotted vertical wall. The sliding bracket member can be adjusted vertically with respect to the fixed bracket member along a guide. This allows the bracket to accommodate shelving standards with a variety of slot spacings. The sliding shim fits between the fixed and sliding bracket members and can be adjusted horizontally along guides in the fixed bracket member. This allows the sliding bracket to be snugly fitted into a wide variety of slot depths. The locking assembly, composed of a screw and rectangular nut, has a dual purpose. The nut is fitted into the fixed and sliding bracket members to prevent the sliding bracket member from sliding so far as to disengage from the fixed bracket member. The screw is passed through the nut and used to fix the position of the sliding shim against the outer wall of the slot. The tabs and guides of the fixed and sliding bracket members are offset from their respective bodies so that the vertically aligned tabs are flush with one wall of the assembled bracket while still allowing the bracket to fit squarely in the slots. Because of this asymmetry, left and right oriented brackets can be made so that they fit in one common pair of vertically aligned slots. Because the components of the bracket interlock easily, they can be integrated before assembly into other elements of a point-of-sale unit such as a shelf or peg bar prior to painting, plating, etcetera. For example, one of the bracket members could be welded to a shelf bottom and painted. Then, after finishing, the bracket can be assembled. OBJECTS AND ADVANTAGES A primary object of the invention is to meet the need for a single upright display bracket which can be used with the wide variety of slot configurations present in current store display uprights. Another object of the present invention is to provide an improved bracket which will eliminate the need to stock many different bracket types, thereby lowering storage costs. A further object of the present invention is to provide an improved bracket which is simple to fabricate and easy to assemble allowing integration with other display components before assembly. Yet another object of the present invention is to provide an improved bracket in which the tabs are offset from the body of the bracket so as to be flush with one of its sides, allowing left and right brackets to be used side by side in a single pair of vertically aligned slots. Other objects, features, and advantages will become apparent to those skilled in the art upon careful consideration of the following detailed description of a preferred embodiment of the invention. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a right side perspective view of a fixed bracket member; FIG. 2 is a right side perspective view of a sliding bracket member; FIG. 3 is a right side perspective exploded view of the locking assembly; FIG. 4 is a right side perspective view of the sliding shim; FIG. 5 is a right side exploded perspective view of the bracket prior to assembly; FIG. 6 is a view similar to FIG. 5 showing the locking assembly about to be placed in position in a nearly assembled bracket and illustrating the bracket's two dimensional movement; FIG. 6a is a front view of a fully assembled bracket; and FIG. 6b is a right side elevational view of the assembled bracket with parts shown in phantom and engaging a pair of vertical slots in an upright wall shown in perspective and in cross-section. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning to the drawings and in particular FIGS. 1 through 4, the universal upright interface bracket consists of 4 basic components: a fixed bracket member 10, a sliding bracket member 12, a locking assembly 14 and a sliding shim 16. A right handed upright bracket will be described. The fixed bracket member 10 (FIG. 1) has three distinct regions: an upper vertical portion 18, a middle horizontal portion 20, and a lower vertical portion 22. The three regions may be formed from a single piece where the upper and lower vertical portions lie in parallel planes and are connected by and are substantially perpendicular to the middle horizontal portion. The upper vertical portion is composed of a rectangular body 23 with a top surface 24, and having a tab 26 extending rearwardly and downwardly. A downwardly opening channel 34 is defined by the fixed bracket vertical back surface 28, the fixed bracket tab inner horizontal surface 30, and the fixed bracket tab inner vertical surface 32. The middle horizontal portion 20 shares back surface 28 with the upper and lower vertical portions and has a centrally located finger slot 36 running from front to back. The lower vertical portion 22 consists of a rectangular body 37 with the back surface 28. It has a finger portion 38 at its bottom bent outward to the right and then downwards forming an angle-iron type construct. At the top and bottom of the rectangular body 37 are upper and lower horizontal guides 40, 42 running from front to back. There is also a forwardly, centrally located vertical slot 44. The sliding bracket member 12 (FIG. 2) is composed of a vertical rectangular body 46 having a vertical back surface 48. It is bent at the bottom to form a horizontal foot portion 50 extending perpendicularly to the left. Extending rearwardly and downwardly from the back of the middle of the rectangular body is a tab portion 52 having an inner horizontal surface 54 and an inner vertical surface 56. A downwardly opening channel 58 is defined by the vertical back surface 48, the tab inner horizontal surface 54, and the tab inner vertical surface 56. At the top of the rectangular body is a finger portion 60 bent outward to the left and then upwards forming an angle-iron type construct. In the middle of the rectangular body is a forwardly, centrally located vertical guide 62 with upper and lower inner surfaces 64, 66. In the foot portion is a centrally located finger slot 68 running from front to back. The locking assembly 14 (FIG. 3) is composed of a screw 70 and a rectangular nut 72 with an upper surface 74 and a lower surface 76. The height and width of the fixed bracket vertical slot 44 (FIGS. 1, 5) should be just larger than the height and depth of the nut so when the nut is inserted in the slot it fits snugly. The width of the sliding bracket vertical guide 62 (FIGS. 2, 5) should be just wider than the depth of the nut. The height of the slot should be significantly more than that of the nut so when the nut is inserted into the guide, it can be freely moved vertically along the length of the guide with minimal front to back movement. The sliding shim 16 (FIG. 4) is a vertical body 78 having the appearance of a right-angled `C` with the open end of the `C`, the shim channel 80, facing forwards. The channel has an inner vertical surface 82 and a height larger than that of the nut 72. The shim also has an outer vertical back wall 84. Extending outward to the left from the top and bottom of the sliding shim, perpendicular to the shim body, are forwardly located upper and lower shim finger portions 86, 88. The bracket is assembled so that the sliding shim 16 is sandwiched between the fixed and sliding bracket members 10, 12 (FIGS. 5, 6). The upper and lower shim finger portions 86, 88 are inserted in the upper and lower fixed bracket horizontal guides 40, 42 so the shim body 78 is adjacent and parallel to the fixed bracket member lower vertical portion 22 . The fixed bracket upper and lower horizontal guides 40,42 have heights just larger than that of the upper and lower shim finger portions 86, 88 while the length of the guides is significantly longer than the front-to-back length of the finger portions. The guides are positioned so that each shim finger portion can be inserted in its corresponding horizontal guide, and the shim can move front to back when seated in the guides with minimal vertical movement. The vertical position and depth of the shim channel 80 is chosen so that when the shim is seated in the fixed bracket horizontal guides 40, 42, the channel is aligned with the fixed bracket vertical slot 44 and the slot is not covered by the shim body 78 at any point along the shim's full range of motion within the horizontal guides. The sliding and fixed bracket members 10,12 are fitted together by inserting the fixed bracket finger portion 38 into the sliding bracket finger guide 68 while simultaneously inserting the sliding bracket finger portion 60 into the fixed bracket finger slot 36. The bracket finger portions have sufficient vertical length to allow substantial vertical motion of the sliding bracket member 10 with respect to the fixed bracket member 12 without the bracket members disengaging. The bracket finger slots 36, 68 and bracket finger members 38, 60 are positioned on the bracket members so that when the bracket members are engaged, the fixed bracket vertical slot 44 and sliding bracket vertical guide 62 are aligned. The positions of the bracket finger slots 36, 68 and horizontal extensions of the bracket finger portions 38, 60 are chosen so that when the fixed and sliding bracket members are engaged, the fixed bracket upper vertical portion 18 and the sliding bracket body 46 and thus the fixed bracket tab 26 and sliding bracket tab 52 lie in the same plane (FIGS. 6, 6a). The rearward extension of the fixed bracket tab 26 and then sliding bracket tab 52 is chosen so that when the fixed and sliding bracket members are engaged, the fixed bracket tab inner vertical surface 32 and the sliding bracket tab inner vertical surface 56 lie along the same vertical axis. The rectangular nut 72 (FIGS. 5, 6a) is fitted snugly in the fixed bracket vertical slot 44 passing through the shim channel 80 and into the sliding bracket vertical guide 62. The nut is positioned so that a screw passing rearwardly through the nut will lie in the plane of the shim body 78 (FIG. 6a). The insertion of the screw 70 into the nut keeps the nut positioned between the two bracket members while the walls of the shim channel prevent the nut from rotating. The vertical length of the sliding bracket vertical guide 62 (FIG. 6b) is just short enough so that when the sliding bracket member 12 is moved downwards in relation to the fixed bracket member 10, the sliding bracket vertical guide upper inner surface 64 hits the nut's upper surface 74 just before the bracket members would disengage. The position of the screw 70 in the nut is used to limit how far forward within the horizontal guides 40, 42 the sliding shim 16 can travel. The sliding shim can move forward until the shim channel inner vertical surface 82 hits the tip of the screw. A downward opening adjustable channel 90 (FIG. 6b) is then defined by the outer vertical shim wall 84, the sliding bracket tab inner horizontal surface 54 and the sliding bracket tab inner vertical surface 56. The assembled bracket (FIG. 6b) is secured to a vertical slotted wall 92 having a front surface 94, a back surface 96 and a thickness 98. The bracket is secured within a pair of vertically aligned slots in the wall--an upper slot 100 having inner bottom surface 102 and a lower slot 104 having inner bottom surface 106, both slots having a depth equal to the wall thickness. The fixed bracket tab 26 is seated in the upper slot 100 so that the tab's inner horizontal surface 30 rest on the slot's bottom surface 102 and the tab's inner vertical surface 32 abuts the back of the vertical slotted wall 96. The upper tab is held in place via a cantilever force. The width of the fixed bracket channel 34 is substantially greater than the thickness of the vertical wall 98 allowing the tab to be easily seated and removed. The sliding bracket member 12 is adjusted vertically with respect to the fixed bracket member 10 so that sliding bracket tab 52 engages the lower slot 104 and the sliding bracket tab's inner horizontal surface 54 rests on the slot's bottom surface 106. The width of the sliding bracket channel 58 is substantially greater than the thickness of the vertical wall 98. The depth of the adjustable channel 90 is reduced moving the sliding shim 16 back so the outer vertical shim wall 84 abuts the front surface of the vertical slotted wall 94 and the sliding bracket tab's inner vertical surface 56 abuts the back surface of the vertical slotted wall 96 forming a snug fit. The screw 70 is adjusted until the its end hits the shim channel inner vertical surface 82, holding the shim in position and locking the assembled universal upright bracket in place. A left handed upright bracket can be constructed in a similar manner. The bracket member tabs would then lie along the plane of an outer wall formed by the left handed fixed bracket member's upper vertical portion 18' and the left handed sliding bracket member's body 46'. Left and right handed universal upright brackets can be placed side by side so that the fixed bracket member's upper vertical portions and the sliding bracket member's bodies are flush with each other and the left and right bracket's tabs are flush and aligned with each other. In this configuration, a left and right upright bracket can engaged a single pair of vertically aligned slots in a vertical slot wall. It should be understood, of course, that the specific form of the invention herein illustrated and described is intended to be representative only, as certain changes may be made therein without departing from the clear teachings of the disclosure. Accordingly, reference should be made to the following appended claims in determining the full scope of the invention.

1a

GOVERNMENT INTEREST [0001] The invention described herein may be manufactured, used and licensed by or for the U.S. Government. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The methods of the present invention provide a unique and superior formulation of artesunic acid for parenteral injection and for the manufacture of the formulation under sterile conditions. The methods described herein provide a demonstrably sterile, non-pyrogenic product which dissolves rapidly with no frothing or caking, yielding a clear, conveniently prepared solution the attending physician may administer with confidence. The formulation that is prepared by the methods of the invention is especially suitable for the treatment of severe and complicated malaria. [0004] 2. Brief Description of Related Art [0005] Although malaria affects about 250 million people and kills one to two million children each year, the pharmaceutical industry has shown little interest in developing new or manufacturing established antimalarial drugs not only because risks are significant, but the returns on investment are so low. [0006] Currently, the most promising and most rapidly acting antimalarial drugs are derivatives of artemisinin (qinghaosu) obtained from qinghao or sweet wormwood ( Artemesia annua ); these drugs have been developed and manufactured in China. Three compounds of the qinghao family have been used: the parent artemisinin and two of its more-active derivatives: a water-soluble hemisuccinate, artesunate (AS), FIG. 2 , and an oil-soluble ether, artemether (AM). Both derivatives are metabolized to a common biologically active metabolite, dihydroartemisinin (DHA). Although this facile conversion (hydrolysis) to DHA contributes to the AS rapid antimalarial activity, it also limits the choices of practical AS dosage formulations. [0007] Artesunic acid is also known to be effective in the treatment of severe (neuropathic) malaria, Artesunate versus quinine for treatment of severe falciparum malaria, a randomized trial , Dondorp, et al; Lancet, vol. 366, pages 717-725, Aug. 27, 2005, incorporated herein in its entirely by reference. However, Artesunic Acid is an intrinsically unstable compound, susceptible to decomposition by heat, radiation, and virtually any aqueous solution. Prior studies have confirmed the breakdown of artesunate in aqueous solutions. [0008] AS has been used for injection with good results. However, there are drawbacks of the current commercially available AS dosage form. It is a two-component product consisting of a dry-fill powder of sterile artesunic acid in a vial and a sterile 5% sodium bicarbonate solution in an ampoule. This product, “Artesunate For Injection”, is manufactured by Guilin Pharmaceutical Factory, Guangxi, China. This presently used formulation, when dissolved in the supplied bicarbonate buffer solution, results in fizzing and incomplete solution so that the concentration (dose) to be delivered may be uncertain. [0009] The formulation of artesunic acid mentioned above is manufactured in China, and prepared by an undivulged method which results in a product of poor dissolution characteristics, and which froths and cakes upon introduction of the dissolution medium (5% bicarbonate). As the AS dissolves, carbon dioxide is evolved and trapped in the small volume of the closed vial. The formed gas bubbles carry un-dissolved AS particles throughout the vial, thereby reducing contact between these particles and the dissolution medium and lengthening the time needed to completely dissolve the AS. Moreover, this phenomenon reduces the investigator's ability to see if the solution is complete so the next preparation step, which is to dilute the AS/bicarbonate solution with 5 mL of sterile 5% glucose solution, can begin. These delays can unduly lengthen the overall solution preparation time, resulting in a shorter time period over which the prepared solution can be administered. [0010] Further and most importantly, the product coming from China is not manufactured under the U.S. Food and Drug Administration's current Good Manufacturing Practice (cGMP). [0011] Therefore, it is an object of the present invention to provide an AS product and a method for preparing an AS product that dissolves quickly, thoroughly and does not cake or fizz upon dissolution. [0012] It is another object of the present invention to prepare an AS product that does not require an additional step of diluting with glucose and is immediately usable upon dissolution. [0013] Another object of the present invention is to develop a method for the production of an artesunic acid solution for the intravenous or intramuscular treatment of malaria that is sterile and manufactured under current Good Manufacturing Practice (cGMP) as required by the U.S. Food and Drug Administration. [0014] Another object of the present invention is to sterilize artesunic acid powder without decomposition. [0015] Another object of the invention is to prepare an artesunic acid product that has a shelf life of two years. [0016] These and other objects will become apparent upon further reading of this application. SUMMARY OF THE INVENTION [0017] The invention is a method for the manufacture of an intravenous or intramuscular formulation of artesunic acid. First the artesunic acid powder is sterilized with ethylene oxide and placed into a sterile container. Nitrogen is used to purge water vapor from the container, after which the container is hermetically sealed. When used, the sterilized powder is dissolved in sterile sodium phosphate buffered solution to produce a solution suitable for intravenous or intramuscular administration. The sodium phosphate buffered solution dissolves the artesunic acid powder without caking or frothing, resulting in an improved drug product. The invention also relates to the formulation and a method of treating a patient with severe and complicated malaria. BRIEF DESCRIPTION OF THE FIGURES [0018] FIG. 1 is drug manufacturing flow diagram; [0019] FIG. 2 is the chemical structure of α-Artesunic Acid. DETAILED DESCRIPTION [0020] The AS parenteral dosage form must be sterile and not produce CO 2 when the AS dissolves. To avoid CO 2 evolution, we used a non-carbonate-containing, physiologically compatible basic medium. We also manufactured our drug product under cGMP. Dissolution Medium [0021] The dissolution medium is sodium phosphate buffered solution. [0022] In addition to avoiding the production of gas, the dissolution medium must rapidly dissolve the AS, produce a solution in which the dissolved AS is sufficiently stable, and yields a solution of physiologically acceptable pH and osmolality. After many trials and errors, we found that a 0.30±0.05 M, pH 8.0±0.3 sodium phosphate solution meets all of the above requirements and is preferred. Slight variations from these values are acceptable. [0023] The solute in the dissolution medium has been identified as sodium phosphate by spectral and chromatographic evidence. The average phosphate concentration is 0.30 plus or minus 0.05 M. The average solution volume is 11.0 plus or minus 0.5 mL. The average solution pH is 8.0 plus or minus 0.3. [0024] Preparation of the 0.30M, pH 8.0 sodium phosphate solution, following a USP procedure, was straightforward and under cGMP. Sterile phosphate solution, 0.30 M, pH 8.0, is manufactured by mixing appropriate weights of monobasic and dibasic sodium phosphate in distilled water to a molarity of 0.30 M and pH of 8.0. The phosphate solution is then sterilized by filtration through a 0.22μ filter into 20 mL vials (12.2 mL/vial). The vials are sealed and then stored at room temperature. [0025] Sterility of the product, achieved through sterile filtration of the phosphate solution and autoclave of the filled, sealed vials, was accomplished smoothly by Afton Scientific Corporation, Charlottesville, Va. 22902. After having met USP requirements for identity of the product, product sterility, endotoxin, solution concentration, volume, pH, osmolality, and particulates, 10,900 vials of this medium were labeled Afton Batch 57804, assigned WR135946; BR18064, and designated as Component Two of our AS dosage form. The USP procedure is found in 2005 USP 28/NF 23, p2855; Composition of Standard Buffer Solutions, incorporated herein by reference. Active Component [0026] The active component is Artesunic Acid (AS), 110 mg/vial, SRI Batch No. 14462-16, from SRI International, Menlo Park, Calif. [0027] The Chemical Abstracts (CA) Index name for artesunic acid is: butanedioic Acid, [3R-(3α,5a,6,8a,9α,10α,12,12aR*)]-mono(decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin-10-yl) ester. The CA Registry Number is 88495-63-0, and the molecular formula is C 19 H 28 O 8 . The formula weight of α-artesunic acid is 384.43 g/mol. This name also defines the stereochemistry at C-10 which, according to the CIP convention, is based on the priority of groups attached to C-10. The 10α- designation refers to the O-succinal group oriented back or toward the peroxide bridge. The 10- designation refers to the O-succinal group oriented away from the peroxide bridge. The molecular formula, C 19 H 28 O 8 , corresponds to a molecular composition of C, 59.36%; H, 7.34%; and 0, 33.29%; and a molecular weight of 384.43. α-Artesunic Acid is shown in FIG. 2 . [0028] The formulation development of the active component AS requires sterilization of the bulk drug. For a sterilization process to be acceptable, not only sterility of the bulk chemical must be shown, but the process must not alter the physical or chemical nature or the stability of the material. The high purity AS bulk drug, a finely milled, white crystalline powder manufactured by Knoll AG, Listal, Switzerland was used. [0029] An acceptable EtO treatment cycle was developed and employed as follows: Sterilization of Bulk Artesunic Acid [0030] The bulk AS was sterilized before dry fill. Gas sterilization was used. Below are the salient points of the method and the determinations for sterility and pyrogenicity. Artesunic Acid is treated for one hour at 102 degrees Fahrenheit and 100% humidity. The chamber is evacuated and ethylene oxide is introduced and maintained at constant pressure and 102 degrees Fahrenheit for four hours. The sterilant cycle is stopped; the chamber is evacuated and washed twice with nitrogen and once with air, all at 102 degrees Fahrenheit. Slight variations of this sterilization method are possible. A sample of treated AS is chromatographed. Chromatograms for both treated and untreated AS are identical. AS is stable under the conditions of treatment. Samples are tested for residual ethylene oxide, ethylene chlorohydrin and ethylene glycol. Neither ethylene chlorohydrin nor ethylene glycol was detected. Ethylene oxide was detected but at levels well below the FDA proposed limit. A microbial limits test was performed and validated to determine the inhibitory properties of AS. The test was negative. AS has no inhibitory properties in this test. (USP 27<61> & <71>). Sterility tests were performed to discover the possible presence of bacteria, fungi, and spores. Samples were doped before treatment with a spore strip, bacteria, and fungi. No colony forming units were found in any test. The treated material is sterile. (USP 27<71>). The Limulus Amebocyte Lysate test was performed to determine the endotoxin levels in the treated AS. Endotoxin levels were below the detectable level in the treated AS. (USP 27<85>) [0037] Ethylene oxide is an effective sterilant for bulk artesunic acid. Results from alidated sterility tests on sterilized artesunic acid meet USP requirements for sterility testing. Sterilized artesunic acid also meets USP requirements for endotoxins. [0038] The EtO-treated AS was dry filled into sterile vials. The best mode for this purpose was to use a portable, manually operated powder dispensing machine was purchased from M&O Perry Industries, Corona, Calif. 92880. Owing to the propensity of the AS bulk drug to clump and cling to the metal surface of the machine, characteristics that prevent both complete filling and complete discharge of the machine loads, the machine was fitted with a plastic liner that reduced the clinging and enabled quantitative discharges. The installation qualification (IQ)/operation qualification (OQ)/and performance qualification (PQ) were performed to qualify the filling machine for cGMP manufacturing. The Model LM-14 is a compact, portable bench top unit complete with carrying handle. It is an ideal machine for small fill weight, low volume applications. Other filling machines exist which are suitable for large operations. [0039] Pre-cleaned and sterilized 20-mL vials, sterilized gray butyl rubber stoppers and flip-off aluminum seals were purchased. In a class 100 room, under laminar flow, the vials were filled in a glove box with EtO-treated AS. Scheduled weight checks were performed to ensure the filled weights met specifications. The filled vials were stoppered, sealed, and tested for release. After meeting requirements for sterility, identity, purity, content uniformity, and after constitution in sodium phosphate buffer, for solution pH, osmolality, and particulate counts, 5,500 of the filled vials were labeled SRI Batch 14462-16, assigned WR256283:BR29487, and designated as Component One of our AS dosage form. [0000] Analytical Methods of Specifications for Sterile Intravenous Artesunate (110 mg/Vial) [0000] Tests Analytical Methods Specifications Appearance Visual Fine crystalline powder Color Visual White to almost white Identity IR Conforms to Reference Must comply Spectrum HPLC HPLC SRI TM 1900.200 Must comply Assay (HPLC) HPLC 98.0 to 102.0% calculated on water-free basis pH SOP SRI 004.009 7.2-7.7 Particulate USP 788>, small volume No More Than (NMT) 6000 Matter in injections particles of size 10 μm/vial. Injections NMT 600 particles of size 25 μ/vial. Uniformity USP 905>, Solids in None outside 88-132 mg/vial, of Dosage Single Unit Containers RSD of 10 vials ≦6.0% in Units Level 1; if fail, go to Level 2. Sterility USP 71> Sterile Bacterial USP 27 through Sup 85> 35 EU/mL Endotoxins, LAL, Kinetic Placebo [0040] The selection of a material for the AS placebo was based on a likeness in appearance and physical characteristics to that of the AS dosage form, in addition to being biologically inert. The placebo for the AS Dosage Form was Mannitol, 200 mg/vial. [0041] A large number of possible placebos were investigated. The two final candidates were mannitol and glucose, with the former having a slight edge. Because the particle size of the commercially available USP mannitol was larger than that of the AS bulk drug, the mannitol was milled and sieved to match the size and appearance of the AS powder prior to sterilization. Sterilization by irradiation initially looked promising, but after two weeks on the shelf the irradiated mannitol became discolored. Ultimately, treatment with EtO proved successful, and the sterilized mannitol was dry-filled into the same type of glass vials as the active material and processed identically. Because the density of our mannitol was nearly twice that of the AS bulk drug, the filled placebo mass was nearly twice that of the active, to maintain comparable filled volumes. After having met requirements on content uniformity, identity, and purity, and after constitution with phosphate, for solution pH, osmolality, and particulate counts, 2,500 vials of the placebo were labeled SRI Batch 14462-28 and designated WR016506:BR29487. To maintain anonymity, a common label, identifying both the AS and Placebo, was used for vials of the active as well as vials of its placebo. [0042] In Phase I clinical trials the placebo was ethylene oxide treated mannitol, exhibiting the same appearance and dissolution characteristics as the Active Pharmaceutical Ingredient (API). The placebo was manufactured by SRI International. All clinical materials are stored, maintained, and shipped by the repository contractor (monitored and managed by The Department of Chemical Information). The repository contractor also prepares the double-blinded samples of artesunic acid or placebo for clinical use under guidance from the Department of Chemical Information. The placebo has provided an acceptable control for the recently completed phase I clinical trials. [0000] Analytical Methods and Specifications for Sterile Placebo for Injection (200 mg/Vial) [0000] Tests Analytical Methods Specifications Appearance Visual Fine crystalline powder Color Visual White to almost white Absence of Artesunic Acid I.R. None detected Mannitol Content USP (Identity) Passes Ethylene Oxide Residual USP 71> 200 ppm Ethylene Chlorohydrin Residual NV SOP 12C-25 (ECH) 120 ppm Sterility USP 71> Microbial growth is not observed Uniformity of Dosage Units USP <905>, solids in None outside 88-132 mg/vial, Single Unit Containers RSD of 10 vials ≦6.0% in Level 1; if fail, go to Level Particulate Matter in Injections USP <788> No More Than (NMT) 6000 particles of size 10 μm/vial. NMT 600 particles of size 25 μ/vial. Dosage [0043] A typical dosage of α-artesunic acid for parenteral administration is 10 mg/mL for a 10 mL injection. 110 mg is the unit dose for manufacture. Typically, using a sterile syringe, 11 mL of sterile Phosphate buffer for injection will be added to the 110 mg artesunate vial and the vial swirled for about 4-6 minutes for full dissolution. Dosing is 1-4 mg/Kg body weight for intravenous administration with the possibility of up to 8 mg/Kg in some cases. Preferred dosing is 2-3 mg/Kg body weight for intravenous administration for three days. A drip bag is also suitable for administration of the dose. A dosage of 50 mg/mL is suitable for IM injection. IM treatment will be in the range of 1-5 mg/Kg body weight. Give dosage one to two times per day for 3 days for IM. Because the present inventors use a phosphate buffer solution, they are able to obtain a higher concentration of AS for injection than that which can be obtained with the 5% glucose dilution medium required by the Guilin formulation. Discussion [0044] The cGMP-manufactured α-artesunic acid parenteral dosage form of the invention offers several advantages over current, commercially available version(s) of Artesunate drug. [0000] 1. The cGMP-manufactured sterile dissolution medium, a 0.30 M, pH 8.0 solution of sodium phosphate, completely dissolves the α-artesunic acid in 2-3 min, requiring only gentle swirling. This rate of dissolution is several fold faster than that found for the Guilin product, following its directions for preparation given in its package insert. 2. Because the dissolution of AS in phosphate is not accompanied by gaseous evolution, as in the case where bicarbonate is used, determining solution completeness is readily achieved. 3. The solution prepared in phosphate is ready for administration, as no further preparation is required. The Guilin product, on the other hand, requires an additional step of dilution of the AS/bicarbonate solution with 5 mL of 5% glucose, which also must be sterile. 4. The pH of our 10 mg AS/mL solution in phosphate is 7.2, whereas that for 10 mg AS/mL solution in bicarbonate/glucose is 7.9, a solution pH that is higher than ideal for parenteral administration. 5. The osmolality of our 10 mg AS/mL solution in phosphate is 320 and that for the 10 mg AS/mL solution in bicarbonate/glucose is 410, a value also higher than ideal for parenteral administration. 6. The phosphate buffer solution of the GMP manufactured formulation allows AS concentrations high enough for effective IM treatment. [0045] Although hydrolysis of AS in phosphate or bicarbonate/glucose begins almost immediately upon dissolution, the rates of decomposition in the two media are comparable. After two hrs at ˜24° C. the solutions were still visibly clear and therefore still can be administered. [0046] In keeping with US FDA requirements, vials of the phosphate vehicle, the AS, and the placebo are undergoing accelerated and shelf-life stability studies. Efficacy in Trials: [0047] An Investigational New Drug Application (IND-64769) on this drug product has been filed with the FDA and has been approved for use in clinical trials. Phase Ia Safety and Tolerance single dose clinical trials hare been concluded and were successful. [0048] Phase Ia Safety and Tolerance of GMP Formulation [0049] Phase Ia is a single dose double-blind placebo-controlled, randomized study to evaluate the safety and tolerance of the GMP formulation of intravenous artesunate. The study has been completed successfully as is necessary to proceed to Phase IB and Phase II trials. Phase Ib and Phase II trials are in progress. [0050] Phase Ib Safety, Tolerance and Pharmacokinetics/Pharmacodynamics of GMP Formulation [0051] A Phase Ib is a double-blind, placebo-controlled, randomized multiple dose escalation study to evaluate the safety, tolerance, and pharmacokinetics/pharmacodynamics of GMP formulation of intravenous artesunate in healthy human subjects in 3 doses using a dose escalation format using a placebo control. An objective is to determine the safety of multiple dose administration of escalating doses of artesunate that bracket the anticipated compassionate use dose of 2.4 mg/kg by measuring adverse events (AE) and cardiovascular responses (heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)). Another objective is to determine the safety and tolerability of the compassionate use of 3 doses of artesunate in escalating doses of 0.5, 1.0, 2.0, 4.0, and 8.0 mg/kg with placebo control. The primary and secondary outcomes are to assess AE and hemodynamic and cardiac responses (BP,HR, ECG) and to determine pharmacokinetic parameters of artesunate and its major metabolite DHA as well as to assess preliminary dose-toxic response. [0052] The study design is as follows: Phase I, randomized, double-blind, placebo-controlled trial using multiple ascending doses of intravenous artesunate to determine its safety, tolerability and pharmacokinetics in healthy male and female subjects. Subjects will be screened within 21 days of dosing. At the screening visit, subjects will undergo baseline VS, PE, CBC with smear, differential and indices, reticulocyte count measured by flow cytometry, haptoglobin, COAGs, Chem, UA, urine drug screen, urine HCG and medical and medication history. Eligible subjects will be scheduled for a 6-hour outpatient visit for pre-dose ECGs and VS done to approximately match dosing schedule on Day 1. On Day 0, subjects will be admitted to the CPU to begin the inpatient phase of the study. Subjects will have a brief physical and review all procedures for the inpatient stay. On Day 1, pre-dose, VS and ECG will be performed. Subjects then will receive IV study drug or placebo. Subjects will be closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment of spontaneously reported AEs. Blood will be drawn for blood count and chemistry analysis within 12 hours of the first and last doses. PK will be drawn at designated times after each dose administered. On Days 2 and 3 subjects will receive their second and third doses, respectively, of study drug or placebo followed by close clinical monitoring and laboratory measurements as described for the first doses given. Subjects will be discharged 24 hours after the third dose of drug or placebo and followed as outpatients on Days 7, 10, and 15. The study population will consist of 40 healthy male and non-pregnant female adults given artesunate GMP manufactured for injection intravenously. [0053] The duration of the study will be a screening of up to 21 days; 5 days (four nights) inpatient and 3 outpatient visits (last visit day 15) per patient. [0054] Phase II Trials: [0055] In Phase II trials, the artesunic acid parenteral dosage form of the invention vas given intravenously to human subjects in Africa to treat malaria. In trials in Africa, COL Peter Weina, Chief, Department of Pharmacology, Walter Reed Army Institute of Research has reported 30 adult male and female volunteer patients with uncomplicated malaria have been successfully treated using the treatment regimen as outlined in this application. Successfully treated is defined as safely clearing P. falciparum malaria parasites from the blood. Patients were given a single dose of 1-4 milligrams per kilogram body weight in the form of an injection through an IV catheter (a tube with a needle attached) once a day for 3 days in a row. There were no adverse effects from the GMP IV treatment of the artesunate of the invention. The single adverse effect was with the standard-of-care positive control drug Malarone. Stability Studies [0056] Six thousand dry-filled vials of formulated artesunate for clinical use have been packaged. One thousand of the vials have been reserved for long-term stability testing under various conditions, including elevated temperatures and humidities, to test the integrity and durability of the packaging system. As packaged for clinical use, 20 ml vials have been dry-filled with 110 mg of ethylene oxide sterilized artesunate, stoppered, and sealed. Stability studies at Knoll have shown at least two years stability for bulk artesunic acid stored under nitrogen @ 25° C. [0057] The sterilized bulk drug of the invention has been tested and is still undergoing stability studies. The sterilized bulk drug has shown no evidence of degradation for 20 months at 25° C. The stability studies are still ongoing. [0058] Having generally described this invention, a further under-standing can be obtained by reference to certain specific examples which are provided herein for purposes of illustration only and are not intended to be limiting unless otherwise specified. EXAMPLES Example 1 GMP Formulation and Packaging [0059] Upon receipt of the accessible portions of the European Drug Master File (DMF) for artesunic acid from Knoll, the inventors compared their analytical protocols for artesunic acid to those used in the DMF. The DMF method used by Knoll is as follows: [0060] Validation of an HPLC-Based Assay for AS [0061] HPLC was performed using the following conditions: [0000] LC system Solvent Delivery Waters 600 Pump System Controller Injector Waters 717+ Auto Sampler Detector Waters 996 Photo Diode Array (PDA) Quantitation Empower, Build Number 1154 Software Method Conditions Column YMC ODS-AQ 2 250 mm Length × 4.6-mm ID, 3 μm Mobile Phase 35:65 A:B where A = 0.01M potassium dihydrogen phosphate, pH 3.8, and B = Acetonitrile Flow Rate 1.20 mL/min; pressure~2400 psig Injection Size 30-μL Run Time 20 min Detection UV @ 205 nm The reference solutions (n = 5 each) were prepared by accurately weighing between 3.472 to 15.977 mg of the reference and dissolving each in 1.00 mL of acetonitrile. A series of 30-μL injections were made to deliver 104.2 to 479.3 μg of reference on column for assay. [0062] Calculations (Apply to Both Reference and Sample) [0063] The mass of sample on column (m x , μg) was calculated using equation one (EQ. 1) [0000] m x =W x ×( V 1 /V x )  Eq. 1 [0000] where, W x is the sampled mass (mg) of the reference or sample (S) as weighed, V x is the volume of solvent (1.00 mL acetonitrile) used, and V 1 is volume of solution injected (30 μL). An area to mass on column response factor (RF A ) vas Calculated for the reference standard using equation two (Eq. 2) [0000] RF A =( A R /m R )×(100%/ P R )  Eq. 2 [0064] Where, A R is the reference peak area, and P R is the reference purity (>99%) 3 . Sample peak area data was used in equation three (Eq. 3) to calculate the mass (m s ) of the sample, [0000] m s =A S ×(100%/ RF A )  Eq. 3 [0000] where A s is the sample peak area. [0065] Duplicating all the experimental conditions used by Knoll, the inventors confirmed the results of its previously validated HPLC assay. Upon validation of the imported Knoll assay, it was adopted as one of the assays to be used by the inventors to confirm the identity of artesunic acid samples and to test the purity of such samples. The major advantage of the Knoll method was lowering the LOD from 2 ug to 0.075 ug on column and decreasing the assay time from 16 minutes to 8 minutes. The major disadvantage is its inability to determine AS in phosphate. Precision, linearity, quantation, and accuracy were comparable for both methods. [0066] The inventors verified the identity and determined the purity of three samplings of WR256283; BQ38641, (Knoll Lot 2.03). This was the milled sample of the bulk Knoll drug substance used in formulation of the injectable artesunic acid for clinical trials. The three samples were taken to confirm the identity and uniformity of the received material (Sample A from the top of the container, Sample B from the middle of the same container, and Sample C from the bottom of the container). They were compared to a reference sample received Jun. 29, 2001 (WR256283; BP18288) using a number of analytical tests including, but not limited to, Fourier Transform Infrared Spectroscopy, Proton Nuclear Magnetic Resonance Spectroscopy, Elemental Analysis, High Performance Liquid Chromatography, Thermogravimetric Analysis, Residual Solvents by Gas Chromatography, and Inductively Coupled Plasma. The samples were confirmed as being identical samples of artesunic acid. Purity was determined with an HPLC-based assay using the external standard method, with a known reference purity of >99%. HPLC results confirmed sample purity was 99.3 plus or minus 0.3%. Residual solvents in the Knoll material include heptanes (0.09%) and ethyl acetate (0.04%), plus trace amounts (<0.01%) of methanol and ethanol. Lead was not found. [0067] SRI verified that an ethylene oxide sterilization treatment (4 hours at 102 degrees F.) does not degrade artesunate; the treated material meets USP requirements for sterility. The EtO treated sample was purged with nitrogen to remove residual ethylene oxide. Subsequently, bioburden, bacteriostasis, fungistasis, and endotoxin tests were performed to validate the sterility treatment method. Tests for ethylene oxide derivatives were negative and the residual EtO was found to be well below the FDA recommended levels. Tests for artesunate breakdown products, including dihydroartemisinin, were similarly negative. Results from validated bioburden and LAL tests on sterilized artesunate met USP requirements for sterility and endotoxins. The average chromatographic purity after ethylene oxide treatment was found to be 99.9 plus or minus 0.4% relative to the reference standard. Qualitative and quantitative assay results verified the chemical integrity of the ethylene oxide-treated artesunate. These results establish the time zero data point for future ethylene oxide-treated artesunate stability studies. [0068] Six thousand dry-filled vials of formulated artesunic acid for clinical use have been packaged. One thousand of the vials have been reserved for long-term stability testing under various conditions, including elevated temperatures and humidities, to test the integrity and durability of the packaging systems. As packaged for clinical use, 20 ml vials have been dry-filled with 110 mg of ethylene oxide sterilized artesunic acid, stoppered, and sealed. Stability studies at Knoll have shown at least two years stability for bulk artesunic acid stored under nitrogen @ 25° C. Example 2 Preclinical Toxicology [0069] Tests of the dry-filled artesunate formulation were used in the GLP 14-day dog toxicity study. A concentrated formulation of 50 mg AS/ml was developed and manufactured for a 14-day cGLP toxicity study in dogs. The dry-filled artesunic acid formulation used in the GLP 14-day dog toxicity study was confirmed to be of high purity by independent analysis. The artesunic acid content weights, calculated from determining the mg of artesunic acid/mL in reconstituted samples, met the requirements set forth in USP Article <905> and ranged between 501 to 519 mg/vial. [0070] The potential toxicity of GMP artesunate of the invention was tested in beagle dogs. The artesunate was administered daily by rapid intravenous infusion (over 4 to 6 minutes) for 14 days. Four groups consisting of 4 dogs/sex/group were treated daily with doses of artesunate at 10, 20, 35, or 50 mg/kg/day at dose volumes of 1 mL/kg. One group of 4 dogs/sex received sterile 0.3 M phosphate buffer (control article) and served as the control group. The study was divided into two parts. After 14 doses, 2 dogs/sex/group were necropsied on study day (SD) 15. The remaining two dogs/sex/group were allowed a 2-week treatment-free recovery period and were necropsied on study day 29. Measurements included survival, clinical observations, body weights, electrocardiography, hematology, clinical chemistry, coagulation parameters, gross pathology, organ weights, and histopathology (Wu and Senate, 2004). Intravenous doses of artesunate up to and including 50 mg/kg/day did not result in test article-related effects on mortality, clinical observations, body weights, body weight gains, food consumption, electrocardiographic output, clinical chemistry and coagulation, gross pathology, organ weights, and histopathology. During the course of the study, erythema, diarrhea, emesis, mucoid feces, and soft feces were observed sporadically in both control and test article-treated groups, and were not considered to be test article-related. Intravenous administration of artesunate at doses of 20, 35, or 50 mg/kg/day for 14 days in beagle dogs resulted in lowered red blood cell parameters (RBC, HGB, HCT, and RETIC) measured on study day 15. The lower reticulocyte counts suggested that there was not a regenerative response to the lower RBCs. The lowered red blood cell parameters found on study day 15 were not present on study day 29. [0071] Based on the results of this study, artesunate, when administered intravenously for 14 days at doses up to and including 50 mg/kg/day, did not result in any other test article-related adverse effects except on the measure hematology. At doses of 20 mg/kg/day and above, intravenous administration of artesunate for 14 days resulted in a transient test article-related effect on red blood cell parameters, including RBC, HGB, HCT, and RETIC. [0072] Having now fully described the invention, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth herein.

1a

CROSS REFERENCE TO ANOTHER APPLICATION The present application is copending with and is entitled to the benefit of the filing date of provisional application no. 60/006,166 filed Nov. 2, 1995 and also entitled PRACTICE DEVICE. TECHNICAL FIELD OF THE INVENTION The present invention relates to a novel, improved device for improving batting, pitching, and fielding skills. BACKGROUND OF THE INVENTION As in many other endeavors, practice is the activity which a ball player can most profitably utilize to improve his or her game. Thus, batting practice can be utilized to enable one to hit the ball more effectively; practice can also be counted on to improve a pitcher's control and delivery and a player's ability to field a ball. Live practice is effective. However, it has the disadvantage that a number of players in addition to the one who is practicing are required. A batter, for example, must be supported by a pitcher, a catcher, and fielders. Consequently, for an entire team to take batting practice involves an investment in time and manpower which may make it impractical at best for a player to take extra practice or to practice when other players are not available. Live practice is also constrictive in that a playing field is required. This has not surprisingly resulted in a number of practice devices being proposed and disclosed in: U.S. Pat. Nos. 5,040,791 to Ratajac et al.; 708,573 to Miles; 1,554,409 to Coffee; and 5,340,101 to Lawson et al. and in a brochure made available by Sports Lab USA and entitled SOLOHITTER. Typically, these heretofore proposed practice devices are heavy and bulky and present problems in storage and in moving them from place-to-place. Furthermore, prior art devices allow one to practice only a single skill. For example, Sports Lab USA supplies separate products for practicing fielding and batting. Another common drawback of those products heretofore designed for batting practice is that a struck ball oscillates for a considerable period of time after being struck before coming to rest in its original position. This is both distracting to the batter and time consuming. Heretofore proposed products designed for batting practice also commonly have the disadvantage that no provision is made for adjusting the baseball or softball component of the device so that, for example, low, high, inside, and outside pitches can be emulated. Thus, the use of such a device to practice batting is of questionable value. SUMMARY OF THE INVENTION There have now been invented, and disclosed here, certain new and novel practice devices which do not have the disadvantages discussed above and which are otherwise superior to those practice devices heretofore proposed. These novel practice devices have the advantage that they can be readily configured for batting or pitching or fielding practice, thereby eliminating the need of a separate device for practicing each of these skills. Also, in this respect, the devices of the present invention have a novel backstop and strut arrangement which allows the inclination of the backstop to be adjusted so that balls striking the backstop net will rebound as ground balls or in the air as the user prefers. The ball-suspension systems of practice devices employing the present invention are of perhaps particular significance. A pivotable suspension arm allows a tethered practice ball to be displaced from side-to-side of a home plate incorporated in the device and thereby emulate inside and outside pitches as well as pitches which are down the middle of the plate. Associated with the suspension arm are a motion damping system to which the ball is coupled and a tether coupled to the motion damping system below the ball. Struck balls rapidly return to their nominal or rest position. The damping system almost instantaneously dissipates oscillations and other movements of the ball encountered when the ball is halted at the rest position by the tether. Consequently, the ball is motionless and can be struck again as soon as the batter is ready; the batter need not wait for the ball to come to rest. Also, the damping arrangement is so designed that the height of the rest position can quickly be adjusted to emulate pitches which are high, low, etc. Another extremely important advantage of practice devices embodying the principles of the present invention is that they are collapsible into a compact package and can be stored in considerably less space than the Sports Lab USA and other heretofore proposed, rigid frame devices. Another important feature of practice devices embodying the principles of the present invention is that they can be reconfigured into a cartlike configuration and are provided with wheels which can concurrently be lowered to roll the practice device from place-to-place. A surface-engaging support for the backstop unit of the device in that case serves as a cart handle. Also, in this configuration, the backstop unit (at this point folded) provides a platform on which bats, ball bags, and other equipment can be loaded. That considerably simplifies the task of transporting equipment from one location to another. By later returning the wheels to the out-of-the-way locations they occupy when the device is in use, the cart configured device can again be stored in a small space. The practice device can be easily and quickly erected from either of the two alternate configurations just discussed and can be broken down into those configurations with equal facility. Furthermore, only one person is needed to erect and break down the device. Practice devices embodying the principles of the present invention also have the advantages of being rugged and durable. To a considerable extent, off-the-shelf tubing and components are employed. This is a particular advantage from the viewpoint of manufacturing costs. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a practice device employing and embodying the principles of the present invention; the practice device includes a backstop with a resiliently displaceable net and a component for outlining a strike zone at a selected location on the net, and the practice device is shown erected and configured for batting practice; FIG. 2 is a side view of the practice device; FIG. 3 is a view similar to FIG. 2 but with a game ball component of the practice device displaced by a bat-generated impact and with elastically extensible cords of a ball-supporting system stretched and thereby possessed of potential energy for immediately thereafter restoring the ball to the at rest location shown FIG. 2; FIG. 4 is a top view of the FIG. 1 practice device showing how a cantilever-mounted arm which is located at the top of the device can be pivoted to move the ball to locations emulating inside and outside pitches as well as pitches over other parts of the home plate shown in FIG. 4; the arm is part of the ball-suspension system which also includes the inextensible and elastically extensible cords shown in FIGS. 1-3; FIG. 5 is a fragmentary view of the FIG. 1 practice device showing: (a) a part of its backstop unit lower frame, (b) one of two wheels located at opposite sides of the device to make the device rollable from place-to-place, and (3) a bracket for supporting the wheel from the backstop unit frame; in this figure, the wheel is shown rotated to a horizontal position to immobilize the practice device on a supporting surface; FIG. 6 is a view similar to FIG. 5 but with the mobility-imparting wheel swung downwardly and interposed between the practice device framework and the supporting surface to make the practice device mobile; FIG. 7 is a fragmentary view of the FIG. 1 practice device showing one of two sleeve-and-cord connector arrangements at opposite sides of the device; these connectors allow vertical standards of the practice device backstop unit to be broken down in the course of reconfiguring the practice device for storage and/or for movement from one location to another; FIG. 8 is a section through the vertical standard shown in disassembled form in FIG. 7; this figure shows how the sleeve of the connecting arrangement holds upper and lower sections of the standard together in vertically aligned relationship as well as a flexible cord which keeps the two sections together when the standard is disassembled; FIG. 9 is a perspective view of a fitting which is installed on a horizontal frame member at the upper margin of the practice device backstop unit; this fitting allows the ball-supporting, cantilevered arm to be pivoted horizontally as shown in FIG. 4 for the purposes discussed in the description of that figure and to also be pivoted vertically to adjust the height of the ball above home plate; FIG. 10 is a vertical section through the upper, horizontal member of the backstop unit framework and the FIG. 9 fitting installed on that member; FIG. 11 is a perspective view of the home plate unit employed in the FIG. 1 practice device; FIG. 12 is a side view of the home plate unit fixed by suction cups to a smooth supporting surface such as a gymnasium floor; FIG. 13 is a side view of the home plate unit anchored to an earthen playing surface by a spike driven into the ground; FIGS. 14 and 15 show a telescopable strut which is employed to hold the backstop unit of the FIG. 1 practice device in an erect, operative position (FIG. 14) being collapsed to the minimum length configuration shown in FIG. 15; this is the first step employed in folding the practice device up into a compact, easily storable configuration; FIG. 16 shows the cantilevered, ball-supporting arm swung from the operative, FIG. 2 position in which the arm extends at right angles to the backstop unit through an arc of 90 degrees against the backstop unit; this is the second step in preparing the practice device for storage; FIG. 17 shows the cantilevered arm displaced longitudinally in the FIG. 10 fitting so that the free end of the arm will not extend beyond the vertical standards of the backstop unit framework; FIG. 18 shows two, U-shaped, surface-engaging supports which hold the backstop unit of the practice device upright in use being collapsed toward each other and against the backstop component; this is the third and final step in folding the practice device to its storage configuration; FIG. 19 is a side view of the practice device in the storage configuration; FIG. 20 is a view similar to FIG. 15 in which the telescopable, backstop-supporting strut has been collapsed as shown in that figure and the ball-supporting, cantilevered arm has been swung to the side and displaced through the FIG. 10 fitting as shown in FIG. 16 so that the arm will not protrude the margins of the backstop unit; these are the initial steps in configuring the FIG. 1 practice device so that the device can be wheeled from one location to another; FIG. 21 is a view similar to FIG. 20 but with: (a) the vertical standards of the backstop unit framework disconnected as shown in FIG. 7; (b) the backstop unit subsequently folded up as shown in FIG. 16; (c) the telescopable, backstop unit-supporting strut of the practice device removed; and (d) the wheels of the practice device lowered as shown in FIG. 6 so that the practice device can be rolled from one location to another; FIG. 22 is a view similar to FIG. 21 but with the backstop unit-supporting strut stored on the folded up backstop unit; FIG. 23 is a view similar to FIG. 22 but with: (a) the backstop folded against the U-shaped, ground-engaging component of the practice device nearest the backstop unit; (b) the further or rearmost of the ground-engaging, U-shaped components folded slightly toward the near one of those components to function as a handle; and (c) an equipment bag placed on the folded up backstop for transport with the practice device; FIG. 24 is a view similar to FIG. 23 but with the dual-function, ground-engaging support and handle component being folded toward the collapsed backstop unit to make the FIG. 1 practice device more compact and thus more easily stored; FIG. 25 is a side view of the practice device with the U-shaped, dual-function component folded against the backstop unit and with the wheels of the practice device folded up as shown in FIG. 5 to maximize the compactness of the practice device for storage; FIG. 26 is a side view of the FIG. 1 practice device erected but with the cantilevered, ball-supporting arm in the stowed position of FIG. 17 and the remainder of the ball-suspension system out-of-the-way so that the device can be employed for pitching and/or fielding practice; this figure also shows how extension and retraction of the collapsible, backstop-supporting strut can be employed to adjust the angle of the backstop so that a ball thrown against the backstop net will be returned as a ground ball or an air ball; FIG. 27 is a view similar to FIG. 9. of a universal fitting which functions both a backstop unit-supporting foot and a support-to backstop unit-connector and can replace the separate components employed in the FIG. 1 practice device for these two different purposes; FIG. 28 is a fragmentary, perspective view of a practice device as shown in FIG. 1 but equipped with the FIG. 27 fitting and a telescopable, cantilevered arm which eliminates the necessity of displacing that arm in the fitting when the practice device is erected for use and collapsed for storage and/or for rolling movement from one location to another; FIG. 29 is a fragmentary view of a practice device of the character shown in FIG. 1 but with a different type of strut-associated suspension system fitting; and FIG. 30 shows an alternate arrangement for connecting up components of the suspension system. DETAILED DESCRIPTION OF THE INVENTION The practice device shown in FIGS. 1-26 of the drawings is identified in FIGS. 1-4 by reference character 40. The major components of the practice device are a backstop unit 42; a suspension system 44 for a ball 46; and U-shaped, surface-engaging components 48 and 50. Components 48 and 50 cooperate with a telescopable strut 52 to maintain backstop unit 42 in an erect position which may vary between the limits identified by reference characters 54 and 56 in FIG. 26 as suggested by arrows 57a and 57b. Practice device 40 also has wheels 58 and 60 which can be lowered to roll the device from place-to-place and a home plate 62. Backstop unit 42 includes a rectangular frame 64, a net 66, composed of filaments 67, and a cord 68 which can be threaded into net 66 at a location selected by a user to outline a strike zone. Backstop frame 64 has top and bottom rails 70 and 72 and side rails 74 and 76. Supporting feet 78 and 79 are fixed to bottom rail 72 at opposite ends of that rail. Backstop frame side rails 74 and 76 each have two sections (74a and 74b and 76a and 76b) which are held in longitudinally aligned, end-to-end relationship by a sleeve 80 (see FIG. 8) when practice device 40 is set up for batting, fielding, or pitching practice. Sliding sleeve 80 in the arrow 81 direction (FIG. 7) allows the side rails to be disjointed and backstop unit 42 folded in two in the course of the converting the practice device to the cart configuration of FIG. 23. Bungee cord connector systems 82 keep the sections (74a/74b and 76a/76b) from becoming totally separated and making the backstop unit hard to handle. Net 66 is open mesh construction. Its filaments 67 are fabricated of resilient material so that balls striking the net will bounce back toward one using practice device 40. The ball-suspension system 44 utilized when device 40 is configured for batting practice includes an elongated, cantilevered arm 83 extending at normally from and supported at one end from the top rail 70 of backstop frame 64 in the fitting shown in detail in FIGS. 9 and 10 and identified by reference character 84. This fitting allows the opposite, free end 86 of the arm to be swung horizontally as indicated by arrow 90 in FIG. 4. As a consequence, ball 46 can be moved from side-to-side of home plate 62 as shown in the same figure. Thus, ball 46 can be readily positioned to emulate inside and outside pitches and pitches which cross the center of home plate 62. Also, fitting 84 allows arm 83 to be swung to an out-of-the-way position for storage and transportation of practice device 40 (see FIG. 15). Caps 85a and 85b on the opposite ends of arm 83 keep one from perhaps being injured by sharp edges at the ends of the arm. Ball-suspension system 44 also includes an elastic damping unit 94 and a tether 98 composed of two inextensible cords 100 and 102. In the exemplary practice device 40 shown in the drawings, damping unit 94 of suspension system 44 is composed of three bungee cords 104, 106, and 108 joined in end-to-end relationship by connectors or couplings 110 and 112. An inelastic cord 114 is strung through ball 46 and immobilized along the cord between two knots, one above and one below the ball. The upper knot is shown in FIGS. 1-3 and identified by reference character 116. One end of bungee cord 104 is fixed to the upper end of cord 114 by connector 115. From there, the bungee cord is trained through a pulley 118 suspended from cantilevered arm 83 near the free end 86 of that component by an eye bolt 119 and through a second pulley 120 suspended from arm 83 at the opposite, frame-associated end 121 of the arm. The second bungee cord 106 extends from connector 110 through a pulley 122 suspended from telescopable, backstop unit supporting strut 52 intermediate the upper and lower ends of that component. Pulley 122 is attached to a fitting 123 which is mounted on and slidable along telescopable strut 52. The third bungee cord 108 extends from connector 112 through: (1) a pulley 124 suspended from the bottom rail 72 of backstop frame 64, and (2) a pulley 126 suspended from home plate 62 by a quick release fitting 127 (see FIG. 11) to (3) a connector 128 which couples bungee cord 108 to the lower end of ball-supporting cord 114. As is best shown in FIG. 4, the two cords 100 and 102 of tether 98 are tied at one end, and at the same location 129 beneath ball 46, to the ball-supporting cord 114. From there, tether component 100 is trained through the eye of an eye bolt 130 at the lower end of backstop frame side rail 74 and then through a ratchet-type keeper or latch 132. Latch 132 is best shown in FIG. 4 and is suspended from telescopable strut 52 toward the lower end of that component by a fitting 134 which is adjustable along the strut as indicated by arrow 136 in FIG. 2. The second of the tether cords 102 similarly extends from the location 129 where it is tied to cord 114 beneath ball 46 through the eye of an eye bolt 138 at the opposite side of backstop frame 64 and toward the lower end of side rail 76 and then through a second ratchet-type latch 140 also suspended from fitting 134 (see FIG. 4). Fitting 123 is adjusted along strut 52 to raise and lower ball 46, thus emulating high and low pitches. Displaceable fitting 134 can at the same time be moved along strut 52 as necessary to accommodate the ball height-adjusting displacement of fitting 123. Tether components 100 and 102 are tightened to slightly tension the cords of damping system 94 by pulling equally on ball 46 to displace it in the arrow 144 direction (see FIG. 2.) from a straight line 145 extending between bungee cord-supporting pulleys 118 and 126. The represented displacement of ball 46 in FIG. 1 closely approximates the displacement actually-employed in setting up practice device 40 for batting practice. Greater displacement, for example to the position identified by reference character 146 in FIG. 2 with the consequent, illustrated bowing of bungee cords 104 and 108 and ball-supporting line 114 would place too much tension on the bungee cord; and the practice device would not function properly; i.e., it would not rapidly damp movements of ball 46 as the ball returns to its rest position after being struck. Turning now to FIG. 3, the impact of a bat drives ball 46 toward backstop unit 42 as suggested by arrow 148. This stretches and displaces the elastic bungee cords 104, 106, and 108 of damping system 94 as shown by arrows 104a, 104c, 106a, and 108a, storing potential energy in those segments; and the cords 100 and 102 of tether 98 becomes slack. Next, as the ball reaches the end of its movement toward net 66, the stored potential energy is converted to kinetic energy which returns ball 46 to the rest position shown in FIGS. 1 and 2 as indicated by arrow 150 in FIG. 3. Damping system bungee cords 104, 106, and 108 contract to their original lengths and return to their at rest positions with the motions of the cords being indicated by arrows 104b, 104d, 106b, and 108b as this occurs. As ball 46 reaches the rest position, inelastic tether lines 100 and 102 become taut and keep ball 46 from traveling in the arrow 150 direction beyond that position. With the tether tied to ball-supporting cord 114 beneath ball 46 and with damping system 94 tensioned to the extent just described, system 94 efficiently damps the oscillations of ball 46 as its supporting line 114 is brought to an abrupt halt by tether 98. As a consequence, ball 46 is almost immediately restored to and made motionless in the rest position after being struck. This is a highly desirable feature of the present invention as rigged for batting practice because the batter does not have to wait for the ball to quit moving (a common failing of heretofore proposed batting practice devices) before striking the ball again. As is best shown in FIGS. 1 and 4, and as can be appreciated from FIG. 26, backstop unit 42 is supported from the playing surface (identified by reference character 152 in FIG. 26) by feet 78 and 79 and by U-shaped supports 48 and 50 irrespective of whether the practice device 40 is rigged for batting practice, pitching practice, or fielding practice. The feet keep the practice device from scratching a gymnasium floor (or similar surface) on which it may be placed. Component 48 is pivotally connected to the bottom rail 72 of backstop frame 64; and the second U-shaped support component 50 is pivotally mounted to the transverse leg 154 of component 48. Consequently, the two U-shaped members can be folded against each other and against backstop unit 42 to configure practice device 40 for storage (see FIGS. 16-19) or into a cartlike arrangement so that the practice device can be rolled from one to location to another (see FIGS. 20-24). The pivotal connection between components 48 and 50 also allows ground-engaging component 50 to be rotated through a small angle relative to component 48, thereby adapting component 50 to serve as a cart handle (see FIGS. 23 and 24). When practice device.40 is configured and rigged for batting practice, backstop unit 42 is positioned in an upright or vertical orientation as shown in FIGS. 1-3 and as indicated by phantom line 156 in FIG. 26. For pitching and fielding practice, the backstop unit may be tilted forwardly by strut 52 (typically through a maximum arc of 20 degrees as shown in phantom lines in FIG. 26) so that a ball striking backstop net 66 will be returned as a ground ball. Conversely, the backstop unit may be tilted backwardly (typically through a maximum angle of 45 degrees as shown in full lines in FIG. 26) so that a ball striking net 66 will rebound from the net in the air. The telescopable strut 52 employed to hold backstop unit frame 64 at the wanted angle includes an elongated upper component 158; an elongated, tubular component 160 in which component 158 is slideably mounted; and a tubular clamp 161 supported on lower component 160 for locking the telescoping components 158 and 160 together. Backstop unit 42 is immobilized in the selected orientation between the limits shown in FIG. 26 by adjusting the length of strut 52. At its upper end, strut 52 is pivotally connected to the upper rail 70 of backstop frame 64 by fitting 84 (see especially FIGS. 9 and 10). The lower end of the strut is pivotally fixed to the transversely extending leg 162 of surface-engaging U-shaped bracket 50 by a T-shaped fitting 164 mounted on that leg. Strut 52 is removably fixed to both of the just-identified fittings so that it can be removed and stowed when practice device 40 is reconfigured as a cart (see FIG. 23). With practice device 40 configured as a cart, backstop unit 42 serves as a deck on which the illustrated equipment bag 165 and other equipment can be loaded. As discussed above, fitting 84 allows cantilevered arm 83 of ball-suspension system 44 to be rotated in the horizontal direction (see arrow 90 in FIG. 4). Arm 83 can also be slid through that fitting as indicated by arrow 166 in FIG. 16. This is taken advantage of in configuring practice device 40 for storage and as a cart (see FIGS. 16 and 17) so that the arm will lie in the same plane as the backstop unit 42 and will not extend beyond the sides of the backstop unit frame 64 (see FIGS. 16 and 17). Thus, the dimensions of the package into which the erected practice device can be reconfigured are minimized. The wheels 58 and 60 which allow the reconfigured practice device 40 to be rolled from one location to another are supported from the longitudinally extending legs 168 and 170 of U-shaped support 48 (see FIG. 4) by rotatably displaceable fittings 172 and 174. What happens when each of the wheels 58 and 60 is swung down to make the practice device rollable is the same for both wheels. Consequently, only the operation of wheel 58 is here described. As that wheel reaches the operative, FIG. 6 position, pins 176 and 178 engage slots in fitting 172. These slots are shown in FIGS. 5 and 6 and identified by reference characters 180 and 182. Also, a spring-loaded button 184 engages the end 185 of fitting 172 opposite slots 180 and 182. With pins 176 and 178 engaged in slots 180 and 182 and button 184 engaging fitting end 185, wheel 58 (or 60) is locked in the down, FIG. 6 position. The depressing of spring-loaded button 184 allows the wheel-supporting fitting (172 or 174) to be slid in the direction indicated by arrow 186 in FIG. 5 until pins 176 and 178 clear slots 180 and 182. The wheel can then be swung upwardly as indicated by arrow 188 in the same figure to raise the wheel 58 or (60) and lower the feet 78 and 79 of practice device 40 to the supporting surface 152 and immobilize that device at the wanted location (see FIG. 1). The same displacement from of wheels 58 and 60 from the FIG. 6 position to the FIG. 5 position can also be employed to move the wheels out of the way for the storage of practice device broken down 40. The practice device for storage with wheels 58 and 60 thus configured is shown in FIGS. 16, 17, and 25. Home plate 62 is of conventional shape and dimensions. The home plate can be anchored to the playing surface by placing a weight 190 on the plate (see FIGS. 1 and 4). If the surface is smooth--for example, a gymnasium floor--suction cups 191 attached to the bottom 192 of the home plate can instead be used to anchor the home plate to supporting surface 152 (see FIG. 12). Also, home plate 62 can be anchored by driving a spike 194 into the ground as shown in FIG. 13. The spike is connected to an eye bolt 196 at the rear edge 197 of home plate 62 by a tether 198. The eye bolt 196 just described is located both toward the rear edge 197 of home plate 62 and in the center of that practice device component. As is perhaps best shown in FIGS. 1, 4, and 11, two other eye bolts, identified by reference characters 202 and 204, are also located toward the rear edge 197 of home plate 62 but at opposite sides 206 and 208 of the home plate. By coupling damping system fitting 127 to eye bolt 202, ball 46 can be positioned as shown in FIG. 4 to emulate a pitch which is on the inside of the plate to a left-handed hitter. Similarly, by connecting the fitting to the eye bolt 204 at the opposite side 208 of home plate 62, ball 46 can be positioned to emulate a ball which is on the outside of the plate to the left-handed batter. As indicated above, practice device 40 can be employed to improve pitching and fielding skills as well as one's batting. When used to practice pitching or fielding, ball-supporting arm 83 is left in the stowed position of FIG. 17 or returned to that position as appropriate; and the assembly of damping system 94, tether 98, and ball 46 is unhooked from home plate 62 (see FIG. 14) and stowed by fixing quick release fitting 123 to backstop unit 42 (see FIG. 15) unless this has already been done. Next, the inclination of backstop unit 42 is adjusted by increasing or decreasing the length of strut 52 as discussed above. The practice device is then ready for use with the exception that, if pitching is being practiced, the user may wish to relocate the cord 68 outlining the strike zone. FIG. 27 depicts an L-shaped dual function fitting 210 which can be incorporated in practice devices embodying the principles of the present invention. This fitting has a foot 211 and replaces the foot-providing fittings 78 and 79 shown in FIGS. 1-3. Also, it has a socket 212 into which the ends of the longitudinally extending legs 168 and 170 of ground-engaging, U-shaped bracket 48 can be fitted. This makes unnecessary the fittings 214 and 216 (see FIGS. 4, 5, and 6) employed in practice device 40 to couple bracket 48 to the frame 64 of backstop unit 42. Fitting 210 is clamped to bottom rail 72 of backstop unit frame 64 with a fastener 216a which is threaded through the fitting and rotated with a knob 216b. FIG. 28 illustrates a second type of ball-supporting, cantilevered arm 217 which can be substituted for the arm 83 described above. Arm 217 is composed of two, elongated, telescoping components 218 and 219. Depressing a spring-loaded button 220 allows component 218 to be displaced in the arrow 222 direction to house that component in companion element 219 arm as indicated by reference character 224. With support arm 217 thus collapsed and swung to the side as shown by arrow 226 in FIG. 28, the stowage of arm 217 is completed. This eliminates the above-discussed step of sliding the arm through its supporting fitting so that the stowed arm will not extend beyond the side margins of backstop unit 42. It is believed that the nature and use of practice device 40 will be apparent from the drawings and the foregoing text to those versed in the arts to which the present invention relates. Nevertheless, to insure that this is the case, further details of the practice device are provided below. In particular, it was pointed out above that backstop unit 42 includes a rectangular frame 64 and a net 66. As shown in FIG. 1, net 66 is surrounded by frame 64. The net is attached to the frame with fasteners 228 spaced at generally equal intervals around frame 64. The fasteners 228 are identical. Each includes an elastic cord 230 with ends (not shown) fastened in a ball-like fitting 232. A filament 67 at the periphery of net 66 is trapped against one of the four rails 70 . . . 76 by stretching cord 230 around the filament and the rail with a loop 234 at the end of cord 230 opposite fitting 232 then being trained over that component and released to complete the process. Elastic cord fasteners 228 do not have to be employed, but have the advantage that they allow net 66 to be readily removed and replaced, as necessary. Referring now to FIGS. 7 and 8, the bungee cord connector systems 82 for the backstop frame side rails 74 and 76 are identical. The illustrated connector system for side rail 76 includes eye bolts 236 and 238 and an elastic connector such as the illustrated bungee cord 240. Eye bolt 236 is installed in lower side rail component 76a and retained in place by a threaded fastener 242. Eye bolt 238 is similarly retained inside upper side rail section 76b by a threaded retainer 244. Bungee cord 240 is fastened at its lower end 246 to eye bolt 236. The bungee cord extends from the eye bolt upwardly through tube 76a, a cap 248 at the upper end 250 of tube 76a, and a cap 252 at the lower end 254 of upper tubular component 76b, and is fastened at its upper end 256 to eye bolt 238. As discussed above, and as is best shown in FIG. 7, bungee cord connector systems 82 allow backstop unit 42 to be broken down and folded in half for storage (see also FIGS. 16 and 17) while keeping the two, upper and lower backstop unit sections 258 and 260 together in an easily handled relationship when this is done. Turning now to FIGS. 9 and 10, it was pointed out above that the cantilevered, ball-supporting arm 83 is mounted in a fitting 84. That fitting includes castings 261, 262, and 264. Casting 261 has a downwardly extending barrel 266; parallel, integral brackets 268 and 270 extending normally from barrel 266; and transversely extending barrel 272. The top rail 70 of backstop unit frame 64 extends through the barrel 272 of casting 261. Fasteners 274 (one shown in FIG. 9) are threaded through barrel 272 and top rail 70 to lock fitting 84 to that rail as shown in FIG. 10. Casting or fitting component 262 has a vertical barrel 276 and a horizontal barrel 278. Barrel 276 is rotatably seated in the vertical barrel 266 of frame-associated casting 261 with a polymeric sleeve bearing 279 and a polymeric washer 280 being installed between the two castings so that casting 262 can rotate freely in casting 261. The cantilevered support arm 83 for ball-suspension system 44 is housed between casting 262 and casting 264, which have complementary, semicircular arm-receiving annuli 282 and 284. These two castings are clamped together by a fastener 286 which extends through integral flanges 288 and 290 of these castings and a retainer 292 threaded onto the lower end of fastener 286. Referring still to FIGS. 9 and 10, both the pulley 120 of ball-suspension system 44 and the supporting strut 52 for backstop unit 42 are mounted to fitting 84. In particular, strut 52 includes a clevis 296 at the upper end of the strut's upper tubular component 158. Clevis 296 is detachably fixed to tube 158 so that strut 52 can be removed in the course of configuring practice device 40 as a cart. Specifically, the clevis 296 and strut 52 are connected by a pin 298 which extends through a hole 299 in the upper end 300 of strut component 158 and an aligned hole 301 through the shank 302 of clevis 296 as indicated by the broken line 304 in FIG. 9. To keep this pin from being lost, it is preferably connected by the illustrated handle 306, ring 308, and lanyard 310 to the clevis. At its upper end, clevis 296 is pivotally connected to the casting 261 of fitting 84 by a pivot pin 311. That pin extends seriatim through the arm 312 of clevis 296, the clevis mounting brackets 268 and 270 of fitting 261, and a second arm 313 of the clevis. Pin 311 is retained by a hand manipulatable knob 314 threaded on the free end of the fastener; i.e., the end opposite head 316. Tightening knob 314 clamps the arms 312 and 313 of clevis 296 against mounting flanges 268 and 270 to provide a rigid connection between strut 52 and backstop frame 64. As is perhaps best shown in FIG. 10, pulley 120 includes a support ring 318 captured in the eye 320 of a conventional eye bolt 322. The shank 324 of the eye bolt is threaded through the bottom 326 of casting 262 and secured against rotation by a lock washer 328. Pulley 120 is thereby securely fixed to fitting 84, at the same time retaining sufficient play to accommodate the movement of the bungee cord 104 trained through that pulley. Referring now to FIGS. 1-4, the use of tubular clamps and threaded fasteners with hand-manipulatable knobs as just described is employed throughout practice device 40 to couple together components of that device. Thus, longitudinally extending legs 330 and 332 of surface engaging support 50 are installed in clamps 334 and 336. Each of these clamps includes a component 338 through which the transverse leg 154 of surface engaging support 48 extends and a component 342 threaded through the associated component 338 and tightened against support leg 154 by a knob 344. That locks support 50 to support 48 in a backstop unit-supporting relationship as shown in FIGS. 1-4 or in a folded relationship as shown in FIG. 19 when practice device 40 is stowed. Similar clamps or fittings are employed to support the pulley 122 and ratchet or one-way clutches 132 and 140 of ball suspension system 44 and to lock the upper and lower components 158 and 160 of collapsible strut 52 together. These clamps are referred to above and identified by reference characters 123, 134, and 161. All three of these clamps are mounted on and slidable along the lower component 160 of strut 52. Like the clamps 334 and 366 discussed above, those identified by reference characters 161, 123, and 124 each have a main body component 338, a fastener component 342 threaded through the associated component 338, and a hand-manipulatable knob 344 for locking the clamp to the component on which it is mounted, in this case the lower component 160 of collapsible strut 52. As discussed above, clamp 161 allows the length of strut 52 to be adjusted to hold backstop unit 42 at the wanted angle with respect to the surface on which practice device 40 is located. Clamps 123 and 134 allow pulley 120 and the two ratchets 138 and 140 can be adjusted to levels providing optimum performance of elastic damping unit 94. Yet another clamp of the character just described is employed to couple the lower end of strut 52 to the ground supporting component 50 of practice device 40. This clamp, also shown in FIGS. 1-4, is mounted on the transverse leg 162 of support 50 and is identified by reference character 164 as mentioned previously. This clamp includes a component 354 through which the support leg extends and to which the lower end of strut component 160 is attached along with a screw-like component 356 threaded through clamp component 354 and a knob 358 for locking clamp component 354 to strut element 160. Referring now to FIGS. 5 and 6, it was pointed out above that the wheels 58 and 60 of practice device 40 are supported from the U-shaped ground-engaging component 48 of practice device 40 by tubular fittings 172 and 174 and that these fittings are slideably mounted on longitudinally extending legs 168 and 170 of the support. In particular, each of these wheels is mounted between the depending flanges 360 and 362 of a wheel-supporting bracket 364 on an axle 366 mounted at its opposite ends to flanges 360 and 362. Bracket 364 also has a horizontally oriented, plate-like element 368 to which wheel-supporting flanges 360 and 362 are attached at their upper ends. Each of the two brackets 364 is mounted to the associated fitting 172 or 174 by: (a) U-bolts 370 and 372 which extend through bosses 374a-d on element 368; and (b) four fasteners 376, which clamp fittings 172 and 174 between wheel supporting bracket 364 and U-bolt clamps 370/372. Referring now to FIGS. 14-19, the erected practice device 40 (see FIG. 1) is reconfigured into a compact package for storage by first unhooking fitting 127 from home plate 62, displacing it in the arrow 377 direction, and then attaching the fitting to net 66 toward the upper margin of that practice device component (FIG. 14). Then, clamp 161 is loosened and strut 52 is collapsed as indicated by arrow 378 in the same figure. Next, the cantilevered support arm 83 for ball suspension system 44 is rotated 90 degrees as shown by arrow 379 (FIGS. 15 and 16) and slid through fitting 262 (FIG. 16) until the arm lies along the top rail 70 of backstop frame 64 (FIG. 17) as indicating by arrow 166. Then, sleeves 80 (FIGS. 7 and 8) are slid upwardly until the upper ends of lower backstop frame side rail components 74a and 76a are cleared; and the upper half 258 of the backstop unit is folded as suggested by arrow 380 in FIG. 7 until that half of the backstop unit lies against the lower half 260 of the unit (FIGS. 16 and 17). Next, clamps 334 and 336 are loosened; and: (1) surface engaging support component 48 is folded against backstop frame 64; and (2) ground engaging component 50 is folded against component 48 (FIG. 18), also collapsing strut 52 against the backstop frame (FIG. 19) as indicated by arrow 379a in FIG. 18. To erect practice device 40; i.e., to reconfigure it from the compact, stowable package shown in FIG. 19 to the operating configuration shown in FIG. 1, the steps just described are essentially reversed. As discussed above, practice device 40 may also be reconfigured as a cart, rolled to a storage location, and then reconfigured into a compact unit for storage. To configure practice device 40 into a cart, ball suspension system 44 is unhooked from home plate 62 and stowed as discussed above. Then, backstop supporting strut 52 is collapsed also as discussed above (FIG. 20). Next (FIG. 21), the upper and lower sections 258 and 260 of backstop unit 44 are disjointed as previously described and folded together (FIG. 21). As shown in that figure and in FIG. 22, the fastener 356 of T-shaping fitting 164 (FIG. 3) is then loosened by rotating knob 358; and the pin 298 which couples the upper end 300 of strut 52 to clevis 296 is removed. The strut is removed and stowed on the backstop unit as indicated by FIG. 21 arrows 381a and 381b (FIG. 22). This is followed by collapsing the backstop unit and ground engaging support 48 together in the manner discussed above and adjusting support 50 at an angle to support 48 as suggested by arrow 382 in FIGS. 23 and 24. Support 50 then functions as a handle for pulling the practice device and baggage such as the previously mentioned equipment bag 165. Once a storage location is reached, support 50 is folded against support 48 and backstop unit 42 in the manner previously discussed. Finally, wheels 58 and 60 are displaced from the wheels down position shown in FIG. 6 to the wheels up position shown in FIG. 5 in the manner discussed above to complete the configuration of the practice device for storage. Various modifications of practice device 40 have been discussed above. Another modification, shown in FIG. 29, involves a replacement of the above-discussed clamp-type fittings 123, 134, and 161 with the single fitting 384 illustrated in the just-mentioned figure. This fitting has a tubular barrel 386 through which the lower component 160 of backstop unit-supporting strut 52 extends, a fastener (not shown) threaded through barrel 386, and a knob 388 for rotating the threaded fastener until it engages strut component 160 and clamps the latter against upper strut component 158 to lock those two components together. Fitting 384 also has integral flanges 390 and 392. The pulley 122 of ball suspension system 44 is attached to flange 390 by keeper 394, and the tension adjusting ratchets 132 and 140 of that system are detachably coupled to fitting flange 392 by S-shaped hooks 396 and 398. Yet another modification of device 40 of practical significance is shown in FIG. 29 and in FIG. 30. In device 40, the bungee cords 104, 106, and 108 of elastic damping unit 94 and ball supporting cord 114 are connected up by hooking together those complementary fittings at the apposite ends of those cords which make up connectors 110, 112, 115, and 128. Representative are the bungee cords 104 and 106 and the terminating fittings 400 and 402 of connector 110 shown in FIG. 29. The hooks of those fittings were found to be somewhat susceptible to breakage. This problem is eliminated, in accord with the modification shown in FIG. 30, by separating the fittings with an elastomeric O-ring such as the one identified by reference character 404. The U-shaped hooks 406 of the fittings are snared in the O-ring as shown in FIG. 30. O-ring 404 thus cushions impacts on the elements 406 of fittings 402 and 400, reducing to an inconsequential level the possibility of those elements breaking. The invention may be embodied in many forms without departing from the spirit or essential characteristics of the invention. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive. The scope of the invention is indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

1a

RELATED APPLICATIONS [0001] This application is a Continuation-In-Part of and claims priority to U.S. Provisional Patent Application Serial No. 60/353,642, filed on Jan. 31, 2002 for Racing Visions, L.L.C., and for Provisional Patent Application Serial No. 60/374,440 filed on Apr. 22, 2002 for Racing Visions, L.L.C. BACKGROUND OF THE INVENTION [0002] 1. The Field of the Invention [0003] The invention relates to controlling a scaled vehicle using an alternate remote control system. Specifically, the invention relates to controlling a scaled vehicle by interfacing an alternate, enhanced remote control system to the vehicle's original remote controller. [0004] 2. The Relevant Art [0005] Hobbyists own hundreds of thousands of scaled, remote control vehicles. Users can maneuver or race these vehicles individually using a vehicle's original controller systems. However, there is a growing demand to employ scaled vehicles in increasingly sophisticated events that exceed the capabilities of the original controllers. Remote scaled-vehicle competitions require increased organization and control of drivers, many of whom are young or novice competitors. A track marshal may need to temporarily control vehicles in order to position them for the start of a race, resolve accidents or mechanical failures, and maintain order on the track. [0006] There is a growing interest in driving remote control vehicles using advanced maneuvering and feedback systems. However, advanced features, services, and functionality cannot be made available to existing scaled vehicle users because their vehicles use a variety of incompatible controllers. Currently, enhanced remote control systems must be closely integrated with a racing or driving venue. Racing venue operators cannot economically supply the variety of expensive enhanced remote control systems needed to allow all users operate their vehicles with a venue's added features, services, and functionality. Without access to advanced remote control systems, vehicles cannot be controlled in centrally managed and directed events and competitions. Users also cannot take advantage of advanced driving and racing services such as remote vision, driving simulator cockpits and controls, or computer enhancement of a user's driving. [0007] What is needed are methods, apparatus, and systems for allowing more sophisticated remote vehicle controllers to control and operate existing scaled vehicles by adapting a vehicle's original remote controller for use with an alternate controller. In particular, what is needed is a method, apparatus, and system for interfacing an enhanced remote control system with the transmitter of an existing remote controller, thereby allowing the enhanced remote control system to manipulate a vehicle with modest modifications to the original controller and without changes to the vehicle. BRIEF SUMMARY OF THE INVENTION [0008] The various elements of the present invention have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available scaled remote vehicles. Accordingly, the present invention provides an improved apparatus, method, and system for maneuvering existing scaled vehicles with an enhanced remote control system. In one aspect of the present invention, a method of interfacing an enhanced controller of a remote control system to an original remote controller of an existing scaled vehicle is presented. A user controls a scaled vehicle through an enhanced controller while using the additional features, services, and functionality of the remote control system. [0009] In another aspect of the present invention, an apparatus is also presented and provided with an enhanced controller that converts a user's control inputs into a control signal. The enhanced controller also modifies the control signal to match the operating parameters of the original remote controller and the scaled vehicle. The apparatus is further provided with a connection to an original remote controller. The connection supplies the enhanced controller's control signal to the remote controller's transmitter. The apparatus allows a user to control a scaled vehicle with an alternate enhanced controller through the vehicle's original remote controller. [0010] Various elements of the present invention are combined into a system for maneuvering a scaled vehicle. The system provides a user with an enhanced controller for generating a control signal. The system substitutes the enhanced controller's control signal for the control signal of the original scaled vehicle remote controller. The system employs the vehicle's original remote controller to broadcast the enhanced controller's control signal to the scaled vehicle. [0011] The present invention facilitates a user controlling an existing scaled vehicle with an enhanced remote vehicle controller system. The present invention may also support an advanced operational environment, including video, audio, motion, and/or force feedback to the user. In one embodiment, the present invention facilitates a track marshal taking control of an existing scaled vehicle to manage recreational and racing events. The present invention further supports modification of a user's driving commands to improve or change maneuvering performance. These and other features and advantages of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS [0012] In order that the manner in which the advantages and objects of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: [0013] [0013]FIG. 1 is a block diagram illustrating one embodiment of a remote control system in accordance with the prior art; [0014] [0014]FIG. 2 is a block diagram illustrating one embodiment of an enhanced controller/remote controller system of the present invention; [0015] [0015]FIG. 3 is a block diagram illustrating one embodiment of a remote control system of the present invention; [0016] [0016]FIG. 4 is a block diagram illustrating one embodiment of an enhanced controller of the present invention; [0017] [0017]FIG. 5 is a flow chart illustrating one embodiment of a remote control method in accordance with the prior art; and [0018] [0018]FIG. 6 is a flow chart illustrating one embodiment of a remote control method in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0019] Many of the functional units described in this specification have been labeled as modules, in order to more particularly emphasize their implementation independence. For example, a module may be implemented as a hardware circuit comprising custom VLSI circuits or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components. A module may also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices or the like. [0020] Modules may also be implemented in software for execution by various types of processors. An identified module of executable code may, for instance, comprise one or more physical or logical blocks of computer instructions which may, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified module need not be physically located together, but may comprise disparate instructions stored in different locations which, when joined logically together, comprise the module and achieve the stated purpose for the module. [0021] Indeed, a module of executable code could be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices. Similarly, operational data may be identified and illustrated herein within modules, and may be embodied in any suitable form viola 20 and organized within any suitable type of data structure. The operational data may be collected as a single data set, or may be distributed over different locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network. [0022] Referring to FIG. 1, a remote control system 100 is illustrated that is representative of the environment wherein the present invention may be deployed. The remote control system 100 allows a user to maneuver a scaled vehicle 150 . The depicted remote control system 100 includes a remote controller 110 and a scaled vehicle 150 . The remote controller 110 includes a mechanical control input module 120 , a transducer module 130 , an encoder module 135 , and a transmitter module 140 . The scaled vehicle 150 includes a receiver module 160 , a decoder module 165 and an actuator module 170 . [0023] In one embodiment, a user may maneuver the scaled vehicle 150 by manipulating the mechanical control input module 120 . The transducer module 130 converts a mechanical control input into an electrical control signal. The encoder module 135 encodes the control signal. The transmitter module 140 broadcasts the control signal. The receiver module 160 of the scaled vehicle 150 receives the control signal. The decoder module 165 decodes the control signal. In response to control signal, the actuator module 170 manipulates an actuator, such as a steering mechanism, of the scaled vehicle 150 . Manipulating an actuator of the scaled vehicle 150 allows the user to maneuver the scaled vehicle 150 . [0024] [0024]FIG. 2 is a schematic block diagram illustrating one embodiment of an enhanced controller/remote controller system 200 of the present invention. The depicted system 200 includes an enhanced controller module 210 and a marshal controller module 230 . The depicted system 200 further includes a remote controller 110 with a mechanical control input module 120 , a transducer module 130 , an encoder module 135 , a control circuit connection module 220 , and a transmitter module 140 . [0025] The system 200 maneuvers a scaled vehicle 150 with an enhanced controller module 210 configured to introduce a control signal into the original remote controller 110 of the scaled vehicle 150 . In this way, the enhanced controller module 210 provides a control interface for maneuvering a scaled vehicle 150 . Control interfaces may be items commonly found in a standard vehicle 150 including a steering wheel, handlebars, gas pedal, brake, clutch, stick shift, speedometers, or gauges. Control interfaces may alsoincludejoysticks, game pads, and pointing devices. The enhanced controller module 210 converts an input to a control interface into a control signal. [0026] The enhanced control module 210 connects to an original remote controller 110 of a scaled vehicle 150 through a control circuit connection module 220 . The control circuit connection module 220 replaces a control signal that is input into a remote controller's 110 encoder module 135 . The control signal is broadcast to a scaled vehicle 150 by the transmitter module 140 . The mechanical control input module 120 and the transducer module 130 are not used by the remote control system 200 . [0027] The marshal controller module 230 provides means for a track marshal to maneuver a scaled vehicle 150 . Through the marshal controller module 230 a track marshal may override a control signal of the enhanced control module 210 . In one embodiment, the marshal controller module 230 may facilitate positioning or removal of a scaled vehicle 150 in a racing event. [0028] [0028]FIG. 3 is a block diagram illustrating one embodiment of an enhanced remote control system 300 of the present invention. The remote control system 300 provides a plurality of feedback, race management, and performance enhancement features to a user controlling a scaled vehicle 150 using an original remote controller 110 . The depicted system 300 includes a remote controller 110 , an enhanced controller 210 , a control signal modification module 310 , a video feedback module 320 , a motion feedback module 330 , a force feedback module 340 , an olfactory feedback module 350 , an audio feedback module 360 , a tactile feedback module 370 , and a track management module 380 . [0029] The enhanced controller 210 generates a control signal from a user control input. The control signal is broadcast to a scaled vehicle 150 through the remote controller 110 as illustrated in FIG. 2. Control inputs may come from a variety of devices including steering wheels, gear-shift levers, gas pedals, brake pedals, handle bars, joy sticks, control yokes, control levers, or game controllers. [0030] The control signal modification module 310 provides services for modifying a control signal from the enhanced control module 210 . The control signal modification module 310 modifies the control signal to conform to a remote controller 110 of an existing scaled vehicle 150 . [0031] In one embodiment, the control signal modification module 310 improves the maneuvering performance of a scaled vehicle 150 . The control signal modification module 310 may slow the response of the control signal to control inputs, improving the maneuvering performance of novice drivers. The control signal modification module 310 may also simulate the maneuvering response of a target vehicle. [0032] The video feedback module 320 in one embodiment provides services for displaying a video image. The image may be provided from at least one video camera 106 mounted on a scaled vehicle 150 . In an alternate embodiment, the video image is provided from at least one video camera mounted adjacent a track. The video image may also be simulated from the positions of a scaled vehicle 150 . [0033] The motion feedback module 330 in one embodiment provides a user with a sensation of the motion of a scaled vehicle 150 by modifying the physical position of the user in from an original position. For example, small motions of a user's driving cockpit may simulate acceleration, cornering, and braking. The force feedback module 340 provides a user with force feedback in a control interface of the enhanced controller 210 . For example, a steering wheel control interface may resist being turned by a user or a clutch may vibrate or resist being released. Similarly, a gear-shift lever may also simulate grinding if the user attempts to shift gears incorrectly. [0034] The olfactory feedback module 350 may in one embodiment provide a user with a smell or scent associated with a racing experience. The olfactory feedback module 350 may introduce a subtle scent resembling high-octane fuel. In a similar manner, the audio feedback module 360 may provide a user with audio feedback similar to that of a racing experience. For example, the audio feedback module 360 may provide a user with audio feedback from microphones mounted on the scaled vehicle 150 . In an alternate embodiment, the audio feedback module 360 may provide simulated racing sounds based on the status of control inputs. For example, the audio feedback module 360 may be configured to provide the sound of squealing tires while the user initiates a turn, or the sound of an accelerating engine as the user depresses an accelerator pedal. The tactile feedback module 370 in one embodiment provides a user with the tactile sensations associated with maneuvering a vehicle. A stream of air may simulate wind striking a driver. The air stream may increase or decrease depending on the speed of the scaled vehicle 150 . [0035] The track management module 380 in one embodiment provides services for a track marshal to control a scaled vehicle 150 independent of a user's enhanced controller 210 . Allowing a track marshal to independently control a scaled vehicle 150 facilitates racing or orderly track use. A track marshal may use the track management module 380 to correctly position all scaled vehicles 150 for the start of a race. A track marshal may also use the track management module 380 to take control of a vehicle 150 that is behaving erratically and remove the vehicle 150 from the track. [0036] [0036]FIG. 4 is a block diagram illustrating one embodiment of an enhanced controller 600 of the present invention. The enhanced controller 400 converts a user control input for maneuvering a scaled vehicle 150 into a control signal capable of driving the transmitter 140 of the vehicle's original remote controller 110 . The enhanced controller 400 is substantially similar to the enhanced controller 210 of FIG. 2 and includes a mechanical control input module 410 , a transducer module 420 , an analog to digital module 430 , a digital processing module 440 , and a digital to analog module 450 . [0037] The illustrated mechanical control input module 410 accepts a user control input. The mechanical control input module 410 may include a steering wheel, a control lever, a handlebar assembly, an accelerator pedal, a brake, a clutch, a gear-shift lever, or a joystick. The transducer module 420 converts a mechanical motion of the mechanical control input module 410 into an analog electrical signal. The analog to digital module 430 converts the analog electrical signal of the transducer module 420 into a digital control signal. [0038] The digital processing module 640 in one embodiment processes a digital control signal to conform to a remote controller 110 of an existing scaled vehicle 150 . The digital processing module 440 may modify the digital control signal to improve the maneuvering performance of the user and scaled vehicle 150 . For example, the digital processing module 440 may slow the response of a digital control signal for a novice user so that the scaled vehicle 150 is more easily maneuvered. The digital processing module 440 may also modify control signals simulating the response of a target vehicle. In one instance, a track marshal may override the digital control signal with an alternate digital control signal, allowing the track marshal to take control of a scaled vehicle 150 . [0039] The digital to analog module 450 converts the processed digital control signal into an analog signal. The analog signal is provided to the control circuit connection module 220 as shown in FIG. 2. [0040] [0040]FIG. 5 is a flow chart illustrating one embodiment of a remote control method 500 in accordance with the prior art. The remote control method 500 facilitates maneuvering of a scaled vehicle 150 by a user. Although for purposes of clarity the steps of the remote control method 500 are depicted in a certain sequential order, execution of the steps within an actual system, such as the system 100 of FIG. 1, may be conducted in parallel and not necessarily in the depicted order. [0041] The depicted remote control method 500 includes a user inputs step 510 , a mechanical to electrical step 520 , an encode control signal step 525 , a control signal transmission step 530 , a control signal receiving step 540 , a decode control signal step 545 , a control actuation step 550 , and an end step 560 . The control inputs step 510 accepts a user control input for maneuvering a scaled vehicle 150 . Control inputs are accepted from a steering wheel, a control lever, a gear-shift lever, an accelerator pedal, a brake pedal, a handle bar, a control lever, or a joystick. The mechanical to electrical step 520 converts the user's mechanical control input motion into an control signal. The encode control signal step 535 encodes the control signal. The control signal transmission step 530 broadcasts the control signal from a remote controller 110 . The control signal receiving step 540 receives a control signal at a scaled vehicle 150 . The decode control signal step 545 decodes the control signal. The control actuation step 550 modifies the position of actuators on a scaled vehicle 150 according the parameters of the control signal. The change in actuator position controls the motion of the scaled vehicle 150 , allowing the user to maneuver the scaled vehicle 150 . The method 500 then terminates at the end step 560 . [0042] [0042]FIG. 6 is a flow chart illustrating one embodiment of a remote control method 600 of the present invention. The remote control method 600 facilitates maneuvering of a scaled vehicle 150 by a user through an enhanced remote control system 300 . Although for purposes of clarity the steps of the remote control method 600 are depicted in a certain sequential order, execution of the steps within an actual system, such as the system 200 of FIG. 2, may be conducted in parallel and not necessarily in the depicted order. [0043] The depicted remote control method 600 includes a user inputs step 610 , a mechanical to digital step 620 , a digital processing step 630 , and a digital to analog step 640 . The control method 600 further includes the encode control signal step 525 , the control signal transmission step 530 , the control signal receiving step 540 , the decode control signal step 545 , the control actuation step 550 of the remote control method 500 of FIG. 5, and an end step 650 . [0044] The user inputs step 610 accepts a user input for maneuvering a scaled vehicle 150 . The mechanical to digital step 620 converts the user input into a digital control signal. The digital processing step 630 processes the digital control signal. For example, the digital processing step 630 modifies the digital control signal to conform with an original remote controller 110 of a target scaled vehicle 150 . The digital processing step 630 may also modify the digital control signal to improve the maneuvering performance of the user and scaled vehicle 150 . The digital processing step 630 may further modify the digital control signal to simulate the response of a target vehicle. In one embodiment, a track marshal may override the digital control signal with an alternate digital control signal, allowing the track marshal to take control of a scaled vehicle 150 . [0045] The digital to analog step 640 converts a digital control signal into an analog control signal. The encode control signal step 525 encodes the control. The control signal transmission step 530 broadcasts the control signal using the original remote controller 110 of the scaled vehicle 150 . The control signal receiving step 540 receives a control signal at a scaled vehicle 150 . The decode control signal step 545 decodes the control signal. The control actuation step 550 modifies the position of actuators on a scaled vehicle 150 according the parameters of the control signal. The change in actuator position controls the motion of the scaled vehicle 150 , allowing the user to maneuver the scaled vehicle 150 . The method 600 then terminates at the end step 650 . [0046] The present invention allows a user to maneuver an existing scaled vehicle 150 with an enhanced controller/remote control system 200 that supports additional features, services, and functionality. In particular, the present invention supports the maneuvering of an existing scaled vehicle with an enhanced remote control system 300 with improved control inputs, added feedback options, and provided with capabilities to manage a sophisticated racing event. [0047] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

1a

FIELD OF THE INVENTION [0001] The present invention relates to an apparatus and method for the analysis of body tissue by Electrical Impedance Tomography. It is particularly applicable for detecting or monitoring change in volume of the body tissue. A particular application of the invention is the detection of internal bleeding within a living body, particularly intraperitoneal bleeding. Also disclosed is an electrode belt suitable for bioelectrical use and in particular for detection of internal bleeding. BACKGROUND ART [0002] Electrical Impedance Tomography (EIT) is an imaging method that seeks to create cross-sectional maps of electrical resistivity or impedance distribution inside the body. This has previously been done using a 16 electrode array fixed to the external perimeter of a body about a transverse plane for example as described in U.S. Pat. No. 4,617,939 (Brown & Barber). The electrical current causes a change in the electrical potential on the surface of the body being examined. The other electrodes of the array are used to measure the electrical potential on the surface of the body and thereby monitor the electric field created by the current pattern. Distortions in the field pattern may be related to changes in the impedance distribution inside the body. As the solution of impedance distribution from surface voltage measurements is generally ill-posed, it has not been effective for producing good static images of body organs. This has limited the adoption of the technique for general use. [0003] The EIT process may be contrasted with other bio-electrical procedures such as bioimpedance spectroscopy. Bioimpedance spectroscopy is a process whereby four electrodes are situated at standard reference points on the body (for example, right and left wrists, right and left ankles). The actual positioning of the electrodes could vary with application. The impedance measurements are made with this group of four. Two electrodes are nominated for current flow and the other two are used for measuring voltages. Impedance is measured as a function of frequency (say, over the range 1 kHz to 1 MHz) and the results may be displayed as an R vs. X (resistance vs. reactance) plot over this range or simply as the modulus |Z| or phase or some version of this. The impedance or R or X or related measure would be considered as a dependent variable of measures such as for example % water or % fat, sex, height, extent of bleeding (these being things that may be given a priori or solved for) in a standardized empirical function and so a given Z would be used to extract a parameter such as the extent of bleeding. The success of the process depends significantly on how good the empirical function is and how ‘standard’ the subject. Use of this procedure to detect intraperitoneal bleeding has had very limited success. [0004] Serious injury to internal organs—for example, as can be suffered during blunt trauma associated with road accidents—is usually indicated by the presence of internal bleeding. It is the rate of the internal bleeding, in addition to the total amount of blood lost, which is indicative of serious injury and relative urgency of treatment. A rate of more than 30 ml per minute is usually an indication that intervention may be necessary. Bleeding is usually monitored by monitoring vital signs such as pulse rate, blood pressure and skin colour. However, this is not always a consistent way to detect serious internal bleeding—particularly among younger trauma victims. [0005] The use of EIT for detecting bleeding was discussed in the paper: “Detection and Quantification of Intraperitoneal Fluid Using Electrical Impedance Tomography” by Rosalind J Sadleir and Richard A Fox, IEEE Transactions on Biomedical Engineering, Vol. 48, No. 4, April 2001, pages 484-491. [0006] While EIT has shown considerable promise for detection of intraperitoneal bleeding and other uses, its use has been limited due to certain problems inherent in the technique as used to date. The problem solved by EIT is inherently non-linear which has limited the usefulness of images reconstructed according to linearized approximations. Additionally, the accuracy of the results is limited due to extraneous variations occurring during the test period. Chief amongst these is the effect of breathing. Impedance measurements are particularly sensitive to the changes in abdominal shape and lung air quantity during the breathing cycle. In addition, the electrodes previously used for obtaining EIT images of the abdomen have typically comprised a belt with 16 electrodes adapted to be positioned all around the perimeter of the abdomen. This can be problematic for practical use on patients, especially those where spinal injury is involved. Such belts have also been susceptible to pick up of electrical noise on voltage inputs. [0007] Throughout this specification, the term “tissue” will be taken here to include fluids such as blood and lymphatic fluids as well as other types of tissue. [0008] The above description of the prior art is given to assist the reader form an understanding of the nature of the invention disclosed herein. However, this description is not to be taken as indicating that the disclosure in that prior art in any way forms part of the common general knowledge in the art. DISCLOSURE OF THE INVENTION [0009] According to a first aspect, the invention resides in an EIT system adapted to detect changes in tissue volume within a body portion, the EIT system comprising a plurality of electrodes adapted in use to extend in a substantially linear orientation across one surface only of the body portion and to be applied in electrical contact with the skin of the body portion, a current source adapted to cyclically apply an electric current between one pair of the electrodes, a voltage measuring means to measure the voltage across each of the other pairs of the electrodes resulting from the current, a data collection system and a data analysis system to analyse data resulting from the voltages that are measured by the voltage measuring means, wherein the analysis system is configured to obtain quantitative information related to amounts and rates of conductive tissue changes occurring in the body, based on an EIT analysis equivalent to that obtained from data derived from electrodes spaced around the full perimeter of the body portion. [0010] According to a preferred feature of the invention, the processing means establishes a model of the body portion under analysis comprising a plurality of elements and wherein a parameter representative of an electric field present in each element resulting from the current is calculated from the voltages that are measured and wherein the values of at least a portion of the parameters that are calculated for the elements are amended to substantially reconstruct values that would be obtained from measurements of voltages around the perimeter of the body portion and wherein the change of value of the parameter in a portion of elements over time is indicative of internal bleeding within the body portion. [0011] According to a preferred feature of the invention, the data analysis system implements a series of steps to reconstruct the parameter values of the elements, the steps comprising: calculate the difference between a reference data set and a measured data set of the voltages as measured to establish a vector; multiply the data set by a reconstruction matrix to obtain a reconstructed image having a plurality of pixels; integrate the values of the pixels in the reconstructed image to obtain a value of the parameter; apply spatial filtering to correct for non-uniformity of parameter over the image plane monitor change in the value of the parameter over a period of time to provide an indication of change of tissue volume. [0017] According to a preferred feature of the invention, a detected change in tissue volume is representative of internal bleeding. [0018] According to a preferred feature of the invention, the parameter is defined as Resistivity Index calculated in accordance with one of: [0000] RI = ∫ Ω   σ    S or RI = ∑ p = 1 TP    σ   A p for a two-dimensional array, or [0000] RI = ∫ Ω   σ    V or RI = ∑ p = 1 TP    σ   V p for a three-dimensional array, where dA p and dV p are the areas or volumes of two or three dimensional image elements respectively. [0021] According to a preferred feature of the invention, the data analysis system further implements the steps of: using empirical sensitivity calibration to provide an estimate of the parameter in terms of blood volume; dividing the estimated blood volume by time interval between reference and measured data sets to provide an estimate of the rate of bleeding; determining an alarm category depending on the rate of bleeding that has been calculated: [0025] According to a preferred feature of the invention, the data analysis system applies a digital filter to the data to provide temporal filtering of the data to thereby remove or at least minimise the effect of breathing on the EIT analysis. [0026] According to a preferred feature of the invention, the electrodes are provided in a belt adapted to be lain across an anterior surface of the body portion and having a length such that the ends to not extend fully around said body portion, the electrodes being spaced along the length of the belt. [0027] According to a preferred feature of the invention, each electrode comprises a contact face adapted to contact the skin of the body portion wherein the contact face is of elongate form having an elongate axis oriented substantially transverse to the linear spacing of the electrodes. [0028] According to a preferred feature of the invention, the current source, voltage measuring means and data collection system are associated with an on-patient module adapted to be carried by the body having the body portion, wherein the data analysis system is provided by a remote processor and wherein data communication is provided between the on-patient module and the remote processor. [0029] According to a preferred feature of the invention, the data communication is by wireless communication. [0030] According to a preferred feature of the invention, the on-patient data module comprises processing circuitry and a telemetry transceiver that will allow data to be transferred to and from the processor. [0031] According to a preferred feature of the invention, the processing circuitry selects the pair of electrodes to which a current is applied and the pair of electrodes across which voltage is measured at any point in time. [0032] According to a further aspect, the invention resides in a method for detecting changes in tissue volume using an EIT system, the method comprising the steps of: applying a current between a pair of electrodes spaced at the surface of a body portion; measuring, at predetermined intervals, and at a multiplicity of locations in a plane through the body portion, the voltage between pairs of electrodes at the surface of the body portion resulting from the applied current to provide a set of voltage measurements, wherein the electrodes extend in a substantially linear orientation across one side only of the body portion; determining the changes of the voltage measurement between consecutive sets of voltage measurements; generating a reconstructed image of the body portion; determining the resistivity index of the tissue within the body portion from the reconstructed image; deriving a volume of tissue from the determined resistivity index; determining the rate of change of tissue volume between consecutive sets of voltage measurements. [0040] According to a preferred feature of the invention, the method includes the further step of initiating an alarm where the rate of change of tissue volume is above a predetermined value. [0041] According to a preferred feature of the invention, the resistivity index is calculated by generating a vector indicative of the changes in voltage measurements between consecutive sets of voltage measurements; and multiplying the vector by a reconstruction matrix, the resultant matrix being the reconstructed image. [0042] According to a preferred feature of the invention, the resistivity index is calculated by integrating the pixel values from the reconstructed image. [0043] According to a further aspect the invention resides in an electrode belt adapted for use with an EIT system, the belt comprising a plurality of electrodes spaced along the elongate length of the belt and having contact faces adapted to make electrical connection with the skin of a body portion under examination wherein the belt is adapted to provide engagement of the electrodes on one side only of the body portion. [0044] According to a preferred embodiment, the contact faces are substantially rectangular with a length in the range of 75 mm to 100 mm and a width in the range of 5 to 25 mm. [0045] According to a preferred feature of the invention, the belt is flexible to enable the belt to conform to the profile of the body portion upon which it is placed to facilitate contact of each electrode with the body portion. [0046] According to a preferred embodiment, the body portion is the abdomen and the ends of belt are formed with a curvature to facilitate contact of electrodes in the vicinity of the sides of the abdomen when in use. [0047] According to a preferred embodiment at least some of the electrodes are provided with an adhesive surround to facilitate secure engagement of the electrode with the skin. [0048] According to a further aspect the invention resides in an electrode belt adapted for use in bioelectrical measurements, wherein the belt is of elongate form having at least four electrodes spaced along the elongate length of the belt, the belt comprising a plurality of layers wherein the belt is constructed to provide active shielding. [0049] According to a preferred feature of the invention, the belt comprises a core and shielding components, arranged in a multi-layer structure to provide active shielding. [0050] According to a preferred feature of the invention, one of the outer layers comprises a plurality of apertures spaced along the length of the layers to thereby expose an underlying conducting layer and thereby define a corresponding plurality of electrodes. [0051] According to a preferred feature of the invention, each electrode has a conductive track connecting each electrode with a termination. [0052] According to a preferred feature of the invention, the belt is manufactured by a process similar to that used for printed circuit board manufacture. [0053] According to a preferred feature of the invention, the belt is adapted for use with EIT measurements. [0054] According to a further aspect, the invention resides an apparatus for detecting changes in tissue volume and its rate of change by EIT analysis comprising: [0000] first processing means; second processing means; and electrode means adapted to apply a predetermined current between a pair of electrodes spaced at the surface of a body portion, under control of the first and second processing means and also adapted to measure in a plane through the body portion, the voltage between pairs of electrodes at the surface of the body portion resulting from the applied current to provide a set of voltage measurements, wherein the electrodes extend in a substantially linear orientation across one side only of the body portion; the first processing means being operable to receive the set of measured voltages and to provide the set of voltage measurements to the second processing means, the first processing means being further operable to receive sets of voltage measurements at predetermined intervals and to provide these sets to the second processing means, the second processing means being operable to determine the changes in the voltage measurement between consecutive sets of voltage measurements; to provide a reconstructed image of the body portion; to determine the resistivity index of the tissue from the reconstructed image; to derive a volume of tissue from the determined resistivity index; and to determine the rate of change of tissue volume between consecutive sets of voltage measurements. [0055] Preferably, the first processing means is further operable to measure voltage noise levels. [0056] Preferably, the second processing means is further operable to initiate an alarm where the rate of change of tissue volume is above a predetermined value. [0057] Preferably, the second processing means is operable to determine the resistivity index by calculating a vector indicative of changes in voltage measurements between consecutive sets of voltage measurements; multiplying the vector by a reconstruction matrix, the resultant matrix being the reconstructed image. [0058] Preferably, the resistivity index is generated by integrating over pixels in the reconstructed image. [0059] Preferably, the electrode means comprises a belt including a multiplicity of substantially equidistantly spaced electrodes, whereby current can be applied to any pair of the multiplicity of electrodes, and the voltage measured from one or more pairs of the multiplicity of electrodes. [0060] Preferably, the first processing means is operable to apply current to all pairs of electrodes on the belt, and to take voltage measurements from all possible pairs of electrodes, for each current electrode pair. [0061] Preferably, the second processing means is provided remote from the first processing means. [0062] Preferably, the current is applied to all pairs of electrodes on the belt, and voltage measurements are measured from all possible pairs of electrodes, for each current electrode pair. [0063] Thus, the apparatus and method of the present invention provides a significant number of advantages over known methods. It detects the rate of bleeding, and is particularly suitable for use with young people. It is non-invasive, low cost, and can avoid the need for surgery. It is small, portable and light and easy to use, and so could be used, for example, at the scene of an accident. In addition, it does not necessarily require special skills. It is sensitive, and can be used even for small amounts of fluid. [0064] The belt has the advantage that it does need to be placed all the way around a patient's abdomen, thereby reducing any discomfort to the patient or risk of aggravating an existing injury, and facilitating its use for operators. [0065] The invention will be more fully understood in the light of the following description of several specific embodiments: BRIEF DESCRIPTION OF THE DRAWINGS [0066] The description is made with reference to the accompanying drawings, of which: [0067] FIG. 1 is a block diagram of the component parts of the apparatus of the present invention; [0068] FIGS. 2A to 2G are plan views of the layers that make up the electrode belt of the apparatus of FIG. 1 ; [0069] FIG. 3 is an enlarged schematic cross-section through an electrode on the belt of FIGS. 2A to 2G illustrating the layered structure; and [0070] FIG. 4 is a schematic block diagram of the components of the on-patient module 2 of FIG. 1 ; [0071] FIG. 5 is a diagrammatic representation of the processing flow of information by the processor; and [0072] FIG. 6 illustrates a 16×16 array for use in representing data measured by the apparatus of FIG. 1 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0073] The embodiments of the invention are directed to an EIT system and method adapted to detect changes within a body. They are particularly suited to detecting internal bleeding within the peritoneum. [0074] As previously mentioned, EIT systems apply a current to a body and measure voltage between electrodes placed on the surface of the body. From these measurements it has been possible to calculate the electric field which is created in a two-dimensional plane or three dimensional volume as a result of the electric current flow. A variation in electric field results from changes in resistivity of the various tissues within the region. From these resistivity changes, it is possible to create an image of changes in organs and tissue present in the region. While this has been done in the past, the quality of the images that have resulted have been quite poor and thus the process has had limited practical imaging application. The inventors have recognised that while intrinsic image quality may be poor, the process may be used to provide a parameter calculated from the output of an EIT imaging system which is subject to change and can be monitored in real-time. Internal bleeding is a particular phenomenon which causes the specified parameter to vary due to the significantly different resistivity of free blood in comparison with that of other tissue in the abdomen. Pooling of blood (or other conductive fluids) create a localised anomalous electrical conductivity which perturbs current flow within the body, and therefore perturb impedance measurements made on the body surface. These perturbations can be measured via the imaging process, to enable calculation of the rate of change, volume and location of the anomalous fluid. In this way the inventors have identified a manner in which EIT can be used to identify and monitor internal bleeding by non-invasive means. [0075] As the most common cause of intraperitoneal bleeding is blunt trauma received in motor vehicle accidents the inventors have been concerned to develop apparatus that may be used for use with such patients who may well be suffering other injuries, including spinal injuries and/or be unconscious. EIT equipment of the prior art is often not suitable for use in such circumstances. [0076] The first embodiment is described with reference to FIGS. 1 to 6 . As shown in FIG. 1 , the first embodiment is an EIT system 1 adapted to detect internal bleeding in the peritoneum and comprises a flexible electrode belt 3 , an on-patient module 2 and a processing means 4 . [0077] As better shown in FIGS. 2A to 2G , the electrode belt 3 is of elongate form having a plurality of electrodes 7 equally spaced along its length. Unlike the belts of the prior art which are adapted to be placed around the perimeter of the abdomen, the belt of the embodiment is arranged to be placed against the anterior surface of a patient's abdomen, so that it runs substantially from one side of the patient's abdomen to the other side. It is thus considerably shorter than conventional electrode belts which have been used for EIT. In typical use, the belt 3 is placed proximate the umbilicus. The belt has some flexibility to enable it to adapt to the contour of the abdomen and hold the contact faces of all electrodes in firm contact with the skin of the abdomen to thereby ensure satisfactory electrical conduction. In use, the contact faces are pre-gelled with an appropriate conductive paste to assist contact with the skin, and contact is further assured by means of adhesive surrounding each electrode face. It can be seen that the belt thus define a substantially linear array of electrodes across the abdomen, as required for EIT analysis. The electrode belt 3 is used to apply a current between a selected pair of the electrodes and to make measurements of voltages between remaining pairs of electrodes. [0078] The contact faces of the electrodes are elongate and preferably of substantially rectangular form. The elongate axes of the contact faces are oriented transversely to the elongate direction of the belt, so that when the belt is applied to the abdomen the contact faces lie substantially parallel to a central axis of the abdomen. Elongate electrodes have been found to produce a more uniform parameter sensitivity in images. Internal bleeding can be present anywhere within a large region of the abdomen, and, in use, the belt 3 is usually applied centrally in the region of the umbilicus. The elongate shape of the contact faces of the electrodes ensures that the electric field applied to the abdomen is relatively uniform over a wide region of the abdomen and that, consequently, the rates estimated and gathered from the abdomen are relatively insensitive to their axial location relative to the electrodes. The length of the contact faces is selected as a compromise to provided extended length while ensuring good contact with the body. Typically, a length in the range of 75 mm to 100 mm has been found to be optimum, although lengths outside these limits will still function. The width is selected to ensure good contact area, while providing adequate spacing between electrodes. Typically, a width in the range of 5 mm to 25 mm has been found to be suitable. [0079] The contact faces are composed of silver/silver chloride or any other suitable electrode material. Each electrode 7 has a conductive track 8 connecting the electrode 7 to an electrical termination 9 . [0080] While the EIT system of the invention can be adapted to function with electrode belts constructed in the manner of the prior art, it is very desirable to minimise electrical noise. Because the measurement of voltages between a pair of electrodes is intrinsically a high impedance measurement, when the voltage signals are processed, they are susceptible to noise. Thus, noise suppression or insulation must be used. In the present embodiment, active shielding is provided in which a coaxial configuration is used by means of the novel construction of the belt. In this way, signals are transmitted from the belt to the on-patient module 2 , with the signal being applied both to the core and to the shield of the coaxial configuration. By doing this, there is no capacitive coupling between the shield and the core, because there is no differential voltage between the core and the shield. A low impedance shield voltage is generated using follower amplifiers in the on-patient module 2 . [0081] The electrode belt of the embodiment is constructed in a manner similar to a flexible printed circuit. In the present embodiment, the coaxial configuration is created using a seven-layer arrangement—as is illustrated in FIGS. 2A to 2G . FIGS. 2A to 2G each show one of the seven layers. [0082] The two outer layers 10 a , 10 b comprise an insulating material and one 10 a includes apertures 12 to allow the electrodes 7 to contact the patient's skin. There is also provided an aperture 11 for a termination 9 . [0083] As mentioned above, each electrode 7 comprises a core and shield arrangement. FIG. 2C illustrates the core layer 10 c . The core layer comprises the electrodes 7 , each electrode having a printed conductive strip 8 , which will be used to connecting the electrode 7 to the coaxial cable 5 . Each conductive strip 8 leads to a termination 9 , which in turn connects to the coaxial cable 5 . The conductive strips 8 are also made from a suitable conductive material such as silver. On either side of the core layer 10 c are insulating layers 10 d and 10 e , which provide a layer of insulation between the core and the shielding. It can be seen from FIGS. 2A to 2G that one insulating layer 10 e provides insulation over the electrodes 7 , while the other layer 10 d does not, thereby allowing the electrodes 7 to protrude through the apertures 12 on the outer layer 10 b . On either outer side of the insulating layers 10 d and 10 e are the shielding layers 10 f and 10 g . These layers 10 f , 10 g include shielding for the electrodes 7 and conducting strips 8 of the core layer 10 c , and are also made of a conductive material such as silver. [0084] The two outer layers 10 a , 10 b are then placed on the outside. The belt 3 is printed using conventional printing techniques, with alternate layers of silver and insulating material. The traces of the different layers have different widths. The shielding layers 10 f , 10 g have the same, and thickest, width and are printed in silver. The insulating layers 10 e , 10 d have a smaller width and are printed in insulating material. The core layer 10 c has the smallest width and is also printed in silver. If the shielding layer 10 f is printed first, then subsequent layers laid down will take on the shape indicated in FIG. 4 , thus forming a complete shielding layer around the core. FIG. 4 shows, as mentioned above, the detail of a single electrode 7 , and illustrates this. [0085] As mentioned above, the core and shielding conductive strips are terminated with a suitable termination 9 including a core portion and a shield portion that can then be coupled to a coaxial cable 5 . The termination 9 comprises sixteen separate terminations—a core and shielding component for each electrode 7 . [0086] In this way, signals can be sent to and from the electrodes 7 from the on-patient module 2 , to carry out the appropriate measurements as will be described in more detail below. [0087] The on-patient module 2 comprises processing circuitry and a telemetry transceiver 21 that will allow data to be transferred to and from the processor 4 . In the embodiment, the data is transmitted by wireless communication to remove the need for a physical connecting cable between the body under test and the processor. Nevertheless, it should be appreciated that a wired connection could be used as an alternative. [0088] The components of the on-patient module 2 are illustrated schematically in FIG. 4 . These components are standard components and are mounted, in a conventional, known manner on a printed circuit board (PCB) (not shown). The on-patient module 2 applies current to a selected pair of adjacent electrodes 7 , and reads voltages from other pairs of adjacent electrodes 7 . Current is supplied via a current multiplexer 13 and a constant current source in response to signals from a direct digital synthesiser (DDS) 14 , and digital signal processor (DSP) 16 . As an example, the DSP 16 can be an Analog Devices ADSP-2181 and the DDS 14 can be an Analog Devices AD9850. The actual current is provided by a current source 23 provided between the DDS 14 and the current multiplexer 13 . A current monitor 15 measures the actual current applied to the electrodes 7 —which may be slightly different to the constant current selected to be applied to the electrodes 7 , due to the source resistance of the body—and transmits the measured value of the current to the DSP 16 , to ensure that the correct current value of the current is communicated to the processor 4 . The DDS 14 controls the frequency of the current signal to be applied to the current multiplexer 13 . In the present invention, the current is usually selected at around 3 mA and 62 kHz, although this can be varied. [0089] When current is applied to a pair of adjacent electrodes, then the resulting voltages between other pairs of electrodes on the electrode belt 3 are measured These voltages are input via a voltage multiplexer 17 to a differential amplifier 18 to provide a voltage difference, dV, which is then input to an analogue to digital converter (ADC) 24 , which then provides a 14-bit data signal to the DSP 16 corresponding to this voltage difference. [0090] Controlling signals and data can be sent to and from the DSP 16 to the remote processor 4 via a serial communications port 20 . As mentioned above, this data is sent using radio telemetry, and a suitable radio telemetry transceiver 21 is provided on the on-patient module 2 . However, it will be understood that other communications means—either wireless of fixed line—could be used. The on-patient module 2 also includes a battery (not shown), which supplies power to the components, as well as to the electrode belt 3 . [0091] The software for the on-patient module 2 resides on an EPROM 22 . Upon reset of the DSP 16 , it boots from the EPROM memory. [0092] The software consists of a main routine and approximately 20 subroutines carrying out various functions. The main routine carries out the initialisation of the various circuit elements on the PCB and then enters an infinite loop waiting for events, to which it responds. Events are initiated by the receipt of characters on the serial port 20 of a UART board coupled to the DSP 16 and memory mapped into the DSP data area. The arrival of particular character strings causes selected activities to be executed within the software subroutines. Several interrupts are enabled for the DSP 16 . A timer interrupt is used to start and stop activities that need to be done in a timely fashion. The transmission and reception of characters on the UART connected to the DSP is also done using interrupts. [0093] Character strings sent to the UART 20 from the processor 4 are used to invoke the following activities: Test whether the On-Patient Module 2 is on and communicating properly. Select two electrodes on the electrode belt 3 , to which the current is to be supplied. Select electrodes on the electrode belt 3 , from which voltages are to be measured—this is usually all other possible pairs of electrodes on the belt, that is apart from the electrodes to which the current is supplied. Select the gain of the differential amplifier 18 used to amplify the voltage measured on the selected voltage electrodes. Select the frequency for transmission of the signal to the electrodes i.e. that of the current applied to the belt 3 . Four frequencies are available—15625 Hz, 31250 Hz, 62500 Hz and 125000 Hz. The default is 62500 Hz. Carry out a single measurement of current (using the current monitor 15 ), and the voltage using the presently selected current and voltage electrode pairs from the belt electrodes 7 . Carry out a complete measurement of all possible voltage and current readings from all possible current electrode pairs on the electrode belt 3 . In one instantiation, eight current source positions and forty voltage measurements are made in total. Electrode pairs include the two end electrodes between which measurements are taken/current is applied. Stop all measurements, calculations and activities being undertaken. Measure On-Patient Module 12 battery health. [0103] Prior to the initiation of the above functions—by the receipt of a character string by the UART serial port 20 connected to the DSP 16 —the DSP 16 transmits a string back out the serial port 20 to the processor 4 , to verify that the command was received. The DSP 16 carries out all the logic to convert the bit stream arriving at its serial port into meaningful characters. Characters sent through the UART serial port 20 are mapped into the memory of the DSP 16 . The clocking signal of serial port 1 is used to control the triggering of the ADC 24 . The timer interrupt is set up to allow timer interrupts to be used to start and stop data gathering. Interrupts for the reception and transmission of data on the serial port of the UART serial port 20 are enabled. All extraneous serial port interrupts are cleared and nesting of interrupts is disabled. Programmable flag pins are set to be outputs rather than inputs. [0104] The DDS 14 operates in a conventional, known manner. [0105] The current monitor 15 includes a programmable gain amplifier that amplifies the signal to the current monitor 15 . The differential amplifier 19 amplifies either one of the battery signal or the voltage from the selected voltage electrodes. Both amplifiers have their gains set to one of 4 values. The gain of the current monitor PGA may be set to 1, 10, 100 or 1000. In practice it is set to 1000 because the current monitor signal is small. The gain of the other PGA is set to 1 (for battery signal) or 10, 100 or 1000 (for voltage measurement). Two control lines are required for both amplifiers to program one of the four gains. These control lines are connected to programmable flag outputs on the DSP 16 and thus gains are set by the DSP 16 . A programmable switch is used to select what signals are sent to the second PGA above—that is either the voltages from electrodes 7 or battery voltage and subsequently to the ADC 24 . [0106] There are four 8-channel multiplexers on the PCB. Two are in the current multiplexer 13 and two are in the voltage multiplexer 17 . The multiplexers select one of the eight electrodes 7 to be the positive current electrode, and a second to be the negative current electrode i.e. each selects one of the pair of electrodes to which the current is applied; and the positive voltage electrode and the negative voltage electrode i.e. the pair of electrodes between which a voltage measurement is taken. The multiplexers are set by logic levels supplied by two 8-output programmable latches connected to the DSP 16 . One latch is programmed to output the four logic levels (3 inputs to set the channel and 1 to enable) required for each of the 2 multiplexers in the electrode current circuit and the other is likewise programmed to output settings for the voltage multiplexers. The latches reside on the data bus of the DSP 16 and are programmed with a write to the DSP's data bus. [0107] A programmable switch is used to select whether the ADC 24 is supplied with a signal from the current monitor 15 , or via the differential amplifier 18 . This switch is set by a logic level output from a programmable flag on the DSP 16 . Clocking of the ADC 24 is carried out by the clock line from serial port 1 on the DSP 16 . No other use is made of serial port 1 . Clocking of the ADC 24 is undertaken at a rate of 32 times the frequency transmitted through the current electrodes of the electrode belt 3 . The clocking rate is set by writing a counter value into a register on the DSP 16 . [0108] The output of the ADC 24 is wired to the IDMA port on the DSP 16 . [0109] Prior to enabling a voltage or current measurement the IDMA port is set up to start writing into a particular memory location in the DSP's random access memory (RAM), thus storing the measured value at the selected memory location. The DSP's IDMA port increments the pointer to the write location after each analogue to digital conversion. [0110] In one instantiation, 8000 samples of waveforms are recorded. This corresponds to 250 periods of the transmitted waveform with 32 measurements per period. The 14 bits from the ADC 24 are written into the 14 least significant bits of the chosen 16-bit location in the RAM. The second most significant bit is zero. The most significant bit is an overflow test bit from the ADC 24 . [0111] The 8000 samples are then used to provide a measured value for the current and voltage. Thus, after 250 periods are recorded for the required measurement, that measurement is processed and the results transmitted to the processor 4 via the UART serial port 20 . A baseline level for each measurement is calculated. This is done to allow for voltage offsets on amplifiers, the ADC 24 and the electrodes 7 . [0112] In one instantiation, each of the 32 voltages in the period of the current or voltage waveform is estimated by averaging them over the 250 periods. This results in 32 numbers. Once appropriately normalised they are compared with the full averages over 250 periods to derive a standard deviation measure of the validity of signal measurement. [0113] After subtraction of the baseline level, the amplitude of the AC signal from the current monitor or voltage electrodes is calculated by summing the square of the 32 averaged samples. [0114] For calculation of the battery voltage (a DC signal), a simple normalised average of the 8000 samples is calculated. [0115] Data and standard deviations are formatted as 32-bit real floating-point numbers and transmitted out the UART serial port 20 to the processor 4 . [0116] The processing of the data by the processor 4 is represented diagrammatically by FIG. 5 . The processor 4 may take any suitable form such as a handheld computer or personal digital assistant, for example a Hewlett Packard Jornada or iPAQ palm size computer or any serial capable device. In the embodiment, the processor is associated with a version of the Windows CE operating system, although it will be recognized that other suitable operating systems may be used. [0117] The analysis of the data is directed to the calculation of a parameter which is representative of conductivity within the portion of the body being monitored. It is the change of this parameter which provides an indication in increase in volume of body tissue as in the case of internal bleeding. This parameter can be monitored over time to determine the rate of internal bleeding. This parameter has been termed the “Resistivity Index” (RI). [0118] In order to process the information, the abdomen may be modelled as a disk-shaped region. This is represented in FIG. 6 . As shown in FIG. 6 , the disk-shaped region 60 is represented by a 16×16 array 61 . A 16×16 array is used on the basis that 16 electrodes would be placed substantially equidistantly around the circumference i.e. abdomen, with the applied electric field patterns resulting in values for electrical conductivity in the surrounding tissue at each of 256 array locations. This is typical of EIT processing that has been conducted in the prior art. However in principle there is no restriction on the number of pixels used in an image. The array may be represented as a planar surface in two dimensions as shown in FIG. 6 , or may be mapped as a three dimensional cylindrical array of voxels. [0119] The Resistivity Index involves adding up the total conductivity change observed within an image since this total change should reflect the total volume of anomaly that has appeared. In the case of the pixellation shown in FIG. 6 , calculating the Resistivity Index will just involve adding all pixel values since all pixels are the same area, but in general should allow for variations in pixel size and therefore in general the Resistivity Index should be calculated by summing the quantity (dudS) where S is the region described in the model, e.g. a cylinder. [0120] The equation defining this relationship may thus be expressed as shown below for a two-dimensional array: [0000] RI = ∫ Ω   σ    S [0000] or for a three-dimensional array: [0000] RI = ∫ Ω   σ    V [0121] Alternatively, these may be expressed in discrete format. For a two-dimensional array, the relationship below is given, where A p is the area of the pixel in question and TP is the total number of pixels: [0000] RI = ∑ p = 1 TP    σ   A p [0122] For a three-dimensional array, the relationship below is given, where V p is the volume of the voxel in question and TP is the total number of voxels: [0000] RI = ∑ p = 1 TP    σ   V p [0123] As shown in FIG. 5 , the processor 4 receives data from the on-patient module 2 which is operated on at 42 with the stored reconstruction matrix 43 to provide a reconstructed image 44 . The image per se may be displayed on the display 53 of the processor. This image is then combined with stored spatial filter matrix 45 to provide a filtered image 47 . A Resistivity index is then calculated at 49 . Preferably, the Resistivity Index is processed with a temporal filter 50 at 51 to remove breathing effects. Finally a scaling is applied to derive a blood volume estimation. This process is now described in more detail below. [0124] The processor 4 therefore receives information as to the voltages measured between respective electrode pairs for a given measured current between a predetermined pair of electrodes. Measurements are received for all possible electrode pairs. In an instantiation using 8 adjacent current electrode pair positions and adjacent voltage measurements this comprises a total of 40 measurements—that is for each electrode pair to which current is applied, there are 5 voltage measurements to be taken. There are 8 different electrode pairs (including the two end electrodes)—making the total number of measurements 40 i.e. 8×5. In addition, the actual current value measured between each of the eight adjacent current pairs is measured and transmitted, making a total of 48 measurements sent to the processor 4 . [0125] These 40 voltage measurements, normalised by dividing by each relevant current measurement, are saved to file in memory in the processor 4 . [0126] Routines concerned with data collection are: [0000] Routine Name Function select_measurement(int type); Select Voltage, current or battery check setup_current(int cPair); Requests particular current pair be used setup_shorted_current(int cPair); Sets up shorted current source (used for measuring offsets in channels) setup_volts(int vPair); Requests particular voltage pair be used get_data(double *mean, Collect a particular data value double *sigma); get_volt_data get_curr_data get_battery_data DataOnly(int nsamp); Collect complete set of data without CSubject class DataPresent( ); Ping [0127] Other routines include: [0000] BatteryVoltsOK( ); Entire routine to check on module battery voltage [0128] And routines concerned with Higher Level Data collection include: [0000] CollectShortedData( ); Collect a complete set of shorted data CollectData(CSubject *patient); Collect complete set of data BreathingCycleOk(double *respIndex); Function to filter out breathing cycle effects in measurements Calibrate(BOOL *pflag, int *gflag, Calibrate module CSubject *patient, CVIndex *vValues); BeltContactOk(int contactNo); Checks that RMS noise on differential voltage measurements is low. In this routine, for each adjacent voltage pair, the differential voltage is measured. If the standard deviation in the measurement is above a threshold, then it is determined that the contact of the belt to the patient is bad.) [0129] Processing these 40 measurements will give an indication of the conductivity of the tissue within the abdomen at the time that the measurement is taken. By repeating these measurements regularly at predetermined intervals, any changes in the measured conductivity indicates changes in the tissue composition e.g. through the presence of internal bleeding, as well as the approximate location of that change. [0130] Once all the measurements have been saved to a file associated with the processor 4 , then the processor 4 is operable to carry out the Reconstruct routine mentioned above, to determine the rate of change of blood volume in the abdominal cavity, and, if necessary, trigger any alarm. [0131] Routines concerned with data reconstruction include: [0000] Routine Name Function LoadBMatrix(wchar_t *filename); Reads in reconstruction matrix from file void RemoveOffset(CCompleteMeas *data); Removes offset from voltage and/or current data XferandNormalise(CSubject *mSubject, Normalises voltage data by CCompleteMeas *set); current data, moves it to CSubject data structure Process(Csubject *exp, Csubject *ref, Calculates vector of changes in Csubject *w); data from reference set. This vector, denoted w, is multiplied by the reconstruction matrix to produce an image and hence an estimation of blood volume Reconstruct(CSubject *ref, CSubject *exp, Process, reconstruct, estimate RIType *ri, RIType *riblood, BYTE *pixel, RI, embed image in larger BOOL fStatus) background, interpolate d_sparsemult(double *colinput, double Performs multiplication of *colresult, int n, int length, SPARSELIST voltage differences by *eltlist); reconstruction matrix Partial(Csubject *b, RIType *ri); Sum Pixel Values Discretize(double **bhires, int *pixels); Rescale hiresolution image to 0->256 Reconstruct(CSubject *w, CRecon *b) Multiply Processed data by Reconstruction matrix BloodConvert(RIType ri, RIType *riblood); Convert Partial output (of RIType) to blood volume CalculateRate(RIType *rate, RIType *blood); Estimate rate in terms of blood quantity by dividing the quantity determined by output of Partial by time interval between this data and reference data collection time. int CheckAlarm(RIType *rate); Classify rate calculated below by severity [0132] In the present embodiment, eight electrodes are provided over half the abdomen—numbered “0” to “7”—and this must be accounted for, and which will be discussed further below. [0133] By solving Laplace's equation for the region of interest (for the abdomen the region shape will usually be assumed cylindrical), the expected resultant electric field from current electrodes placed at positions around the circumference of the region 60 can be determined and can be used to derive expected conductivity values measured at any of the 256 locations within the array 61 , for current electrode pairs placed around the circumference. Thus, a 256×256 reconstruction matrix can be derived from these calculations for all possible electrode pairs. This reconstruction matrix will be used by the processor 4 to provide indications of changes in tissue conductivity within the abdomen—as will be discussed in more detail below. [0134] This Reconstruct routine comprises a number of sub routines. [0135] A flow chart for this reconstruct routine is as follows: 1. Process—that is calculate the difference between reference (ref) and current (exp) data sets to obtain vector, w 1.1. Reconstruct—this comprises multiplying the data vector w (256×1 matrix) by a reconstruction matrix (256×256) to obtain a reconstructed image. 2. If necessary, reduce spatial variation of image parameters by filtering, and apply temporal filtering to remove breathing artefacts 3. Integrate the pixels in (256×1 or 16×16) reconstructed image to obtain an RI estimate 4. Scale rate estimate using empirical sensitivity to obtain RI in terms of blood volume 5. Divide estimated blood volume by time interval between reference and current data sets 6. Depending on the rate that has been calculated, determine alarm category: [0143] Thus, the process subroutine calculates the change between the present measurements and the last set of measurements—referred to herein as “exp” and “ref” respectively. Thus the change=(exp−ref). This is done by calculating a vector, w, of changes in data from the reference (“ref”) data, which can later be multiplied by the reconstruction matrix to produce an image and hence an estimation of blood volume—as will be discussed in more detail below. [0144] The resultant 256×1 matrix is an approximate reconstructed image, and, from there, values for the “resistivity index” (RI) can be obtained by integrating pixel values in this reconstructed image. [0145] This RI value can then be used to provide an estimate of blood volume. This is done by using empirically derived values of blood volume as a function of RI. The value of estimated blood volume can be used to determine the rate of change of blood value by dividing the estimated blood volume by the time interval between the reference (ref) and current (exp) data sets, and if this value falls greater than a predetermined value, then an alarm can be triggered. [0146] As mentioned above, variations to the measurements that can be attributed to the patient's breathing can be accounted for within the processing—if required. [0147] The elongate shape of the electrodes 7 , on the electrode belt 3 , enable correlation between the reconstructed image and the amount of tissue that the image represents. Elongate electrodes overcome the problem that the use of conventional-shaped (small diameter, circular) electrodes would present, in that, if an amount of tissue such as blood, were to move a small axial distance out of the plane of the electrodes then the resistivity index would be very different. Providing elongate electrodes—as described above—overcomes this problem to some extent and allows the vector/reconstructed image to be used to derive the information required. [0148] The processor can be used to select to a variety of parameters for operation and function. For example, the following functions are accessible using the processor 4 : Starts automatic collection at specified time intervals Stop automatic measurements Changes time interval between measurements Checks RMS noise appearing on adjacent electrode voltage measurements to determine contact quality Change the bleeding rate displayed between /sec, /min or /hr Executes a measurement Restarts measurements (change patient) Saves data from a session Checks for communication between the processor 4 and on-patient module 2 Setup communication (serial port) between the processor 4 and on-patient module 2 Checks Battery of module 2 Changes measurement frequency (at present measurements are made at 62.5 kHz). Change phase of measurement e.g. to take quadrature (reactive) measurements rather than resistive measurements. [0162] It will be obvious to person skilled in the art, that variations are possible within the scope of the present invention. For example, the apparatus could be used to detect other fluids or other tissue—such as cancerous tissue—and in other areas of the human body, and could be adapted for use with animals. [0163] It will be appreciated that advances in technology may lead to other ways of implementing certain aspects of the embodiments. Those skilled in the art will appreciate that the wireless communication may be implemented in other ways than that described. [0164] In an adaptation of the embodiment, the belt is provided with some stiffness to hold the belt in curved form, having greater curvature proximate the ends. Such a belt is adapted to support electrodes very close to the sides of patient, maintaining those electrodes in good contact with the skin. In the present embodiment mechanical contact between the skin and electrodes is facilitated by adhesive electrode surrounds. [0165] It will be clear that the invention is not restricted to a belt having the number of electrodes described in the embodiment. With too few electrodes, there is insufficient resolution of voltage variations across the abdomen, so that is becomes impractical to generate a clear enough reconstruction using this method. For some uses, acceptable results may be obtained with a belt having only four electrodes, although for most uses, at least 8 electrodes would be preferred. The number of electrodes might also be increased above eight to improve resolution. Clearly, such an array will require more processing power and data transmission bandwidth to be effective. But the effectiveness of taking this step will be limited in any event. As the number of electrodes is increased, the relative resolution improvement reduces so that the benefit becomes insignificant. [0166] It is also to be appreciated that the purpose of the belt is to provide a straightforward means of applying a group of electrodes to the skin in the desired area. It would also be possible provide a linear array of electrodes which are adapted to contact the skin in an arrangement which would not be considered as a belt in conventional terminology. For instance, the electrodes might be associated with a mattress such that contact with the electrodes might be maintained merely because the patient was to lie upon the mattress. Such an array would still contact the abdomen on one side only and require EIT analysis in the same manner as previously described to thereby provide the monitoring for internal bleeding. [0167] Throughout the specification, unless the context requires otherwise, the word “comprise” or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

1a

TECHNICAL FIELD The present invention relates to medical devices and more particularly to means for retaining or preventing dislodgement of a lead positioned within a body. BACKGROUND Medical devices often include a therapy generator and one or more elongate leads, coupled thereto, which are positioned within a patient's body to deliver therapy from the generator. Such therapy may be in the form of electrical stimulation, delivered via electrical conductors extending through a lead body, or fluid infusion, delivered via a lumen extending through a lead body. Some examples of electrical stimulation include pacing and defibrillation; some examples of fluids, which may be infused, include drugs, nutrients, and genetic materials. In many applications, leads are inserted through one or more blood vessels and are ultimately positioned within a blood vessel where the lead must be retained for a period of time in order to deliver the therapy. Therefore it is desirable to provide lead retention means allowing insertion or forward motion of lead, to position the lead within a vessel, while preventing retraction or rearward motion of the lead during therapy delivery. BRIEF DESCRIPTION OF THE DRAWINGS The following drawings are illustrative of particular embodiments of the invention and therefore do not limit its scope, but are presented to assist in providing a proper understanding of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. The present invention will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements, and: FIG. 1 is a plan view with a partial section of a lead including means for retention according to one embodiment of the present invention; FIG. 2A is an enlarged plan view of a retention means according to one embodiment of the present invention; FIG. 2B is an enlarged partial section view of means for retention according to an alternate embodiment; FIG. 2C is an enlarged plan view of means for retention according to another embodiment; FIG. 2D is an enlarged partial section view of means for retention according to yet another embodiment of the present invention; FIG. 3 is a plan view of a lead which may incorporate retention means according to embodiments of the present invention; FIGS. 4A–B are plan views of a portion of a lead body including retention means according to an alternate embodiment of the present invention; FIGS. 5A–B are schematic views of a portion of a lead body including retention means according to yet another embodiment of the present invention; and FIG. 6 is a schematic view of a medical device, which may incorporate retention means according to embodiments of the present invention. DETAILED DESCRIPTION The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides a practical illustration for implementing exemplary embodiments of the invention. FIG. 1 is a plan view with a partial section of a lead 10 including means for retention 15 according to one embodiment of the present invention. FIG. 1 illustrates lead 10 including a lead body 12 , a connector 16 coupled to a proximal end 121 of the lead body 12 and an electrode 14 coupled to a distal end 122 of the lead body 12 ; a conductor 13 , extending within an outer sheath 11 , couples electrode 14 to connector 16 , in order to deliver electrical stimulation, and forms a lumen for slideably engaging a stylet 18 . Means and materials for constructing such a lead are well known to those skilled in the art. FIG. 1 further illustrates retention means 15 formed along an outer surface of lead body 12 in proximity to distal end 122 . According to embodiments of the present invention, retention means 15 allows insertion of lead body 12 through a vessel, for example a vessel 607 as illustrated in FIG. 6 , while preventing retraction of lead body 12 within the vessel due to an interference of retention means 15 along a wall of the vessel that contacts lead body 12 . Retention means according to some embodiments of the present invention extends along a length greater than or equal to approximately 1 mm and may be implemented along any portion of a lead body alone or in conjunction with other retention means; further, retention means 15 may be an integral part of outer sheath 11 or may be formed on a separate collar fitted about lead body 12 , either in-line with or about outer sheath 11 . Suitable materials for outer sheath 11 and retention means 15 include those that are biocompatible, examples of which include, but are not limited to, silicone and polyurethane. Various embodiments of retention means include projections formed along retaining segments as illustrated in FIGS. 2 A–D and 4 A– 5 B. It should be noted that alternate embodiments include, but are not limited to, retaining segments extending around an entire circumference of a lead body and segments extending only about a portion of the circumference of the lead body. For example, a plurality of projections may lie in a line, single file, along a length of a retaining segment, as illustrated in FIG. 2A , or each individual projection may extend circumferentially about all or a portion of a retaining segment, as illustrated in FIG. 2C , or a plurality of projections may lie approximately side-by-side about all or a portion of a circumference, as illustrated in FIG. 2D . In some embodiments, retaining segments as a whole or just the projections may be formed of a bioadsorbable material, examples of which include those taught in lines 10 – 24 of U.S. Pat. No. 6,173,206. According to these embodiments, if a lead body is chronically implanted, the retaining segment or projections would remain intact long enough to hold the body in place for a period of time up to tissue encapsulation of the body; this may facilitate extraction of a chronically implanted lead. One example of an appropriate bioadsorbable material, polydioxanone is described along with means for molding the material in U.S. Pat. No. 4,490,326, the teachings of which are incorporated by reference herein. FIG. 2A is an enlarged plan view of means for retention according to one embodiment of the present invention. FIG. 2A illustrates a retaining segment 380 including a plurality of barb-like projections 385 positioned in a single-file line along a length of the segment 380 ; each of the plurality of projections 385 include a length L and extend laterally from a lead body 312 toward a proximal end 321 at an angle 33 , which, according to some embodiments, is less than approximately 45 degrees. According to this embodiment of the present invention and various other embodiments illustrated herein length L is greater than approximately 100 microns. FIG. 2A further illustrates projections 385 as portions of a wall 387 forming retaining segment, having been lifted out of wall 387 according to one embodiment of the present invention. FIG. 2B illustrates an alternate retaining segment 30 extending along a length of lead body 312 and including tread-like projections 31 extending laterally from lead body 312 to form a textured surface adapted to engage a vessel wall, similar to, for example, a sole of a shoe designed to facilitate traction. According to some embodiments of the present invention, projections, i.e. 385 , 31 , are directly formed in outer surfaces, being integral with a bulk material underlying the surfaces, but, according to alternate embodiments, the projections are formed of separate materials either embedded in or adhered to these surfaces. Alternative methods of forming examples of these embodiments will be described herein below. FIG. 2B further illustrates retaining segment 30 including a coating 36 , which is soluble in body fluids; according to this embodiment, coating 36 fills in around projections 31 and remains intact temporarily, during positioning of lead body 312 , so that lead body 312 may be moved back and forth through a vessel if repositioning is necessary. Suitable materials forming coating 36 are soluble in body fluids (within a temperature range encompassing normal body temperature), non-toxic, biocompatible and non-pyrogenic; examples of such a material include sugar derivatives, such as mannitol and dextrose, salts, such as sodium chloride and potassium chloride, and polyvinylpyrrolidone (PVP). Portions of U.S. Pat. No. 4,827,940 teaching methods for forming and applying a mannitol solution are incorporated by reference herein. According to an alternate embodiment, a covering in the form of a thin wall tube may be deployed over retaining segment 30 in place of coating 36 . It should be noted that any of the embodiments described herein may include such a coating or a covering facilitating positioning of lead bodies. FIG. 2C is an enlarged plan view of means for retention according to another embodiment. FIG. 2C illustrates a retaining segment 300 coupled to a portion of lead body 312 and including a proximal end 3210 and a plurality of projections 310 , each of which extend around all or a portion of a circumference of lead body 312 and extend laterally from lead body 312 at angle 33 with terminal ends 311 of projections 310 directed toward proximal end 3210 . FIG. 2D is an enlarged partial section view of means for retention according to yet another embodiment of the present invention. FIG. 2D illustrates a retaining segment 350 including a plurality of fish scale-like projections 355 positioned side-by-side about a circumference of lead body 312 and along a length of segment 350 and including terminal ends 351 directed toward a proximal end 3215 . FIG. 2D further illustrates projections 355 as discrete elements embedded in an underlying surface 375 of segment 350 according to one embodiment of the present invention. FIG. 2D also illustrates, by way of a dashed line connecting projections 355 around a circumference, another embodiment in which embedded elements forming projections may be rings or portions of a coil circling a portion of or the entire circumference of segment 350 creating projections similar to projections 310 illustrated in FIG. 2C . According to further alternate embodiments, some or all projections of a retaining segment, for example projections 385 , 31 , 310 and 355 ( FIGS. 2A–D ), each include micro-features further enhancing engagement of the projections with the vessel wall. In FIG. 2A such a feature is illustrated on one of projections 385 as a hole or indentation 25 ; in FIG. 2B such a feature is illustrated as a modified surface 26 on one of projections 31 wherein surface 26 includes texture, adhesive spots, or some material promoting thrombotic adhesion to vessel wall. Methods for forming various embodiments of retaining segments, for example those depicted in FIGS. 2A–D , include, but are not limited to, molding, extrusion, cutting, laser ablation, and coating. These methods may form projections directly in outer surfaces, such that they are integral with a bulk material underlying the surfaces, or may integrate the projections with the surface by embedding or adhering. According to some embodiments of the present invention, transfer or injection molding, using methods known to those skilled in the art, are used to form a retaining segment including projections, examples of which include those depicted in FIGS. 2B–C . According to other embodiments, a cutting process may be used to create projections on a retaining segment, for example segment 380 illustrated in FIG. 2A ; a blade may be used to nick the surface or to cut all the way through a wall of the retaining segment. Alternatively, laser ablation may be used to create projections from a bulk material of a retaining segment, i.e. FIGS. 2B–C , or by exposing, at a surface of the segment, portions of materials which have been embedded within the bulk material underlying the surface during, for example, a molding or extrusion process, i.e. FIG. 2D . U.S. Pat. No. 5,580,699 describes a suitable laser ablation process, which may be used to form retaining segments and the pertinent teachings of the '699 patent are incorporated by reference herein. U.S. Pat. No. 4,272,577 describes an extrusion process for forming ski bases having direction-dependent friction coefficients wherein harder particles, within a plastic matrix flowing through a slit nozzle, become obliquely oriented relative to the surface of the base; in one case, by means of a temperature gradient across the nozzle. We contemplate that similar methods may be developed by those skilled in the art, according to the teachings of the '577 patent, in order to extrude retaining segments according to the present invention, and incorporate by reference the pertinent teachings of the '577 patent herein. Some composite materials suitable for embodiments of the present invention include but are not limited to polyamide and polyimide particles, polyester fibers, carbon fibers or particles and any combination thereof blended with silicone. According to further alternate embodiments a coating applied to a surface of a retaining segment may form projections and or micro-features on projections, for example similar to those illustrated in FIGS. 2B–C . Stewart et al. describe an example of a suitable coating process via plasma deposition in commonly assigned U.S. Pat. No. 6,549,811, which is incorporated by reference in its entirety herein. Furthermore coatings including particles blended within, for example a silicone medical adhesive including biocompatible metal particles or hard plastic particles may form an embodiment of the present invention for example similar to those illustrated in FIGS. 2B and 2D . FIG. 3 is a plan view of a lead 40 , which may incorporate retention means according to embodiments of the present invention. FIG. 3 illustrates lead 40 including a proximal portion 43 , a first preformed bend 41 extending from proximal portion 43 to an intermediate segment 45 and a second preformed bend 42 extending from intermediate segment 45 to distal segment 46 , which is terminated by a tip 44 . Such a lead is fully described in commonly assigned U.S. Pat. No. 5,999,858, which is herein incorporated by reference in its entirety. According to embodiments of the present invention, first and second bends 41 and 42 acting as means for retention of lead body in a coronary vessel, for example a coronary sinus 605 or a branch vessel 607 thereof illustrated in FIG. 6 , are supplemented by any of the retaining segments described herein, which may be formed along the lead body surface at first bend 41 , intermediate segment 45 , second bend 42 , distal segment 46 , or any combination thereof. Any other combination of bends within a lead body is within the scope of the present invention. FIGS. 4A–B are partial plan views of one embodiment of lead 40 showing only a portion at first bend 41 , which includes a retaining segment formed by projections 51 . According to some embodiments of the present invention a retaining segment may be activated by a bending of a lead body as illustrated in FIGS. 4A–B . If a stylet, for example stylet 18 shown in FIG. 1 , is inserted into lead 40 to straighten preformed bend 41 , projections 51 become approximately parallel with an outer surface of lead 40 , as illustrated in FIG. 4A . Once the stylet is removed preformed bend 41 reforms such that projections 51 protrude laterally and are thus activated to prevent rearward motion of lead 40 within a vessel. If it becomes necessary to reposition lead 40 , the stylet may be reinserted to straighten bend 41 thus bringing projections into approximate alignment with the surface of lead 40 . It should be noted that the embodiment illustrated in FIG. 2D may be of the type illustrated in FIGS. 4A–B . FIG. 3 further illustrates lead 40 including an anchoring sleeve 48 positioned about proximal portion 43 thereof. According to an additional embodiment of the present invention, means for retention as illustrated herein, may be formed along an outer surface of proximal portion to provide frictional forces complementing anchoring sleeve 48 at a venous entry point. The means for retention may either engage an inner surface of anchoring sleeve 48 or engage a vein wall in proximity to the entry point. FIGS. 5A–B schematic views of a portion of a lead body including retention means according to yet another embodiment. FIGS. 5A–B illustrate a lead body 20 including a plurality of hair-like projections or fibers 205 each attached at one end to lead body 20 and directed by their attachment points 23 to extend out from and along a length of body 20 toward a proximal end 221 of body 20 . According to the illustrated embodiment, as lead body 20 is advanced distally in a vessel 207 per arrow A, as in FIG. 5A , projections 205 are suspended proximally; when lead body 20 is retracted proximally per arrow B, as in FIG. 5B , projections 205 are forced toward a distal end 222 of body 20 to become bunched up and wedged between body 20 and a wall of vessel 207 , thereby providing retention means for lead body 20 . Projections may be formed from a bioadsorbable polymer, for example polyglyocolic acid or polylactic acid. Alternately projections 205 may be formed from polyester fibers or some other material promoting thrombotic adhesion with the vessel wall to enhance retention within vessel 207 ; such thrombotic projections may include a non-thrombogenic coating adapted to dissolve after the lead is positioned per FIG. 5B , examples of which include a benzalkonium chloride-heparin solution and polyvinylpyrrolidone. Projections 205 may be attached at attachment points 23 by embedment within lead body 20 or by adhesive attachment, for example by means of silicone medical adhesive. FIG. 6 is a schematic view of an exemplary medical device, which may incorporate retention means according to embodiments of the present invention. FIG. 6 illustrates the medical device including a therapy generator 600 coupled to a lead 60 implanted within branch vessel 607 emanating from coronary sinus 605 . Lead 60 including a connector terminating a proximal portion 62 , an electrode in proximity to a distal end 66 and a conductor extending through an outer insulative sheath (similar to lead 10 illustrated in FIG. 1 ) may deliver electrical therapy, or may deliver infusions of therapeutic fluids from generator 600 through a central lumen. FIG. 6 further illustrates potential retention segment sites 65 , 61 , and 63 along lead 60 where projections of retention segments according to embodiments of the present invention would engage a wall of vessels 605 and 607 to prevent rearward dislodgment of lead 60 from vessel 607 . Although embodiments of the present invention are described in the context of therapy delivery, diagnostic devices adapted for insertion within a blood vessel may also incorporate retention means described herein and thus fall within the scope of the present invention. In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims.

1a

[0001] The present invention relates to an injection device for administering doses of liquid drug. The injection device is particularly suitable for self-injection of liquid drugs, such as insulin for treating diabetes, by the user or patient. BACKGROUND OF THE INVENTION [0002] Within some therapy areas the tendency of a patient to adhere to the prescribed therapy is dependent on the simplicity of the specific treatment regimen. For example, many people with type 2 diabetes are diagnosed with the disease at a relatively high age where they are less prone to accept a treatment that intervenes too much with their normal way of living. Most of these people do not like constantly being reminded of their disease and, as a consequence, they do not want to be entangled in complex treatment patterns or waste time on learning to operate cumbersome delivery systems. Basically, people with diabetes need to keep track of, and minimise, their glucose excursions. Insulin is a well-known glucose lowering agent which has to be administered parenterally to be effective in the body. At present, the most common way of administering insulin to a patient is by subcutaneous injections. Such injections have previously been performed using a vial and a syringe, but in recent years so-called injection devices, or injection pens, have gained more and more attention in the marketplace. Many people have found these injection devices easier to handle, particularly as they do not require the user to carry out a separate drug filling procedure before each injection. [0003] In some prior art injection devices which are suitable for self-injection, the user has to set a desired dose size using a dose setting mechanism of the injection device and subsequently inject the previously set dose using an injection mechanism of the injection device. In this case the dose size is variable, i.e. the user must set a dose size which is suitable in the specific situation each time a dose is to be injected. [0004] Other prior art injection devices are adapted to inject a dose of fixed size each time it is operated. In this case the user has to prepare the injection device in an appropriate manner to set the fixed dose size, using a dose setting or loading mechanism, and subsequently inject the dose using an injection mechanism. [0005] WO 2009/092807 discloses an injection device which is simple and intuitive to handle and therefore easy for the patient to learn using. The disclosed injection device is loaded or prepared with a predetermined dose of liquid drug by the mounting of a protective cap with a twisting operation. The injection means is automatically disabled when the protective cap is mounted on the device and automatically enabled when the protective cap is dismounted from the device. The injection device automatically sets the predetermined dose when the protective cap is mounted so as to eliminate any risk of misadjusting the dose size by the user. [0006] While the cap induced dose preparation of the disclosed injection device is desirable for its simplicity and minimization of the required number of manipulation steps for preparing the injection device, the fixed nature of the dose size may be impractical in certain situations. The user may need to adjust the size of the predetermined dose. The decision to adjust dose size is often taken right before the time of injection which may be many hours from the time where the injection device was prepared and the user condition such as a glucose level changed in the meantime. It would thus be desirable to provide an improved injection device which allows the user to make such a dose size adjustment of an already prepared or loaded injection device just before administration or injection. It would also be beneficial if the dose size adjustment can be made, in the prepared state, without spilling any drug [0007] In the following disclosure of the present invention, aspects and embodiments will be described which address one or more of the above objects or which address objects apparent from the disclosure as well as from the description of exemplary embodiments. SUMMARY OF INVENTION [0008] A first aspect of the invention relates to an injection device for administering doses of liquid drug, comprising a cartridge having a movable piston arranged therein and adapted to hold the liquid drug. The injection device further comprises a dose setting structure responsive to mounting of a removable cap to place the injection device in a prepared state with a dose of a first size and a user operable dose adjustment structure configured to, in the prepared state, adjust the dose of the first size to set a dose of a second size. An injection structure of the injection device comprises a piston rod coupled to the movable piston and configured to advance the piston a predetermined axial distance inside the cartridge from a first position in the prepared state to a second position in an unprepared state corresponding to delivery of the dose of the second size. [0009] The present injection device allows the user to prepare the device with the dose of the first size by a simple mounting of the removable cap. The mounting may comprise a twisting or helical movement of the removable cap injection device therefore only requires a minimum of manipulation steps by the user. In accordance with the invention, the user operable dose adjustment structure is capable of adjusting the dose of the first size to set a dose of a second size in the prepared state of the injection device. This user is accordingly allowed to increase or decrease the size of a previously, i.e. at the time of mounting of the removable cap, set dose. This is beneficial because a decision to adjust the dose size is often taken right before the time of injection which may be many hours from the time where the injection device was prepared with the dose of the first size. The user condition such as a glucose level may have changed in the meantime. The user operable dose adjustment structure may be configured to adjust the dose size in discrete step(s) or continuously in a predetermined range within upper and lower limits for the second dose size. Depending on the user's or patient's condition at the time of drug administration, the user may choose to maintain an already set dose of the first size, in which case the first and second dose sizes are identical, or decrease/increase the dose of the first size to set a second dose of a different size. [0010] During preparation or loading of the injection device, the movable piston is displaced to the first position in response to the mounting of the removable cap. A source of energy or mechanical force is preferably charged/loaded in that connection so that the device can be fired or unloaded and the injection made by stored energy delivered by the energy source. [0011] The first position of the movable piston may be defined by a proximal clamping structure operatively coupled to the piston rod to retain the piston rod in the first position. In certain embodiments of the invention, the proximal clamping structure is fixedly attached to, or engraved in, the housing of the injection device. In certain embodiments the proximal clamping structure comprises a proximal shelf while other such embodiments comprise a circumferential slot, aperture or groove in the housing. The circumferential slot, aperture or groove may be configured to guiding a trajectory of a sliding element of the dose setting structure. [0012] The second or distal position of the movable piston is preferably defined by a distal clamping structure operatively coupled to the piston rod to arrest the piston rod in the second distal position. The distal clamping structure defines an end-of-dose stop for the moveable piston. The moveable piston is preferably rigidly connected to the piston rod at least in an axial direction of the housing of the injection device so these are advanced the same predetermined axial distance during delivery of the dose of the second size. The dose setting structure is preferably configured to sequentially advancing the piston rod in axial direction for each new dose delivery. [0013] In a number of useful embodiments of the injection device, the dose adjustment structure is configured to axially translate at least one of the distal clamping structure and the proximal clamping structure in the housing of the injection device to adjust the dose size. The dose adjustment structure is preferably configured to perform axial translation or movement of only a single one of the proximal and distal clamping structure to simply mechanical design. The axial translation of the proximal or distal clamping structure, in response to actuation of the dose adjustment structure, adjusts the predetermined axial distance by which the movable piston, and preferably the piston rod, is advanced during delivery of the dose of the second size. The user operable dose adjustment structure may comprise a circumferentially extending dose dial rotatably mounted about the housing of the injection device. The dose dial preferably comprises an inner threaded structure engaging the distal clamping structure or the proximal clamping structure to axially translate the distal or proximal clamping structure, respectively, by rotation of the dose dial. An outer surface of the dose dial may comprise a corrugated surface to improve the user's grip on the dial. In other embodiments, the dose dial is integrated with a proximally protruding injection button of the injection device as described in further detail in connection with the FIGS. 5 a )- b ). [0014] A number of advantageous embodiments of the present injection device comprise a toothed sliding element adapted to engage mating teeth of a toothed axially extending section of the piston rod. The dose setting structure is configured to retain or arrest the toothed sliding element on the proximal clamping structure to set the first position of the piston rod. The mating teeth may be configured to allow unidirectional movement of toothed sliding element relative to the piston rod only. In this manner the toothed sliding element can move freely over the piston rod in proximal direction but is rigidly coupled to the piston rod in distal direction. Hence, the arrest of the sliding element on the proximal clamping structure also fixes a first or proximal position of the piston rod. In this embodiment, the dose adjustment structure may advantageously be configured to vary an axially extending geometry of the toothed sliding element to adjust the dose size. This may be accomplished by varying the axial position of a radially extending finger or protrusion of the sliding element that is configured for engagement with an axially fixed, i.e. non-translatable, distal clamping structure so as to adjust the predetermined axial distance by which the movable piston, and preferably the piston rod, is advanced during dose delivery. [0015] According to a preferred embodiment of the invention, the user operable dose adjustment structure comprises a clutch mechanism configured to decouple the dose setting structure from the injection structure in the prepared state so as to allow increasing or decreasing the dose of the first size without spilling liquid drug. The clutch mechanism may comprise an axially biased and toothed nut, rotatably mounted on the piston rod. The teeth of the toothed nut are configured to selectively engage or disengage mating teeth of a toothed member of the dose setting structure. The toothed member of the dose setting structure is preferably formed as a separate intermediate element configured for engagement with the sliding element, but may alternatively be integrated with the toothed sliding element. In response to the user's mounting of the removable cap to prepare the injection device, the intermediate element may be axially displaced in proximal direction whereby the mating teeth of the intermediate element and toothed nut are disengaged, for example by the action of a compressed nut spring supplying the axial bias force to the toothed nut. By this step or action, the toothed sliding element, which forms part of the dose setting structure, is decoupled or disengaged from the toothed piston rod and toothed nut, which form part of the injection structure. According to this embodiment, the clutch mechanism may be configured to decouple the dose setting structure from the injection structure during an initial step or phase of the preparation or loading sequence of the injection device. This embodiment of the clutch mechanism prevents dosage spill caused by handling errors such as partial loading of the injection device by incomplete or partial mounting of the removable cap. In this situation, a subsequent dismounting of the removable cap would lead to unloading or firing of the injection device with accompanying drug spill if the piston rod had been in operative engagement with the toothed sliding element during the loading sequence. This type of undesired drug spill can be avoided by utilization of the above-mentioned configuration of the clutch mechanism. [0016] In yet another embodiment of the invention, the clutch mechanism is formed by rotational engagement and disengagement of mating teeth structures formed in the toothed piston rod and the toothed sliding element. In this embodiment, the dose setting structure may be configured to rotate the toothed sliding element about the longitudinal axis of the housing during preparation of the device when the toothed sliding element reaches the first position. The toothed piston rod and the toothed sliding element may be engaged during axial translation of the toothed sliding element towards the first position during a preparation step of the injection device. The rotation of the toothed sliding element causes the disengagement between the mating teeth structures of the toothed piston rod and the toothed sliding element. [0017] According to one such embodiment, the toothed piston rod comprises a first axially extending segment of teeth of a first radial height occupying a first predetermined circumferential surface of the toothed piston rod. A second axially extending segment of teeth of a second radial height, smaller than the first radial height, occupies a second predetermined circumferential surface of the toothed piston rod. The engagement and disengagement is preferably provided by rendering the radial height of the teeth of the second segment sufficiently small to avoid engagement with a radially protruding tooth or teeth of the sliding element when the sliding element is arrested in the first position after rotation. Consequently, the toothed sliding element is decoupled from the toothed piston rod and rendered in an axially translatable state. The first radial height of the teeth of the first axially extending segment is on the other hand set to a value which ensures engagement between the mating teeth structures of the toothed piston rod and toothed sliding element. Therefore, the toothed sliding element can be coupled to the toothed piston rod by a suitable rotatory movement thereof in connection with a firing step of the injection device. The angle of rotation of the sliding element may naturally be adapted to fit the respective angular extensions of the first and second predetermined circumferential surfaces to ensure appropriate engagement and disengagement between the mating teeth structures of the toothed piston rod and toothed sliding element is accomplished. In a number of preferred embodiments, the angle of rotation of the toothed sliding element relative to the toothed piston rod lies between 10 degrees and 180 degrees such as between 20 and 90 degrees. [0018] The skilled person will understand that different types of energy sources may be applied for advancing the injection structure from the first to the second position in connection with dose delivery. In a preferred embodiment, the energy source driving the injection structure comprises a compression spring. The compression spring may be operatively coupled between the toothed sliding element and the housing of the injection device. The mounting of the removable cap to prepare the injection device causes axial compression of, and energy storage in, the compression spring due to the axial translation in proximal direction of the toothed sliding element. [0019] In another preferred embodiment of the invention, the dose setting structure comprises a torsionally pre-tensioned spring operatively coupled between the sliding element and the housing. The torsionally pre-tensioned spring is configured to rotate the toothed sliding element into engagement with the proximal clamping structure at the first position of the toothed sliding element. In some of these embodiments, the proximal clamping structure may comprise the axially translatable shelf, the axial position of which can be moved by actuation of the dose adjustment structure to adjust the dose size. In other embodiments, the axial position of the proximal clamping structure may be fixed relative to the housing and comprise a circumferentially extending slot, groove or channel in an annular wall section of the housing. The circumferentially extending slot, groove or channel is configured to guide the rotation or rotary movement of the sliding element about the longitudinal housing axis for example by engagement with a matingly shaped finger or protrusion of the toothed sliding element. The rotation of the toothed sliding element ensures that the sliding element is safely retained or arrested at the proximal clamping structure in the prepared state so as to minimize any risk of unintended firing of the injection structure. The rotary movement ensures that this indication is provided only after the sliding element has been safely retained at the proximal clamping structure. In addition, the rotary movement of the toothed sliding element may be used to release, rotate and axially translate an injection button arranged in operative engagement with the toothed sliding element such as to indicate a prepared state of the injection device. The injection button may be axially translated a pre-set distance in proximal direction to move from a depressed state, indicating an unprepared state of the injection device, to a protruding state indicating the prepared state of the injection device. The dose setting means may be configured to render the injection button partly, or preferably entirely, contained within the housing contour in its depressed state. In the prepared state of the injection device, the injection button may in response to user actuation or depression thereof be configured to operatively engage and rotate the toothed sliding element a predetermined distance along the proximal clamping structure. The predetermined distance is preferably designed such that the rotation of the toothed sliding element is terminated when it reaches an axially extending slot in the annular wall section of the housing. The axially extending slot guides further distal advancement of the sliding element in axial direction driven by the spring force from the compressed helical spring. [0020] In an advantageous embodiment, the above-mentioned torsionally pre-tensioned spring and the compression spring are integrally formed as a single helical compression spring, thus minimizing the number of separate components of the injection device and simplifying assembly or manufacturing processes. In this embodiment, the axially extending slot in the annular wall section of the housing may be adapted to guide the axial movement in proximal direction of the toothed sliding element in connection with preparation of the injection device. The rotational movement of the toothed sliding element may, as mentioned above, be guided by the circumferentially extending slot in the annular wall structure. The axially extending slot and the circumferentially extending slot may be combined to form an L-shaped slot structure. BRIEF DESCRIPTION OF THE DRAWINGS [0021] Preferred embodiments of the invention will be described in additional detail in connection with the appended drawings, in which: [0022] FIGS. 1 a ) and 1 b ) are respective central axial cross-sectional views of an injection device in accordance with a first embodiment of the invention, [0023] FIGS. 2 a ) and 2 b ) illustrate first and second steps, respectively, of a preparation and firing sequence of the injection device depicted on FIG. 1 , [0024] FIGS. 2 c ) and d ) illustrate third and fourth steps, respectively, of the preparation and firing sequence of the injection device depicted on FIG. 1 , [0025] FIGS. 2 e ) and f ) illustrate fifth and sixth steps, respectively, of the preparation and firing sequence of the injection device depicted on FIG. 1 , [0026] FIGS. 3 a ) and 3 b ) depict a user operable dose adjustment structure in respective cross-sectional views to illustrate steps of a dose adjustment function of the injection device depicted on FIG. 1 , [0027] FIGS. 4 a ) and 4 b ) are respective central cross-sectional views of a user operable dose adjustment structure of an injection device in accordance with a second embodiment of the invention, [0028] FIGS. 5 a ) and 5 b ) are respective central axial cross-sectional views of an injection device in accordance with a third embodiment of the invention, [0029] FIGS. 6 a ) and 6 b ) illustrate first and second steps, respectively, of a preparation and firing sequence of the injection device depicted on FIG. 5 in accordance with the third embodiment of the invention, [0030] FIGS. 6 c ) and 6 d ) illustrate third and fourth steps, respectively, of the preparation and firing sequence of the injection device depicted on FIG. 5 in accordance with the third embodiment of the invention, [0031] FIGS. 6 e ) and 6 f ) illustrate fifth and sixth steps, respectively, of the preparation and firing sequence of the injection device depicted on FIG. 5 in accordance with the third embodiment of the invention, [0032] FIG. 6 g ) illustrates a seventh step of the preparation and firing sequence of the injection device depicted on FIG. 5 in accordance with the third embodiment of the invention, [0033] FIG. 7 a ) is a central cross-sectional view of a user operable dose adjustment structure of the injection device depicted on FIG. 5 in accordance with the third embodiment of the invention, [0034] FIG. 7 b ) is a perspective view of a sliding element with a variable axial dimension mounted in the user operable dose adjustment structure depicted on FIG. 5 a ), [0035] FIG. 7 c ) is a central cross-sectional view of an end-of-content feature of the injection device depicted on FIG. 5 a )- b ) under normal operating conditions; and [0036] FIG. 7 d ) is a central cross-sectional view of the end-of-content feature of the injection device depicted on FIG. 5 a )- b ) in an end of content mode. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0037] FIGS. 1 a ) and 1 b ) are respective central axial cross-sectional views of an injection device 1 in accordance with a first embodiment of the invention wherein the depicted cross-sectional views are made at an angular separation of 90 degrees by rotation of the injection device 1 about a central longitudinal axis 3 . [0038] The injection device 1 is illustrated in a prepared or loaded state ready to deliver a dose of liquid drug to a user or patient by self-administration. The injection device 1 comprises a tubular housing 20 , a cartridge 85 holding a volume of liquid drug and an injection button 5 protruding axially from the tubular housing 5 . An injection needle (not shown) is attached to a distal portion of the cartridge 85 for subcutaneous injection of a predetermined dose of liquid drug in accordance with the user's setting of a dose size. A toothed elongate piston rod 30 is rigidly attached or coupled to a movable piston 70 via a piston foot 65 . The movable piston 70 is arranged within an interior volume of the cartridge 85 . Consequently, advancing the toothed piston rod 30 a predetermined distance axially in distal direction will cause a corresponding axial displacement of the movable piston 70 and cause a dose of the liquid drug to be expelled via the injection needle. A dose setting structure is responsive to mounting of a removable cap 80 to place the injection device 1 in the prepared or loaded state with a dose of liquid drug of a first size. The dose setting structure comprises an intermediate element in the form of a pusher 50 configured for engagement with the removable cap 80 and axially displaceable by mounting of the removable cap 80 . The pusher 50 is configured for engaging a sliding element 35 and axially displacing the sliding element 35 in proximal direction, i.e. towards the injection button 5 . The displacement of the sliding element 35 leads to a loading or preparation of the injection device 1 with a dose of liquid drug of the first size as explained in further detail below. The sliding element 35 comprises teeth arranged on an inner surface and configured to engaging mating teeth of the toothed elongate piston rod 30 . The mating teeth of the sliding element 35 and toothed elongate piston rod 30 are configured to solely allow unidirectional displacement of the sliding element 35 relative to the toothed elongate piston rod 30 or piston rod. Only proximal displacement of the sliding element 35 relative to the piston rod 30 is allowed. Consequently, the mating teeth of piston rod 30 and the sliding element 35 are brought into operative engagement when the latter moves in an opposite direction, i.e. a distal direction towards the second or distal position defined by an adjustable shelf 60 . [0039] The sliding element 35 is coupled to a helical compression spring 25 co-axially arranged around a tubular neck or portion of the sliding element 35 . The compression spring 25 is torsionally pre-tensioned and compressible by proximal displacement of the sliding element 35 during a loading sequence or operation of the injection device 1 . The loading sequence therefore causes potential energy or spring force to be stored in the compression spring 25 for release in connection with forward firing or advancement of the piston rod 30 and movable piston 70 during injection of the set dose of liquid drug. One end portion of the compression spring 25 engages the sliding element 35 and an opposing end portion engages a spring base 15 rigidly attached to the housing 20 . [0040] The injection device 1 furthermore comprises user operable dose adjustment structure comprising dose dial 55 and configured to, in the prepared or load state, increase or decrease the dose of the first size to set a dose of a second size. The dose dial 55 is configured to adjust a position, relative to the housing 20 , of an axially translatable distal clamping structure in form of the adjustable shelf 60 so as to vary the dose size in accordance with the user's adjustment of the dose dial 55 as explained in further detail below. The user operable dose adjustment structure additionally comprises a clutch mechanism configured to decouple the dose setting structure from the injection structure in the prepared state. The clutch mechanism comprises the pusher 50 which is configured to selectively engage or disengage a toothed nut 40 operatively coupled to the piston rod 30 as as explained in further detail below in connection with FIGS. 2 b )- 2 f ). [0041] The injection button 5 is configured to noticeably project from the housing 1 in the prepared state of the injection device 1 as depicted on FIGS. 1 a ) and 1 b ) to indicate a current state of the injection device to the user or patient. By depression of the injection button 5 a firing sequence is initiated where the sliding element 35 is released from a a proximal clamping structure and the piston rod 30 advanced from a first or proximal position relative to the housing 1 to the second or distal position in an unprepared or unloaded state of the injection device 1 . An axial distance between the first and second positions accordingly corresponds to the delivery of the dose of the second size. [0042] The clutch mechanism comprises a toothed nut 40 , a nut spring 45 and a toothed inner peripheral surface of the pusher 50 . The clutch mechanism is configured to decouple the dose setting structure from the injection structure in the prepared state of the injection device so as to allow dose adjustment in the prepared state by actuation of the dose dial 55 without advancing the toothed piston rod 30 and the moveable piston 70 and spillage of liquid drug as explained in further detail below. [0043] FIG. 2 a ) illustrates a first step of the loading and firing sequence where the injection device 1 depicted on FIG. 1 is loaded or prepared. In connection with the first step, loading or preparation is initiated by the user by twisting the replaceable cap 80 onto the injection device 1 following a helical trajectory as indicated by arrow 72 . [0044] FIG. 2 b ) illustrates the second step of the loading and firing sequence where the injection device 1 is loaded or prepared. The pusher 50 is the first portion of the dose setting structure to move in response to the mounting of the removable cap 80 . As previously explained, the piston rod 30 can only move in one direction, distally, relative to the housing 20 of the injection device. This effect is created by a pair of one way snaps mounted in the housing 20 and engaging the teeth on piston rod 30 . The pusher 50 is rotationally locked to the housing 20 . The pusher 50 is axially displaced by the twisting operation of the removable cap 80 , but the toothed nut 40 , which is rotatably mounted on the piston rod 30 , stands still due to an inner thread (not shown) that engages a mating thread on the piston rod 30 . The disengagement between the toothed nut 40 and the pusher 50 allows the toothed nut 40 to rotate as it is pushed proximally/upwards by the pusher 50 and the nut spring 45 . The toothed nut 40 will start to rotate due to the threaded non-locking interface with the mating teeth on the piston rod 30 . [0045] The teeth of the toothed nut 40 are arranged around a circumferential outer perimeter of the toothed nut 40 . The teeth of the pusher 50 , which are arranged on an inner tubular surface of the pusher 50 as explained above, are forced to disengage the mating teeth on the toothed nut 40 by this translation due to an axially directed biasing force supplied by the nut spring 45 . The toothed nut 40 can now rotate freely about the piston rod 30 . In effect, the dose setting structure has been decoupled from the injection structure because the piston rod 30 is no longer operatively coupled to the sliding element 35 . [0046] FIG. 2 c ) illustrates the third step of the loading and firing sequence where the injection device 1 is undergoing loading or preparation. In this step, the helical compression spring 25 is compressed and loaded with axial spring force and a torque. The axial force is later on used to supply dose delivery force or energy during a user initiated firing or dose delivery sequence as explained below. The torque is obtained by torsionally pre-tensioning the helical compression spring 25 and using this torque to radially rotate the sliding element 35 into engagement with a proximal clamping structure at a first or proximal position of the piston rod 30 . The helical twisting of the removable cap 80 is configured to axially translate the pusher 50 and the sliding element 35 to a first position guided by an axial slot (not shown) in a tubular wall section of the housing 20 . At the first position, a circumferentially and essentially horizontally extending slot or channel 32 in the tubular wall section guides rotary movement of the sliding element 35 about a longitudinal housing axis 3 (refer to FIG. 1 a )). The combination of the axial slot and the circumferentially extending slot 32 forms an L-shaped slot in the housing 20 . The toothed nut 40 is free to rotate in the non self-.locking thread engaging the piston rod 30 when the pusher 50 and the sliding element 35 translate. [0047] FIG. 2 d ) illustrates the fourth step of the loading and firing sequence where the injection device 1 is loaded or prepared. The sliding element 35 will rotate because of the freedom in the housing 20 and the torque generated by the pretensioned helical compression spring 25 . Furthermore, the injection button 5 is rotated and axially translated, in response to the axial displacement and rotation of the sliding element 35 , from an unloaded or unprepared state indicated by its non-protruding placement inside the housing 20 of injection device to a loaded or prepared state indicated by the protruding placement depicted in FIG. 2 d ). Consequently, after completion of step 4 , the injection device is rendered in the prepared state with the removable cap 80 mounted on the injection device. The sliding element 35 rests in the circumferentially extending slot 32 in the housing 20 with the sliding element 35 decoupled from the pusher 50 . It is now possible to adjust the axial position of the adjustable shelf 60 which effectively defines the second position or end-step of the sliding element 35 . Since the first position of the sliding element, as defined by the circumferentially extending slot 32 , remains fixed, the predetermined axial distance which the sliding element 35 and piston rod 30 travels during the dose delivery is varied. This leads in turn to the desired adjustment of the size of the initially set dose. [0048] FIG. 2 e ) illustrates the fifth step of the loading and firing sequence where the injection device 1 is fired or unloaded. The sliding element 35 rests in the circumferentially extending slot 32 in the housing 20 when the removable cap 80 is removed by the user as explained above. Furthermore, the pusher 50 is configured to translate a small distance axially and engage with the toothed nut 40 so as to rotationally lock to, or engage, the toothed nut 40 by virtue of the mating sets of teeth arranged on the pusher 50 and the toothed nut 40 as explained above. The engagement can be made in a manner where the interacting teeth make an incremental rotation of the toothed nut 40 to compensate for possible tolerances caused by small variations in the user's mounting process of the replaceable cap 80 . This will improve the dose accuracy. [0049] When the injection button 5 is depressed as indicated by the arrow adjacent to the button 5 , the sliding element 35 will also be forced to rotate due to a helical spiralling movement of the injection button 5 under engagement with an end surface of the sliding element 35 . The rotary movement of the sliding element 35 is guided by the circumferentially extending slot 32 and continues until the sliding element 35 reaches the axial slot in the housing 20 . [0050] FIG. 2 f ) illustrates the sixth step of the loading and firing sequence where the injection device 1 is fired or unloaded. When the sliding element 35 reaches the axial slot in the housing 20 , the sliding element 35 is translated axially in distal direction because of the axial force generated by the compressed helical compression spring 25 . The toothed nut 40 will translate axially in a corresponding manner because of the locked engagement with the pusher 50 . The toothed nut 40 , which is coupled to the piston rod 30 by the threaded interface, will subsequently advance the piston rod 30 and the movable piston 70 inside the cartridge 85 to make a dosing in accordance with the user selected dose size. The depicted end-of-dose or second position of the piston 70 , and corresponding end position of the piston rod 30 , is defined or set by the adjustable shelf 60 operating as the distal clamping structure or end-stop. The adjustable shelf 60 interrupts any further distal advancement of the piston 70 once the adjustable shelf 60 engages the toothed nut 40 . [0051] FIGS. 3 a ) and 3 b ) depict the user operable dose adjustment structure in respective cross-sectional views and illustrate functionality of the dose adjustment structure of the injection device 1 depicted on FIG. 1 . FIG. 3 a ) illustrates a current state of the injection device 1 after completion of step 4 above, i.e. the current state is the prepared state where the dose already has been set to a first size. This first size will correspond to a previously injected dose size. The user is now able to adjust the dose of the first size to set a dose of a second size in accordance with his/hers current condition by axially moving the adjustable shelf 60 either distally or proximally. The adjustable shelf 60 is translatable inside the housing 20 . The dose dial 55 is configured for rotation about the housing 20 but is unable to move axially or translate relative to the housing 20 . The dose dial 55 comprises an internal thread 62 which mates to a corresponding circumferential end structure of the adjustable shelf 60 as illustrated. The adjustable shelf 60 is accordingly forced to move axially in response to rotation of the dose dial 55 . Since the sliding element 35 is rests safely on the proximal clamping structure (the circumferentially extending slot 32 ), the axial position of the adjustable shelf 60 can be safely adjusted without inducing any corresponding displacement of the piston rod 30 and movable piston 70 . Therefore, without causing any spillage of the liquid drug. On the other hand, the adjustment of the axial position of the adjustable shelf 60 leads to the desired dose size adjustment because any positional change alters the axial distance of travel of the piston rod 30 and piston movable piston 70 during the firing sequence or dose delivery. [0052] FIG. 4 a ) is a central cross-sectional view of a user operable dose adjustment structure of an injection device 400 in accordance with a second embodiment of the invention. The injection device 400 has many features in common with the above-described first embodiment of the injection device. However, the dose adjustment structure of the first embodiment utilized axial movement of a distal clamping structure (the adjustable shelf 60 ) to adjust the desired dose size in the prepared state of the injection device 1 . The present injection device 400 utilizes axial movement of a proximal clamping structure (for example an adjustable shelf) to adjust the dose size in the prepared state of the injection device 400 . A distal clamping structure or end-stop remains fixed. Furthermore, the present injection device 400 utilizes a different type of clutch mechanism to decouple a dose setting structure from an injection structure in the prepared state of the injection device where the clutch mechanism is formed integrally with a toothed piston rod 430 and a sliding element 435 . [0053] FIG. 4 a ) shows the injection device 400 in the prepared state ready to deliver a dose of liquid drug to a user or patient by self-administration when the user depresses an injection button (not shown) similar in structure to the one depicted on FIG. 1 . The injection device 400 comprises a tubular housing 420 , a cartridge 485 holding a volume of liquid drug. The injection button (not shown) is protruding axially from a proximal end of the housing 420 . An injection needle (not shown) is attached to a distal portion of the cartridge 485 for subcutaneous injection of a predetermined dose of liquid drug in accordance with the user's setting of a dose size. The toothed elongate piston rod 430 is rigidly attached to a movable piston 470 . The movable piston 470 is arranged within an interior volume of the cartridge 485 . Consequently, advancing the piston rod 430 a predetermined distance axially in distal direction will cause a corresponding axial displacement of the piston 470 and cause the liquid drug to be expelled via the injection needle (not shown). A dose setting structure is responsive to mounting of a removable cap 480 to place the injection device 400 in the illustrated prepared or loaded state with a dose of liquid drug of a first size. The dose setting structure comprises a pusher 450 configured for engagement with the removable cap 480 and axially displaceable by mounting of the removable cap 480 . The pusher 450 is configured for engaging a sliding element 435 and axially displaces the sliding element 435 in proximal direction, i.e. the direction indicated by arrow 490 which is towards the injection button. The displacement of the sliding element 435 in proximal direction leads to the loading of the injection device 400 with a dose of liquid drug of a first size as explained in further detail below. The sliding element 435 comprises teeth engaging mating teeth of the piston rod 430 . The mating teeth of the sliding element and piston rod are configured to solely allow unidirectional displacement in the proximal direction of the sliding element 435 relative to the piston rod 430 . Consequently, the piston rod 430 is advanced together with the sliding element 435 when the latter is advanced in the opposite direction, i.e. a distal direction towards a second or distal position defined by the fixed distal clamping structure or end-stop as explained below in connection with FIG. 4 b ). The sliding element 435 is coupled to, or engages, a helical compression spring 425 co-axially arranged around a tubular portion or neck of the sliding element 435 . An opposite end of the helical compression spring 425 is operatively coupled to the housing 420 in similar manner to the first embodiment of the injection device. The injection device 400 furthermore comprises a user operable dose adjustment structure actuated by the dose dial 455 and configured to, in the prepared or load state, increase or decrease the dose of the first size to set a dose of a second size. The dose dial 455 is configured to adjust a position of an axially translatable proximal clamping structure in form of a proximal adjustable shelf 460 so as to vary the set dose size in accordance with the user's adjustment of the dose dial 455 as explained in further detail below in connection with FIG. 4 b ). [0054] FIG. 4 b ) is a perspective view of the user operable dose adjustment structure of the injection device 400 in partial cross-section. As previously mentioned, the injection device 400 is placed in its prepared state where the sliding element 435 rests on the proximal adjustable shelf 460 and the helical compression spring 425 is axially compressed. The sliding element 435 comprises an axially extending finger 437 which rests on an upper plane surface 462 of the adjustable proximal shelf 460 so as to define a first or proximal position of the piston rod 430 . The piston rod 430 comprises a first axially extending segment of teeth 434 extending across a first predetermined circumferential surface of the toothed piston rod 430 . The teeth have a first radial height. Another axially extending segment of teeth 432 is placed adjacently to the first axially extending segment of teeth 434 so as to occupy a second predetermined circumferential surface of the piston rod 430 . The teeth of the second segment 432 have a radial height which is smaller than the first radial height. A radially protruding tooth 439 of the sliding element 430 is configured for engagement with individual teeth of the first axially extending segment of teeth 434 . However, in the illustrated state the radially protruding tooth 439 is placed at the teeth of the second segment 432 which have a radial height sufficiently small to avoid engagement with the radially protruding tooth 439 of the sliding element 435 . Consequently, the sliding element 435 is decoupled from the piston rod 430 and rendered axially translatable by movement or adjustment of the axial position of the upper plane surface 462 of the adjustable proximal shelf 460 . The axial position of the sliding element 435 can accordingly be adjusted without adjusting the axial position of the piston rod 430 and the moveable piston 470 so as to avoid drug spillage during dose size adjustment. [0055] During firing of the injection device 400 , the sliding element 435 is firstly rotated about the longitudinal housing axis 403 of the injection device which causes the axially extending finger 437 or finger to travel across the upper plane surface 462 of the adjustable proximal shelf 460 in rotary movement until the finger 437 reaches a slot or aperture 436 in the upper plane surface 462 . During this rotary movement of the sliding element 435 , the radially protruding tooth 439 is rotated as well until it is placed at the first axially extending segment of teeth 434 or first segment of teeth of the toothed piston rod 430 . Due to the larger radial height of the teeth of the first segment of teeth 434 , the radially protruding tooth 439 of the sliding element is now brought into a locked engagement with the teeth of the first segment of teeth 434 . Consequently, the sliding element 435 is now coupled to the piston rod 430 such that piston rod will translate axially together with the sliding element 435 in the distal direction towards the second position of the piston rod and piston. The skilled person will appreciate that an integrally formed clutch mechanism resides in the described cooperation between the sliding element 435 and the piston rod 430 . This integrally formed clutch mechanism operates by rotational engagement and disengagement of the mating teeth structures 432 , 434 , 439 formed in respective ones of the toothed piston rod 430 and the slider element 435 . [0056] Once the finger 437 has reached the slot or aperture 436 in the adjustable upper shelf 460 , the spring force or energy stored in the axially compressed helical compression spring 425 will advance the sliding element 435 and the piston rod 430 (now brought into engagement by the clutch mechanism) in axial direction. The sliding element 435 and the piston rod 430 will advance together until the finger 437 contacts or engages a non-adjustable or fixed lower shelf 464 which blocks further axial advancement of the sliding element 435 and the piston rod 430 . The fixed lower shelf 464 therefore defines an end-of-dose or the second position of the piston 470 and corresponding second or distal position of the piston rod 430 after delivery of the set dose size. [0057] The depicted user operable dose adjustment structure of the injection device 400 allows the user to increase or decrease a dose of a first size to set a dose of a second size by axially moving the adjustable proximal shelf 460 either distally or proximally to respectively decrease or increase the dose size. The adjustable proximal shelf 460 is translatable inside the housing 420 . The tubular dose dial 455 is configured for rotation about the housing 420 but unable to move axially relative to the housing 420 . The dose dial 455 comprises an internal thread which mates to a corresponding circumferential end structure of the adjustable shelf 460 in a manner similar to the above-described dose dial 55 (refer to FIG. 3 b )) of the first embodiment. The adjustable shelf 460 is accordingly forced to move axially in response to rotation of the dose dial 455 . Even though the sliding element 435 rests on the upper plane surface 462 of the adjustable shelf 460 as illustrated on FIG. 4 b ), the sliding element 435 is decoupled from the piston rod 430 by the operation of the clutch mechanism as described above. Therefore, the position of the adjustable shelf 460 can be adjusted axially without inducing any corresponding movement of the piston rod 430 and movable piston 470 . The position of the adjustable shelf 460 , and therefore the dose size, can accordingly be adjusted without spillage of liquid drug. Furthermore, the adjustment of the axial position of the adjustable shelf 460 leads to the desired dose size adjustment because the positional change alters the axial distance of travel of the piston rod 430 and piston movable piston 470 . [0058] The loading or preparation of the injection device 400 is generally similar to the one for the first injection device 1 described above in connection with FIGS. 2 a )- d ) albeit with a different operation of the clutch mechanism. The helical compression spring 425 is torsionally pre-tensioned and compressible by proximal displacement of the sliding element 435 during the loading sequence of the injection device 400 . The torque obtained from the torsionally pre-tensioned helical compression spring 425 is used to rotate the the sliding element 435 once the adjustable proximal shelf 460 is reached and bring the finger 437 into engagement with the upper plane surface 462 in connection with the mounting of removable cap 480 by helical twisting. Once the removable cap 480 has been mounted, the injection device 400 is automatically rendered in a prepared state with a dose of the first size where the finger 437 of the sliding element 435 rests safely on the upper plane surface 462 of the adjustable upper shelf 460 . FIGS. 5 a ) and 5 b ) are respective central axial cross-sectional views of an injection device 501 in accordance with a third embodiment of the invention wherein the depicted cross-sectional views are shown at an angular separation of 90 degrees by rotation of the injection device 501 about a central longitudinal axis 503 . [0059] The injection device 501 has many features in common with the above-described first embodiment of the injection device 1 on FIG. 1 . The dose adjustment structure of the first embodiment utilized axial movement of a distal clamping structure (the adjustable shelf 60 ) to adjust the desired dose size in the prepared state of the injection device 1 . In contrast, the dose adjustment structure of the present injection device 501 is configured to vary an axially extending geometry of a toothed sliding element 535 to adjust the dose size in the prepared state. In the present injection device 501 , the respective axial positions of a distal clamping structure and a proximal clamping structure remain fixed. Furthermore, a user operable dose dial is integrated with an injection button of the injection device 501 as explained in further details below. [0060] The injection device 501 is illustrated in an unprepared or unloaded state after delivery of a dose of liquid drug to a user or patient by self-administration. The injection device 501 comprises a tubular housing 520 , a cartridge 585 holding a volume of liquid drug and an injection button 505 protruding axially from the housing 520 . An injection needle (not shown) is attached to a distal portion of the cartridge 585 for subcutaneous injection of a predetermined dose of liquid drug in accordance with the user's setting of a dose size. A toothed elongate piston rod 530 is rigidly attached to a movable piston 570 via a piston foot 565 . The movable piston 570 is arranged within an interior volume of the cartridge 585 . Consequently, advancing the toothed piston rod 530 a predetermined distance axially in distal direction will cause a corresponding axial displacement of the piston 570 and cause a dose of the liquid drug to be expelled via the injection needle. A dose setting structure is responsive to the mounting of a removable cap 580 to place the injection device 501 in a prepared or loaded state with a dose of liquid drug of a first size. The dose setting structure comprises a pusher 550 configured for engagement with the removable cap 580 and axially displaceable by mounting of the removable cap 580 . The pusher 550 is configured for engaging a sliding element 535 and axially displaces the sliding element 535 in proximal direction, i.e. towards the injection button 505 . The displacement of the sliding element 535 leads to a loading or preparation of the injection device 501 with a dose of liquid drug of the first size as explained in further detail below. The sliding element 535 comprises teeth engaging mating teeth of the toothed elongate piston rod 530 or piston rod. The mating teeth of the sliding element 35 and the piston rod 530 are configured to solely allow unidirectional displacement in proximal direction of the sliding element 535 relative to the toothed elongate piston rod 530 or piston rod. Consequently, the piston rod 530 is advanced together with the sliding element 535 when the latter moves in an opposite direction, i.e. a distal direction towards the second or distal position defined by the fixed distal clamping structure formed as a cut-out or shelf in the housing 520 . [0061] The sliding element 535 is coupled to a helical compression spring 525 co-axially arranged around a tubular portion of the sliding element 535 . The compression spring 525 is torsionally pre-tensioned and compressible by proximal displacement of the sliding element 535 during a loading sequence of the injection device 501 . The loading sequences therefore causes potential energy or compression force to be stored in the helical compression spring 525 for release in connection with forward firing or advancement of the piston rod 530 and movable piston 570 during injection of the liquid drug. One end portion of the compression spring 525 engages the sliding element 535 and an opposing end portion engages a spring base 515 rigidly attached to the housing 520 . [0062] The injection device 501 furthermore comprises user operable dose adjustment structure or dose dial 555 configured to, in the prepared or load state, increase or decrease the dose of the first size to set a dose of a second size. The dose dial 555 is configured to adjust an axial position of an axially translatable finger (refer to item 537 on FIGS. 7 a )- b ) so as to vary the dose size in accordance with the user's adjustment of the dose dial 555 as explained in further detail below. A fixed position distal clamping structure 560 or distal shelf is formed in the housing 520 and defines an end-stop for advancement of the axially translatable finger of the sliding element 535 . [0063] The user operable dose adjustment structure additionally comprises a clutch mechanism configured to decouple the dose setting structure from the injection structure in the prepared state. The clutch mechanism comprises a pusher 550 configured to selectively engage or disengage a toothed nut 540 operatively coupled to the piston rod 530 as as explained in further detail below in connection with FIGS. 6 b )- 6 f ). [0064] The injection button 505 is configured to noticeably project from the housing 520 in the prepared state of the injection device 501 as depicted on FIG. 6 d ) to indicate a current state of the injection device 501 to the user or patient. By depression of the injection button 505 in the prepared state, a firing sequence is initiated where the sliding element 535 is released from the proximal clamping structure and the piston rod 530 advanced from a first or proximal position relative to the housing 501 to the second or distal position in an unprepared or unloaded state of the injection device 501 . A predetermined axial distance between the first and second positions accordingly corresponds to the delivery of the dose of the second size. [0065] The clutch mechanism comprises a toothed nut 540 , a nut spring 545 and a toothed inner peripheral surface of the pusher 550 . The clutch mechanism is configured to decouple the dose setting structure from the injection structure in the prepared state of the injection device so as to allow dose adjustment in the prepared state by actuation of the dose dial 555 without advancing the toothed piston rod 530 and piston 570 and spillage of liquid drug as explained in further detail below. [0066] FIG. 6 a ) illustrates a first step of a loading and firing sequence of the injection device 501 where the device is loaded or prepared. In connection with the first step, loading or preparation is initiated by the user by twisting the replaceable cap 580 onto the injection device 501 following a helical trajectory as indicated by arrow 672 . [0067] FIG. 6 b ) illustrates a second step of a loading and firing sequence of the injection device 501 where the device is loaded or prepared. The pusher 550 is the first portion of the dose setting structure to move in response to mounting of the removable cap 580 . As previously explained, the piston rod 530 can only move axially in one direction, a distal direction, relative to the housing 520 of the injection device. This effect is created by a pair of one way snaps 552 mounted in the housing 520 and engaging the teeth on piston rod 530 . The pusher 550 is rotationally locked to the housing 520 . The pusher 550 is axially displaced by the twisting operation of the removable cap 580 , but the toothed nut 540 , which is rotatably mounted on the piston rod 530 , stands still due to an inner thread (not shown) that engages a mating thread on the piston rod 530 . The disengagement between the toothed nut 540 and the pusher 550 allows the toothed nut 540 to rotate as it is pushed proximally/upwards by the pusher 550 and the nut spring 545 . The toothed nut 540 will start to rotate about the piston rod 530 due to the threaded non-locking interface with the mating teeth on the piston rod 530 . [0068] The teeth of the toothed nut 540 are arranged around a circumferential outer perimeter of the toothed nut 540 . The teeth of the pusher 550 , which are arranged on an inner tubular surface of the pusher 550 as explained above, are forced to disengage the mating teeth on the toothed nut 540 by this translation due to an axially directed biasing force supplied by the nut spring 45 . The toothed nut 540 can now rotate freely about the piston rod 530 . In effect, the dose setting structure has been decoupled from the injection structure because the piston rod 530 is no longer operatively coupled to the sliding element 535 . [0069] FIG. 6 c ) illustrates third step of the loading and firing sequence of the injection device 501 where the device is loaded or prepared. In this step, the helical compression spring 525 is compressed and loaded with axial force and a torque. The axial force is later on used to supply dose delivery force or energy during a user initiated firing or dose delivery sequence as explained below. The torque is obtained by torsionally pre-tensioning the helical compression spring 525 and using this torque to rotate the sliding element 535 about the axis of the housing 501 into engagement with a proximal clamping structure at a first or proximal position of the piston rod 530 . The helical twisting of the removable cap 580 is configured to axially translate the pusher 550 and the sliding element 535 to a first position guided by an axial slot 532 (depicted on FIG. 6 d )) in a annular wall section of the housing 520 . At the first position, the circumferentially extending slot or channel 532 in the tubular wall section guides rotary movement of the sliding element 535 about the longitudinal housing axis 503 . The combination of the axial slot and the circumferentially extending slot 532 forms an L-shaped slot in the housing 520 . The toothed nut 540 is free to rotate in the non-self locking thread engaging the piston rod 530 when the pusher 550 and the sliding element 535 translate. [0070] FIG. 6 d ) illustrates the fourth step of the loading and firing sequence where the injection device 501 is loaded or prepared. The sliding element 535 will rotate because of the freedom in the housing and the torque generated by the helical compression spring 525 . Furthermore, the injection button 505 is rotated and axially translated, in response to the axial displacement and rotation of the sliding element 535 , from an unloaded or unprepared state indicated by its non-protruding placement inside the housing 520 of injection device to a loaded or prepared state indicated by the protruding placement depicted in FIG. 6 d ). Consequently, after completion of step 4 , the injection device 501 is rendered in its prepared or loaded state with the removable cap mounted on the injection device 501 . The sliding element 535 rests in the circumferentially extending slot 532 in the housing 520 with the sliding element 535 decoupled from the pusher 550 . It is now possible to adjust an axial position of the axially translatable finger (refer to item 537 on FIGS. 7 a )- b ) movably mounted in the sliding element 535 . The adjustment of the axial position of the finger leads to an adjustment of the size of the dose as explained in further detail below. The adjustment of the dose size is accomplished by actuating the dose dial 555 by the user or patient as explained in further detail below in connection with FIGS. 7 a )- b ). [0071] FIG. 6 e ) illustrates the fifth step of the loading and firing sequence of the injection device 501 where the device 501 fired or unloaded. The sliding element 535 rests in the circumferentially extending slot 532 in the housing 520 when the removable cap 580 is removed by the user as explained above. When the injection button 505 is depressed as indicated by the arrow adjacent to the button 505 , a first movement of the injection button 505 will disengage mating teeth structures arranged on the injection button 505 and dose adjustment structure. The injection button 505 comprises a radially and inwardly projecting toothed annular structure coupled to mating teeth extending radially outwardly from a tubular proximal end section 539 of the sliding element 535 . After the first movement, the sliding element 535 is able to rotate freely. [0072] FIG. 6 f ) illustrates the sixth step of the loading and firing sequence where the injection device 501 is fired or unloaded. In connection with the first movement of the injection button 505 , the pusher 550 will translate a small distance axially and engage with the toothed nut 450 so as to rotationally lock to, or engage, the toothed nut 540 by virtue of the mating sets of teeth arranged on the pusher 550 and the toothed nut 540 as explained above. [0073] When the injection button 505 is depressed further as indicated by the arrow adjacent to the button 505 , the sliding element 535 is also forced to rotate due to a helical spiralling movement of the injection button 505 under engagement with the end surface of the sliding element 535 . The rotary movement of the sliding element 535 is guided by the circumferentially extending slot 532 and continues until the sliding element 535 reaches the axial slot (not shown) in the housing 520 . [0074] FIG. 6 g ) illustrates the sixth step of the loading and firing sequence where the injection device 501 is fired or unloaded. When the sliding element 535 reaches the axial slot in the housing 520 , the sliding element 535 is translated axially in distal direction because of the axial force generated by the compressed helical compression spring 525 . The toothed nut 540 will translate axially in a corresponding manner because of the locked engagement with the pusher 550 . The toothed nut 540 will subsequently advance the piston rod 530 axially and distally since these components are axially locked to each other. The advancement of the piston rod 530 will lead to a corresponding advancement of the movable piston 570 inside the cartridge 585 so as to make a dosing in accordance with the user selected dose size. The depicted end-of-dose or second position of the piston rod 530 is reached once the axially translatable finger (not shown) reaches the distal shelf or end-stop 560 engraved into the housing 520 as explained below in further detail in connection with FIG. 7 a ). [0075] FIG. 7 a ) is a central cross-sectional view of a user operable dose adjustment structure of the injection device 501 depicted on FIG. 5 . As previously explained, the dose dial 555 is integrated with the injection button 505 . Adjustment of an already set first dose size, i.e. set during the above-described loading steps of the injection device, is achieved by rotation of the dose dial 555 . As previously explained, a radially and inwardly projecting toothed annular structure of the injection button is coupled to the radially and outwardly projecting teeth arranged on the tubular proximal end section 539 of the sliding element 535 . Rotation of the dose dial 555 causes axial translation or movement of the position of the finger 537 as indicated by the axially pointing arrows 538 on FIG. 7 b) due to a threaded interface 536 between a lower tubular portion of the sliding element 535 and the finger 537 in connection with the allocated space in the housing for axial movement of the latter as illustrated. Axial movement of the finger 537 changes the axial distance AD between the finger 537 and the fixed position distal shelf 560 , which defines an end-stop for the finger 537 at engagement as explained above. The end-stop also functions as an end-stop for the residual part of the sliding element 535 and therefore defines a second or distal position of the piston rod 530 after dose delivery due to the interlocked engagement between the sliding element 535 and piston rod 530 during distal advancement in connection with the above-described firing or delivery sequence. In the illustrated situation, the axial distance travelled by the piston rod 530 from the first or proximal position in the prepared state to the second position in the unprepared state is [0076] AD and corresponds to the delivery of the set dose after a possible user adjustment of an initially set first dose size by manipulation of the dose dial 555 . Therefore, adjustment of the axial position of the finger 537 will adjust the travel distance AD of the piston rod 530 in a corresponding manner and adjust the size of the delivered dose of liquid drug. FIG. 7 c ) is a central cross-sectional view of an end-of-content feature of the injection device depicted on FIGS. 5 a )- b ) under normal operating conditions. Under the normal operating conditions, the piston rod 530 is sequentially advanced in axial direction for each new dose delivery. As explained above, the sliding 535 element rotates about the central axis when it reaches the circumferentially extending slot or channel in the tubular wall section of the housing in connection with the loading sequence and the firing sequence. However, in the end of content mode depicted on FIG. 7 d ), the sliding element 535 is prevented from further rotation. A projection 531 arranged in an end portion of the piston rod 530 engages a mating cut out in the finger 537 of the sliding element 535 and locks the piston rod 530 for rotation. If the removable cap is mounted on the injection device by the user in this end of content mode, the sliding element 535 will translate and seek to rotate when it is possible. However, the finger 537 forms part of the sliding element 535 and is rotationally locked thereto. If the injection device is in the end of content mode, the sliding element 535 is blocked for rotation because the finger 537 and the piston rod 530 are unable to rotate. Since the injection button 505 is advanced to its projecting position, indicating a prepared or loaded state of the injection device, by rotation of the sliding element 535 , the injection button 505 will stay in the illustrated depressed state (not protruding from the housing 520 ) and indicate to the user that the injection device has been emptied. [0077] While the above-described injection devices have been designed as disposable devices, the skilled person will understand that the each of the disclosed injection devices by suitable modifications could be provided with suitable means for cartridge replacement to provide a durable injection device.

1a

This is a continuation of application Ser. No. 08/285,135 filed on Aug. 3, 1994, now abandoned. BACKGROUND OF THE INVENTION The present invention generally relates to a luer needle unit and an injector for medical use, and more particularly to a luer needle unit used along with a prefilled syringe, that is, a syringe having pharmaceutical liquid preliminarily filled therein and which allows setting of a disposable needle thereto, and an injector using the luer needle unit. An injector of the aforementioned type has been constructed having various structural configuration. For example, in an injector disclosed in Japanese Utility Model Laid-Open Publication No. 2-96149 (96149/1990), a luer needle is preliminarily set to a supporting cap for supporting it fitted at a mouth of a prefilled syringe. While a needle part of the luer needle is held not to penetrate a sealing cap of the syringe before the use, a disposable needle is fixed at the outside of the luer needle and pressed together with the luer needle to the syringe at the time it is used, whereby the needle part pierces the sealing cap to allow the pharmaceutical liquid in the syringe to flow out through the needle part. In the above construction, since it is necessary to rotate and pull out disposable needle from the syringe after the use in order to dispose of the disposable needle, in some cases, the luer needle alike is rotated and inadvertently taken out concurrently with the disposable needle. The needle part of the pulled out luer needle may hurt the fingers or the like of a user. Moreover, at the setting time of the luer needle to the supporting cap after the supporting cap is fitted at the mouth of the syringe, it may undesirably take place that the needle part of the luer needle pierces the supporting cap due to the absence of a guiding member for the needle part. Therefore, it has been difficult to set the luer needle to the supporting cap. SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a luer needle unit and an injector effectively preventing a user's fingers from being hurt when a disposable needle is to be detached from a luer needle after use while allowing simple and positive mounting of the luer needle to a supporting cap. In accomplishing this and other objects, according to one aspect of the present invention, there is provided a luer needle unit comprising: a luer needle supporting cap to be fitted at a mouth of a syringe having pharmaceutical liquid filled therein beforehand, and a luer needle having one needle part which is selectively held in engagement with the supporting cap at a non-use position where the needle part does not pierce a syringe cap provided at the mouth of the syringe and at a use position where the needle part pierces the syringe cap and, to which a disposable needle is setable, wherein the supporting cap has a flange portion, a cylindrical guiding projecting portion extending at one side of the flange portion and having a through hole through which the needle part is penetrable, and a cylindrical portion extending at the other side of the flange portion to be fitted in the mouth of the syringe, so that a fitting portion of the luer needle is fitted outside the guiding projecting portion due to guidance of the guiding projecting portion, guide protrusions extend in an axial direction of the syringe at one of the confronting surfaces of the supporting cap and luer needle, which are engaged with guide recesses formed at the other of the confronting surfaces of the supporting cap and the luer needle in the axial direction of the syringe, thereby prohibiting relative rotation of the luer needle and the supporting cap and to guide engagement of the luer needle with the supporting cap in the axial direction of the syringe, and a distance at the two positions of the luer needle to the supporting cap is not smaller than a sum of an axial distance between a front end and a base end of a notch portion of the needle part of the luer needle and a thickness of the syringe cap. According to another aspect of the present invention, there is provided an injector equipped with a luer needle unit comprising: a luer needle supporting cap to be fitted at a mouth of a syringe having pharmaceutical liquid filled therein beforehand, and a luer needle having one needle part which is selectively held in engagement with the supporting cap at a non-use position where the needle part does not pierce a syringe cap provided at the mouth of the syringe and at a use position where the needle part pierces the syringe cap and, to which a disposable needle is setable, wherein the supporting cap has a flange portion, a cylindrical guiding projecting portion extending at one side of the flange portion and having a through hole through which the needle part is penetrable, and a cylindrical portion extending at the other side of the flange portion to be fitted in the mouth of the syringe, so that a fitting portion of the luer needle is fitted outside the guiding projecting portion due to guidance of the guiding projecting portion, guide protrusions extend in an axial direction of the syringe at one of the confronting surfaces of the supporting cap and luer needle, which are engaged with guide recesses formed at the other of the confronting surfaces of the supporting cap and the luer needle in the axial direction of the syringe, thereby prohibiting relative rotation of the luer needle and the supporting cap and to guide engagement of the luer needle with the supporting cap in the axial direction of the syringe, and a distance at the two positions of the luer needle to the supporting cap is not smaller than a sum of an axial distance between a front end and a base end of a notch portion of the needle part of the luer needle and a thickness of the syringe cap. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and features of the present invention will become clear from the following description taken in conjunction with the preferred embodiments thereof with reference to the accompanying drawings, in which: FIG. 1 is a sectional view of a part of an injector with a luer needle unit in one embodiment of the present invention; FIG. 2 is an exploded perspective view of the luer needle unit of FIG. 1; FIGS. 3A, 3B and 3C are a plane view of the upper half of the luer needle unit before the injector is used, a sectional view of the injector taken along a line II--II of FIG. 3A, and a bottom view of the lower half of the injector, respectively; FIGS. 4A, 4B and 4C are a plan view of the upper half of the luer needle unit when the injector is used, a sectional view of the injector taken along a line III--III of FIG. 3A, and a bottom view of the lower half of the injector, respectively; FIG. 5 is an enlarged view of a front end of a needle; FIG. 6 is an exploded perspective view of a luer needle unit in another embodiment of the present invention; and FIGS. 7A, 7B, 7C, and 7D are a plan view of the upper half of the luer needle unit of FIG. 6 before an injector is used, a sectional view of the injector of the luer needle unit, a bottom view of the lower half of the injector, and a sectional view of a supporting cap respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Before the description of the present invention proceeds, it is to be noted that like parts are designated by like reference numerals throughout the accompanying drawings. A preferred embodiment of the present invention will be described in detail with reference to FIGS. 1-7. As shown in FIG. 1, an injector according to the embodiment has a syringe cap 5 provided at a mouth 6a of a syringe 6 in which pharmaceutical liquid is already filled. A needle part 3 of a luer needle 2 is penetrable through the syringe cap 5. A luer needle supporting cap 4 is set at the mouth 6a so that the luer needle 2 can be held in engagement with the supporting cap 4 at two positions, that is, a non-use position where a front notch portion 3a of the needle part 3 of the luer needle 2 does not pierce the syringe cap 5 and a use position where the front notch portion 3a penetrates the syringe cap 5. At the same time, a disposable needle 1 can be set to the luer needle 2. The luer needle unit is thus composed of the supporting cap 4 and the luer needle 2. The disposable needle 1 has a needle main body 1a and a generally cylindrical fitting part lb which supports the needle main body 1a and can be fitted into the outer periphery of the luer needle 2. The fitting part 1b is desirably formed of transparent material so that a blood vessel is confirmed at a hollow 1c between the luer needle 2 and the main body 1a. As shown in FIGS. 1-3, the mouth 6a of the syringe 6 is so constructed that an inner surface of a through hole 6b and an outer end face of the mouth 6a are kept in tight contact with the syringe cap 5 made of elastic material such as rubber or the like. Pharmaceutical liquid is sealed in the syringe 6. The syringe cap 5 has a flange portion 5b able to be tightly held in touch with the outer end face of the mouth 6a and, a cylindrical leg portion 5a extended from the flange portion 5b and tightly fitted in the through hole 6b of the mouth 6a. A front end of the needle part 3 of the luer needle 2 is accommodated in an inner fitting recess 5d of the leg portion 5a as will be described later. The needle part 3 pierces a bottom 5e of the inner fitting recess 5d when the injector is used. The supporting cap 4 is generally an integral body of two, large and small cylindrical portions 4a, 4b, respectively via a flange portion 4f. More specifically referring to FIGS. 1-3, the lower cylindrical portion 4a of a larger diameter projecting downward from the flange portion 4f has an engaging projection 4i at the inner peripheral face at the lower end thereof. The supporting cap 4 is accordingly securely fitted at the outer peripheral part of the mouth 6a of the syringe 6, and prevented from slipping off from the mouth 6a. An annular protrusion 4j like a wedge in section is formed at the lower inner face of the flange portion 4f. When the engaging projection 4i is fitted at the syringe mouth 6a, the annular protrusion 4j is pressed in the upper surface of the syringe cap 5 thereby to enhance the contact between the syringe mouth 6a and the syringe cap 5. A cylindrical guide portion 4d of a small diameter extends downwardly from the central part of the lower face of the flange portion 4f inside the lower cylindrical portion 4a, which is fitted into the inner recess 5d of the syringe cap 5 to smoothly guide the needle part 3 of the luer needle 2 in the axial direction along a needle through hole 4e thereinside. The provision of the cylindrical guide portion 4d is not necessarily required if it is not necessary to guide the needle part 3 in the axial direction. The upper cylindrical portion 4b of a smaller diameter than that of the lower cylindrical portion 4a projects at the upper side of the flange portion 4f which is an upper end face of the lower cylindrical portion 4a. Further, a guiding projecting portion 4g projects upward from the central part at the upper face of the flange portion 4f so as to guide the luer needle 2 in the axial direction when the luer needle 2 is fitted into the supporting cap 4, as will be described later. A through hole 4c formed at the central part of the guiding projecting portion 4g serves to guide the luer needle part 3 smoothly. As indicated in FIG. 3A, there are also provided eight rectangular, curved guiding recesses 4k, in the inner peripheral face of the upper cylindrical portion 4b. The guiding recesses 4k are separated equal distances in the circumferential direction and elongated in the axial direction of the upper cylindrical portion 4b. An annular engaging protrusion 4m in the shape of a projecting wedge in section extends at the inner peripheral face of the upper end of the upper cylindrical portion 4b in the circumferential direction orthogonal to the axial direction of the syringe 6. The luer needle 2 has a through hole 2a at the upper face of a main body 2j. The through hole 2a is smaller in diameter than the needle part 3. Moreover, the luer needle 2 has a fitting recess 2b continuous with the through hole 2a. As the needle part 3 is fitted and bonded into the fitting recess 2b, the luer needle 2 is fixed to be unable to move in the axial direction. Since the diameter of the through hole 2a is made smaller than that of the needle part 3, the needle part 3 is surely prevented from popping up from the luer needle 2, namely, towards the disposable needle when the luer needle 2 is pressed towards the supporting cap 4 from the non-use position to the use position. A reference 2c in FIG. 3B indicates a conical surface to smoothly guide the needle part 3 from below the luer needle 2 into the fitting recess 2b. A cylindrical fitting portion 2h extends in the axial direction of the syringe 6 at the lower side of the main body 2j. The fitting portion 2h is set in a luer needle-insertion recess 4h formed between the cylindrical guiding projecting portion 4g and the upper cylindrical portion 4b of the supporting cap 4, and the guiding projecting portion 4g of the supporting cap 4 is fitted in a recess 2g inside the cylindrical fitting portion 2h. In other words, the fitting portion 2h is guided by the guiding projecting portion 4g at the inside thereof, and also by the upper cylindrical portion 4b at the outside thereof. Therefore, the luer needle 2 is more smoothly inserted into the supporting cap 4. The needle part 3 of the luer needle 2 is smoothly guided in the axial direction owing to the through hole 4c in the guiding projecting portion 4g and the through hole 4e of the cylindrical guide portion 4d communicating with the through hole 4c. The cylindrical fitting portion 2h has four guide protrusions 2d spaced an equal distance in the circumferential direction and elongated in the axial direction at the outer face thereof. Therefore, when the guide protrusions 2d are engaged with four of the eight guide recesses 4k of the supporting cap 4, the luer needle 2 is smoothly guided in the axial direction to be fitted to the supporting cap 4. At the same time, the relative rotation of the luer needle 2 to the supporting cap 4 is prevented when the luer needle 2 is set to the supporting cap 4 or when the disposable needle 1 is removed. Furthermore, at the lower and upper ends of the outer peripheral face of the cylindrical fitting portion 2h of the luer needle 2, engaging recesses 2f, 2e are formed in the shape of a recessed wedge in section and are elongated in the orthogonal direction to the axial direction of the syringe 6. At the non-use position where the front end of the needle part 3 of the luer needle 2 does not pass through the syringe cap 5 before use, the engaging protrusion 4m of the supporting cap 4 is engaged with the engaging recess 2f at the lower end of the luer needle 2. On the other hand, at the use position with the front notch portion 3a of the needle part 3 penetrating the syringe cap 5, the engaging protrusion 4m is engaged with the upper engaging recess 2e of the luer needle 2. The distance A shown in FIG. 4B between the two positions, i.e., non-use position and use position of the luer needle 2 to the supporting cap 4 is not smaller than the sum of a distance t in the axial direction between a front end 3c and a base end 3b of the notch portion 3a of the needle part 3 and a thickness m of the syringe cap 5, as shown in FIG. 5. The distance A is set so that, at the non-use position before the notch portion 3a pierces the syringe cap 5, the front end 3c is retained not to penetrate the syringe cap 5 at all, whereas after piercing, the base end 3b is brought to the state fully penetrating the syringe cap 5. By setting the distance A as above, the pharmaceutical liquid in the syringe 6 is positively introduced into the needle part 3 when the luer needle 2 is moved from the non-use position to the use position in the axial direction to the supporting cap 4, because the state where the notch portion 3a of the needle part 3 does not penetrate the syringe cap 5 is changed into the state where the notch portion 3a of the needle part 3 perfectly penetrates the syringe cap 5, i.e., even the base end 3b of the needle part 3 penetrates the syringe cap 5. In the construction described hereinabove, as shown in FIG. 3, the luer needle 2 and the supporting cap 4 are protected by a protecting cover or the like from outside before they are used in the state where the supporting cap 4 is fitted at the mouth 6a of the syringe 6 held in tight contact with the syringe cap 5 and the engaging protrusion 4m of the supporting cap 4 is engaged with the engaging recess 2f at the lower side of the luer needle 2, that is, the luer needle 2 is at the non-use position. Then, when the injector is to be used, a plunger (not shown) is inserted to a gasket (not shown) in the syringe 6 and the disposable needle 1 is fitted outside the luer needle 2. When the luer needle 2 together with the disposable needle 1 is pressed to the supporting cap 4, the lower engaging recess 2f of the luer needle 2 is separated from the engaging protrusion 4m of the supporting cap 4, so that the luer needle 2 is furthermore pressed into the supporting cap 4. As a consequence, the upper engaging recess 2e of the luer needle 2 is engaged with the engaging protrusion 4m of the supporting cap 4, whereby the luer needle 2 is set at the use position. In this state, the front notch portion 3a of the needle part 3 of the luer needle 2 penetrates the syringe cap 5, allowing the pharmaceutical liquid in the syringe 6 to flow outside through the needle part 3. The injector is thus completely assembled. After use of the injector, in order to dispose of the disposable needle 1, the disposable needle 1 is rotated about the axis of the syringe 6 with respect to the luer needle 2 prevented from rotating by the supporting cap 4 and pulled out in the axial direction of the syringe 6 from the luer needle 2. Only the disposable needle 1 can be surely separated easily from the luer needle 2 in the manner discussed above. In the foregoing embodiment, when the luer needle 2 is to be inserted into and fitted to the supporting cap 4, the inner-side guiding projecting portion 4g and the outer-side upper cylindrical portion 4b of the supporting cap 4 guide the fitting portion 2h of the luer needle 2 smoothly in the axial direction, and moreover, the needle part 3 of the luer needle 2 is smoothly guided along the through hole 4c of the guiding projecting portion 4g. Therefore, the luer needle 2 can be smoothly and surely fitted to the supporting cap 4 in a stable manner while the needle part 3 of the luer needle 2 is prevented from piercing the supporting cap 4. The guide protrusions 2d of the luer needle 2 smoothly guide the luer needle 2 in the axial direction in engagement with the guide recesses 4k of the supporting cap 4. The engagement of the guide protrusions 2d with the guide recesses 4k positively prevents the relative rotation of the luer needle 2 and the supporting cap 4. As a result of this arrangement, even when the disposable needle 1 is to be detached by a user from the luer needle 2, in order to dispose of the disposable needle 1 after use of the injector, rotation of the luer needle 2 is rotated along with the disposable needle 1 is prevented as is detachment therefrom to hurt the user by the needle part 3. Because of the provision of the engaging protrusion 4m and the engaging recesses 2e, 2f so as to engage the supporting cap 4 with the luer needle 2 at the non-use position and the use position, the luer needle 2 can be held positively to the supporting cap 4 at the two positions. Moreover, since the distance of the above two positions of the luer needle 2 to the supporting cap 4 is so set as to be not smaller than the sum of the axial distance between the front end and the base end of the notch portion 3a of the needle part 3 of the luer needle 2 and the thickness of the syringe cap 5, when the luer needle 2 is moved with respect to the supporting cap 4 in the axial direction from the non-use position to the use position, the front notch portion 3a of the needle part 3 is changed from the state where the syringe cap 5 is not pierced to the state of completely penetrating the syringe cap 5, i.e., the state where even the base end 3b of the notch portion 3a penetrates the syringe cap 5. Accordingly, the pharmaceutical liquid in the syringe 6 can be positively introduced into the needle part 3. The present invention is not limited to the above embodiment, and can be executed in various embodiments. For instance, instead of the guiding protrusions 2d of the luer needle 2 and the guiding recesses 4k of the supporting cap 4 for preventing the rotation therebetween, guiding recesses can be provided on the luer needle 2 and guiding protrusions can be provided on the supporting cap 4. Although the above guiding protrusions and recesses 2d, 4k are formed between the outer peripheral face of the fitting portion 2h of the luer needle 2 and the inner peripheral face of the upper cylindrical portion 4b of the supporting cap 4 in the above embodiment, it can be so designed as to provide the protrusions and recesses between the inner peripheral face of the fitting portion 2h of the luer needle 2 and the outer peripheral face of the guiding projecting portion 4g of the supporting cap 4. The numbers of the protrusions and recesses are optional. If an odd number of protrusions and recesses are provided, the working force is dispersed in many directions, so that the shift resulting from the size error can be absorbed. Moreover, the supporting cap 4 can have the guiding projecting portion 4g alone at the upper side of the flange portion 4f, with the upper cylindrical portion 4b omitted. In this case, the guiding protrusions and recesses, and the engaging protrusion and recesses are formed between the outer peripheral face of the guiding projecting portion 4g and the inner peripheral face of the fitting portion 2h of the luer needle 2. Instead of disposing the engaging protrusion 4m only at the upper end of the upper cylindrical portion 4b, the protrusion can be formed also at the lower end of the upper cylindrical portion 4b. At the use position, therefore, the two engaging protrusions 4m are fitted with the corresponding engaging recesses 2f, 2e of the luer needle 2, whereby the luer needle is more positively held at the use position and prevented from slipping off from the supporting cap 4 after use. Likewise, the engaging protrusions and recesses can be formed between the outer peripheral face of the guiding projecting portion 4g of the luer needle 2 and the inner peripheral face of the cylindrical fitting portion 2h of the luer needle 2. The sectional shape of the protrusions and recesses need not be a wedge, but can be a circle or a trapezoid or any form so long as it ensures the engagement between the luer needle 2 and the supporting cap 4. The protrusions and recesses need not be formed annularly either. In order to set up the injector, the way is not restricted to the above. Alternatively, the luer needle 2 can be mounted to the supporting cap 4 beforehand at the non-use position, thereby to constitute the luer needle unit. The luer needle unit is assembled with the syringe 6 having the syringe cap 5 tightly secured at the mouth 6a, and kept protected by a protecting cover or the like until the injector is used. Or, the syringe 6 equipped with the syringe cap 5 and the above luer needle unit are protected separately and, at the using time, the syringe 6 and the luer needle unit are assembled to each other and also the disposable needle 1 is set. The engaging recesses 2e, 2f are not necessarily formed in the cylindrical fitting portion 2h as illustrated in FIGS. 2-4, but can be formed on the guide protrusions 2d as are denoted by 20e and 20f in FIGS. 6, 7. In this case, the engaging protrusions 40m are formed inside the guide recesses 4k. In the arrangement as above, engaging faces can be secured at the lower ends of the upper engaging recesses 20e in a direction orthogonal to the axial direction, making it impossible to press the luer needle 2 into the supporting cap 4 from the non-use position to the use position without a certain degree of force. Similarly, the lower engaging recesses 20f can be provided with engaging faces in the orthogonal direction to the axial direction at the upper ends thereof to hinder the detachment of the luer needle 2 from the supporting cap 4 unless not smaller than a certain degree of force acts on the luer needle 2. As shown in FIGS. 6 and 7, a guiding projecting portion 40g of the supporting cap 4 can be formed longer than the upper cylindrical portion 4b thereoutside so as to guide the needle part 3 more stably. Although the present invention has been fully described in connection with the preferred embodiments thereof with reference to the accompanying drawings, it is to be noted that various changes and modifications are apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims unless they depart therefrom.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to an ultrasonic imaging apparatus and a method of acquiring ultrasonic images for generating a Doppler spectrum image. Specifically, it relates to an ultrasonic imaging apparatus and a method of acquiring ultrasonic images that automatically adjust the velocity range of a Doppler spectrum image. [0003] 2. Description of the Related Art [0004] Conventionally known ultrasonic imaging apparatuses concomitantly adopt an ultrasonic pulse reflection method and an ultrasonic Doppler method, in order to obtain cross-sectional images of diagnostic sites and the bloodstream information thereof through ultrasonic manipulation using one ultrasonic probe to display at least the bloodstream information in real time. These ultrasonic imaging apparatuses are used for analyzing the Doppler shift frequency based on the principle of the ultrasonic Doppler method, to obtain bloodstream information from the results of the analysis, the principle of the ultrasonic Doppler method meaning that the received frequency shifts slightly from the transmitted frequency due to the Doppler effect of the ultrasound transmitted to and received at a diagnostic site having a flow such as that of blood in a body, so that the shift frequency (Doppler shift frequency) is proportional to the blood velocity. [0005] In the above-mentioned ultrasonic imaging apparatuses, items (parameters) to be used for a diagnosis are measured for a spectrum image of a Doppler frequency that displays the results of a frequency analysis with the Fast Fourier Transform (FFT) of an obtained Doppler signal in spectrum display with the frequency as the vertical axis, time t as the a horizontal axis, and power (strength) of frequency components as luminance (tone). [0006] The operational flow of this measurement process is described in sequence. (1) On a spectrum image of a Doppler frequency, positions of a maximum flow velocity Vp (V peak) that corresponds to the maximum frequency and a mean velocity Vm (V mean) that corresponds to the mean frequency within a frequency distribution in the axial direction of the frequency are calculated. [0007] (2) Each change in time of the maximum flow velocity Vp and mean flow velocity Vm is traced in the axial direction of the time. (3) On a trace waveform that shows curves of temporal positional changes of the Vp and Vm, a systolic waveform peak PS (Peak of Systolic) and a diastolic waveform peak ED (End of Diastolic) are simultaneously detected during each cardiac cycle (1 heartbeat). (4) Based on information of the PS and ED, various parameters (indexes) for a diagnosis such as an intravascular blood flow volume, HR (Heart Rate) of pulsatile flow, PI (Pulsatility Index), and RI (Resistance Index), etc. are measured, and a process to display those measurements (parameter measurement process) is conducted. [0008] The above-mentioned trace waveform detection processes for Vp and Vm, peak detection processes for PS and ED, and parameter measurement processes such as PI and RI, etc. are basically conducted through manual operation using a freeze image. Moreover, in recent years, ultrasonic imaging apparatuses that conduct the same processes with automatic operation using real-time images have also been widely used. [0009] In the Pulse Doppler (PW) method, a pulse with a predetermined repetition frequency is transmitted and the frequency of the received signal is analyzed with a predetermined sampling frequency. When the sampling frequency fs for this frequency analysis is lower than the Doppler shift frequency, aliasing (folding) occurs. Therefore, to prevent this, it is necessary to increase the pulse repetition frequency (PRF) and shorten the intervals between each observation time. In this case, designating a location to be measured consequently decides the maximum PRF, and once the PRF is decided, the measurable maximum blood velocity is also decided. [0010] This measurable maximum blood velocity is called the velocity range. [0011] For example, to measure the velocity of blood flow that is approximately 30 cm, if a velocity range of approximately 10 cm is set, aliasing occurs and the blood flow cannot be measured. Thus, in this case, it is necessary to set the velocity range at approximately 50 cm. [0012] With a Doppler spectrum display, when the velocity range is too small, a folding portion is generated as described above. In such a case, an operator can manually set the Doppler velocity range at a higher value, by which the folding portion falls within the Nyquist rate (half of the PRF) and a Doppler spectrum image that is smooth on the display can be obtained. [0013] In contrast, when the velocity range is too large, the waveform of a spectrum becomes small, causing difficulty in observation. In such a case, an operator can obtain a Doppler spectrum image that efficiently uses the top and bottom portions of the display screen and is easy to observe by setting the velocity range to a low value. [0014] Moreover, in the ultrasonic Doppler method, a positive sign is assigned to blood flow that goes toward the ultrasonic probe in the direction of blood flow. Moreover, a negative sign is assigned to blood flow that goes away from the probe. When an ultrasonic probe is applied to a specific vessel and the vessel is an artery, the velocity of the blood flow changes depending on heartbeat but does not change between positive and negative, usually placing a disproportionate emphasis on either positive or negative. [0015] For example, with Doppler spectrum display, when a folding portion occurs, an operator may shift the baseline (BL=0) of the Doppler spectrum image by manipulating the baseline shift switch. This is called an adjustment of velocity offset. By shifting this baseline by only −0.25 (amount of baseline shift=−0.25), the folding portion moves beyond the Nyquist rate and a Doppler spectrum that is smooth on the display can be obtained. [0016] A Doppler spectrum image that is obtained with an ultrasonic imaging apparatus will now be described with reference to FIG. 1 . FIG. 1 is a diagram that shows cross-sectional images and Doppler spectrum images acquired by means of an ultrasonic imaging apparatus. A case in which cross-sectional images and Doppler spectrum images are acquired and displayed with a carotid artery as the diagnostic site will now be described. [0017] For example, in a screen 110 , when a vessel shown in an image in which a B-mode cross-sectional image 100 and a color Doppler image 101 are superimposed is designated by a range gate 102 , which is used to designate the location at which a Doppler spectrum image is acquired, a Doppler spectrum image that shows the time change of the blood velocity distribution at that location is obtained and displayed on the screen. On a screen 111 , a Doppler spectrum image 103 with a PRF for determining the velocity range (measurable maximum blood velocity) of 7.1 (kHz) and a velocity offset (BLS: Baseline Shift) of 0 (Hz) is shown (part indicated with a dotted line in the screen 110 ). [0018] Furthermore, for measurement of the state of blood flow based on the shape of the peak determined through an auto trace of the Doppler spectrum image 103 , an operator adjusts the pulse repetition frequency (PRF) and velocity offset (BLS) in a screen 120 so that the state of the blood flow is displayed with a specific ratio in the center of the velocity range (vertical axis). For example, by changing the PRF to 5 (kHz) and shifting the BLS to the negative side, the Doppler spectrum image 103 is enlarged and displayed as shown in screen 121 (part indicated with a dotted line in the screen 120 ). [0019] When measuring the blood velocity, etc. with an ultrasonic imaging apparatus, the blood velocity that is measured changes largely depending on any disorders and the physical condition of the subject, how the probe is applied (angle), the location and width of the intravascular range gate with a PW Doppler, and the diagnostic site. Therefore, conventionally, an operator has performed optimization each time by adjusting the velocity range of the apparatus and shifting the baseline to measure HR, PI, and RI from an enlarged waveform. However, it is cumbersome to adjust the PRF and velocity offset (BLS) to correspond to the velocity range each time the state of blood flow to be diagnosed changes. [0020] Therefore, ultrasonic imaging apparatuses that provide automatic operation for adjustments of the velocity range and velocity offset of a Doppler spectrum image and improved operability of blood flow measurement so that an operator does not need to pay attention to the setup of the apparatus have been proposed (for example, Japanese published unexamined application No. 2005-185731). According to a technique related to the conventional art, a histogram that shows the frequency distribution of a velocity is created by calculating the frequency of a maximum velocity (frequency) based on a Doppler waveform acquired at a predetermined timing (for example, 1 heartbeat), and based on the histogram, the velocity range is determined so that the Doppler waveform is displayed within α % (for example, 70%) of the vertical direction of the display area, and feedback is given. [0021] At this time, to automatically adjust the velocity range of a Doppler spectrum image, stability and reliability during the measurement of a Doppler spectrum are important issues. However, the circulatory organs (heart) have valves to circulate blood, etc., and therefore signals (hereinafter referred to as “valve signals”) are generated when the valves operate. Therefore, with a conventional ultrasonic imaging apparatus, it was difficult to automatically adjust the velocity range for only a blood flow component, particularly for Doppler blood flow diagnoses of a circulatory organ (heart), because valve signals with high power are incorporated along with blood flow signals. SUMMARY OF THE INVENTION [0022] The present invention purposes to provide an ultrasonic imaging apparatus that estimates a waveform that corresponds to an intended cardiac phase and is not affected by the waveforms of valve signals, that automatically excludes any areas incorporating valve signals in a cardiac phase from a measured blood velocity waveform based on the estimated waveform, and that creates a measured blood flow waveform with the effects of the valve signals excluded by interpolating the excluded parts. [0023] Moreover, it purposes to provide an ultrasonic imaging apparatus that automatically excludes any area that incorporates valve signals in a cardiac phase from a measured blood velocity waveform based on an estimated waveform, and that automatically adjusts the velocity range based on the measured blood velocity waveform with the valve signals excluded. [0024] An ultrasonic imaging apparatus of the first aspect of this invention comprises a transceiving part, a Doppler signal-processing part, a memory part, a measured waveform calculation part, an ECG waveform acquisition part, a waveform estimation part, and an interpolation part. Moreover, the transceiving part transmits and receives ultrasound with a repetition frequency that corresponds to a velocity range indicating the measurable velocity to and from a diagnostic site that contains a moving fluid within the body to be examined. The Doppler signal-processing part generates a Doppler spectrum image that shows the velocity of the moving fluid based on signals obtained from the transmission and reception of the ultrasound. The memory part preliminarily stores values that have been modeled based on a model that correlates the standard blood velocity waveform with the ECG waveform. The measured waveform calculation part calculates the measured blood velocity waveform based on the spectrum image of a specified patient. The ECG waveform acquisition part acquires the ECG waveform at a timing corresponding to the measured blood velocity waveform. The waveform estimation part estimates the blood velocity waveform while excluding the effects of valve signals of the patient based on the measured blood velocity waveform, the ECG waveform, and the modeled value. The interpolation part compares the measured blood velocity waveform with the estimated blood velocity waveform, excludes excess parts of the difference over a threshold from the measured blood velocity waveform, and interpolates the excluded parts of the measured blood velocity waveform. [0025] According to this first aspect, a blood velocity waveform with the effects of valve signals excluded can be generated automatically. Through this, a Doppler spectrum image that is not affected by valve signals and that is easy to trace can be generated, enabling the improvement of measurement accuracy of blood flow volume, etc. [0026] Moreover, an ultrasonic imaging apparatus of the second aspect of this invention comprises a transceiving part, a Doppler signal-processing part, a memory part, a measured waveform calculation part, an ECG waveform acquisition part, a waveform estimation part, and a velocity range setup part. Moreover, the transceiving part transmits and receives ultrasound with a repetition frequency that corresponds to a velocity range indicating the measurable velocity to and from a diagnostic site that contains a moving fluid within the body to be examined. The Doppler signal-processing part generates a Doppler spectrum image that shows the velocity of the moving fluid based on signals obtained from the transmission and reception of the ultrasound. The memory part preliminarily stores values that have been modeled based on a model that correlates the standard blood velocity waveform with the ECG waveform. The measured waveform calculation part calculates the measured blood velocity waveform based on the spectrum image of a specified patient. The ECG waveform acquisition part acquires the ECG waveform at a timing corresponding to the measured blood velocity waveform. The waveform estimation part estimates the blood velocity waveform excluding the effects of valve signals of the patient based on the measured blood velocity waveform, the ECG waveform, and the modeled value. The velocity range setup part compares the measured blood velocity waveform with the estimated blood velocity waveform and calculates the velocity range based on the measured blood velocity waveform while excluding excess parts of the difference over a threshold. [0027] According to this second aspect, an optimum velocity range that corresponds to a blood velocity waveform with the effects of valve signals excluded can be calculated automatically. Thereby, a Doppler spectrum image that is easy for an operator to read can be generated. [0028] An ultrasonic imaging apparatus of the third aspect of this invention comprises a transceiving part, a Doppler signal-processing part, a memory part, and an abnormality determination part. Moreover, the transceiving part transmits and receives ultrasound with a repetition frequency based on a velocity range indicating the measurable velocity to and from a diagnostic site that contains a moving fluid within the body to be examined. The Doppler signal-processing part generates a Doppler spectrum image that shows the velocity of the moving fluid based on signals obtained from the transmission and reception of the ultrasound. The memory part preliminarily stores values that have been modeled on a model of a commonly used standard blood velocity waveform based on statistical data of an individual ECG waveform and a corresponding standard blood velocity waveform. The abnormality determination part creates a state space, which is an area that includes a blood velocity waveform that can be considered as a normal state based on statistical data of the individual ideal blood velocity waveform, and it determines that a blood velocity is abnormal when the Mahalanobis' distance of the measured bloodstream information from the state space exceeds a predetermined threshold. [0029] According to this third aspect, any abnormality in blood velocity can be determined automatically. Thereby, oversights of abnormalities in blood velocity can be reduced and abnormalities can be detected at an early stage. [0030] The fourth aspect of this invention is a method of acquiring ultrasonic images comprising: a transceiving step that transmits and receives ultrasound with a repetition frequency that corresponds to a velocity range indicating the measurable velocity to and from a diagnostic site that contains a moving fluid within the body to be examined; a Doppler signal-processing step that generates a Doppler spectrum image that shows the velocity of the moving fluid based on signals obtained from the transmission and reception of the ultrasound, a memory step that preliminarily stores values that have been modeled based on a model that correlates the standard blood velocity waveform with the ECG waveform; a measured waveform calculation step that calculates the measured blood velocity waveform based on the spectrum image of a specified patient; an ECG waveform acquisition step that acquires the ECG waveform at a timing corresponding to the measured blood velocity waveform; a waveform estimation step that estimates the blood velocity waveform of the patient based on the measured blood velocity waveform, the ECG waveform, and the modeled value; and an interpolation step that compares the measured blood velocity waveform with the estimated blood velocity waveform, excludes excess parts of the difference over a threshold from the measured blood velocity waveform, and interpolates the excluded parts of the measured blood velocity waveform. [0031] The fifth aspect of this invention is a method of acquiring ultrasonic images comprising: a transceiving step that transmits and receives ultrasound with a repetition frequency that corresponds to a velocity range indicating the measurable velocity to and from a diagnostic site that contains a moving fluid within the body to be examined; a Doppler signal-processing step that generates a Doppler spectrum image that shows the velocity of the moving fluid based on signals obtained from the transmission and reception of the ultrasound; a memory step that preliminarily stores values that have been modeled based on a model that correlates the standard blood velocity waveform with the ECG waveform; a measured waveform calculation step that calculates the measured blood velocity waveform based on the spectrum image of a specified patient; an ECG waveform acquisition step that acquires the ECG waveform at a timing corresponding to the measured blood velocity waveform; a waveform estimation step that estimates the blood velocity waveform of the patient based on the measured blood velocity waveform, the ECG waveform, and the modeled value; and a velocity range setup step that compares the measured blood velocity waveform with the estimated blood velocity waveform and calculates the velocity range based on the measured blood velocity waveform while excluding excess parts of the difference over a threshold. BRIEF DESCRIPTION OF THE DRAWINGS [0032] FIG. 1 is a diagram that shows cross-sectional images and Doppler spectrum images acquired with an ultrasonic imaging apparatus. [0033] FIG. 2 is a block diagram of an ultrasonic imaging apparatus related to Embodiment 1. [0034] FIG. 3 is a diagram of a flowchart illustrating a sequence of actions of an ultrasonic imaging apparatus related to Embodiment 1. [0035] FIG. 4A is a diagram of a graph for calculating a blood velocity waveform using an ultrasonic imaging apparatus related to the present invention; FIG. 4B is a diagram of a graph when the velocity range of the collective waveforms was set up manually in a conventional ultrasonic imaging apparatus; FIG. 4C is a diagram of a graph that shows an ideal velocity range of an example blood velocity waveform; and FIG. 4D is a diagram of a graph when the velocity range of a blood velocity waveform was set up using an ultrasonic imaging apparatus related to Embodiment 1. [0036] FIG. 5 is a diagram illustrating a parametric model for system identification. [0037] FIG. 6 is a block diagram of an ultrasonic imaging apparatus related to Embodiment 2. DETAILED DESCRIPTION OF THE EMBODIMENTS Embodiment 1 [0038] An ultrasonic imaging apparatus and a method of processing ultrasonic images related to Embodiment 1 of this invention will now be described. FIG. 2 is a block diagram that shows a skeleton framework of the ultrasonic imaging apparatus related to Embodiment 1 of the present invention. [0039] The ultrasonic imaging apparatus 1 related to Embodiment 1 is operable according to known modes such as a B-mode that displays an ultrasonic cross-sectional image (B-mode cross-sectional image), a Doppler mode (pulse Doppler (PW) or continuous Doppler (CW)) that displays bloodstream information, and a CFM (Color Flow Mapping) mode that 2-dimensionally displays bloodstream information, etc. [0040] For an ultrasonic probe 2 , a 1-dimensional ultrasonic probe with a plurality of ultrasonic transducers aligned in one line in a predetermined direction (scanning direction) and a 2-dimensional ultrasonic probe with ultrasonic transducers arranged in a matrix are used. [0041] A transceiving part 3 comprises a transmission part (not shown) that supplies electrical signals to the ultrasonic probe 2 to generate ultrasound and a receiving part (not shown) that receives signals from the ultrasonic probe 2 . [0042] The transmission part of the transceiving part 3 comprises a clock generation circuit, a transmission delay circuit, and a pulsar circuit, which are not shown. The clock generation circuit is a circuit that generates a clock signal that decides the transmission timing and the transmitted frequency of an ultrasonic signal. The transmission delay circuit is a circuit that conducts transmission focus by introducing a delay when ultrasound is transmitted. The pulsar circuit incorporates a pulsar for a few minutes for each individual route that corresponds to each ultrasonic transducer, generates a drive pulse at the transmission timing with the delay, and supplies each ultrasonic transducer of the ultrasonic probe 2 . [0043] Moreover, the receiving part of the transceiving part 3 comprises a pre-amp circuit, an A/D conversion circuit, and a reception delay/adder circuit, which are not shown. The pre-amp circuit amplifies any echo signal that is output from each ultrasonic transducer of the ultrasonic probe 2 for each receiving channel. The A/D conversion circuit conducts A/D conversion of the amplified echo signals. The reception delay/adder circuit provides the delay time necessary to decide the receiving directionality for the echo signals after A/D conversion and adds it. The addition emphasizes the reflected components from the direction according to the receiving directionality. Additionally, signals that have been processed for addition by this transceiving part 3 are called “RF signals.” The RF signals output from the transceiving part 3 are output to a B-mode processing part 4 or a Doppler processing part 5 . Furthermore, when the transceiving part 3 receives a repetition frequency (PRF) from a velocity range setup part 95 , it causes the ultrasonic probe 2 to transmit and receive ultrasound according to the repetition frequency. [0044] The B-mode processing part 4 visualizes the amplitude information of the echo and generates B-mode ultrasonic raster data from the echo signals. Specifically, a B-mode processing circuit conducts a band pass filter process of the RF signals and then detects the envelope curve of the output signals and conducts a compression process using logarithmic conversion of the detected data. The B-mode ultrasonic raster data generated by the B-mode processing part 4 is output to a DSC 6 . [0045] The Doppler processing part 5 comprises an orthogonal phase detection part 51 , a range gate (RG) processing part 52 , a wall filter 53 , and an FFT calculation part 54 . [0046] The quadrature detection part 51 incorporates a reference signal from a reference transmitter and a reference signal with a phase difference of 90 degrees with the RF signals output from the transceiving part 3 . The range gate (RG) processing part 52 excludes any high-frequency components from the incorporated signals to obtain Doppler signals that consist of only Doppler shift frequency components and subsequently extracts Doppler signals from an intended depth in the body to be examined. The wall filter 53 excludes any unnecessary low-frequency Doppler signals that are relatively slow in motion, such as signals from vascular walls and cardiac walls, etc. from the Doppler signals in the body to be examined designated by the range gate from the range gate processing part 52 and extracts Doppler signals of the blood flow to be detected. The FFT calculation part 54 conducts a frequency analysis of the Doppler signals extracted by the wall filter 53 , obtains the Doppler spectrum signals, which are the analytical results, and outputs to the DSC (Digital Scan Converter) 6 . Thereby, a Doppler spectrum image is displayed on a display part 8 along with a B-mode cross-sectional image, for example. [0047] Moreover, when the FFT calculation part 54 receives a velocity offset (BLS) from the velocity range setup part 95 , it changes only the read address of the FFT process for the displacement and adjusts the offset of the velocity. [0048] The DSC 6 converts the ultrasonic raster data into image data that is shown in orthogonal coordinates in order to obtain an image that is shown in an orthogonal coordinate system (Scan Conversion process). The image data is output from the DSC 6 to the display part 8 , and an image based on the image data is displayed on the display part 8 . For example, the DSC 6 generates cross-sectional image data as 2-dimensional information based on the B-mode ultrasonic raster data and outputs the cross-sectional image data to the display part 8 . The display part 8 displays a cross-sectional image based on the cross-sectional image data. [0049] An auto range/auto BLS-processing part 9 receives the Doppler spectrum signals output from the FFT calculation part 54 and calculates the optimum velocity range for the Doppler spectrum signals. The auto range/auto BLS-processing part 9 comprises a measured waveform calculation part 91 , an ECG waveform acquisition part 92 , a waveform estimation part 93 , an interpolation part 94 , and a velocity range setup part 95 . The auto range/auto BLS-processing part 9 is described in detail below. [0050] The measured waveform calculation part 91 detects the measured blood velocity waveform of the Vp (hereinafter referred to as “trace”) by detecting the maximum velocity Vp of the Doppler spectrum signals output from the FFT calculation part 54 and connecting in the direction of that time (for example, the detecting phase or pseudo filtering may be used). Thereby, the measured blood velocity waveform of the maximum velocity Vp becomes a waveform that has traced the maximum velocity Vp of the Doppler spectrum image. Subsequently, the measured waveform calculation part 91 calculates a function Vp(t) that indicates the measured blood velocity waveform (hereinafter referred to as “measured blood velocity waveform Vp(t)”) from the detected measured blood velocity waveform. Furthermore, the measured waveform calculation part 91 transmits the measured blood velocity waveform Vp(t) to the waveform estimation part 93 and the interpolation part 94 . [0051] The ECG waveform acquisition part 92 receives a signal from an electrocardiograph 10 , synchronizes the signal with the measured blood velocity waveform calculated by the measured waveform calculation part 91 , and traces the maximum amplitude in the direction of that time to create an ECG waveform. Furthermore, based on the created ECG waveform, the ECG waveform acquisition part 92 creates a function u(t) that indicates the ECG waveform (hereinafter referred to as “ECG waveform u(t)”). Subsequently, the ECG waveform acquisition part 92 transmits the created ECG waveform u(t) to the waveform estimation part 93 . [0052] Based on pre-collected statistical data of the ECG waveform of an individual patient for each age and disorder and an ideal blood velocity waveform of a corresponding individual patient with no effects of valve signals, a memory part 7 conducts system identification using an ARX model (Auto-Regressive exogenous model) in order to model it into a model of a commonly used ideal blood velocity waveform and preliminarily stores a coefficient series of the model. This ideal blood velocity waveform with no effects of valve signals is the “standard blood velocity waveform” in the present invention. Here, the ARX model is a linear time-variant parametric model that is used for system identification and correlates a present output y(t) with limited past output data y(t−k) and input data u(t−k) (for example, refer to “system identification by MATLAB” by Shuichi Adachi, Tokyo Denki University Press). [0053] The method of calculating the above mentioned coefficient series will now be described. Firstly, ages and disorders are classified into groups, and several hundred cases of ECG (Electrocardiogram) waveforms and ideal blood velocity waveforms with no effects of valve signals are collected for each group. At this time, as a method of obtaining an ideal blood velocity waveform, a blood velocity waveform with no effects of valve signals is obtained by measuring the blood velocity at a part with no reciprocal valves in the circulatory organ. Alternatively, for this purpose, a blood velocity waveform with no effects of valve signals is obtained by a physician with experience by manually eliminating the effects of valve signals from a measured blood velocity waveform based on their experience. [0054] Next, based on the collected ECG waveform and ideal blood velocity waveform, system identification using the ARX model is conducted. This is expressed with the following function, in which u(t) indicates an ECG waveform and yi(t) indicates a commonly used ideal blood velocity waveform. [0000] A ( q )* yi ( t )= B ( q )* u ( t−nk )+ e ( t ) e(t): residual difference (i.e., the difference between the expected value and the measured value) nk: time delay from the commonly used ideal blood velocity waveform that corresponds to the ECG waveform [0000] A ( q )=1 +a 1 q −1 + . . . +a na q −na [0000] B ( q )= b 1 +b 2 q −1 + . . .+b nb q −nb+1 [0000] (A(q) and B(q) are irreducible polynomials of shift operator q) na, nb, nk: integer arguments [0057] Therefore, in the memory part 7 , a coefficient in the model of the commonly used ideal blood velocity waveform as shown below is preliminarily stored for each classified group. [0000] a i =( a 1 , a 2 , . . . , a na ), b j =( b 1 , b 2 , . . . , b nb ) [0000] The waveform estimation part 93 estimates the ideal blood velocity waveform for a patient whose blood velocity is currently being measured. This measurement is based on: the measured blood velocity waveform Vp(t) (received from the measured waveform calculation part 91 ); the ECG waveform u(t) (received from the ECG waveform acquisition part 92 ); and the coefficient a i =(a 1 , a 2 , . . . , a na ), b j =(b 1 , b 2 , . . . , b nb ) stored in the memory part 7 . At this time, it is determined which of the above-mentioned groups the patient belongs to, and a coefficient that corresponds to the group is used for the coefficient that is used for the estimation. This estimated waveform is called an estimated waveform ye(t) as described below. This estimated waveform ye(t) can be expressed as follows. [0000] ye ( t )=−Σ{ a i *V p ( t−i )}+Σ{ b j *u ( t−j )} [0058] The waveform estimation part 95 transmits the estimated waveform ye(t) to the interpolation part 94 . [0059] The interpolation part 94 stores the threshold for differences between the measured blood velocity waveform Vp(t) and the estimated waveform ye(t). Here, this threshold is a value indicating that the measured blood velocity waveform Vp(t) is affected by valve signals at that time when the threshold is exceeded by the difference between the measured blood velocity waveform Vp(t) and the estimated waveform ye(t). Therefore, the purpose of this threshold is to exclude the effects of high-speed valve signals, and if approximation to the estimated waveform is strongly requested, almost all values are excluded. Thus, it is preferable to set this threshold according to any requests on how much range should be left as the range of excluded effects of valve signals and a range of the measured blood velocity waveform Vp(t) after excluding the effects of valve signals. Moreover, the interpolation part 94 calculates the difference between the measured blood velocity waveform Vp(t) and the estimated waveform ye(t) in the patient whose received present blood velocity is being measured and determines parts where the difference exceeds the threshold. [0060] In the present embodiment, a threshold is given for both positive and negative sides. However, this threshold may be set using another method. For example, because the value is higher in parts with the effects of valves compared to the estimated waveform, the threshold value may be set only on the positive side when the estimated waveform is subtracted from the measured blood velocity waveform. Moreover, when the measured blood velocity waveform is subtracted from the estimated waveform, the threshold value may be set only on the negative side. Furthermore, the absolute value of the difference between the measured blood velocity waveform and the estimated waveform may be used to set the threshold for the absolute value. [0061] The interpolation part 94 excludes parts exceeding the threshold from the measured blood velocity waveform Vp(t) of the patient whose blood velocity is currently being measured. [0062] Furthermore, the interpolation part 94 plugs the estimated waveform ye(t) into the excluded parts of the measured blood velocity waveform Vp(t). Moreover, the interpolation part 94 interpolates the gap between the estimated waveform ye(t) and the measured blood velocity waveform Vp(t). The method for this interpolation is not limited to any particular kind, and any methods may be used, including linear interpolation, spline interpolation, or interpolation with a linear prediction using the peak of the measured blood velocity waveform. Moreover, in the present embodiment, interpolation is conducted after plugging the estimated waveform ye(t) into the excluded parts, but the excluded parts of the measured blood velocity waveform Vp(t) may be directly interpolated without plugging the estimated waveform ye(t). The method for this interpolation is also not limited to any particular kind, and any methods may be used, including linear interpolation, spline interpolation, or interpolation with a linear prediction using the peak of the measured blood velocity waveform. At this time, because the process of linear interpolation is simple, the burden applied to the interpolation part 94 is small. On the other hand, with spline interpolation and a method of interpolating with a linear prediction using the peak of the measured blood velocity waveform, the processes are complicated but interpolation can be conducted with a smooth curve, and thus a waveform that is closer to the actual waveform can be created. Furthermore, spline interpolation is effective when the interval for interpolation is short, but with the interpolation method of a linear prediction using the peak of the measured blood velocity waveform, interpolation can be conducted even when the interval for interpolation is long. The blood velocity waveform created by this interpolation part 94 is called the “waveform for range setup” as described below. [0063] The interpolation part 94 transmits the waveform for range setup to the velocity range setup part 95 . [0064] The velocity range setup part 95 conducts statistical computing to calculate the upper limit and the lower limit of the velocity range. Here, statistical computing includes a normal distribution model in which: a histogram is created from the waveform for range setup to calculate the velocity distribution; the mean and the variance are calculated from the distribution of the waveform for range setup that has been weighted based on the velocity distribution; the mean±coefficient×σ becomes estimate values for the upper and lower limits of the velocity range; and a post-smoothing threshold processing model in which values that correspond to the coefficient % of the peak value become the upper and lower limits of the velocity range according to the distribution of the weighted waveform for range setup, etc. The method of calculating this velocity range is described in detail in Japanese published unexamined application No. 2005-185731. [0065] Subsequently, the velocity range setup part 95 calculates the repetition frequency (PRF) that corresponds to the set velocity range. [0066] Moreover, the velocity range setup part 95 calculates the maximum velocity range from the maximum value on the upper side (positive side) from the current reference position (baseline) and the minimum velocity range from the maximum value on the lower side (negative side) using the waveform for range setup and compares the maximum velocity range with the minimum velocity range to calculate the displacement of the baseline (reference position). For example, if the mean value of the maximum velocity range and the minimum velocity range is placed in the center of the screen, the shift amount is calculated by obtaining the distance between the mean value and the baseline (=0). The velocity offset (BLS), which is the displacement of the reference position (baseline), is calculated. [0067] The method of calculating this velocity offset (BLS) is described in detail in Japanese published unexamined application No. 2005-185731. [0068] As described above, once the repetition frequency (PRF) and the velocity offset (BLS) are decided, the velocity range setup part 95 outputs the repetition frequency (PRF) to the transceiving part 3 . Moreover, the velocity range setup part 95 simultaneously outputs the velocity offset (BLS) to the FFT calculation part 54 of the Doppler signal-processing part 5 . [0069] Additionally, in the present embodiment, the auto range/auto BLS-processing part 9 may be constituted as hardware or software. For example, by constituting the auto range/auto BLS-processing part 9 using a CPU and executing a program by reading the program from a memory area (not shown), the functions of the measured waveform calculation part 91 , the ECG waveform acquisition part 92 , the waveform estimation part 93 , the interpolation part 94 , and the velocity range setup part 95 may be executed. [0070] At this time, in the present embodiment, adjustments of the velocity offset and the velocity range are both made, but the ultrasonic imaging apparatus of the present invention is operable only by the adjustment of the velocity range. In that case, the offset is not displaced and always has 0 Hz as a reference, but a Doppler spectrum image with the velocity range adjusted and the folding reduced can be obtained. (Actions) [0071] A sequence of actions of the ultrasonic imaging apparatus related to Embodiment 1 of this invention will now be described with reference to FIG. 3 . FIG. 3 is a diagram of a flow chart illustrating a sequence of actions of the ultrasonic imaging apparatus related to Embodiment 1 of this invention. (Step S 001 ) [0072] Firstly, ultrasound is transmitted to the body to be examined and a B-mode cross-sectional image and a Doppler spectrum image are generated based on the reflected waves from the body to be examined. The Doppler waveform data generated in the FFT calculation part 54 is output from the FFT calculation part 54 to the display part 8 via the DSC 6 and displayed on the display part 8 along with the B-mode cross-sectional image. Furthermore, the Doppler waveform data is output from the FFT calculation part 54 to the auto trace part 7 . (Step S 002 ) [0073] Once the Doppler waveform is acquired in Step S 001 , the measured waveform calculation part 91 traces a marginal region of the Doppler spectrum image (maximum velocity Vp) in the direction of that time to detect the blood velocity waveform of the maximum velocity Vp. Furthermore, the measured waveform calculation part 91 calculates the measured blood velocity waveform Vp(t), which is a function that indicates the blood velocity waveform of the maximum velocity Vp. The measured waveform calculation part 91 then outputs the measured blood velocity waveform Vp(t) to the waveform estimation part 93 and the interpolation part 94 . (Step S 003 ) [0074] In Step S 003 , the ECG waveform acquisition part 92 traces the maximum amplitude of a signal received from the electrocardiograph 10 and calculates the ECG waveform u(t), which is a function that indicates the traced waveform. The ECG waveform acquisition part 92 then outputs the ECG waveform u(t) to the waveform estimation part 93 . (Step S 004 ) [0075] In Step S 004 , the waveform estimation part 93 estimates the ideal blood velocity waveform (estimated waveform ye(t)) of a patient whose blood velocity is currently being measured. This estimation is based on the measured blood velocity waveform Vp(t), ECG waveform u(t), and a coefficient of a model of a commonly used ideal blood velocity waveform preliminarily stored in the memory part 7 . The waveform estimation part 93 then outputs the estimated waveform ye(t) to the interpolation part 94 . (Step S 005 ) [0076] The interpolation part 94 calculates the difference between the measured blood velocity waveform Vp(t) and the estimated waveform ye(t), excludes excess parts of the difference over the stored threshold from the measured blood velocity waveform Vp(t), and interpolates the excluded parts in order to calculate the waveform for range setup. (Step S 006 ) [0077] The velocity range setup part 95 conducts a statistical calculation process based on the waveform for range setup to calculate the repetition frequency (PRF) and velocity offset (BLS). (Step S 007 ) [0078] As described above, once the repetition frequency (PRF) and the velocity offset (BLS) are determined, the velocity range setup part 95 outputs the repetition frequency (PRF) to the transceiving part 3 . At the same time, the velocity range setup part 95 outputs the velocity offset (BLS) to the FFT calculation part 54 in the Doppler signal-processing part 5 . The transceiving part 3 transmits and receives ultrasound to and from the ultrasonic probe 2 according to the repetition frequency (PRF) calculated by the velocity range setup part 95 . Moreover, according to the velocity offset (BLS) calculated by the velocity range setup part 95 , the FFT calculation part 54 changes the read address of the FFT process by the shift amount to adjust the velocity offset. Thereby, the velocity range and the velocity offset (BLS) are updated. [0079] As described above, according to the ultrasonic imaging apparatus 1 related to this embodiment, the velocity range and the velocity offset of the blood velocity waveform with the effects of valve signals excluded based on the Doppler spectrum image acquired by scanning are obtained automatically. Moreover, by using the velocity range and the velocity offset, the Doppler velocity range, etc. can be changed following shifts in the state of the blood flow. EXAMPLE [0080] With reference to FIG. 4A-D , the display of a blood velocity waveform will be described below. For this purpose, an example of a blood velocity waveform with the effects of valve signals excluded by using the ultrasonic imaging apparatus related to the present embodiment is used, along with a comparative example of a blood velocity waveform formed with a conventional method without using the ultrasonic imaging apparatus related to the present embodiment. [0081] FIG. 4A is a diagram of a graph for calculating the blood velocity waveform using the ultrasonic imaging apparatus related to the present invention. FIG. 4B is a graph in which the velocity range of the blood velocity waveform has been set up manually in a conventional ultrasonic imaging apparatus. FIG. 4C is a graph that shows an ideal velocity range of the blood velocity waveform in the present example. FIG. 4D is a graph in which the velocity range of the blood velocity waveform has been set up using the ultrasonic imaging apparatus related to the present embodiment. Each graph of FIG. 4 is a graph that shows the velocity range (kHz) in the vertical axis and time (sec.) in the horizontal axis. [0082] The graph 501 shown in FIG. 4A is a graph that shows the measured blood velocity waveform Vp(t) before the effects of valves have been excluded; the graph 502 is a graph that shows the estimated waveform ye(t); the graph 503 is a graph that shows the ECG waveform ECG(t) that corresponds to the blood velocity waveform of the graph 501 ; and the graph 504 is a graph that shows the blood velocity waveform with the effects of valves excluded using the ultrasonic imaging apparatus related to the present embodiment. [0083] In the example, firstly, the measured blood velocity waveform Vp(t) shown in the graph 501 is created by conducting a Doppler automatic trace for a measured Doppler signal. Then, the estimated waveform ye(t) shown in the graph 502 is created using the ECG waveform ECG(t) shown in the graph 503 and the ideal blood velocity waveform that has been statistically calculated. Subsequently, excess parts of the difference between this estimated waveform ye(t) and the measured blood velocity waveform Vp(t) over the threshold, are excluded and interpolated, thus creating the blood velocity waveform with the effects of valves excluded shown in the graph 504 . [0084] At this time, if the blood velocity waveform is displayed without excluding the effects of valves from the measured waveform Vp(t), the velocity range is required to be 5.6 (kHz). On the other hand, if the effects of valves is excluded by manual operation from the measured waveform Vp(t) according to the relevant art, it is possible to have a velocity range of 3.9 (kHz) as shown in FIG. 4B . However, if the velocity range is calculated based on an ideal waveform statistically calculated considering minimization of the effects of valves, it is ideal to have a velocity range of 3.2 (kHz) for the blood velocity waveform in the present example. Therefore, if the blood velocity waveform with the effects of valves excluded shown in the graph 504 is used using the ultrasonic imaging apparatus related to the present embodiment, it is possible to have the velocity range of 3.2 (kHz) as shown in FIG. 4D . [0085] As described above, while it is difficult to obtain an ideal velocity range using manual operation, it is possible to obtain a velocity range near the ideal velocity range by excluding the effects of valves using the ultrasonic imaging apparatus of the present embodiment. [0086] Here in the present embodiment, the ARX model is used for system identification, but other mathematical models may be used if they are parametric models for system identification (for example, refer to “advanced system identification for control” by Shuichi Adachi, Tokyo Denki University). This parametric model includes an FIR (Finite Impulse Response) model, an ARMAX (Auto Regressive Moving Average eXogenous) model, an OE (Output Error) model, and a BJ (Box and Jenkins) model, as well as the ARX model and other models. The parametric model for system identification is expressed as shown in FIG. 5 . FIG. 5 is a diagram showing the parametric model for system identification. In FIG. 5 , A(z)*y(k)={B(z)/F(z)}*u(k)+{C(z)/D(z)}*w(k). [0000] A ( z )=1+ a 1 *z −1 + . . .+a n *z −n [0000] B ( z )= b 1 *z −1 +b 2 *z −2 + . . .+b m *z −m [0000] C ( z )= c 1 *z −1 +c 2 *z −2 + . . .+c p *z −p [0000] D ( z )=1+ d 1 *z −1 +d 2 *z −2 + . . . +d q *z −q [0000] F ( z )=1+ f 1 *z −1 +f 2 *z −2 + . . . +f r *z −r [0087] Moreover, the parametric model for system identification is expressed as follows. [0000] e ( k )+ d 1 *e ( k− 1)+ . . .+ d q *e ( k−q )= c 1 *w ( k− 1)+ c 2 *w ( k− 2)+ c p *w ( k−p ) [0000] x ( k )+ f 1 *x ( k− 1)+ . . .+ f q *x ( k−q )= b 1 *u ( k− 1)+ b 2 *u ( k− 2)+ b m *w ( k−m ) [0000] y ( k )+ a 1 *y ( k− 1)+ . . .+ a q *y ( k−q )= e ( k )+ x ( k ) [0088] Moreover, in the present embodiment, the velocity range is adjusted after the interpolation, but only the interpolated blood velocity waveform with the effects of valves excluded may be created. With this configuration, the blood velocity waveform with the effects of valves excluded can be acquired, facilitating the measurement of blood flow amount and improving the accuracy of measurement. [0089] Furthermore, the velocity range may be adjusted by using the blood velocity waveform with the effects of valves excluded without interpolation. In this case, the velocity range setup part 95 stores the threshold. The velocity range setup part 95 then compares the estimated waveform with the measured blood velocity waveform to calculate parts that exceed the threshold. With this configuration, the accuracy of the velocity range adjustment decreases by a few %, but because the calculation becomes simple, the speed of calculating the velocity range can be improved. Embodiment 2 [0090] Next, an ultrasonic imaging apparatus related to Embodiment 2 of this invention will be described. The ultrasonic imaging apparatus 1 A related to Embodiment 2 further comprises an abnormality determination part 11 in addition to the ultrasonic imaging apparatus 1 related to Embodiment 1. FIG. 6 is a block diagram illustrating the functions of the ultrasonic imaging apparatus related to Embodiment 2. The determination of an abnormality in the ultrasonic imaging apparatus 1 A is described below. [0091] An abnormality determination part 11 creates a state space based on individual ideal blood velocity waveforms with no effects of valve signals for each age and disorder stored in the memory part 7 as statistical data. At this time, the state space is a space that includes blood velocity waveforms that can be considered as being in a normal state. [0092] The abnormality determination part 11 acquires a measured blood velocity waveform Vp(t) from the measured waveform calculation part 91 . [0093] The abnormality determination part 11 selects a corresponding state space based on the age and disorder of the patient with the blood velocity waveform Vp(t) and calculates the Mahalanobis' generalized distance between the state space and the blood velocity waveform Vp(t). At this time, the Mahalanobis' generalized distance is an index using the correlation between variables and is a distance scale that indicates the distance from the target reference space. [0094] The abnormality determination part 11 determines that the blood velocity is abnormal when the calculated Mahalanobis' generalized distance exceeds the pre-stored threshold for the Mahalanobis' generalized distance. The abnormality determination part 11 then notifies the operator that the blood velocity is abnormal using the display part 8 , etc. [0095] Thereby, any abnormality in blood velocity that exceeds the threshold is automatically reported to the operator, and thus oversights of abnormalities in blood velocity can be reduced and a faster and more accurate diagnosis can be provided for a patient.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention It is well recognized in the field of Urology that persons lose control of their urinary function. This loss of control may be temporary or permanent, depending upon the cause of the loss of urinary function. Temporary loss may be caused by a disease entity which is curable by medical or surgical treatment, whereas permanent loss of control may be caused by an incurable disease entity or physical trauma resulting in partial or total paralysis of the muscles which cause normal urination. The bladder is a dome shaped container with muscular walls and which accepts urine from the kidneys for temporary storage. During normal voluntary urination, the muscles in the bladder wall contract and simultaneously the sphincter muscle surrounding the opening in the bladder which communicates with the urethra relaxes so that the urine stored in the bladder is released into the urethra and expelled from the body. The causes for loss of normal voluntary control of the urination process are manifold and the consequences are indeed severe. If urine cannot be periodically expelled from the bladder, the urine becomes stagnant and bacteria multiply at an exceedingly rapid rate, resulting in infection of the bladder. Chemical changes in the urine due to the infection cause painful urination and can also cause general dibilitation of health. If, after infection occurs, the urine retention is still permitted to continue for any considerable length of time beyond normal voluntary urination frequency, ascending infection can occur, that is the infection in the bladder spreads to the ureters and to the kidneys, thereby causing still more serious consequences, such as failure of one or both of the kidneys to function. If the kidneys do not function to cleanse the blood of impurities and form urine, uremia results and death occurs in the absence of the availability of recently developed artificial kidney machines. If, on the other hand, the kidneys continue to function and fill the non-draining bladder with urine, the bladder can burst, thereby emptying the bacteria laden urine into the abdominal cavity. The usual result of this is peritonitis, which is an inflammation of the peritoneum, the membrane that lines the abdominal cavity, and the results of inflammation of this membrane are always serious. The time between the occurrence of acute peritonitis and death may be only a matter of a few hours to a few days depending upon the severity of the infection. Septicemia, an infection of the blood, is another serious consequence of excessive retention of urine in the bladder, since the bacteria in the bladder, ureters and kidneys invades the blood through the minute blood capillaries in these organs. Obviously other complications, bodily disorders and disfunctions and serious consequences, too numerous to mention herein, can result from failure of proper urination. It is obvious that constant periodic drainage of the bladder to eliminate urine and other body waste material is essential not only to good health but to maintaining life itself. Techniques of treatment for loss of normal voluntary control of the urination process are relatively few in number. Depending on the nature of the cause, a super-pubic technique involving surgery may eliminate the drainage problem in some circumstances. Since surgery is involved, this treatment is traumatic and severe, and is utilized only when absolutely necessary. Drug therapy is effective in some cases to promote drainage of the bladder, but due to the relatively few causes of loss of voluntary control which will respond to drugs and the ever presence of undesirable side effects, drug therapy is considered to be a relatively ineffective method of dealing with the problem. 2. Necessity for Practice of Invention Since the loss of voluntary control over the urinary function is typically a secondary effect caused either by disease or trauma, it has become a well established medical practice to relieve the urinary drainage problem mechanically by means of the process of catheterization. If the primary cause of the loss of voluntary urination control is from a curable disease, the catheterization process is maintained on a temporary basis only for so long as necessary until voluntary control returns. If the cause of loss of control is permanent, as in the case of paralysis such as with paraplegics and quadriplegics, the catheterization process must be maintained on a permanent basis in order to maintain life. In the catheterization process, a tube or catheter is inserted into and through the urethra until the remote or distal end is located within the bladder, usually being disposed just past the sphincter muscle at the juncture of the bladder with the urethra. The near or proximal end of the tube remains outside of the body and there is thus provided a path or channel through which urine in the bladder can drain as the need arises. Once a catheter has been passed through the urethra and inserted into the bladder, it is generally necessary, in connection with the disease and trauma conditions described above, to have the catheter retained in the urinary tract with the distal end of the catheter in the bladder, such retention being in the order of several days to several weeks without removal. Catheters which are designed for use a function are called urinary retention catheters and are typically provided by including an inflatable balloon at the distal end of the catheter which is deflated during insertion of the catheter and which is inflated by passing a fluid, typically water or saline solution through a passage within the catheter, called an inflation lumen. Thereafter, fluid from the bladder drains through the main passage of the catheter, called the drainage lumen. PROBLEMS OF CATHETERIZATION Inserting a catheter into the urethra can be a painful and traumatic experience, the degree of pain and trauma depending on the construction of the catheter being inserted, the technique for inserting it, and the experience and the skill of the person performing the insertion whether that person is the doctor or other individual. Since the designers of catheters have no control over the last named characteristic, the present invention has been developed with the first two characteristics principally in mind, but also with consideration for the fact that the catheter may on many occasions be inserted by other individuals who would not be as skilled as the doctor. The reason for possible pain and trauma is that the urethra, whether male or female, is a relatively tortuous tube of varying cross-sectional dimensions and is normally collapsed along most of its length. The upper portion of the urethra is provided with sphincters or valves which it enters the bladder neck. The female urethra is somewhat shorter and straighter than the male urethra but otherwise both are much the same. The urethra is a very delicate organ and cannot withstand any appreciable amount of lateral pressure against the urethral wall without causing some degree of rupture. Since the urethra has a high concentration of pain sensing nerve endings, any distortion, whether of change in size or shape, is very uncomfortable at the least and usually painful, and any trauma to the urethra is accompanied by a great deal of pain. It is not uncommon for the patient to have to be anesthetized in order to insert many common urinary catheters. In addition to the pain, bacteria in the urethra can enter the blood stream if the urethra is traumatized, with the same result discussed above in connection with rupture of the bladder. Extensive research and development have been carried out over a long period of time in the design of catheters, and a large number of different catheter designs appear in the medical and patent literature. The reason for this is that design characteristics for urinary drainage catheters are highly conflicting from the standpoints of patient discomfort and functionalism. In order to reduce the probability of trauma and resulting pain to the urethra as well as discomfort to the patient during long periods of retention, a urinary drainage catheter should be as thin as possible, highly flexible and pliant, and have a soft rounded end. From the functional standpoint, on the other hand, the catheter must be of sufficiently thick and rigid construction that it will not buckle while being passed through the urethra, it should have as wide a drainage opening and lumen as possible to promote complete drainage and prevent clogging, and the end should be free and unobstructed in order to facilitate the use of the catheter as an aid to the insertion of diagnostic and treatment instrumentation into the bladder. Of great importance is the fact that a retention catheter must have an effective means for retaining the catheter in place in the bladder which will not obstruct either the flow of urine or substantially the complete drainage of urine therefrom, but at the same time has sufficient retaining capability that a patient, particularly a senile patient, cannot forcibly pull the catheter out of the bladder and into the urethra thereby causing extreme damage thereto. Further, any urinary drainage catheter must be formed of a material totally inert to the effects of urine and other waste materials, be capable of absolute sterilization, and be manufacturable to strict tolerances, in high volume and at low cost considering the disposable nature of the product. Still other criteria may be apparent to those skilled in the art. THE PRIOR ART In view of the foregoing diverse criteria, the basic design of commercially available retention catheters has changed very little over the past half century, and the well known Foley retention catheter is almost universally used by doctors, hospitals, nursing homes, etc. to alleviate loss of voluntary bladder control. U.S. Pat. Nos. 2,892,458; 2,936,761; 3,292,627 and 3,394,705 are mentioned as illustrating typical prior art catheters which are usually formed of relatively thick walled construction so as to be insertable without buckling, have a rounded solid tip to prevent trauma to the delicate lining of the urethra, and have side openings adjacent the tip to communicate the interior of the bladder with the drainage lumen. The prior art catheters also have an inflatable balloon portion beyond the drainage opening in order to retain the catheter in place. These catheters, and many more like them, are undesirable from the standpoint that considerable pain may be experienced in introducing a relatively wide, semi-rigid catheter into a relatively narrow urethra. Further, the small side openings can easily clog from clots of sediment material which collects in the bottom of the bladder. Still further, as a result of the solid tip, it is impossible to pass diagnostic or treatment instrumentation through the catheter for the purpose of inspecting or treating the interior of the bladder. The capability of inserting instrumentation through the catheter after it is in place is very important in the urological practice since prior treatment involves the use of anesthesia in order to insert steel tube instrumentations as has been the practice. In U.S. Pat. No. 2,677,375, recognition was given to the desirability of removing the fixed rounded tip so as to provide a drainage opening adjacent the inflatable retention balloon. Strips are provided across the opening for engagement by an inserting stylet. This construction is disadvantageous in that the strips likely to obstruct the passage of sediment clots and thus clog the drainage opening, and even more harmful is the fact that the insertion of such a blunt end as is apparent in this device is almost certain to cause considerable trauma to the delicate wall of the urethra. It is also apparent that is would be at least difficult, if not impossible, to pass instrumentation through this catheter in view of the strips across the open end. Such a device would be wholly unacceptable to the urological practitioner. A significant aspect of the presention invention is the provision of an improved stylet which is utilized both during insertion of the catheter through the urethral passage and thereafter as a cleaning implement. U.S. Pat. Nos. 2,118,631; 2,164,926 and 2,856,934 are cited as representative of prior art stylets which are utilized solely to assist in inserting the catheter, the first two being of the typical push rod type and the third being of the filiform type. Although the use of a stylet to insert the catheter obviates the problem of bucking of the catheter during insertion and thereby permits the catheter to have a relatively thin wall construction, the push rod type used in conjunction with a closed end catheter is undesirable from the standpoint that there is no way of accurately ascertaining when the end of the catheter enters the bladder because the stylet blocks the drainage opening or the drainage lumen or both. The filiform device is undesirable because of the possibility of injuring the delicate wall of the urethral passage during the insertion of the filiform unless great care is exercised because of the fact that the filiform is of necessity very thin and therefore must be relatively rigid and sharp nosed. Other disadvantages of this technique for inserting drainage catheters will be apparent to those skilled in the art. Another significant improvement of the present invention is the novel construction of the inflatable retention balloon to cause the open end of the catheter to expand and widen, which assists in drainage and in retention. Some consideration has been given to this problem as evidenced by U.S. Pat. No. 2,892,458 mentioned above, as well as by U.S. Pat. No. 3,438,375 and 3,889,686. In the first patent, the balloon is constructed to be less inflatable adjacent the lateral drainage opening through the catheter wall so that the balloon cannot overlie and block the opening if the catheter tends to settle in the bladder or is pulled by the patient. In U.S. Pat. No. 3,438,375, the opposite theory is applied and the balloon is constructed to purposely overlie the lateral drainage but be spaced therefrom so that the delicate lining of the bladder cannot be drawn into the opening by sub-atmospheric pressure. In U.S. Pat. No. 3,889,686, a lateral opening is provided below the balloon as well as above so as to promote better drainage. All of these techniques have inherent disadvantages in that they present design problems which are difficult to overcome in manufacturing the catheter, they are not nearly as effective in practice as eliminating the lateral drainage opening altogether so that the inflation balloon presents no interference problem whatever, and they cannot function to allow movement of a stylet to indicate when the balloon is inflated because the rounded tip closes the longitudinal end of the drainage lumen. SUMMARY OF THE INVENTION The present invention substantially obviates if not completely eliminates many of the disadvantages of prior art and commercially available urinary retention catheters and also provides advantages and desirable features not heretofore obtainable with such catheters. The principles of the present invention are embodied in a novel urinary drainage catheter, a novel stylet for use with the catheter and in a novel cooperation in the combination of the catheter and the stylet together. In general, the catheter comprises an elongate cannula formed preferably although not necessarily of a plurality of layers of flexible and pliant materials, the inner and outer layers being of relatively soft latex rubber and an intermediate layer being of relatively thinner but stronger silicone rubber. The cannula has both distal and proximal ends, the length of the cannula being such that the distal end is disposed within the bladder and the proximal end is disposed exteriorly of the urethra when the catheter is in operative position in the body. The cannula has an inner tubular wall surface defining a drainage lumen which extends from the distal end substantially to the proximal end. The distal end is open and unobstructed so as to communicate the interior of the bladder directly with the full cross-sectional area of the drainage lumen. There is means on the inner tubular wall adjacent the distal end which defines a portion of the drainage lumen of slightly different diameter than the diameter of the rest of the drainage lumen, which means forms an abutment for the stylet used to insert the catheter. The catheter also includes an expandable means preferably in the form of an inflatable balloon connected to the inner and outer layers of the cannula adjacent the distal end for retaining the distal end in the bladder and for expanding the distal end of the cannula so as to widen the opening and to dispose the end of the cannula lower in the bladder than it is with the balloon uninflated. In one embodiment, the abutment forming means forms a hinge about which the distal end expands and the abutment means distorts to a shape which allows the stylet to pass beyond the abutment means and move freely back and forth for at least a limited distance, thereby providing an indication that the balloon has inflated. The stylet comprises generally an elongate flexible body member of substantially uniform diameter throughout a major portion of its length. Adjacent one end of the body member is means defining a portion of different diameter than the diameter of the body member and defining an abutment surface adapted to engage with the abutment means disposed in the cannula when the stylet is inserted therein. The stylet is provided with a tapered tip element on the end adjacent the abutment surface, the tip element having a relatively smooth rounded end. The tip element is removably connected to the end of the body member so that it can be removed from the body member after the stylet is withdrawn from the catheter, and a brush element is provided which is connectable to the body member for cleaning the catheter. Both the body member and the tip element have a central bore of relatively small diameter so that the flow of urine therethrough affords a positive indication that the distal end of the catheter has entered the bladder. Having briefly described the general nature of the present invention, a principal object thereof is to provide a retention drainage catheter and stylet for use therewith which avoids the disadvantages of prior art constructions and provides advantages not heretofore attainable in devices of this nature. Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith which avoids to the fullest possible extent any likelihood of injury to the urethra during insertion of the catheter. Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith which is designed to render insertion relatively simple and with a minimum of discomfort so that the insertion process can be carried out without the need for anesthesia. Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith in which the catheter and stylet have a cooperating abutment relationship by which the stylet is used to insert the catheter into the bladder and which does not interfere with the free flow of urine or other waste materials through the catheter. Another object of the present invention is to provide a retention drainage catheter and a stylet for use therewith in which the entire full width portion of the catheter is pulled through the urethra rather than a portion thereof being pushed therethrough. Another object of the present invention is to provide a retention drainage catheter which is constructed to provide the widest possible drainage opening from the bladder directly into the drainage lumen of the catheter in order to minimize if not altogether prevent clogging of the drainage opening due to sediment material collecting in the bladder. Another object of the present invention is to provide a retention drainage catheter through which various types of instrumentation may be passed into the bladder for performing diagnostic or treatment techniques therein. Another object of the present invention is to provide a retention drainage catheter having a novel inflatable retention balloon construction which causes the distal end of the catheter to expand to provide a still wider drainage opening which lies lower in the bladder than with conventional retention catheters. Another object of the present invention is to provide a retention drainage catheter in which expansion of the distal end of the drainage lumen is accomplished in a manner which allows at least limited free movement of the stylet to provide an indication that the balloon has properly inflated. Another object of the present invention is to provide a stylet for use with a retention drainage catheter which provides a positive indication of when the end of the catheter has passed from the urethra into the bladder by permitting a limited flow of urine through the stylet. Another object of the present invention is to provide a stylet for use with a retention drainage catheter in which the stylet is used as a cleaning implement for the catheter after the stylet is removed from the catheter and a brush element is substituted for a rounded tip element used during insertion of the catheter. Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith which is impervious to the effects of urine, is susceptable to complete sterilization and can be easily and inexpensively manufactured in large quantities. These and other objects and advantages of the present invention will be more readily apparent from an understanding of the following detailed description of several preferred embodiments of the invention when considered in conjunction with the accompanying drawings in which: FIG. 1 is a longitudinal sectional view of a retention drainage catheter and stylet for use therewith embodying, in one form, the principles of the invention; FIG. 2 is an enlarged cross-sectional view taken on the line 2--2 of FIG. 1; FIG. 3 is an enlarged cross-sectional view taken on the line 3--3 of FIG. 1; FIG. 4 is an enlarged fragmentary view of the distal end of the catheter shown in FIG. 1 showing a modified form of abutment means between the catheter and the stylet; FIG. 5 is an enlarged fragmentary view similar to FIG. 4 showing a further modified form of abutment means between the catheter and the stylet; FIG. 6 is an enlarged fragmentary view similar to FIG. 4 showing a still further modified form of abutment means between the catheter and the stylet; FIG. 7 is an enlarged fragmentary view of the embodiment of FIG. 1 showing the retention balloon in its inflated condition; FIG. 8 is an enlarged fragmentary view similar to FIG. 7 of the embodiment shown in FIG. 6; and FIG. 9 is a view of a suitable brush cleaning element for use with the stylet. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings and particularly to FIGS. 1-3 thereof, there is shown a retention drainage catheter and inserting stylet therefore in assembled relationship ready for use, the assembly being generally indicated by the reference numeral 10, the catheter and stylet being generally indicated by the numerals 11 and 12 respectively. The catheter has a distal end generally designated by the numeral 14, the length of the catheter being such that the distal end 14 can be fully inserted into the bladder while the proximal end 16 still remains outside of the entrance to the urethra. The catheter 11 is constructed as a multi-layer cannula and has an outer layer 18 of relatively soft and pliant latex rubber which is selected to meet the physical requirements set forth above, but principally which must withstand the corrosive effects of urine and withstand the high temperatures of sterilization. An intermediate layer 20 of silicone rubber is disposed within the outer layer 18, the silicone rubber having greater strength than the latex rubber but otherwise meeting the same physical requirements as the latex rubber. Another layer 22 of latex rubber forms an inner layer disposed within the intermediate silicone layer, the inner wall 24 of the inner layer 22 defining a drainage lumen 26 through which urine drains from the bladder. A principal feature of the present invention resides in the provision of a longitudinal drainage opening 30 at the distal end 14 of the catheter. In the conventional catheters, as shown in the prior art cited hereinabove, the catheter is provided with a rounded bullet shaped tip to facilitate insertion of the catheter through the urethra with a minimum of discomfort and risk of trauma, and a laterally opening drainage port is provided adjacent the tip of the catheter. In the present invention, however, the conventional tip has, in effect, been removed and the several layers of the cannula 11 terminate to define the longitudinal opening 30 which is open and unobstructed in order to communicate the interior of the bladder directly with the full cross-sectional area of the drainage lumen 26 rather than through a restricted lateral opening as in the prior art. The manner in which the layers of the cannula terminate to define the opening 30 is best seen in FIG. 4 wherein the inner latex rubber layer 22 terminates abruptly in an annular wall 32, whereas the intermediate silicone layer 20 and the outer latex layer 18 are both tapered and merge to points adjacent the distal end 14 of the cannula so as to define a smooth, gradually widening portion 34 of the cannula surface from the annular wall 32 to the widest portion of the cannula 11. The reason for this tapering portion is to provide a smooth, gradually expanding insertion portion of the catheter 11 which cooperates with a gradually widening portion of an inserting stylet to be hereinafter described. It will be apparent that the longitudinal opening 30 provides a wider and less obstructed access from the bladder into the drainage lumen than does the lateral openings in the prior art catheters. The catheter 11 includes means for retaining the distal end 14 thereof within the bladder after the distal end has been passed through the urethra and has entered the bladder. Since the juncture of the bladder and the urethra is defined by a sphincter muscle which defines a relatively small opening even when the sphincter muscle is relaxed, it is possible to prevent removal of the catheter by providing the end thereof with an expandable means which overlies a small portion of the bottom of the bladder wall surrounding the sphincter. In the present invention, the preferred means for retaining the catheter in place is the inflatable balloon technique which is well known in the art but which is configurated in the present invention to cooperate in a novel manner with the specific construction of the distal end of the catheter to cause the distal end of the catheter to expand and partly overlie the bottom wall of the bladder. More particularly, the inflatable balloon is a relatively thin layer 36 of latex rubber which is integrally molded or suitably bonded to the outer layer 18 of the cannula at a point 38 downstream from the open end 30, the point 38 being selected to provide a balloon of suitable size to retain the catheter in place when the balloon is inflated. Although the balloon may vary in size depending on the location of the molded or bonded juncture 38, it is the practice to select a reasonable compromise in the size of the balloon based on two conflicting considerations. One is that the balloon should be as small as possible in order to place the drainage opening as close as possible to the sphincter muscle at the bottom of the bladder to facilitate substantially complete drainage of urine and sedimentary waste material in the bladder. The other consideration is that retention drainage catheters are very often used by elderly people who, for one reason or another, have lost voluntary control of the urinary function and the catheter must remain in place for extended periods of time. Due to senility or other factors of mental deterioration of the aged, many of these people have a tendency to try to pull the catheter out without realizing what they are doing, and as a consequence can cause themselves servere injury if the balloon is not large enough to retain the catheter in place even against substantial pulling force. The present invention effectively aleviates both of the aforementioned problems by providing a retaining balloon designed to provide both maximum size for retention purposes and at the same time to keep the drainage opening close to the bottom of the bladder. The ballon layer 36 extends from the molded or bonded juncture 38 to the end of the cannula 11 and has an annular terminal portion 40 which encircles the annular wall 32 of the inner latex layer 18. The balloon layer 36 is separated from the outer layer 18 of the cannula from the juncture 38 to the annular wall 32 where the balloon layer is either integrally molded or suitably bonded to the annular wall 32 so as to form a fluid-tight seal therewith. It will be noted that the teminal portion 40 of the balloon layer 36 is thicker than the balloon layer and is smoothly rounded for ease of insertion as will more clearly appear hereinafter. In its non-inflated condition, the balloon layer lies flat on the tapered surface of the outer layer 18 and forms the gradually widening portion 34 of the cannula. The balloon is inflated by means of an inflation lumen 42 formed in the silicone layer 20, the silicone layer being thicker in the area of the inflation lumen than the rest of the layer as best seen in FIGs. 2 and 3. With reference to FIG. 1, the inflation lumen 42 extends from a terminus 44 within the balloon layer 36 through the silicone layer 20 to a lateral extension 46 of the outer layer 18, the lateral extension terminating in a value housing 48 and a fluid injection end 50. Any suitable value member 52 is provided within the valve housing 48 to prevent the escape of the inflation fluid after the balloon layer 36 has been inflated. The silicone layer 20 is provided for the purpose of resisting any tendency of the inflation lumen 42 to expand into the drainage lumen 26 due to the pressure of the inflating fluid within the inflation lumen 42 and the balloon layer 36. Since the silicone rubber is stronger and less flexible than the latex rubber, it is desirable to maintain the silicone layer as thin as possible around its periphery and to thicken the silicone layer only at the location which surrounds the inflation lumen as shown in FIGS. 2 and 3. The catheter assembly 10 includes a stylet 12 which is used to insert the catheter 11 into the urethra, and as a cleaning implement as will be more fully described hereafter. The stylet 12 is an elongated tube formed of a relatively rigid rubber or plastic material which meets the same physical characteristics as the material of the catheter with respect to being susceptable to sterilization, impervious to urine, etc. The stylet is sufficiently rigid so that it can be pushed through the urethra without buckling, and yet is also sufficiently flexible that it will conform somewhat to the configuration of the urethra during the insertion process, although a certain degree of straightening of the urethra during the insertion process in inherent in any catheterization process. The stylet 12 is formed as a rod 54 having a proximal end 56 and a distal end 58, the length of the rod between the ends 56 and 58 exceeding that of the catheter 11. The distal end is formed as a smooth rounded tip at the end of a tapered removable end portion 60 of the rod 54, the rod and the removable end portion being connected together by any suitable means such as the threads 62 or merely a press fit. The rounded end 58 and the taper on the end portion 60 facilitate a smooth sliding passage of the projecting end of the stylet through the urethra. The stylet is also provided with a longitudinal passageway or bore 64 which extends the entire length of the stylet and functions as a limited drainage passageway through which a small amount of urine can flow when the distal end of the stylet enters the bladder. This provides the person inserting the catheter with an indication of when the tip of the stylet enters the bladder, it being known how much further the catheter and stylet must be inserted into the urethra to dispose the distal end of the catheter in the bladder. The end portion 60 is replaced by a suitable brush element 61 such as that shown in FIG. 9 when it is desired to clean the drainage lumen 26. The stylet and catheter are provided with cooperating abutment means by which the stylet pushes the catheter through the urethra as the stylet is manipulated though the urethra. In the embodiment shown in FIG. 1, a annular boss 66 is formed on the inner surface 26 of the inner latex layer, and a cooperating radial boss 68 is formed on the outer surface of the rod 54. The abuting engagement of the adjacent surfaces of the bosses 66 and 68 prevents the stylet from passing through the catheter and pulls the catheter through the urethra as the person inserting the catheter pushes on the stylet. It will be recognized that, although the annular boss 66 is formed of the relatively soft latex rubber, there is little likelihood that the radial boss 68 on the stylet will slip past the annular boss 66 during insertion of the catheter due to the fact that the tolerance relationships between the stylet and the catheter inside the drainage lumen 26 are very small, and the radial boss 68 is extremely close to, if not actually in sliding contact with, the inner wall 24 of the drainage lumen 26. It will also be noted that the boss 66 on the cannula is located substantially at the widest part of the gradually widening portion 34 of the cannula so that as the stylet pushes the catheter through the urethra, only the portion 34 is in advance of the abutting engagement between the catheter and the stylet. The advantage of this arrangement is that substantially the entire portion of the catheter which is not tapered is being pulled through the urethra with the result that there is no tendency for the catheter to buckle or slide back on the stylet during the insertion process. Three alternative embodiments of the abutment means between the catheter and stylet are shown in FIGs. 4-6. In FIG. 4 a multiple step abutment means is shown in which the inner layer 22 of the catheter is provided with an annular boss 70 which defines an abutment wall 72, and another annular boss or merely a portion 74 of the inner layer 22 of larger diameter from the rest of the inner layer defines another abutment wall 76 spaced rearwardly from the abutment wall 72. Correspondingly on the stylet, a radial boss or merely a portion 78 of the rod 54 which is of reduced diameter from the rest of the rod 54 defines an abutment wall 80, and a radial boss 82 defines another abutment wall 84 spaced rearwardly from the abutment wall 80. It will be observed that the two abutment walls 80 and 84 on the stylet are much more widely separated than the corresponding abutment walls 72 and 76 on the catheter, the reason for which will be made clear hereinafter. It will be apparent that if for any reason the forward abutment wall 80 should slip past the forward abutment wall 72 on the catheter, the rearward abutment wall 84 on the stylet wall engage with the rearward abutment wall 76 on the catheter after the stylet has moved forwardly within the catheter a distance equal to the space between the rearward abutment wall 76 on the catheter and the rearward abutment wall 84 on the stylet. Thus, the plurality of abutment walls provides an added measure of safety against the stylet passing the single abutment menas shown in FIG. 1 as well as another advantage discussed below in connection with the expansion of the inflatable balloon as shown in FIG. 8. It well be noted that the rear abutment wall 76 is located substantially at the widest portion of the gradually widening portion 34 of the cannula and the forward abutment wall 72 is located within the gradually widening portion 34 so that only the gradually widening portion of the cannula is pushed ahead of the abutment means during insertion of the cannula regardless of which of the above described pairs of abutment surfaces are in engagement with each other. Another form of abutment means is shown in FIG. 5 in which the cooperating abutment surfaces formed on the catheter and stylet are in barb-like configuration to give an added measure of assurance against the stylet abutment surface slipping past the catheter abutment surface and failing to pull the catheter through the urethra. Thus, an annular recess 86 is formed on the inner surface 26 of the inner latex layer 22, and a cooperating radial boss or projection 88 is formed on the outer surface of the stylet rod 54. As shown in FIG. 5, the recess 86 is wedge shaped, and the projection 88 is correspondingly wedge shaped so that the recess has an abutment surface 90 and the projection has an abutment surface 92 which surfaces engage when the stylet is inserted into the drainage lumen 26 of the catheter. The abutment surfaces 90 and 92 are both slanted forwardly as they extend outwardly so that the recess 86 and projection 88 have a barb-like configuration. Although the diameter of the radial projection is larger that the diameter of the drainage lumen 26, as distinguished from the FIG. 1 and FIg. 4 embodiments where the stylet projections do not exceed the diameter of the drainage lumen 26, there is nevertheless no difficulty in inserting the stylet into the catheter since the inner latex layer 22 is relatively compressible, and the projection 88 simply compresses the material of the layer 22 as it moves through the drainage lumen 26 until the projection moves into the recess 86. In this embodimemt of the invention, insertion of the stylet into the catheter is further facilitated by inserting the stylet from the distal end of the catheter rather than from the proximal end thereof as would be the direction of insertion for the embodiments shown in FIG. 1 and FIG. 4. It should be noted that insertion of the stylet in all of the disclosed embodiments is made easier by lubricating the stylet prior to insertion with any suitable sterile lubricant. For the same advantage as pointed out above in connection with the abutment means of FIG. 1, the abutment surfaces of the catheter and stylet are located adjacent the widest part of the gradually widening portion 34 of the cannula. FIG. 6 shows another form of multiple step abutment means similar to that shown in FIG. 4 but having the abutment means configurated as shown in FIG. 5. The inner layer 22 of the catheter is provided with a forward annular recess 94 which defines an abutment surface 96 and another rearward annular recess 98 which defines another abutment surface 100 spaced rearwardly from the abutment surface 96. The style is provided with a forward radial projection or boss 102 which defines an abutment surface 104 for engagement with the abutment surface 96 and another rearward annular recess 98 which defines another abutment surface 100 spaced rearwardly from the abutment surface 96. The stylet is provided with a forward radial projection or boss 102 which defines an abutment surface 104 for engagement with the abutment surface 96 on the catheter and a rearward radial boss or projection 106 which defines another abutment surface 108 for engagement with the abutment surface 100 of the catheter. As in FIG. 5, the projections on the stylet are wedge shaped and the abutment surfaces on both the stylet and the catheter are slanted forwardly as they extend outwardly so that the abutment surfaces have a barb-like cooperation when they engage with each other. It will be noted that the abutment surface 104 and 108 on the stylet are much more widely separated than the corresponding abutment surfaces 96 and 100 on the catheter, as in the FIG. 4 embodiment; it will also be noted that the annular recess 98 has a uniform diameter over the length of this recess, and the reason for both of these details of construction will be made clear hereinbelow. As with the FIg. 4 embodiment, if for any reason the forward abutment surface 104 on the stylet should slip past the forward abutment wall 96 on the catheter, the rearward abutment surface 108 on the stylet will engage the rearward abutment surface 100 on the catheter after the stylet has moved forwardly within the catheter a distance equal to the space between the rearward abutment surface 108 on the stylet and the rearward abutment surface 100 on the catheter, thereby providing the same added measure of safety as discussed above in connection with the FIG. 4 embodiment. Again it should be noted that the rearward abutment surface 100 on the cannula is located substantially at the widest part of the gradually widening portion 34 of the cannula and the forward abutment surface 96 is located within the gradually widening portion 34 so that only gradually widening portion of the cannula is pushed ahead of the abutment means during insertion of the cannula regardless of which of the above described pairs of abutment surfaces are in engagement with each other. The present invention provides two unique advantages over any known prior art catheters which advantages are derived from the construction of the embodiments described above and will be more apparent from a description to follow of the manner in which the catheter is used in connection with the insertion and retention of the catheter in the bladder. Both of these advantages result from the manner in which the inflatable balloon operates to cause a certain amount of expansion of the distal end of the cannula thereby widening the opening into the drainage lumen and also, in the plural abutment means of the FIG. 4 an FIG. 6 embodiments, allowing a certain degree of freedom of movement of the stylet within the catheter to provide an indication that the balloon has a fact inflated in the bladder and is retaining the catheter in place. With reference to the embodiments shown in FIGS. 1 and 5, the construction and connection of the inflatable balloon 36, which is the same in both embodiments, causes a certain amount of expansion of the opening 30 at the distal end of the cannula, thus providing a wider opening into drainage lumen to facilitate drainage of waste material over a large area. This expansion results from the forward connection 40 of the balloon 36 to the inner layer 22 of the cannula which causes the balloon to exert a strong radial pull on the end of the inner layer. Since the relatively stronger intermediate layer 20 gradually tapers to practically nothing at the end of the cannula, or may terminate altogether before the end of the cannula, this layer offers little or no resistance to the expansion of the forward end of the cannula. As seen in FIG. 7, when the balloon has been fully inflated, the gradually widening portion 34 of the cannula is flared outwardly from approximately the widest part of the gradually widening portion 34 to the end thereof. By providing the other juncture 38 of the balloon 36 with the outer layer 18 of the cannula at the widest point of the gradually widening portion 34, only that portion 34 of the cannula need be inside the bladder thereby maintaining the balloon relatively flat and the opening 30 as low as possible in the bladder thus promoting maximum drainage of waste material from the bladder. In the embodiments of the invention shown in FIGS. 4 and 6, the expansion effect is enhanced by the construction of the inner layer 22 of the cannula, and in this form of the invention the stylet is utilized to provide an indication that the balloon has inflated. It will be observed that in both of these embodiments the inner layer 22 is thinner in cross-section at least at the location of the rearward abutment surfaces than it is along that portion of the layer 22 within the gradual widening portion 34 of the cannula. The effect of this, as best seen in FIG. 8, is to provide an effective hinge portion of the inner layer about which all three layers of the cannula can bend in response to the radial force exerted on the forward end of the cannula at the terminal portion 40 of the balloon 36. In these two embodiments, the tapered portion 34 of the cannula bends outwardly far enough to cause the forward abutment surfaces on the cannula to disengage from the forward abutment surfaces on the stylet after the balloon is inflated, thereby allowing the stylet to move forwardly in the cannula until the rearward abutment surfaces on the stylet engage with the rearward abutment surfaces on the cannula. This limited movement of the stylet, which will be relatively free movement in both forward and backward directions, provides a positive indication to the person inserting the catheter that the balloon 36 has in fact inflated within the bladder and that there are no leaks in the balloon or other reason present which would prevent inflation of the balloon.

1a

TECHNICAL FIELD This invention relates to suture passing surgical instruments, and more particularly, to a surgical instrument and method for single-handedly passing suture through tissue. BACKGROUND Suture is passed through tissue many ways including, for example, cannulated needles and instruments and needle passing instruments, which in general, require the use of multiple portal entry points in order to transfer the suture through tissue or require the use of additional instruments or devices to facilitate the passage of suture. As described in U.S. Pat. No. 5,935,149, it is known to place the suture at a desired site to be sutured by passing a needle attached to the suture from a first member of a suture passing forceps to a second member of the forceps. The suture is secured at the site by passing the needle through a suture receiving passage in an outer member of a suture securing device to position a portion of the suture therein and inserting an inner member of the suture securing device into the passage to secure the portion of the suture between the inner and outer members. The needle is passed through the passage by threading the needle through a suture threader disposed in the passage and pulling the threader from the passage. The suture threader has one end terminating in the needled suture and an opposite end terminating in a suture receiving loop. SUMMARY In one general aspect of the invention, a surgical instrument includes first and second members configured to receive tissue therebetween. The first member is adapted to receive suture, the second member is coupled to the first member, and a grasper is coupled to the second member for engaging the suture received by the first member. Embodiments of this aspect of the invention may include one or more of the following features. The grasper is coupled to the second member for movement between a retracted position and a suture engaging position. The second member defines a slot for receiving suture from the first member, and the grasper is configured to trap suture within the slot. The first member is configured to move relative to the second member between an open position and a closed, tissue piercing position. The second member defines a passageway for receiving a portion of the first member. The second member defines a slot for receiving suture from the first member. The slot opens into the passageway. The first member includes a needle for piercing tissue. The needle defines an eyelet for receiving suture. The eyelet includes a hole. Alternatively, the eyelet includes two holes. In another alternative, the eyelet includes a cutout. The surgical instrument also includes a handle that controls movement of the first member. The handle includes an articulating handle and a stationary handle. The second member includes a passageway that receives a portion of the first member. The second member includes at least one suture slot that is disposed in a lengthwise side of the passageway. Also, the at least one suture slot opens to the passageway. The first member includes a jaw and a needle arm extending from a distal end of the surgical instrument. The needle arm is adapted to receive suture. The jaw defines a passageway that receives a portion of the needle arm. The second member defines a passageway that receives a second portion of the needle arm. The second member defines at least one suture slot that is disposed in a lengthwise side of the passageway and opens to the passageway. The suture grasper engages the suture and holds the suture in the at least one suture slot. The grasper is disposed on a portion of the second member. The grasper includes a hook. Alternatively, the grasper includes a wedge. In another alternative, the grasper includes a set of jaws. In another alternative, the grasper includes a U-shaped cup. The surgical instrument includes a trigger that controls the grasper. The trigger is a paddle. Alternatively, the trigger is a lever. In another alternative, the trigger is a button. The surgical instrument also includes a grasper guide that is disposed on a portion of the second member. The trigger moves the grasper distally under the grasper guide to engage the suture. A portion of the first member is serrated. A portion of the second member is serrated. In another general aspect of the invention, a method of passing suture includes loading suture into a first member of a suture passing surgical instrument, stabilizing tissue between the first member and a second member of the surgical instrument, passing suture through tissue via the first member of the surgical instrument, holding the passed suture via a suture grasper of the surgical instrument, and removing the first member from the tissue. Embodiments of this aspect of the invention may include one or more of the following features. After loading suture, the surgical instrument is passed through a cannula. The method also includes removing the surgical instrument from the surgical site. Loading suture includes loading suture from a side of the surgical instrument. Loading suture further includes loading suture from the side of the surgical instrument on which the suture grasper is located. The method includes stabilizing tissue and passing suture through tissue simultaneously. The method includes passing suture multiple times. Passing suture multiple times includes loading suture into the first member of the suture passing surgical instrument, and passing suture through tissue via the first member of the suture passing instrument. Conventional instruments and methods for passing suture generally require multiple portal entry points and/or supplemental instruments to facilitate passage of suture. The surgical instrument of this invention overcomes these difficulties. In particular, the instrument and method provide a surgeon with the ability to single-handedly pass suture through tissue. As a result, only one portal and one instrument are required. The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features and objects will be apparent from the description and drawings, and from the claims. DESCRIPTION OF DRAWINGS FIG. 1 is a partial cross-sectional view of an exemplary suture passing surgical instrument. FIG. 2 is a partial cross-sectional view of a distal portion of the surgical instrument of FIG. 1 in which an articulating jaw is closed. FIG. 3A is a side view and FIG. 3B is a perspective view of a push/pull rod for the articulating jaw of the surgical instrument of FIG. 1 . FIG. 3C is a top view of an elongated shaft of the surgical instrument of FIG. 1 . FIG. 3D is a partial cross-sectional view of a proximal portion of the surgical instrument of FIG. 1 . FIG. 4A is a top view of a distal portion of the surgical instrument of FIG. 1 showing a suture grasper capturing the suture and FIG. 4B is a perspective view of the distal portion of the surgical instrument of FIG. 1 showing the eyelet of the needle in line with the suture slots of the passageway. FIG. 5A is an exemplary tip of a suture capture device of the suture grasper and FIG. 5B is an exemplary arm of the suture capture device of the suture grasper of the surgical instrument of FIG. 1 . FIG. 6A is a partial cutaway top view of a trigger portion for the suture grasper shown in an open position and FIG. 6B is a partial cutaway top view of the trigger portion for the suture grasper shown in a closed position. FIGS. 7A–7H illustrate use of the surgical instrument of FIG. 1 . FIGS. 8A–8H illustrate alternative configurations of a suture eyelet of a needle of the surgical instrument of FIG. 1 . FIG. 9 shows a suture threaded through the suture eyelet of the needle of the surgical instrument of FIG. 1 . FIG. 10 shows a suture attached to an exemplary soft tissue attachment device. FIG. 11 is a detailed side view of an articulating jaw of the surgical instrument of FIG. 1 showing serrations. FIG. 12 is a detailed side view of a tissue platform of the surgical instrument of FIG. 1 showing serrations. FIG. 13A is a side view of an alternate implementation of the suture grasper. FIG. 13B is a detailed view of the suture capture device of the suture grasper of FIG. 13A . FIG. 13C is a top view of an alternate implementation of the tissue platform provided with the suture grasper of FIG. 13A . FIGS. 14A–14H are top views of alternative implementations of the suture capture device of the suture grasper. FIG. 15A is a side view of the alternative implementation of the trigger. FIG. 15B is an exploded view of the trigger and a locking mechanism of FIG. 15A . FIG. 15C is a side view of another alternative implementation of the trigger. FIG. 15D is a detailed view of a locking mechanism of the trigger of FIG. 15C . FIGS. 16A–16E are top views of alternative implementations of push/pull rods of the suture grasper. FIG. 17A is a side view of an alternate implementation of the suture passing surgical instrument. FIG. 17B is a perspective view of the push-pull rod of the cross-sectional view of a proximal portion of the surgical instrument of FIG. 17A . FIG. 17C is a detailed cross-sectional view of a proximal portion of the surgical instrument of FIG. 17A . FIG. 17D is a perspective view of a needle arm of the surgical instrument of FIG. 17A . FIG. 17E is a partial cross-sectional view of a distal portion of the surgical instrument of FIG. 17A . FIG. 17F is a perspective view of a first jaw of the surgical instrument of FIG. 17A . FIG. 17G is a perspective view of a second jaw of the surgical instrument of FIG. 17A . FIG. 17H is a view of the suture grasper push rod that can be used in the surgical instrument of FIG. 17A . FIGS. 18A–18E illustrate use of the surgical instrument of FIG. 17 . Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION Referring to FIG. 1 , a single-handed suture passing surgical instrument 100 passes suture 101 through tissue and holds the passed suture such that the instrument can be rethreaded to pass suture through tissue multiple times. An operator actuates a handle 190 to close an articulating jaw 110 through which suture is threaded to pass the suture through tissue, and thereafter actuates a trigger portion 150 to advance a suture grasper 130 along a tissue platform 120 to engage the suture with the suture grasper 130 . The jaw 110 is then opened and the instrument 100 removed with the suture remaining in the tissue and held by the suture grasper 130 . The instrument 100 can be rethreaded and reinserted to the surgical site to pass suture multiple times, for instance, as with a Mason-Allen Stitch. Suture passing surgical instrument 100 includes an elongated shaft 140 with a distal portion 105 and a proximal portion 145 . Located at the proximal portion 145 of the elongated shaft 140 are handle 190 and trigger portion 150 . Located at the distal end 105 are articulating jaw 110 , tissue platform 120 , and suture grasper 130 . The articulating jaw 110 is pivotally attached to the tissue platform 120 , and movement of the articulating jaw 110 is controlled by the handle 190 . In use, distal portion 105 is positioned such that when jaw 110 is closed, tissue is held between an upper surface of the articulating jaw 110 and a lower surface of the tissue platform 120 . The handle 190 includes an articulating handle 191 and a stationary handle 192 . As the articulating handle 191 is moved away from and towards the stationary handle 192 , the articulating jaw 110 is opened and then closed, respectively. The articulating handle 191 is attached to a push/pull rod 128 , which moves along a groove 140 A in the elongated shaft 140 . The rod 128 is attached to the articulating jaw 110 by a pivot hinge assembly 165 , described further below. The suture grasper 130 is controlled by the trigger portion 150 and is located on the tissue platform 120 . Tissue platform 120 is the distal portion of shaft 140 . Generally, the suture grasper 130 is designed to advance forward and hold the suture. The trigger portion 150 includes a trigger mechanism 139 and a rod 138 (see FIG. 5B ). The trigger mechanism 139 is attached to the rod 138 , which runs along the elongated shaft 140 , to control movement of the suture grasper 130 . Referring to FIG. 2 , the articulating jaw 110 is attached at its proximal end 119 to the tissue platform 120 by the pivot hinge assembly 165 . The pivot hinge assembly 165 includes two pins 166 , 168 and a hinge connector 167 . The hinge connector 167 is part of the jaw 110 and is attached to the tissue platform 120 by the pin 166 such that the articulating jaw 110 pivots about the pin 166 as the jaw 110 articulates. The rod 128 is attached to the hinge connector 167 by the pin 168 such that forward and backward motion of the rod 128 causes the jaw 110 to pivot about the pin 166 . Referring to FIGS. 3A–3D , the push/pull rod 128 includes two tabs 128 A, 128 B at its proximal end 129 B. Rod 128 is an elongated square-shaped shaft. At its distal end 129 A, rod 128 slopes away from its axis. Rod 128 includes this slope in order to articulate the jaw 110 in relation to the action of the handle 190 . The rod 128 reciprocates within groove 140 A in the instrument shaft 140 as the articulating handle 191 is moved away from and then towards the stationary handle 192 to open and close the articulating jaw 110 . The instrument shaft 140 also includes a limiting groove 140 B in which tab 128 A is located. The axial movement of tab 128 A in limiting groove 140 B limits movement of the rod 128 in the axial direction because axial movement of tab 128 A within the groove 140 B is constrained by the proximal and distal sides of groove 140 B. The articulating handle 191 defines a handle slot 140 C in which tab 128 B is located providing coupling between the rod 128 and the articulating handle 191 such that as the handle 191 is moved, the rod 128 moves to actuate jaw 110 . Referring again to FIG. 2 , the articulating jaw 110 includes a needle 115 . Generally, the needle 115 is sickle-shaped with a sharp point 113 and is formed of hardened stainless steel or similar material. The needle 115 is formed integral to the articulating jaw 110 and extends from the articulating jaw 110 toward the tissue platform 120 . Needle 115 includes a suture eyelet 111 disposed proximate to the tip 113 of the needle 115 . The needle 115 is sized such that when the articulating jaw 110 is closed, the instrument can fit within a predetermined sized cannula. Thus, the length of the needle 115 varies with different sized cannulas. Referring to FIGS. 4A and 4B , the tissue platform 120 has an U-shaped end 122 C defining a passageway 122 . The passageway 122 includes two suture slots 121 X, 121 Y. The suture slots 121 X, 121 Y are positioned such that when the needle passes through passageway 122 , the needle eyelet 111 is aligned with the slots when the portion of the needle defining the eyelet is within the passageway 122 to consistently place the suture 101 that is threaded through the eyelet in the suture slots 121 X, 121 Y (see FIG. 4B ). The suture rests in one of the suture slots 121 X, 121 Y after the needle 115 has passed through the tissue. The slots 121 X, 121 Y are provided in each of the lengthwise sides 122 A, 122 B of the passageway 122 . Suture grasper 130 acts to move the suture away from the needle 115 and holds the suture, for example, in slot 121 X against surface 121 A. Additionally, as the suture grasper 130 holds the suture against the wall 121 a of the suture slot 121 , the suture grasper 130 also closes the opening in side 122 A to capture the suture in the suture slot 121 X, as explained in more detail below. Referring to FIGS. 1 , 2 , 5 A, and 5 B, the suture grasper 130 is located on the tissue platform 120 and is attached to rod 138 . The suture grasper 130 includes a suture capture device 132 in the form of an arm 133 with an U-shaped tip 134 . The suture grasper 130 is shown to one side of the passageway 122 (the left side as viewed in FIG. 4A ). However, the suture grasper 130 can be located on either side, e.g., right or left, of the passageway 122 . To minimize possible damage to the suture, the suture is threaded through the eyelet 111 from the same side on which the suture grasper 130 is located. Rod 138 is formed as a pair of parallel rods 138 A, 138 B that terminate at their proximal end at a spring plate 137 A. The suture grasper 130 is activated by the trigger portion 150 to capture and hold the suture. The arm 133 of the suture capture device 132 of the suture grasper 130 advances forward to hold the suture in the U-shaped tip 134 against the distal wall 121 A of suture slot 121 X ( FIG. 4A ). The tissue platform 120 includes a grasper guide 170 under which the suture grasper 130 moves. The grasper guide 170 , for example, is formed like a bridge such that as the suture grasper 130 moves forward to hold the suture in suture slot 121 X, the suture grasper 130 follows a direct path towards the distal end 105 of the instrument 100 . The tip 113 of the needle 115 on the articulating jaw 110 passes through the passageway 122 when the articulating jaw 110 is closed. The passageway 122 is slightly wider than the needle 115 . The needle 115 pivots about pin 166 along an arc 110 a (see FIG. 2 ). The needle 115 is shaped with an arch, which corresponds to the radius of the arc 110 a . Thus, when the needle 115 extends through the passageway 122 , it arches over the suture grasper 130 . The arch of the needle 115 limits possible tearing of the tissue as the needle passes through the tissue. Referring to FIGS. 6A and 6B , the trigger portion 150 for moving the suture grasper 130 includes the trigger mechanism 139 , for example, shaped like a paddle, and the push/pull rod 138 . The trigger mechanism 139 rotates about an axis X. The trigger mechanism 139 is attached to the push/pull rod 138 that ends in the U-shaped suture capture device 132 . The trigger portion 150 also includes a rigid pin 139 A that follows a J-shaped groove 139 B in the trigger mechanism 139 and a spring 137 . In its resting position, the suture grasper 130 is in an open, locked position with pin 139 A located in the hook side 139 B 1 of the J-shaped groove 139 B, as shown in FIG. 6A . To create the forward movement of the suture grasper 130 necessary to capture the suture, the trigger mechanism 139 is rotated counter-clockwise (looking from the proximal end 190 down the shaft 140 ) to move the pin 139 A from the hook side 139 B 1 of the J-shaped groove 139 B to the long side 139 B 2 of the J-groove 139 B, as shown in FIG. 6B . The movement of the pin 139 A within the groove 139 B forces the push/pull rod 138 forward and the trigger mechanism 139 proximally and then distally against the spring 137 . The forward movement of the suture grasper 130 is created as the spring 137 moves forward against a spring plate 137 A and back against a spring brake or spring plate 137 B. To return the suture grasper 130 to its resting position, the trigger mechanism 139 A is rotated clockwise, e.g., moved from the long side 139 B 2 of the J-shaped groove 139 B back to the hook side 139 B 1 of the J-shaped groove 139 B. Referring to FIGS. 7A–7K , an operator uses the suture passing surgical instrument as follows. As shown in FIGS. 7A (top view) and 7 B (side view), an operator opens the articulating jaw 110 , i.e., articulating the jaw 110 away from tissue platform 120 , by moving handle 190 and loads suture into the suture eyelet 111 of the needle 115 . As shown in FIG. 7C (top view), the operator moves handle 190 to close articulating jaw 110 to hold the suture in the eyelet 111 . Then, as shown in FIG. 7D (side view), the operator passes the instrument 100 down a cannula to the surgical site. As seen in FIG. 7E (side view), after placing the instrument 100 in the surgical site, the operator moves handle 190 to open articulating jaw 110 to place the needle 115 under the targeted tissue. As shown in FIGS. 7F (side view) and 7 G (top view), the operator moves handle 190 to close articulated jaw 110 to capture the targeted tissue between the jaw 110 and the tissue platform 120 . The needle 115 on the articulating jaw 110 pierces the tissue as the tissue is grasped between the tissue platform 120 and the articulating jaw 110 , carrying the suture through the tissue. Next, as shown in FIGS. 7H (side view) and 71 (top view), the operator moves trigger portion 150 to advance suture grasper 130 forward to hold suture in the suture slot 121 Y. As shown in FIGS. 7J (side view) and 7 K (top view), the suture passed through the tissue is trapped on the proximal side of the tissue. As shown in FIGS. 7L (side view) and 7 M (top view), the operator moves handle 190 to open articulating jaw 110 to release the tissue. As the jaw 110 is opened, the suture grasper 130 holds the suture against wall 121 A of suture slot 121 X. As the operator begins to withdraw the instrument 100 from the surgical site, the free end of the suture slides out of eyelet 111 of needle 115 . As shown in FIGS. 7N (side view) and 7 O (top view), the free end 101 A of the suture 101 (the end that was threaded through the eyelet 111 ) remains above the tissue platform 120 . The other end of the suture is located in suture slot 121 X and passes through the tissue. The operator moves handle 190 to close jaw 110 to withdraw instrument 100 through the cannula (not shown). The instrument may be rethreaded and reinserted through the cannula to the surgical site in order to pass suture multiple times. For instance, where most tendon tissue are fibrous bundles, a repair that can be less prone to tearing along the fibrous bundle structure can be possible when the suture is secured perpendicular to the bundle cord with multiple passes of the suture. By passing suture through a different tissue bundle, the suture/tendon interface can be improved. Numerous alternative implementations or configurations of elements of the surgical instrument are possible. For instance, referring to FIGS. 8A–8H , the suture eyelet disposed proximate to the tip of the needle can have a variety of shapes and/or orientations. For example, FIG. 8A shows a rounded hole 211 as the suture eyelet, whereas FIG. 8B shows an oval or oblong hole 311 as the suture eyelet. In an alternative implementation, there can be more than one hole 411 , as shown in FIG. 8C . Or, the suture eyelet can be a cutout in the side of the needle proximate to the tip. For example, FIGS. 8D and 8E show cutouts 511 , 611 that extend into the needle, toward the jaw 110 . Alternatively, FIG. 8F shows a cutout 711 disposed below the tip 713 of the needle 715 that extends in both toward the tip 713 and toward the jaw 110 . Or, the eyelet can be located on the rounded side of the needle, as shown in FIGS. 8G and 8H (e.g., cutouts 811 , 911 ). The various positions and shapes of the suture eyelets affect a surgeon's ability to load/unload suture, to penetrate tissue, and to minimize procedure length. For instance, the suture may be threaded through the rounded hole or closed eyelet type of suture eyelets, as shown, for example, in FIG. 9 . While loading suture requires a bit more skill, the closed eyelet type of suture needle penetrates tissue more easily and accurately. Additionally, for example, the double eyelet needle shown in FIG. 8C may be used to pass two sutures simultaneously to form a mattress stitch with one pass and hence, reduce surgical time. With the cutout-type of suture eyelet, the suture is easier to load/unload, but tissue is more difficult to penetrate. Regardless of type or orientation of suture eyelet, suture is loaded on the same side that the suture grasper is located. The various embodiments discussed can include “free” suture or suture attached to a soft tissue attachment device. As shown in FIG. 9 , the “free” suture (suture not attached to an external device) is threaded through the suture eyelet 111 of the needle 115 . The ability to use “free” suture with the suture passing surgical instrument provides a surgeon with the flexibility to use intricate weaving (suture) patterns without the demand of visualizing each suture transfer. Alternatively, referring to FIG. 10 , suture is attached to a soft tissue attachment device, e.g., an anchor, prior to being threaded through the suture eyelet 111 . Referring to FIG. 11 , the surface 117 of the horizontal portion of the articulating jaw 110 (the surface facing the tissue platform 120 ) includes serrations 124 (see also FIG. 2 ). The serrations 124 , for example, are “V” shaped and provide an increased surface area against which to hold the tissue. The shape, number, and length of the serrations 124 can, for instance, vary. The serrations 124 can be, for example, grooves, ribs, or ridges. Alternatively, the surface 117 is smooth, i.e., without serrations, as shown in FIGS. 8A–8H . Referring to FIG. 12 , the surface 127 of the tissue platform 120 (the surface that faces the articulating jaw 110 ) includes serrations 123 (see also FIG. 2 ). The serrations 123 of the tissue platform 120 are, for instance, V-shaped and provide a larger surface against which to hold the tissue after the needle 115 has penetrated the tissue. The shape, number and length of the serrations 123 can vary. For example, the serrations 123 can be grooves, ribs, or ridges. A surgeon may want to move the tissue after it has been grabbed to ensure that the tissue will reach the attachment site. Or, if the detached tissue creates adhesions to other tissue surfaces, by pulling on the held tissue, the surgeon can determine if it is necessary to release or cut those adhesions free. Referring to FIGS. 13A–13C , an alternative implementation of the suture grasper 230 includes a suture capture device 232 having two opposing jaws 233 , 234 that, when advanced forward, flex outward to open around the suture and then spring shut to enclose the suture between the two jaws 233 , 234 . The suture grasper 230 is moved forward by activation of a push-pull rod 238 by an alternative implementation of the trigger mechanism 339 , a thumb push plate. The opposing jaws 233 , 234 of the suture grasper 230 initially contact an expansion pin 280 , which causes the jaws 233 , 234 to open. The jaws 233 , 234 of the suture capture device 232 include a plurality of grasping teeth 233 a , 234 a on their facing surfaces for holding the suture. The suture grasper 230 continues to move forward until the expansion pin 280 enters the expansion pin release slot 285 , at which point the opposing jaws 233 , 234 of the grasper 230 close on the suture. A grasper guide 270 provides directional guidance for the suture grasper 230 as the grasper moves forward along shaft 140 to capture the suture from the needle (not shown). The grasper guide 270 is a raised structure, e.g., a bridge, under which the suture grasper 230 moves. In this implementation of the guide 270 , the expansion pin 280 is located between the grasper guide 270 and the tissue platform 120 . Other implementations or configurations of a suture capture device include, for example, a hook or pick that advances forward or moves backward, pushes the suture away from the needle, and captures the suture. For example, the hook may be a forward-moving hook 332 , as shown in FIG. 14A ; a backward-moving hook 432 , 632 , as shown in FIGS. 14B and 14D ; a forward-moving wedge 532 , 732 , as shown in FIGS. 14C and 14E ; or a forward- or backward-moving hook 1032 , as shown in FIG. 14H . Alternatively, as shown in FIGS. 14F and 14G , the cup-shape of the suture capture device can have sides of different lengths ( FIG. 14F ) 832 or a flat base of the cup ( FIG. 14G ) 932 . As illustrated, for example, in FIGS. 14D–14H , the suture capture device alternatives are shown located on the left side of the tissue platform. However, the suture capture device can be located on the right side of the tissue platform, for example, as in FIGS. 14A–14C , if the suture were loaded from a different direction. Referring to FIGS. 15A and 15B , in an alternate implementation, the trigger portion 250 includes a trigger mechanism 239 , which is a hinged lever 239 attached to a push-pull rod 238 that ends in, e.g., one of the suture capture devices of FIGS. 14A–14H . A locking mechanism 236 , such as a spring or ratchet-type lock is used to hold the suture capture device, e.g., suture pick or hook, in a retracted position and to retain the suture capture device in a suture holding position. After the needle 115 has passed through the tissue, the lever 239 is pulled towards the handle 190 by the surgeon's finger. This action advances the push/pull rod 238 forward. The suture capture device then captures the suture from the needle and holds it in the suture slot. When the surgeon releases lever 239 , the locking mechanism acts to hold the suture capture device in its suture holding position. To release the suture, the lever 239 is actuated again to advance the push/pull rod 238 and release the suture. Referring to FIGS. 15C and 15D , in another alternative implementation, the trigger portion 350 includes a trigger mechanism 339 in the form of a button 339 , and a push rod 338 . The thumb-operated button 339 activates the push rod 338 , which moves the suture grasper 130 in a forward direction to capture the suture with the suture capture device, e.g., suture capture device 232 , after the articulating jaw 110 is closed and the suture needle 115 has penetrated the tissue. The button 339 is attached to the push rod 338 and the push rod 338 runs through a single or a series of rings 335 that direct the suture grasper 130 forward to grasp the suture. The articulating jaw 110 is then opened and removed from the tissue. A locking mechanism 336 for the suture grasper 130 is provided to secure the suture grasper 130 in position once the suture grasper 130 has been activated to hold the suture in the suture slot 121 . The locking mechanism can be a spring type mechanism that holds the suture capture device in a retracted position and retains the suture capture device in a suture holding position. Alternatively, as shown, the locking mechanism includes a plurality of teeth 336 A that mate with a latch 336 B, for example, within ring 335 (see FIG. 15D ) or on the instrument handle 190 (not shown), in order to lock the suture grasper 130 in place. To release, the locking mechanism 336 , button 339 is pushed away from the handle 190 to separate teeth 336 A and latch 336 B. Referring to FIGS. 16A–16E , other implementations of the push/pull rod of the suture grasper include, for example, a dual split rod configuration 438 or a single rod configuration 538 , 638 , 738 , 838 . In the single rod configurations, the rod can have locking teeth 736 , 836 , as shown, for example, in FIGS. 16D and 16E . In each implementation, the rod is attached at its proximal end to a thumb-plate, for example, the button 339 of FIG. 15B or an articulating lever, for example, lever 239 of FIG. 15A . Referring to FIGS. 17A–17H , an alternate implementation of a suture passing surgical instrument 1700 includes an elongated shaft 1740 with a distal portion 1705 and a proximal portion 1745 . At the proximal end of the elongated shaft, there is a handle 1790 , a control arm 1712 , and a trigger portion 1750 . At the distal end, there is a set of jaws 1718 , 1720 , a suture grasper 1730 , and a moveable needle arm 1710 . The jaw 1718 is controlled by the handle 1790 and attached to the elongated shaft 1740 by a pivot hinge assembly 1765 , as described above in relation to articulating jaw 110 . The needle arm 1710 is attached to a push/pull rod 1712 A and includes a needle 1715 at its distal end. The push/pull rod 1712 A runs along the elongated shaft 1740 and is actuated by a lever 1712 attached to the handle 1790 . The surgeon activates the lever 1712 with his finger to move the needle arm 1710 forward and backward. The suture grasper 1730 is controlled by the trigger portion 1750 and disposed on jaw 1720 , which is similar to the tissue platform 120 described above. The trigger portion 1750 includes a trigger mechanism 1739 , e.g., a thumb-operated button, and a rod 1738 . The thumb-operated button 1739 is attached to the rod 1738 , which runs along the elongated shaft 1740 to control the movement of the suture grasper 1730 , as described above. The trigger portion 1750 permits the surgeon to control when the surgeon captures the suture from the needle 1715 , after the needle 1715 and the suture have been passed through the tissue and are exposed above the jaw 1720 . As described above, the surgeon activates the button 1739 with his thumb to move the suture grasper 1730 forward to grasp the suture. The trigger portion may have similar alternatives and variations as previously described. Referring to FIG. 17B , the push/pull rod 1728 includes two tabs 1728 A, 1728 B at its proximal end and moves along a groove 1740 A of the instrument shaft 1740 , as described above. Referring to FIGS. 17C and 17D , the needle 1715 on the needle arm 1710 is shaped like a tapered rectangle that ends in a sharp tip 1713 . The needle 1715 is formed of nitinol, hardened stainless steel, or similar materials. The needle 1715 optionally is formed integral to the needle arm 1710 or separately and then rigidly attached (i.e., welded or mounted) to the needle arm 1710 . The needle 1715 initially extends from the needle arm 1710 , which is parallel to the pair of jaws 1718 , 1720 , and has a suture eyelet 1711 disposed therein. Needle arm 1710 is attached to push/pull rod 1712 A at pivot 1710 A. The suture eyelet 1711 is disposed proximate to the tip 1713 of the needle 1715 . As described above, the suture eyelet 1711 can, for example, open to the front or side of the needle and have various alternative shapes. An operator moves the needle arm 1710 to articulate away from the set of jaws 1718 , 1720 in order for suture to be threaded onto the needle 1715 . A “free” suture (not attached to anything) or suture attached to a soft tissue attachment device, e.g., an anchor is threaded through the suture eyelet 1711 of the needle 1715 . The ability to use “free” suture with the suture passing surgical instrument provides a surgeon with the flexibility to use intricate weaving (suture) patterns without the demand of visualizing each suture transfer. After suture is threaded through the needle 1715 , an operator moves lever 1712 to return the needle arm 1710 parallel to the set of jaws 1718 , 1720 . Movement of the push/pull rod 1712 A distally causes the needle arm 1710 to move distally until tip 1713 of needle 1715 contacts deflector 1718 A of jaw 1718 . Contact with deflector 1718 A by needle 1715 causes needle 1715 to pivot towards jaw 1720 about pivot 1715 A such that needle 1715 passes through passageway 1722 B of jaw 1718 and passageway 1722 A of jaw 1720 . Referring to FIG. 17E , the surface 1729 of the jaw 1720 (the surface that faces the jaw 1718 ) and the surface 1717 of the horizontal portion of the jaw 1718 (the surface facing the jaw 1720 ) can be smooth and/or serrated. The serrations 1723 , 1724 , respectively, can vary in shape, number, and length, as described above. Referring to FIGS. 17F and 17G , the set of jaws 1718 , 1720 (shown in these figures without grooves for clarity) includes passageways 1722 A, 1722 B through which the needle 1715 of the needle arm 1710 passes. Each passageway 1722 A, 1722 B is slightly wider than the needle 1715 . The passageway 1722 A of the jaw 1720 includes two suture slots or grooves 1721 X, 1721 Y in which the suture rests after the needle 1715 has passed through the tissue. In this implementation, the grooves 1721 X, 1721 Y are provided in each lengthwise side 1722 A 1 , 1722 A 2 of the passageway 1722 A. The suture capture device 1732 moves the suture away from the needle 1715 and holds the suture for example in the suture slot 1721 X against surface 1721 A as described above. Jaw 1718 includes passageway 1722 B, which is defined by a central rectangular cutout. The Jaw 1718 can have similar grooves, as described above in relation to jaw 1720 . Jaw 1720 includes a U-shaped end 1720 A defining passageway 1722 A. A grasper guide 1770 , as described above, is located on the jaw 1720 . Referring to FIGS. 17A and 17H , suture grasper 1730 is disposed on jaw 1720 and has similar alternatives as those described above. Referring to FIGS. 18A–18E , an operator uses the suture passing surgical instrument 1700 of FIG. 17A as follows. In the position of instrument 1700 as shown in FIG. 18A , the operator has moved lever 1712 to move moveable needle arm 1710 of the suture passing surgical instrument 1700 away from the set of jaws 1718 , 1720 to load suture through eyelet 1711 . Then, the operator moves lever 1712 to return needle arm 1710 parallel to the set of jaws 1718 , 1720 , as shown in FIGS. 18B and 18D . The operator moves lever 1712 to move moveable needle arm 1710 distally toward the deflector 1718 A of jaw 1718 . Upon contacting deflector 1718 A, moveable needle arm 1710 pivots about pivot 1715 A toward jaw 1720 and pierces the tissue held by the jaws 1718 , 1720 through passageway 1722 A, 1722 B, as shown in FIGS. 18C and 18E . The operator moves lever 1712 moveable needle arm 1710 distally toward the deflector 1718 A of jaw 1718 . Upon contacting deflector 1718 A, moveable needle arm 1710 pivots about pivot 1715 A toward jaw 1720 and pierces the tissue held by the jaws 1718 , 1720 through passageway 1722 A, 1722 B. Next, the operator activates trigger portion 1750 to advance suture grasper 1730 distally to hold the suture in suture slot 1721 X. The operator moves lever 1712 to move needle arm 1710 back out of the set of jaws 1718 , 1720 . The needle 1715 moves out of the tissue through passageway 1722 A, 1722 B. The operator then moves the lever 1712 to return the needle arm 1710 parallel to the set of jaws 1718 , 1720 . The operator moves handle 1790 to open the set of jaws 1718 , 1720 to release the tissue and then the operator moves handle 1790 to close the jaws 1718 , 1720 . The free end of the suture remains above the jaw 1720 . The other end of the suture is located in the suture slot 1721 X and through the tissue. The operator removes instrument 1700 from the surgical site. The instrument may be rethreaded and reinserted through the cannula to the surgical site in order to pass suture multiple times. A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope. For example, the tissue platform may include one suture slot or the needle may pass through tissue to either side of the articulating jaw or set of jaws. Alternatively, the passageway may be offset to accommodate orientation of the needle or suture eyelet. The suture capture device may be or may include a latch or a cutout. The trigger portion may include a button or other mechanism to activate movement of the suture grasper. The needle may be formed separately from the jaw and then rigidly attached, e.g., welded or mounted to the jaw. The eyelet of the needle may open to the front of the needle or to the inside of the needle. Additionally, the instrument can be used in many surgical environments, including, for example, open, mini-open, and endoscopic, and with visualization, limited visualization, or no visualization of the suture grasper. Also, other devices for attaching tissue to bone or tissue to tissue will work with the device and can be carried into the operative site and attached or secured by the device. The type of material used, i.e., material construction, braided or monofilament or combinations of construction and material type, synthetic, natural, permanent or reabsorbable, can vary, and a variety of material diameters are possible. Loose or highly mobile tissue can be translocated as desired by the surgeon. Also, the same suture strand can be passed through tissue multiple times and in various directions. Accordingly, other implementations are within the scope of the following claims.

1a

RELATED APPLICATIONS This patent application is a continuation of U.S. patent application Ser. No. 08/717,285 filed Sept. 20, 1996 now U.S. Pat. No. 5,833,705 which is a continuation-in-part of U.S. patent application Ser. No. 08/497,331 filed Jun. 30, 1995, now U.S. Pat. No. 5,582,619 and U.S. patent application Ser. No. 08/607,593 filed Feb. 27, 1996, now abandoned. FIELD OF THE INVENTION This invention is an implantable vaso-occlusive device. It is typically a vaso-occlusive coil comprised of a primary helically wound coil which may then be wound into a secondary shape. Central to the invention is the use of a stretch-resisting member extending through the lumen formed is fixedly attached to the coil in at least two locations. The stretch-resisting member may be formed into coil tips at the ends of the coil using simple equipment such as soldering irons or the like. The tips are typically of the same diameter as is the coil body itself. This stretch-resisting member is for the primary purpose of preventing stretching of the coil during movement of that coil, e.g., by retrieval or repositioning after deployment. The device typically has a self-forming secondary shape made from a pre-formed primary linear helically wound coil, although it need not have the secondary form. External fibers may be attached to the device and affixed to the pre-formed linear member to increase thrombogenicity. The vaso-occlusive member may be also be covered with a fibrous braid. The device is typically introduced into the body through a catheter. The device is passed axially through the catheter sheath and assumes its secondary form upon exiting the catheter. BACKGROUND OF THE INVENTION Vaso-occlusion devices are surgical implements or implants that are placed within the vasculature of the human body, typically via a catheter, either to block the flow of blood through a vessel making up that portion of the vasculature through the formation of an embolus or to form such an embolus within an aneurysm stemming from the vessel. One widely used vaso-occlusive device is a helical wire coil having windings which may be dimensioned to engage the walls of the vessels. Other less stiff, helically coiled devices have been described, as well as those involving woven braids. For instance, U.S. Pat. No. 4,994,069, to Ritchart et al., describes a vaso-occlusive coil that assumes a linear helical configuration when stretched and a folded, convoluted configuration when relaxed. The stretched condition is used in placing the coil at the desired site (by its passage through the catheter) and the coil assumes a relaxed configuration--which is better suited to occlude the vessel--once the device is so placed. Ritchart et al. describes a variety of shapes. The secondary shapes of the disclosed coils include "flower" shapes and double vortices. A random secondary shape is described, as well. Vaso-occlusive coils having attached fibrous elements in a variety of secondary shapes are shown in U.S. Pat. No. 5,304,194, to Chee et al. Chee et al. describes a helically wound device having a secondary shape in which the fibrous elements extend in a sinusoidal fashion down the length of the coil. These coils, as with Ritchart et al., are produced in such a way that they will pass through the lumen of a catheter in a generally straight configuration and, when released from the catheter, form a relaxed or folded shape in the lumen or cavity chosen within the human body. The fibrous elements shown in Chee et al. enhance the ability of the coil to fill space within the vasculature and to facilitate formation of embolus and subsequent allied tissue. There are a variety of ways of discharging shaped coils and linear coils into the human vasculature. In addition to those patents which apparently describe only the physical pushing of a coil out into the vasculature (e.g., Ritchart et al.), there are a number of other ways to release the coil at a specifically chosen time and site. U.S. Pat. No. 5,354,295 and its parent, 5,122,136, both to Guglielmi et al., describe an electrolytically detachable embolic device. A variety of mechanically detachable devices are also known. For instance, U.S. Pat. No. 5,234,437, to Sepetka, shows a method of unscrewing a helically wound coil from a pusher having interlocking surfaces. U.S. Pat. No. 5,250,071, to Palermo, shows an embolic coil assembly using interlocking clasps mounted both on the pusher and on the embolic coil. U.S. Pat. No. 5,261,916, to Engelson, shows a detachable pusher-vaso-occlusive coil assembly having an interlocking ball and keyway-type coupling. U.S. Pat. No. 5,304,195, to Twyford et al., shows a pusher-vaso-occlusive coil assembly having an affixed, proximally extending wire carrying a ball on its proximal end and a pusher having a similar end. The two ends are interlocked and disengage when expelled from the distal tip of the catheter. U.S. Pat. No. 5,312,415, to Palermo, also shows a method for discharging numerous coils from a single pusher by use of a guidewire which has a section capable of interconnecting with the interior of the helically wound coil. U.S. Pat. No. 5,350,397, to Palermo et al., shows a pusher having a throat at its distal end and a pusher through its axis. The pusher sheath will hold onto the end of an embolic coil and will then be released upon pushing the axially placed pusher wire against the member found on the proximal end of the vaso-occlusive coil. Vaso-occlusive coils having little or no inherent secondary shape have also been described. For instance, in U.S. patent application Ser. No. 07/978,320, filed Nov. 18, 1992, entitled "Ultrasoft Embolization Coils with Fluid-Like Properties" by Berenstein et al., is found a coil having little or no shape after introduction into the vascular space. None of these devices are helical coils which contain a stretch-resisting member contained therein. SUMMARY OF THE INVENTION This invention is a vaso-occlusive device comprising a helically wound coil which is formed by winding a wire into a first or primary helix to form an outer helical member having first and second ends. A stretch resistant member extending through the lumen formed is fixedly attached to the coil in at least two locations. The primary helix, with its included stretch-resistant member, may be wound into a secondary form and heat-treated to preserve that form, desirably prior to the step of including the stretch-resisting member into the coil. The secondary form may be one which, when ejected from a delivery catheter, forms a specific shape. Such a shape might, e.g., fill a vascular cavity such as an aneurysm, or perhaps, a fistula. The stiffness of the various parts of the coil may be tailored to enhance the utility of the device for specific applications. Fibrous materials may be woven into the member or tied or wrapped onto it. The device is used simply by temporarily straightening the device and introducing it into a suitable catheter, the catheter already having been situated so that its distal opening is at the selected site in the body. The device is then pushed through the catheter and, upon its ejection from the distal end of the catheter into the vascular cavity, assumes its relaxed or secondary shape. The device is typically used in the human vasculature to form emboli but may be used at any site in the human body where an occlusion such as one produced by the inventive device is needed. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A shows a side view, partial cutaway of a vaso-occlusive coil made according to the invention having a generally linear fibrous stretch-resisting member. FIG. 1B shows a side view, partial cutaway of a vaso-occlusive coil made according to the invention having a generally linear wire stretch-resisting member. FIG. 1C shows a side view, partial cutaway of a vaso-occlusive coil made according to the invention having a generally helical stretch-resisting member. FIGS. 2A, 2B, and 2C show side view, partial cutaways of typical ends of the inventive vaso-occlusive coils. FIGS. 3A and 3B show a side view, partial cutaways of electrolytically severable joints in combination with a vaso-occlusive coil made according to the invention. FIGS. 4A and 4B show a side view, partial cutaway of a typical mechanically detachable joint in combination with a vaso-occlusive coil made according to the invention. FIG. 5 shows a "C" shaped secondary shape for the inventive vaso-occlusive device. FIG. 6 shows a clover-leaf secondary shape for the inventive vaso-occlusive device. FIG. 7 shows a double-looped secondary shape for the inventive vaso-occlusive device. FIG. 8 shows attachment of external fibrous material to the inventive vaso-occlusive device. FIG. 9 shows attachment of external braided fibrous material to the inventive vaso-occlusive device. FIGS. 10A-10D show a procedure for introducing a vaso-occlusive coil such as found in the other Figures into an aneurysm. DESCRIPTION OF THE INVENTION FIGS. 1A, 1B, and 1C show side-view partial cross-sections (or cutaways) of highly desirable variations of the inventive coil (100, 200, 210). The variations shown in FIGS. 1A and 1B are made up of a helically wound outer coil (102, 202) having a first end (104, 204) and a second end (106, 206). We refer to this form as the as the "primary" winding or shape. These variations include a stretch-resisting member (108, 208, 214) which is shown to be fixedly attached both to the first end (104, 204) and to the second end (106, 206). In certain circumstances, it may be desirable to attach the stretch-resisting member (108, 208) only to one of the two ends, to at least one site between the to ends, or to neither of the two ends. Clearly, for attaining stretch resistance, the stretch resisting member must be attached to at least two points on the coil. The stretch-resisting member (108) of the variation shown in FIG. 1A is fibrous and desirably polymeric. It may be a thermoplastic or thermosetting and comprise a bundle of threads or a single filament melted onto, glued, or otherwise fixedly attached to the vaso-occlusive coil (100). In some instances, it may also be desirable to include one or more metallic strands in the stretch-resisting member (108) to provide stiffness or electrical conductance for specific applications. The stretch-resisting member (208) of the variation shown in FIG. 1B is a simple wire or "ribbon" which is soldered, brazed, glued, or otherwise fixedly attached to the first end (204), second end (206), or to the coil at one or more locations intermediate to those the ends. The variation shown in FIG. 1C includes a stretch-resisting member (214) which is comprised of a helically wound coil which is soldered, brazed, glued, or otherwise fixedly attached to the first end (204) or second end (206) or in one or more intermediate locations. The stretch-resisting member (214) in this configuration provides a greater measure of lateral flexibility than the wire variation (208 in FIG. 1B). It may be wound in either the same direction as is the outer coil (202) or in the alternate direction. A modest drawback to this variation is that it will stretch more than the FIG. 1B variation when axially stressed. The materials used in constructing the vaso-occlusive coil (102, 202) and the stretch resisting member (108, 208, 214) may be any of a wide variety of materials; preferably, a radio-opaque material such as a metal or a polymer is used. Suitable metals and alloys for the wire making up the primary coil (102, 202) and the stretch-resisting member (108, 208, 214) include the Platinum Group metals, especially platinum, rhodium, palladium, rhenium, as well as tungsten, gold, silver, tantalum, and alloys of these metals. These metals have significant radio-opacity and in their alloys may be tailored to accomplish an appropriate blend of flexibility and stiffness. They are also largely biologically inert. Highly preferred is a platinum/tungsten alloy, e.g., 8% tungsten and the remainder platinum. The ribbon or coil stretch-resisting members (208, 214) may also be of any of a wide variety of stainless steels if some sacrifice of radio-opacity and flexibility may be tolerated. Very desirable materials of construction, from a mechanical point of view, are materials which maintain their shape despite being subjected to high stress. Certain "super-elastic alloys" include various nickel/titanium alloys (48-58 atomic % nickel and optionally containing modest amounts of iron); copper/zinc alloys (38-42 weight % zinc); copper/zinc alloys containing 1-10 weight % of beryllium, silicon, tin, aluminum, or gallium; or nickel/aluminum alloys (36-38 atomic % aluminum). Particularly preferred are the alloys described in U.S. Pat. Nos. 3,174,851; 3,351,463; and 3,753,700. Especially preferred is the titanium/nickel alloy known as "nitinol". These are very sturdy alloys which will tolerate significant flexing without deformation even when used as very small diameter wire. If a superelastic alloy such as nitinol is used in the device, the diameter of the coil wire may be significantly smaller than that used when the relatively more ductile platinum or platinum/tungsten alloy is used as the material of construction. The coils may be made of radiolucent fibers or polymers (or metallic threads coated with radiolucent or radio-opaque fibers) such as Dacron (polyester), polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoro-ethylene), Nylon (polyamide), or even silk. Should a polymer be used as the major component of the vaso-occlusive coil member, it is desirably filled with some amount of a radio-opaque material such as powdered tantalum, powdered tungsten, bismuth oxide, barium sulfate, and the like. The coil material is first wound into a primary coil (102, 202). The primary coil is typically linear after it has been wound. Generally speaking, when the coil (102, 202) is a metallic coil and that coil is a platinum alloy or a superelastic alloy such as nitinol, the diameter of the wire used in the production of the coil (102, 202) will be in the range of 0.00025 and 0.006 inches. The wire is wound into a primary coil (102, 202) having a primary diameter of between 0.003 and 0.025 inches. For most neurovascular indications, the preferable primary coil (102, 202) diameter is 0.008 to 0.018 inches. We have generally found that the coil wire may be of sufficient diameter to provide a hoop strength to the resulting device sufficient to hold the device in place within the chosen body site, lumen or cavity, without substantially distending the wall of the site and without moving from the site as a result of the repetitive fluid pulsing found in the vascular system. The axial length of the primary coil will usually fall in the range of 0.5 to 100 cm, more usually 2.0 to 40 cm. Depending upon usage, the coil may well have 10-75 turns per centimeter, preferably 10-40 turns per centimeter. All of the dimensions here are provided only as guidelines and are not critical to the invention. However, only dimensions suitable for use in occluding sites within the human body are included in the scope of this invention. Once the primary coil (102, 202) is wound, the stretch-resisting member (108, 208) is inserted into the lumen of the primary coil (102, 202) and secured to the coil as desired. Ends (104, 204, 106, 206) are preferably of the same diameter as is the primary coil (102, 202). Suitable polymeric materials for the polymeric stretch-resisting member (108) can be either thermosetting or thermoplastic. Thermoplastics are preferred because they allow simplification of the procedure for constructing the device (100) since they may be melted and formed into the end or ends (104, 106). Simple devices such as soldering irons may be used to form the ends. Thermosetting plastics would typically be held in place by an adhesive. Suitable polymers include most biocompatible materials which may be made into fibers but include polyester such as polyethyleneterephthalate (especially Dacron) and polyamides including the Nylons, polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoro-ethylene), or even silk. Especially preferred because of the long history of safe and effective usage in the human body is fibrous polyethyleneterephthalate (PET) sold as Dacron. FIG. 2A shows a side-view partial cross-section of one end of inventive coil (100). FIG. 2A also shows the helically wound outer coil (102) having an end (106) which is formed from a formerly molten fiber which also makes up the stretch-resisting member (114). An end of this type may be considered to have modestly higher vaso-occluding properties than a metallic end. Other functional equivalents to this structure include ends (106) formed of glues such as epoxies and their equivalents, and which are mechanical in nature. FIG. 2B shows an external knot (112) which fixes the length of the coil member (102) and keeps it from stretching; FIG. 2C shows a reformed mass of formerly molten polymer or of glue which is of a diameter larger than the inner diameter of coil (102) and prevents the coil from stretching. The knot (112) and block (114) are not shown to be attached to the coil (102) but may be. The variations shown in FIGS. 1A, 1B, 1C and 2A, 2B, and 2C are designed to be deployed by use of a pusher and a catheter in the manner discussed in Ritchart et al, discussed above. Other methods (and concomitant fixtures or joints to accomplish those methods) may also be used. For instance, the end of the device may be adapted to accept an electrolytically severable joint of the type discussed in U.S. Pat. No. 5,354,295 and its parent, U.S. Pat. No. 5,122,136, both to Guglielmi and Sepetka, described above. FIGS. 3A and 3B depict, in partial cross section, such variations. The vaso-occlusive coil (130, 230) is attached to a fill member (132, 232). The fill member (132, 232) preferably comprises a thermoplastic formed into place or an epoxy or the like and adheres, in turn, both to the stretch resistant member (134, 234) and the core wire (136, 236). The core wire (136, 236) in this variation has an enlarged member which is embedded in the fill member (132, 232). The core wire (136, 236) is insulated, typically with a combination of polytetrafluoroethylene and parylene (polyparaxyxylene), except for a small sacrificial joint (138, 238) which is intended to be the site of the electrolysis as the joint (138, 238) is eroded or severed and the coil deployed into the body site. The details of this variation (sans stretch-resistant member (136, 236)) are discussed in Gia et al, U.S. Pat. application Ser. No. 08/367,061, filed Dec. 30, 1994, the entirety of which is incorporated by reference. FIG. 4A shows still another variation of a joint for releasing the inventive coil into a site within the human body. In this instance, the joint is mechanically deployed. The primary coil (140) incorporates interlocking clasps, one (142) located on an end of the coil (140) and one (144) located on the end of a pusher (146). The stretch-resisting member (148) is attached to the interlocking clasp (142) via a filler block (154). Again, the filler block (154) comprises a material (e.g., a thermoplastic or adhesive material) which may be placed in the coil and will adhere to the stretch-resistant member (148). The coil assembly (150), made up of the primary coil (140), interlocking clasp (142), and stretch-resisting member (148) is deployed by retracting catheter body (or sheath) (152). FIG. 4B shows a variation of the device depicted in FIG. 4A which does not employ special filler block material (154) for adhering to the stretch-resistant member. Other mechanically deployable joints suitable for use with the inventive coil are described in: U.S. Pat. No. 5,234,437, to Sepetka, (shows a method of unscrewing a helically wound coil from a pusher having interlocking surfaces). U.S. Pat. No. 5,250,071, to Palermo, (shows an embolic coil assembly using interlocking clasps mounted both on the pusher and on the embolic coil) U.S. Pat. No. 5,261,916, to Engelson, (shows a detachable pusher/vaso-occlusive coil assembly having an interlocking ball and keyway-type coupling) U.S. Pat. No. 5,304,195, to Twyford et al. (shows a pusher-vaso-occlusive coil assembly having an affixed, proximally extending wire carrying a ball on its proximal end and a pusher having a similar end, which two ends are interlocked and disengage when expelled from the distal tip of the catheter) U.S. Pat. No. 5,312,415, to Palermo (also shows a method for discharging numerous coils from a single pusher by use of a guidewire which has a section capable of interconnecting with the interior of the helically wound coil). U.S. Pat. No. 5,350,397, to Palermo et al. (shows a pusher having a throat at its distal end and a pusher through its axis. The pusher sheath will hold onto the end of an embolic coil and will then be released upon pushing the axially placed pusher wire against the member found on the proximal end of the vaso-occlusive coil). The entirety of which are incorporated by reference. As was noted above, the devices of this invention may have the simple linear shape shown in FIGS. 1 and 2 or may have shapes which are not so simple. FIGS. 5, 6, and 7 show what are termed "secondary" shapes in that they are formed from the primary coil by the simple act of winding the primary coil on a form of a desired shape and then heat treating the so-formed shape. FIG. 5 shows a "C" shaped coil assembly (160) having a stretch-resistant member (162). FIG. 6 shows a clover-leaf shaped coil assembly (164) also having a stretch-resistant member (162). FIG. 7 shows a double-loop coil assembly (166). These are indicative of the various secondary shapes suitable for this invention. Additionally, these inventive devices may also be used in conjunction with various external fiber adjuncts. FIG. 8 shows a partial side-view of a linear variation of the inventive device (170) having filamentary material (172) looping through the coil (174). This method of attachment is described in greater detail in U.S. Pat. Nos. 5,226,911 and 5,304,194, to Chee et al, the entirety of which are incorporated by reference. A further description of a desirable fiber attachment is shown in U.S. patent application Ser. No. 08/265,188, to Mirigian et al, filed Jun. 24, 1994. FIG. 9 shows a partial cutaway of a device (180) having a braided covering (182) of a filamentary material and a stretch-resisting member (184). This method of enveloping a coil is described in greater detail in U.S. Pat. Nos. 5,382,259, to Phelps et al, the entirety of which is incorporated by reference. The fibrous woven or braided tubular materials may be made from a biocompatible materials such as Dacron (polyester), polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoroethylene), Nylon (polyamide), or silk. The strands forming the braid should be reasonably heavy, e.g., having tensile strength of greater than about 0.15 pounds. The materials mentioned, to the extent that they are thermoplastics, may be melted or fused to the coils. Alternatively, they may be glued or otherwise fastened to the coils. Preferred materials are Dacron. FIGS. 10A-10D depict a common deployment method for introduction of the inventive vaso-occlusive devices described here. It may be observed that these procedures are not significantly different than those described in the Ritchart et al. patent mentioned above. Specifically, FIG. 10A shows the distal tip of a delivery catheter (310) which is within the opening (312) of an aneurysm (314) found in an artery (316). The distal or end section of the vaso-occlusive device (318) is shown within the catheter (310). In FIG. 10B, the distal end portion of the vaso-occlusive device (318) has exited the distal end of the catheter (310) and has wound into a secondary shape within the aneurysm (314). FIG. 10C shows the completion of the formation of the secondary shape within the aneurysm (314). FIG. 10D shows the separation of the vaso-occlusive device (318) from the pusher, placement within the aneurysm (314), and the withdrawal of the catheter from the mouth of the aneurysm. Once the inventive coil is in place in an aneurysm or other site, there may be an occasion during which the coil must be moved or even withdrawn. For instance, in FIG. 10D, the coil might extend through the mouth (312) of the aneurysm into the artery. Occlusion would not be desirable in the artery. A device such as the endovascular snare shown in U.S. Pat. No. 5,387,219, to Rappe, may then be used to grasp the exposed coil and move it or retrieve it from the body. The stretch-resisting member of this invention prevents the coil from stretching into a single strand of wire and multiplying in length. Modification of the above-described variations of carrying out the invention that would be apparent to those of skill in the fields of medical device design generally, and vaso-occlusive devices specifically, are intended to be within the scope of the following claims.

1a

This is a continuation of application Ser. No. 08/015,396 filed on Feb. 9, 1993, now abandoned. BACKGROUND OF THE DISCLOSURE 1. Field of the Invention This invention relates to an improved method of application of Minoxidil to stimulate hair growth by means of iontophoretic transport to the hair follicle after converting Minoxidil to an ionic form. 2. BACKGROUND OF THE INVENTION The patent literature is replete with compositions and processes for stimulating mammalian hair growth and/or keratin formation. Of these, Minoxidil (6-piperidino-2,4-diaminopyrimidine-3-oxide) is a drug which has been found to be useful in promoting hair growth. Minoxidil is normally applied as an active ingredient topically to the area where hair growth is desired. U.S. Pat. No. 4,970,063 describes and defines compositions and methods using what is defined as "Minoxidil," said patent being incorporated herein by reference. Other U.S.A. patents which teach the use of Minoxidil for hair growth are U.S. Pat. Nos. 3,461,461; 3,910,928; 4,139,619; and 4,596,812. It is believed that Minoxidil promotes hair growth after diffusion to the hair follicles. The precise site and mechanism of action have not as yet been elucidated. Although Minoxidil is effective in promoting hair growth after it reaches the hair follicle, the clinical efficacy of topical application is limited by low water solubility and by the fact that the outer layers of skin are an effective barrier to penetration of polar molecules such as Minoxidil. The technique of iontophoresis employs a small electric current to transport ionic drug compounds into the skin or other tissue. Iontophoresis is believed to increase drug entry through so-called "shunt pathways" provided by hair follicles and sweat glands. Since hair follicles are a major pathway for iontophoretic drug delivery, iontophoresis is potentially the ideal method of administering Minoxidil to the hair follicles. Water is the preferred solvent for use in iontophoresis. Minoxidil itself has a low solubility in water and, because it has no net ionic charge, does not migrate in an iontophoretic field. In fact, due to the dipolar nature of Minoxidil, there is some evidence that the iontophoretic field inhibits even the passive migration by electro-osmosis often observed with non-charged compounds in electric fields. Thus, although Minoxidil is effective in promoting hair growth after it reaches the hair follicles, presently there has been no therapeutic delivery system that utilized a transport mechanism other than passive diffusion in its attempt to deliver Minoxidil across the skin's membrane barrier to the hair follicle. SUMMARY OF THE INVENTION The present invention is directed to the application of ionic derivatives or salts of Minoxidil which can effectively be transported via iontophoresis to hair follicles where they promote hair growth. Specifically, the invention is directed to the cationic derivatives of Minoxidil, such as taught in the aforesaid U.S. Pat. No. 4,970,063, which are purified and then applied in an electric conductive solution, usually aqueous, to the area where hair growth is desired and transported to the hair follicles by means of iontophoresis. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The term "Minoxidil" as used herein refers to the compound 6-(1-piperidinyl)-2,4-pyrimidinediamine 3-oxide (the uninverted name used by Chemical Abstracts Service during the ninth and/or subsequent Collective Index Periods and having the Chemical Abstracts Registry Number [38304-91-5]). The Merck Index, Eleventh Edition (published by Merck & Co., Inc., Rathway, N.J., U.S.A., 1989) lists a number of other names, including 6-piperidino-2,4-diaminopyrimidine 3-oxide and 6-amino-1,2-dihydro-1-hydroxy-2-imino-4-piperidinopyrimidine, one of the tautomers of Minoxodil. Reference is also made to U.S. Pat. Nos. 4,970,063 and 3,461,461. Ionic specifically cationic derivatives of Minoxidil are formed according to a preferred embodiment of the present invention by means such as set forth in the following general procedure. GENERAL PROCEDURE FOR CREATING IONIC DERIVATIVES OF MINOXIDIL A solution of 4.2 g (0.02 mole) of Minoxidil (6-piperidino-2,4-diaminopyrimidine-3-oxide) in 100 ml of 95% alcohol at about 70° C. is placed in a 500 ml three-necked flask equipped with a reflux condenser, stirrer and a dropping funnel. The stoichiometric amount of an organic acid (0.01 mole of d-tartaric acid or 0.02 mole of one of the other acids listed below) dissolved in 100 ml of 95% ethanol at a temperature of about 70° C. was placed in the dropping funnel and added to the stirred Minoxidil solution in a dropwise fashion over a period of about one hour. Upon completion of the addition, the reaction mixture is stirred, for from 16 to 24 hours, while being maintained at a temperature of about 70° C. Any significant amount of solid present is removed by filtration. The remaining solution is transferred to a 500 ml one-necked flask and concentrated to about 50 ml under reduced pressure using a Roto Vac device. The precipitates formed are collected by vacuum filtration and purified by recrystallization from absolute alcohol. Seven prototype salts or cationic derivatives were prepared using the general procedure. The salt obtained from the reaction with 5-nitro-2-furoic acid was bright yellow in color; all other compounds were white solids. The salts were characterized by their melting points, elemental analyses, infrared spectra, proton NMR spectra and carbon 13 NMR spectra. The percentage yields, melting points and elemental analyses are summarized in Table 1. TABLE 1__________________________________________________________________________ MOLECULAR MELTINGORGANIC ACID FORMULA OF % POINT, ELEMENTAL ANALYSISREACTANT PRODUCT YIELD °C. % C % H % N__________________________________________________________________________[R-(R*,R*)]-2,3- C.sub.22 H.sub.36 N.sub.10 O.sub.8 87% 212-214 Theory 47.14 6.47 24.99dihydroxy-butan- Found 46.48 6.19 24.46edioc acid (d-tar-taric acid)2,4,6(1H,3H,5H)- C.sub.13 H.sub.19 N.sub.7 O.sub.4 86% 198-200 Theory 46.29 5.68 29.06pyrimidinetrione Found 45.05 5.77 28.16(barbituric acid)3,4-dihydroxy- C.sub.16 H.sub.21 N.sub.5 O.sub.5 89% 212-214 Theory 52.89 5.83 19.27benzoic acid Found 52.49 5.96 22.37(protocatechuicacid)2,3,4-trihydroxy- C.sub.16 H.sub.21 N.sub.5 O.sub.6 62% 226-228 Theory 50.66 5.58 18.46benzoic acid Found 50.22 5.57 20.133,4,5-trihydroxy- C.sub.16 H.sub.21 N.sub.5 O.sub.6 85% 211-212 Theory 50.66 5.58 18.46benzoic acid Found 50.63 5.84 21.82(gallic acid)5-nitro-2-furoic C.sub.14 H.sub.18 N.sub.6 O.sub.6 55% 226-228 Theory 45.90 4.95 22.94acid Found 45.81 4.82 22.845,5-dimethyl- C.sub.14 H.sub.22 N.sub.6 O.sub.4 65% 165-167 Theory 49.70 6.55 24.84oxazolidine-2,4- Found 50.21 6.68 26.16dione(dimethadione)__________________________________________________________________________ Equations for the reactions of Minoxidil with the seven organic acids listed in Table 1 are listed below. Equations for the reactions of Minoxidil with various acids ##STR1## The cationic derivatives of Minoxidil are not limited to those produced by the seven acids which are listed but may be produced with other organic and inorganic acids. IONTOPHORETIC TRANSPORT OF CATIONIC DERIVATIVES OF MINOXIDIL The transdermal iontophoresis of cationic derivatives of Minoxidil was demonstrated in laboratory experiments utilizing fresh, full-thickness mouse skin with clipped hair, which has been reported to be an excellent model for studying the drug permeability of human skin. Iontophoresis was conducted with side-by-side diffusion cells obtained from the Crown Glass Co. A piece of mouse skin was clamped between the two half-cells, and the donor cell was filled with an aqueous solution of one of the ionic derivatives of Minoxidil. The receiver cell was filled with 0.05 molar sodium chloride solution. An electric current was applied across the two half-cells using silver/silver chloride electrodes inserted into both cells through teflon plugs. The donor cell electrode was always the anode (positive pole +) except where otherwise noted. An electric stimulator was used to apply a 0.8 milliamp, current to a diffusion area of 0.64 cm 2 for periods of up to 90 minutes, and the iontophoretic mobility of the ionic derivatives of Minoxidil was determined by sampling the receiver cell compartment at various times throughout the study. The concentration of cationic derivatives of Minoxidil in the receiver cell was measured by ultraviolet spectrophotometry. Data was also obtained under passive conditions without any electric current. The results of 4 to 8 separate experiments with each Minoxidil ionic derivative were used to calculate the average flux for passive and active iontophoretic conditions and these data are shown in Table 2 below. Iontophoresis significantly enhanced the skin permeation of the Minoxidil ionic derivatives. The Minoxidil tartrate derivative of those tested showed significant improvement in iontophoretic mobility across the skin. These results demonstrate that iontophoresis can be used to enhance the delivery of Minoxidil to the skin. TABLE 2__________________________________________________________________________Active (Iontophoretic) and Passive Flux (ug/cm.sup.2 /h) of MinoxidilIonic Derivates.sup.1MINOXIDIL IONICDERIVATES.sup.2 5-30 MINUTES 30-90 MINUTES 5-90 MINUTES__________________________________________________________________________Dimethadione 0.1%ACTIVE 68.6 ± 10.3 136.0 ± 19.8 95.8 ± 13.3PASSIVE 25.7 ± 5.5 25.8 ± 2.4 17.2 ± 1.6Dimethadione 0.2%ACTIVE 74.0 ± 15.3 146.6 ± 9.9 97.7 ± 6.6PASSIVE 34.9 ± 5.8 29.2 ± 1.7 19.5 ± 1.2Tartrate 0.1%ACTIVE 65.4 ± 19.4 189.7 ± 36.2 144.6 ± 23.0PASSIVE 59.2 ± 17.6 25.6 ± 6.2 29.6 ± 6.6Tartrate 0.2%ACTIVE 74.3 ± 21.8 180.4 ± 26.7 140.9 ± 22.7PASSIVE 23.3 ± 4.7 20.6 ± 6.8 20.2 ± 5.8Trihydroxybenzoate 0.1%ACTIVE 37.2 ± 5.8 62.4 ± 9.9 59.7 ± 7.8PASSIVE 24.7 ± 4.3 24.5 ± 3.4 21.9 ± 3.6Trihydroxybenzoate 0.2%ACTIVE 53.2 ± 5.6 173.9 ± 29.0 115.9 ± 19.4PASSIVE 4.3 ± 1.9 6.0 ± 1.8 4.0 ± 1.2__________________________________________________________________________ .sup.1 Values are the mean and standard error of 4 to 8 separate studies. .sup.2 The terminology for the derivatives is expressed as the common nam for the acid used and the concentration is expressed as percentage of Minoxidil base. In practice, one method of practicing the invention is to mix the cationic derivative salt of Minoxidil as a distilled water solution in proportion of 0.1 mg/ml to a saturated solution. An iontophoretic device such as manufactured and sold by General Medical Co. under the registered mark LECTRO PATCH would be used. Both treatment pads are saturated with the Minoxidil salt solution. The saturated treatment pads are placed on the skin where enhanced growth is desired. This particular device will only accept up to 1 milliamp (mA) of current. Other iontophoretic devices, such as New Life Litronic Stimulator manufactured by Mid-western Electronics Inc. Model No. 0880 can deliver up to 0.5 mA per cm 2 can also be used. The tolerance of an individual patient determines time and milliamp limits above 0.5 mA per cm 2 . While the invention has been described with a certain degree of particularity, it is manifest that many changes may be made in the details of construction and the arrangement of components without departing from the spirit and scope of this disclosure. It is understood that the invention is not limited to the embodiment set forth herein for purposes of exemplification, but is to be limited only by the scope of the attached claimed or claims, including the full range of equivalency to which each element thereof is entitled.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority from U.S. Provisional Patent Application Ser. No. 62/012,538, filed on Jun. 16, 2014, the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to a vertically worn, retention strap-free, rear, pod pack for carrying one or more, typically multiple, tubes of paintballs (called “pods”) for use during paintball games or practices. BACKGROUND OF THE INVENTION [0003] The majority of the paintball pod packs on the market today are worn around the player's waist and secured with one or more elasticized straps that are adjustable secured with hook-and-loop closure systems. On the rear of the pack and adjacent the player's back are a series of one or more, typically 3-10, slots or tunnels where pods are carried and stored during a game. Pods are generally carried with the pod's lid oriented in a downward direction and removed by pulling the pod down and out from the pack. Vertical pull (e.g., U.S. Pat. No. 6,158,642) and horizontal pull (e.g., U.S. Pat. No. 7,559,445 and US 2005/0121485) have also been disclosed. [0004] The pod slots in a vertical pull harness come in one of two types, generally. The first is a semi-rigid tunnel that allows the pods to be removed and replaced with one hand. The second type of slot is an elastic band that is secured to the underlying waistband of the pack between or adjacent the semi-rigid tunnel slots. Once a pod is removed from these elastic bands, they are not readily replaced during play. The user would drop the empty pod and collect the empty pods once the game had concluded. [0005] The vertical pull pod packs on the market today all use some type of hook-and-loop retention strap system to hold the individual pods in the semi-rigid slot of the pack. The hook portion of the fastener is on a lower retention strap, potentially an elasticized strap. This retention strap is attached to the waistband behind the pods and wraps downwardly, across the tube slot opening and upwardly to engage a loop fabric portion on the front of the pod slot. The retention strap thus secures the paintball pod within the slot of the pack. Typically, the upper end of the slot has an elasticized top strap or cover of some type that can be urged upwardly by stretching the retention strap across the opening of the pod tunnel and into a secured position on the outside of the tunnel with a corresponding loop portion of a hook-and-loop fastening system. The elastic of the upper end provides a downward force to provide a downward assist force when the retention strap is removed so the player can withdraw the pod downwardly and out from the tunnel. Examples of such paintball harnesses are shown in U.S. Pat. Nos. 6,962,278 and 7,100,810. [0006] Unfortunately, the disengaged retention straps hang loosely down when not in use, and the hook-bearing portion of the strap often becomes engaged with adjacent loop portions of the pod slots, the pack assembly or even the player's shirt thereby impeding clear access to the pods and slots. To align the straps again correctly requires the use of two hands or assistance from another person. [0007] In a strap-based pack system, sound connections between the retention strap and the pod tunnel are important. If not executed correctly, pods can slip from an unsecured slot and spill out on the ground thereby contaminating the paintballs with loose dirt and debris. Such contaminated paintballs cannot be reused without fouling the marker and represent a costly loss to the player. [0008] Strap-based packs that rely on hook-and-loop closure systems are also prone to wear as the hook and loop portions become frayed, warn or fouled with debris over time. Such wear affects the ability of the strap to remain securely closed. [0009] Strap-based systems also use valuable time to operate. As in most team sports, reloading time is critical in paintball games. Delays associated with pod removal and discharge into the loader reservoir can waste valuable seconds or even minutes that could lose the game for the affected player. [0010] Given that current devices are difficult to use, require assistance or complete removal of the harness for paintball loading, and have a propensity for Velcro misalignment that reduces pod holding force, it is clear there is a need for an improved paintball pod holder. [0011] It would be desirable to have a vertical pull pod pack harness that could hold a paintball pod securely in its slot of the pack during even extreme physical movement. [0012] It would also be desirable to have a vertical pull paintball pod holder that could be loaded and unloaded easily and quickly using one hand. [0013] Finally, it would be desirable to have a paintball pod holder that could withstand repeated use and still maintain its holding force on the pod within its slot in the carrying pack. SUMMARY OF THE INVENTION [0014] It is an objective of the invention to provide a paintball pod holder that will securely retain pods during even physical activity without the use of retention straps that must be pulled open to release the pod from its slot in the pack. [0015] It is also an objective of the invention to provide a paintball pod holder that allows unimpeded one-handed removal of pods and reinsertion of empty pods. [0016] It is also an objective of the invention to provide a paintball pod holder that will retain its holding force on the pod despite repeated use. [0017] In accordance with these and other objectives that will become apparent from the description herein, a holder for generally cylindrical or round objects according to the invention includes at least one retention tunnel mounted on a waistband, wherein said retention tunnel comprises: (a) an elastic band having four sides and stretchable in a stretch plane, (b) a semi-rigid stabilizing plate that is relatively wider than said elastic band in said stretch plane, wherein said stabilizing plate is attached to said elastic band on either side of said band transverse to said stretch axis whereby said tension from said elastic band causes said stabilizing plate to bend and form a retention tunnel exhibiting elastic, radial, compression forces on a paintball pod inserted into said tunnel. [0018] The invention also contemplates a method making the holder for use in a carrying harness that is especially well suited for paintball pods. This method comprises: [0019] (a) sewing an elastic band having a stretch plane to a first end of semi-rigid stabilizing plate having a length to a second end that is greater than said elastic band along the stretch axis, the sewing occurring on one side of the elastic band in a direction transverse to the stretch plane; [0020] (b) stretching said elastic band along said stretch axis to the second end of said stabilizing plate; [0021] (c) sewing the stretched end of said elastic band to the second end of the stabilizing plate in a direction transverse to said stretching plane, wherein tension from said elastic band would urge said stabilizing plate to bend and form an arc if not restrained; [0022] (d) sewing said elastic band along at least one edge thereof to said stabilizing plate in a direction that is substantially parallel to said stretch plane, whereby elastic tension from said elastic waistband urges said stabilizer plate to bend, and said elastic band bends to form at least a portion of a saddle-shaped, hyperbolic paraboloid within an arc of the bent stabilizing plate thereby forming a paintball pod retention tunnel subject to the transverse holding effects of at least a portion of the saddle-shaped, hyperbolic paraboloid elastic band; and [0023] (e) securing the first and second ends of said stabilizing plate to a back plate that is attached to elastic waistband straps. [0024] The paintball pod holder of the present invention provides a new way of retaining paintball pods within the retention tunnel or slot of a paintball harness but without the use of retention straps over the removal end of the tunnel. Users save valuable time because filled pods can be removed from the retention tunnel slot easily with one hand and also reinserted without the delays associated with conventional retention straps. The invention also does not suffer from the entangling effects of disengaged, hook-and-loop, retention straps or the risk of spill from a retention strap that is not properly secured to its mating connection. BRIEF DESCRIPTION OF THE DRAWINGS [0025] FIG. 1 illustrates how an elastic band is first sewn to a semi-rigid stabilizing plate on one side, stretched, and then secured at its stretched end to the stabilizing plate. [0026] FIG. 2 shows a view of the elastic band that has been secured at opposing ends along its stretch plane to the semi-rigid stabilizing plate that has been urged into a curved bend. [0027] FIG. 3 depicts the formation of a paintball pod retention tube when the bent stabilizing plate and elastic band curved into a saddle-shaped, hyperbolic, paraboloid are secured to a back plate. [0028] FIG. 4 presents an isometric view of a paintball retention tunnel and saddle-shaped elastic within the retention tunnel under the arc of the bent stabilizing plate. [0029] FIG. 5 illustrates how a filled paintball pod is inserted into the retention tunnel. [0030] FIG. 6 depicts a carrying vertical pull paintball harness having four retention tunnels, three auxiliary elastic bands that can be used to carry additional pods, and a horizontal elastic waistband for the harness. [0031] FIG. 7 is a cross sectional view of a retention tunnel showing the outer stabilizing plate and the curved, inner elastic band that provides the transverse retention force within the tunnel. [0032] FIG. 8 is a conventional hyperbolic paraboloid and is similar to the shape assumed by the elastic band within the retention tunnel of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0033] The present invention provides a holder with a novel structure for retaining generally cylindrical objects, preferably paintball pods, within a retention tunnel or slot on a carrying harness. In particular, the retention tunnel is formed by a semi-rigid stabilizer plate that is secured by at least two of its edges to a smaller piece of elastic band. When that band is stretched and secured to the stabilizing plate, the plate is urged into a bent shape that forms an interior tunnel of elastic that becomes curved to form a saddle-shaped, hyperbolic, paraboloid that extends inwardly into the formed tunnel. The contours of this curved elastic within the retention tunnel provide a convenient and effective transverse elastic pressure that pushes against a pod inserted into the tunnel and holds it there until removed. [0034] This retention tunnel may then be attached to a back plate with its own waistband and/or mounted on an inner waistband that is overwrapped with the outer waistband for additional security. Hook-and-loop fasteners are compatible with the durable synthetic fabric that are conventionally used for paintball harnesses and are preferably used liberally to provide multiple points of support about the user's waist. [0035] Preferably, the elastic band exhibits elasticity along a single, planar direction and is shorter in length along that stretch plane than the semi-rigid stabilizing plate. [0036] The stabilizing plate is the outer shell of each retention tunnel and should be sufficiently rigid to be self-supporting but should also allow bends without changing length or width dimensions. The stabilizing plate is also preferably made of a weather resistant fabric material that can be sewn together with the elastic band and, optionally, a back plate that carries the other retention tubes and any auxiliary elastic loops for added carrying capacity. [0037] The back plate is also desirably semi-rigid and should have sufficiently structural integrity and durability to hold one or more, preferably 3-6, retention tunnels (made of the stabilizing plate and stressed elastic band) in place. This back plate also creates the floor of each retention tunnel and should permit some degree of bending to permit a generally cylindrical tube to be inserted into each retention tunnel. [0038] In making the retention tunnel according to the invention, the stabilizing plate and elastic band are positioned and sewed along one end that is transverse to the stretch plane of the elastic. The elastic is extended along its stretch plane and then sewed along this second end. If released, the elastic will contract and bend the stabilizing plate into an arc. [0039] In the preferred retention tunnel, the elastic band and stabilizing plate are sewn together along at least two, preferably at least three, and even more preferably along all four ends of the elastic band—two seams transverse to the stretch plane along each side of the tunnel and two seams substantially parallel to the stretch plane at the front and rear openings of the tunnel. The stressed elastic band assumes a generally saddle-shaped, hyperbolic paraboloid shape in which elastic under tension extends into the retention tunnel to provide the holding force on pods loaded therein. It will be understood that the elimination of a sewn seam may form a retention web having the shape of a partial hyperbolic paraboloid. [0040] Using the present invention, users are able to load generally cylindrical round objects or sports balls. Such objects include paintball pods, water bottles, sporting equipment, working tools, or other gear into the holding tunnel using only one hand. The holding tunnel will prevent the inserted item from falling out without utilizing holding straps that extend over the insertion opening and which would have to be removed before making an unobstructed opening for removal of the retained item. When removing the paintball pod, or other item requiring secure storage, the user simply pulls it out of the holding tunnel with one hand without the need to release any holding straps first. [0041] The present invention can be used in various areas of sport such as, for example, a water bottle and equipment holder. It could also be used in hunting or for military to secure and carry equipment, e.g., flashlights, flares, lights and other such generally cylindrical objects without using any holding straps. The one-handed ease with which items can be inserted and removed saves time in critical situations. The present invention can hold bottles or containers of water and equipment for athletes such as long-distance runners, skiers, and climbers. It can also serve as a ball holder for sporting games such as golf and tennis. Among other applications, the invention can be used by hunters or military personnel to provide secure storage with easy, quick access. It is convenient to describe the retention tunnels and associated harness with reference to their use in holding generally cylindrical paintball pod tubes having a closed end and an open end that is releasably closed with a frictional or locking lid. [0042] The retention tunnels can be attached to a wide variety of paintball pod carrying harnesses for use in a number of orientations, e.g., top pull, side pull and vertical downward pull. Plain elastic loops can also be attached to the tunnel support harness to provide additional pod carrying capacity, with the recognition that empty pods are not readily replaced into such elastic loops. Preferably, the retention tunnels of the invention are oriented on the harness for a downward pull removal. [0043] Preferably, the carry pack has two or more pod retention tunnels that are oriented vertically for a downward pull to release the retained pods. This means that loading the pods involves inserting each pod vertically and upwardly through the bottom opening and into the pod retention tunnel. As noted above, each retention tunnel is secured to the carry pack and indirectly via hook-and-loop system to an elastic waistband that is adjustably secured via another hook-and-loop connection. The retention tubes are dimensioned so that radial, transverse, frictional force from the interior wall of the retention tunnel wall on the outer wall of the inserted pod retains the pod within said carry pack. This allows the carry pack to avoid the use or need for restraining straps that would otherwise be needed in a conventional carry pack to cover the bottom openings of each retention tunnel and retain the inserted pod therein. [0044] The attached figures are conveniently used to describe preferred, exemplary, embodiments of the invention. Similar structures will use the same reference numbers in the various figures. [0045] Referring now to FIG. 1 , an elastic band 1 having a stretch plane 2 is sewn near first end 3 of semi-rigid stabilizing plate 4 to secure elastic band 1 and stabilizing plate 4 together. [0046] Stabilizing plate 4 preferably exhibits a length along stretch plane 4 that is longer than the resting, unstretched length of elastic band 1 . Stitches 5 that secure the first end 6 of the elastic band to the first end 3 of stabilizing plate 4 preferably extend the length of elastic band 1 in a direction that is transverse to stretch plane 2 . This allows elastic band 1 to be stretched along stretch plane 2 and be secured, preferably with sewing stitches, along second end 7 of elastic band 1 and near second end 8 of stabilizing plate 4 . [0047] As shown in FIG. 2 , if stabilizing plate 4 was released, the elastic tension would urge plate 4 into a bent or arcuate shape. Such a shape and construction would be useful as a retention tunnel for a pod harness, but the preferred structure includes additional sewn seam connections 9 , 10 along the remaining edges of elastic band 1 and stabilizing plate 4 that will ultimately serve as the open ends of the retention tunnel. FIG. 3 shows a retention tunnel 11 in which seam 10 is located in the front of tunnel 11 and seam 9 is at the rear. Elastic band 1 is secured to stabilizing plate 4 along all four edges of elastic band 1 . Elastic band 1 is under some curvature stress due to the attachments within the longer stabilizing plate 4 and thereby forms a configuration akin to that of a saddle-shaped, hyperbolic paraboloid (see FIG. 8 ). The elastic band 1 is under tension between the stabilizing plate sides and thereby creates the paraboloid having an elastic diameter which is smaller than a paintball pod. So when a paintball pod gets pushed in to the “holding tunnel” the elastic band 1 gets pushed up and to the sides. This creates an applied pressure on the short ends to hold the pod securely within the tunnel. [0048] FIGS. 4 and 5 depict a retention tunnel according to the invention and the insertion of a filled paintball pod 13 into the forward tunnel opening 14 . A plurality of such retention tunnels, e.g., 3-6 tunnels, can be secured to a back plate and form a harness of the type shown in FIG. 6 . [0049] As sketched in FIGS. 3 and 7 , retention tunnel 11 is secured to a back plate 12 . Such back plates may be attached directly to one or more elastic straps 16 (see FIG. 6 ) that serve as an elastic waistband for the player or, as is more conventional, indirectly mounted on an inner elastic waistband 15 bearing hook-and-loop fasteners to secure the harness to the player. The elastic waistbands attached to the back plate can then be extended to overwrap the connection of the inner waistband 15 and form a second, outer, waistband that provides additional support for the harness when carrying a full complement of loaded pods 13 . [0050] FIG. 7 further illustrates a cross sectional view of a retention tunnel 11 with the stressed and curved elastic band 1 in position within retention tunnel 11 formed within the curvature of stabilizing plate 4 . FIG. 7 further shows elastic end straps 16 , 17 that can serve as a delimiting travel stop for pods 13 inserted into tunnel 11 . [0051] It is understood that the embodiments illustrated in the present invention are preferred and are not intended to serve as substantive limitations on the scope of the appended claims.

1a

RELATED APPLICATIONS This application is related to Provisional Application Ser. No. 60/548,425 filed Feb. 25, 2004 entitled “DISPLAY INTEGRATED VIBRATING ALARM” to which priority under 35 USC §119 is claimed. FIELD OF THE INVENTION The present invention relates to an underwater breathing apparatus, and, more particularly, to the provision of alert systems to monitor diving parameters, including breathing gas status. BACKGROUND OF THE INVENTION In Closed Circuit Mixed Gas Diving and/or other SCUBA diving applications, wherein a diver is breathing different levels of oxygen, nitrogen, helium and sometimes carbon dioxide, it becomes important that a diver be notified of certain dangerous conditions in the breathing gas or when the amount of a breathing gas is low. In the prior art, divers typically monitor levels and amounts of gas by meters, gauges and electronic displays that are secured to a diver and audible alarms. The prior art also employs light systems, which can be seen by a diver while breathing the gas of a system and provide a visual warning. The meter, gauges and display systems mounted on the arm or other area on the diver do not effectively alert the diver to dangerous conditions, since they cannot be constantly monitored by the diver. One problem with alert systems found in the prior art that feature only a light notification, such as a flashing bulb or activation of a LED, is that it can be obscured by other bright lights from another diver or the sun in shallow or clear water. Auditory (“beeper”) type alarms have been used in numerous diving systems for years. The disadvantage to such systems is that often circumstances are such that an individual diver cannot hear the alarm, or mistakes others alarms for his own, or vice-versa, resulting in the diver ignoring the alarm he hears. In the prior art, most underwater alarm systems utilized audible alarms to indicate problems that the individual diver has with his system. These alarms could often be unheard (due to various factors, such as external hoods being worn by the diver) and were often mistaken for other alarms being transmitted by other diver's units in a group diving situation, resulting in confusion. Vibrating alarms have also been used in similar applications with similar shortcomings. SUMMARY OF THE INVENTION The foregoing and other problems and deficiencies in known diving monitor and alarm systems are solved and a technical advance is achieved by the display integrated vibrating alarm system of the present invention. In accordance with an aspect of the present invention, there is provided an alarm apparatus for use with a breathing apparatus that provides a source of breathable air to a user, and the alarm apparatus comprises a tactile signal generator that is selectively energized in response to a signal representing at least one parameter corresponding to the breathing apparatus status to generate a tactile signal that is capable of being felt and heard by the user wearing the alarm apparatus. The tactile signal may be a vibration, and such vibration may be generated by a motor that rotates an eccentric weight. The user wearing the alarm apparatus feels the tactile signal stimulating nerve endings in the skin, deep tissue, teeth, and/or skeletal bones, joints. The user wearing the alarm also hears the tactile signal, as the tactile signal also couples into the bone structure to stimulate the user's/diver's auditory system (i.e., acoustic energy coupled into the bone structure reaches and stimulates the diver's Cochlea). One or more parameters corresponding to the breathing apparatus may include at least one status condition for the breathing gas, such as, for example, one or more of the following: at least one of an amount, level, and partial pressure of at least one component in the breathing gas; and/or an amount, level, and pressure of gas in tanks or containers supplying the breathing gas to the diver. In accordance with another aspect of the present invention, the alarm apparatus includes a light emitting device responsive to the same and/or a different signal representing at least one parameter corresponding to the breathing apparatus status. The light emitting device and the tactile signal generator may be both energized at substantially the same time to provide a visual signal and a tactile signal to the user. Alternatively, the tactile signal generator may be energized at a time delay after the light emitting device is energized in the event that the light emitting device remains energized for a predetermined period of time (e.g., the light emitting device remaining energized indicating that the alarm condition persists and thus the user should be further alerted by a tactile signal). In accordance with yet a further aspect of the present invention, a signal to which the tactile generator is responsive and/or a signal to which a light emitting device is responsive (which, in some implementations, may be the same signal) may be coupled (e.g., directly connected or indirectly (e.g., via circuitry) connected) to the output of at least one sensor. Additionally, or alternatively, such a signal may be provided by a dive computer and corresponds to dive computer data. In accordance with a further aspect of the present invention, a tactile signal is generated to have one or more signal characteristics that are modulated to convey additional information about the parameter or parameters being monitored. Signal characteristics that may be modulated include frequency, intensity, duration, repetition frequency, and pattern. Differently modulated signals may represent, for example, different parameters, different warning levels for a given parameter, and/or quantitative information about a given parameter. In accordance with an aspect of the present invention, a tactile alarm, preferably in combination with a visual and/or audible alarm, is provided which would indicate to the diver that his particular unit was the one transmitting an alarm signal, and could not be mistaken for any other device. Further, since the alarm can be designed to be worn on the face, either on the mask or on the mouthpiece, the vibrator serves two functions, one as a tactile alarm that the diver can feel during operation, but also through bone-conduction of sound, as an auditory alarm as well. As will be appreciated in view of the foregoing and the ensuing description, an illustrative, non-exclusive, and non-limiting feature of the present invention is that a tactile alarm generated in accordance therewith cannot be easily ignored, overlooked or confused as to source, thus eliminating the possibility of mistaking the alarm for that of another user/diver by providing a personal tactile sensation to the individual user/diver who is wearing the system. DESCRIPTION OF THE DRAWING The foregoing and other features and advantages of the present invention will become more apparent in light of the following detailed description of exemplary embodiments thereof, as illustrated in the accompanying drawings, where: FIG. 1 is a display integrated vibrating alarm (DIVA™) system according to an illustrative embodiment of the present invention; FIG. 2 is a cutaway view of the DIVA™ of FIG. 1 ; FIG. 3 is a sectional view of the DIVA™ of FIG. 1 , shown at section 4 - 4 ( FIG. 1 ); FIGS. 4(A and B) is a view of the distal end of the DIVA™ of FIG. 1 its end cap; FIG. 5 is an illustrative embodiment of a mounting bracket for mounting the DIVA™ of FIG. 1 ; FIG. 6 illustrate a DIVA™ of FIG. 1 mated with the mounting bracket of FIG. 5 ; FIG. 7 is an illustrative mounting of the DIVA™/bracket combination of FIG. 6 mounted to a dive surface valve (“DSV”). DETAILED DESCRIPTION Display Integrated Vibration Alarm (DIVA™), which refers to an embodiment of the present invention, provides an improved alarm and motoring system which can monitor Oxygen Levels during Closed Circuit Mixed Gas Diving Operations (such as, e.g., SCUBA) and provide both visual and tactile cues to the user. Among the DIVA™'s functionality, the unit can visually display or indicate the status of a diver's breathing Loop Oxygen Content as displayed in Partial Pressure, as well as alert the diver if the Oxygen Levels in his breathing gas fall above or below thresholds that are considered dangerous. A vibrating portion of the DIVA™ device allows for tactile cues to make the diver-user aware of any potentially dangerous condition of his breathing gas mixture due to the device's being mounted on the diver's mask or mouthpiece (so as to allow translation of any vibrating motion caused by the vibrating portion of the device to the diver himself). Preferably, the vibrations also couple into the bone structure to stimulate the diver's auditory system (i.e., acoustic energy coupled into the bone structure reaches and stimulates the diver's cochlea). With reference to FIG. 1 , an illustrative embodiment of the display integrated vibration alarm (DIVA™) system of the present invention is shown. This embodiment of the DIVA™ is adapted to use for closed circuit rebreather (“CCR”) system applications. The illustrative DIVA™ 100 comprises a housing 120 , which in this embodiment, is chosen to be a stainless steel cylinder. A removable end cap 140 is disposed on a proximal end of the cylinder with a translucent or transparent cap 130 sealing the distal end of the cylinder. Visible behind the cap 130 is a light emitting device 110 , which in this embodiment is implemented as a light emitting diode (LED) device. In this illustrative embodiment, threaded portion 150 , provides a mechanism to removably secure end cap 140 to cylinder 120 . In this configuration, the system does not allow the intrusion of water such that the system is sealed from the environment. End cap 140 is a nut/cap of a Swagelok fitting (or the like) which allows for a sealed connection of cable or conduit to DIVA™ 100 . In FIG. 2 , a cutaway view of the DIVA™ 100 of FIG. 1 is shown, to reveal the inside of the DIVA™. A vibration generator 210 is provided, disposed within the housing 120 , and in this embodiment, behind (along the longitudinal axis X of the DIVA™ 100 ) the LED. In the illustrative embodiment, the vibration generator is a Sealed Vibrating Motor 210 , which, when activated, spins an eccentric weight at approximately 7,000 rpm. The vibration generator 210 in the DIVA™ can thus provide a tactile cue to the diver, and can also provide an audible cue if the vibrations are coupled to the diver. For instance, when deployed such that it is mounted to the diver's mask or mouthpiece, the DIVA™ will not only transmit pulses of vibration to the diver's head (via conduction to the bone of the diver's head (e.g., jaw and/or skull)), but also perceivable sound is created—thus the diver feels and hears his alarms at the same time, eliminating a disorienting situation occurring in know systems—that where a diver is unsure if a particular alarm is his or that of a fellow diver. The vibrating motor 210 is preferably connected to one or more sensors (not shown) via connection through accessway 220 . (See, e.g., conduit 600 shown in FIG. 7 ) When a sensor detects a predetermined alarm condition, for e.g., a certain amount, level and/or partial pressure of one or more components in the breathing gas, such as, oxygen, helium, nitrogen or carbon dioxide, it sends an electronic signal to the vibrating motor in the housing to activate the motor, thus alerting the diver as discussed above. The sensor triggered alarm can also be activated by sensors which detect a certain pressure or amount of gas in the tanks or containers supplying the breathing gas to the diver. In an alternative embodiment, the diver can program a (dive) computer or other electronic device to vary the levels of gas and/or type of gas which activates the motor—i.e., the alarm thresholds are settable by the user. In accordance with a further implementation of the present invention, the vibration signal may be generated to have one or more signal characteristics that are modulated to convey additional information about the parameter or parameters being monitored. Signal characteristics that may be modulated include, for example, frequency, intensity, duration, repetition frequency, and pattern. Differently modulated signals may represent, for example, different parameters, different warning levels for a given parameter, and/or quantitative information about a given parameter. Parameter levels/amounts that trigger the vibration signal, as well as the vibration signal characteristics (e.g., pattern, repetition frequency, etc.) may be user programmable or otherwise user settable. By way of example, two parameters that may be monitored by DIVA™ are the amount of air remaining in the tank, and the partial pressure of oxygen. If the amount of air remaining in the tank becomes lower than a first predetermined amount, then a one-second pulse may be generated approximately every minute. As the air remaining in the tank drops below one or more predetermined lower levels, then a one-second pulse would be repeated at correspondingly higher repetition rates. Similarly, the oxygen partial pressure level may be represented by a pattern of two one-third second vibration pulses separated by a short delay (e.g., one-third second), and the repetition frequency of this pattern may be increased as the oxygen partial pressure becomes increasingly dangerous. Alternatively, for example, the pattern of vibration pulses may indicate the partial pressure of oxygen, and the pattern may be repeated at fixed time intervals or at a time interval that depends on the criticality of the oxygen partial pressure level. For instance, two vibration pulses per pattern may indicate a safe level, three pulses per pattern a less safe level, etc. Alternatively, the number of pulses per pattern and/or the pattern itself may be more specifically mapped to oxygen partial pressure quantities, at least over a range of oxygen partial pressure values. For instance, over the range of 0.4 to 0.8 atm, a partial pressure amount may be quantized/rounded in 0.2 increments and represented as a number of consecutive one-third second pulses, separated by a one-third second delay, with each pulse representing 0.2 atm. Thus, 0.4 atm would be represented by two consecutive one-third second pulses. Over the range of 1.0 to 1.8 atm, the partial pressure amount may be quantized/rounded in 0.2 increments and represented as a two-third second vibration pulse (representing 1.0) followed by a number of consecutive one-third second pulses each representing 0.2 atm, with a one-third second delay between each vibration pulse in the pattern. Thus, a 1.2 concentration would be signaled as a two-thirds of a second pulse followed by a single one-third second pulse. Oxygen concentration amounts above or below this range may be signaled by a common warning, such as a continuous vibration or a continuous one-third second vibration/one-third second delay pulse train. In this way, the oxygen partial pressure quantity over the range of 0.4 to 1.8, quantized/rounded in 0.2 atm increments, is conveyed to the user through the vibrations. The repetition rate of these patterns may be increased for more dangerous quantities (i.e., approaching hypoxic or hyperoxic levels). As may be appreciated, in this way, the user recognizes the one-second vibration pulse as signaling the amount of air remaining in the tank, and the shorter vibration pulse pattern (i.e., having one-third second and possibly two-third second pulses) as signaling the oxygen partial pressure, with the pulse/pattern repetition frequency and/or the pattern as corresponding to the amounts of these monitored parameters. While independently deployable, in the illustrative embodiment, the vibrating alarm is combined with a visual indicator, which in the illustrative case is a three color LED 11 that can transmit light of three different colors, red, green, or red/green, which together yields orange. The three-color LED allows conveyance of more information by a combination of colors, in contrast to a more limited array of alarms which would be available with a single color LED. The LED can be programmed to provide various levels of alert or other status conditions in the diver's breathing gas, such as low gas levels, low tank pressure, or different concentrations or partial pressures of specific components of the breathing gas. The DIVA™ can be worn by a scuba diver on their diving mask or breathing mouthpiece such that the distal end of the housing 120 , through which the LED 110 is visible, is positioned so it can be viewed by the diver. The DIVA™ is mounted such that the LED 110 is positioned directly in the diver's field of vision. The LED and vibration motor can be programmed to trigger at the same threshold or their triggering can be offset or staggered. All DIVA™ Alarms/Notifications thresholds and settings are software adjustable/settable. The DIVA™ Alarms include: Low/High Set-Point out-of-range (On/Off) Fast Ascent Warning (On/Off) Deco Stop Violation Warning (On/Off) Hypoxic Mix Alarm (On/Off) As shown in FIG. 3 , cap 130 is used to seal the distal end of the housing 120 . In the illustrative embodiment the cap is a mushroom-shaped, optically passive cap, which simply allows light from the LED to exit the housing. In the illustrative embodiment, the cap 130 is formed as a convex lens for enhancing focusing of emissions of the LED in the diver's field of vision. At the distal end of the housing 120 , an o-ring 310 removably retains and seals cap 130 , which is the form of a “mushroom” in a fashion mated to the housing. FIG. 4A shows convex cap 130 of the illustrative embodiment. The cap is mushroom shaped and has a portion 420 which will sealably mate to the interior aperture formed by the cylinder of housing 120 . Portion 420 optionally has a recess 430 so as to not impact LED 110 , when mated. FIG. 4B shows the mated cap/o-ring assembly and where portion 420 will sealably mate to the housing 120 . In the illustrative embodiment, as mentioned, housing 120 can be made from stainless steel, the LED 110 is a 1.5 v tricolor LED, the vibrating motor 210 is a 1.5 volt DC vibrating motor, cap 130 is a transparent acrylic cap, and a watertight cable gland arrangement (attachable through accessway 220 ) which prevents water from entering the unit during diving operations, connects either directly to a sensor in the breathing gas; on a device storing the breathing gas, usually in a pressurized state; and/or to electronics controlling and/or monitoring the sensors in the breathing system. In the illustrative embodiment, the DIVA™ 100 is 2.35 inches long and the housing 120 is machined from 316 Stainless Steel. The DIVA™ can be deployed in a number of ways, none of which are critical, although some may work better than others. In the illustrative embodiment, the DIVA™ is attached to the Dive Surface Valve DSV (as will be explained in detail below with respect to FIGS. 5-7 ). In alternative embodiments, the housing may be mounted on a mouth piece that gives the diver access to the breathing gas, such that when the motor is activated, it vibrates the mouthpiece of the diver, which is received by the teeth and skeletal structure of the diver's head amplifying the vibrating alarm and virtually eliminating any possibility that the alarm could not be detected by the diver. Alternatively, the housing can also be mounted on a mask providing a direct alert to the diver's head. In this way, in accordance with a preferred implementation of the present invention, the diver wearing the DIVA™ alarm apparatus feels the tactile/vibration signal stimulating nerve endings in the skin, deep tissue, teeth, and/or skeletal bones, joints, and also hears the tactile signal, as the tactile/vibrating signal also couples into the user's bone structure to stimulate the diver's auditory system (i.e., acoustic energy coupled into the bone structure reaches and stimulates the diver's cochlea). With reference to FIGS. 5-7 , DIVA™ 100 is mountable via a mount specific bracket. FIG. 5 illustrates a bracket 500 for mounting the DIVA™ 100 to an Inspiration DSV, as the illustrative embodiment. The bracket includes: a mounting aperture 510 , through which the DIVA™ is inserted and secured; aperture 520 through which conduit to connect DIVA™ 100 to a dive computer or controller; and slot 530 for mounting to a diver contact surface. FIG. 6 illustrates the DIVA™ 100 attached to bracket 500 , with Swagelok end cap 140 securing the DIVA™ 100 through aperture 510 as well as securing cable 600 , routed through aperture 520 , to DIVA™ 100 . FIG. 7 shows the DIVA™ 100 mounted to DSV 700 , through slot 530 , which allows some adjustment of the height of the DIVA™ (relative to the diver's head) to suit the personal preference of a diver. An illustrative embodiment of operation of an embodiment of the present invention will now be described. In this illustrative embodiment, the LED indication is programmed so as to flash a different color in a specific code so that the diver is visually made aware of a particular status—e.g., that of the oxygen concentration of the diver's breathing gas. Thus when, e.g., the oxygen content of their breathing gas pass a threshold of life supportability, the LED indicator will provide a visual cue to the diver. Should the diver, through inattention or distraction, not notice or ignore this visual indication, the vibrating motor 210 is activated to provide the cue, thereby alerting the diver to imminent danger. The illustrative embodiment of the DIVA™ 100 connects to a dive computer or display (“HUD”) controller in a configuration with three Oxygen Sensors. The HUD controller utilizes a pattern of flashes, Red, Green and Orange (a combination of the Red and Green side of the LED flashing at once). Since the HUD is designed (in this embodiment) for the use of three Oxygen Sensors, it will be appreciated that a complete sequence of flashing is comprised of a series of three patterns. The pattern of flashing is a function of the fraction of a ppO2 (oxygen partial pressure) for each sensor read. The LED will flash Orange (both Red and Green at the same time) for a ppO2 of 1.0. For every POINT above 1.0 (i.e. 1.1, 1.2, 1.3, etc.) the GREEN LED will flash once. For every POINT BELOW 1.0, the RED LED will flash once. For example: If the gas mixture in the loop has a ppO2 of 1.2, the HUD will flash two Greens THREE TIMES (remember, it is responding to all three sensors). It will look to the diver's eye like this: Green Green—slight pause—Green Green—slight pause—Green Green—longer pause, then a repeat of the same pattern. Conversely, if the gas mixture in the loop had a ppO2 of 0.8 (two points below 1.0), your HUD will flash two Reds THREE TIMES. It will look like this: Red Red—slight pause—Red Red—slight pause—Red Red The exemplary coding of the LED signals is as follows: PARTIAL PRESSURE OF OXYGEN (1.0 AND ABOVE) LED FLASHES 1.0 1 ORANGE (FOR EACH SENSOR) 1.1 1 GREEN 1.2 2 GREEN 1.3 3 GREEN 1.4 4 GREEN 1.5 5 GREEN 1.6 6 GREEN 1.7 7 GREEN 1.8 AND ABOVE SOLID GREEN PARTIAL PRESSURE OF OXYGEN (1.0 AND BELOW) LED FLASHES 1.0  1 ORANGE (FOR EACH SENSOR) .9 1 RED .8 2 RED .7 3 RED .6 4 RED .5 5 RED .4 6 RED .3 AND BELOW 7 RED The present invention has been illustrated and described with reference to particular embodiments and applications thereof. It will be readily apparent to those skilled in that art that the present invention will have applications beyond those described herein for purposes of description of the invention. For example, the present invention can be adapted for use in any environment where flexible structure formation is desired by implementing the principals taught herein. To facilitate discussion of the present invention, a preferred embodiment is assumed, however, the above-described embodiments are merely illustrative of the principals of the invention and are not intended to be exclusive embodiments thereof. It should be understood by one skilled in the art that alternative embodiments drawn to variations in the enumerated embodiments and teachings disclosed herein can be derived and implemented to realize the various benefits of the present invention. By way of example, it is understood that although the embodiments have been described with respect to specific configurations, in practice, and also depending on the application, different configurations may be allowed and/or certain other configurations may be desired. By way of more specific illustrative examples, those skilled in the art will understand in view of the foregoing illustrative embodiments that the DIVA™ enclosure may include power supply and or control circuitry for energizing and/or controlling the vibration generator and/or LEDs in response to a signal provided via conduit 600 . Such control circuitry may be provided to also decode a signal provided via conduit 600 , wherein such signal may be encoded to specify different alarm conditions, etc. Alternatively, the DIVA™ enclosure may not include such control and/or power supply circuitry, and all signaling for energizing and/or controlling the LEDs and vibration generator would be provided via conduit 600 . Alternatively, such power supply and/or control circuit functionality may be partitioned between components internal and external to the DIVA™. Additionally, as may be appreciated, in various implementations, conduit 600 may be implemented to include one or more electrical conductors (e.g., wires), and additionally or alternatively, one or more signals may be provided by, for example, an optical or pressure signal provided via conduit 600 . Additionally, with respect to signaling provided to the DIVA™, those skilled in the art understand that such signaling may include signaling related to the user's/diver's condition and/or environment. Further, such signaling may represent any data included within the dive computer, such as dive table time limits, dive time duration, depth limits, air supply limits, direction, distance, water temperature, assent rates, heart rate, breathing rate, etc. Accordingly, it should further be understood, therefore, that the foregoing and many various modifications, omissions and additions may be devised by one skilled in the art without departing from the spirit and scope of the invention. It is therefore intended that the present invention is not limited to the disclosed embodiments but should be defined in accordance with the claims which follow. Finally, it is further noted that while the system described and shown hereinabove in accordance with the present invention provide many useful features and advantages, the geometric designs and shapes of each of the individual components, as depicted in the various drawings, represent ornamental designs that may be subject to separate protection thereof.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is based upon and claims the benefit of priority from U.S. Provisional Patent Application No. 61/947,858, filed on Mar. 4, 2014; the entire contents of which are incorporated herein by reference. BACKGROUND Field of the Disclosure The present disclosure relates to a material spreader for spreading materials from a container onto an open area, such as a field. Normally, materials such as manure or fertilizers are evenly spread over an entire surface of the field using a material spreader. Description of the Related Art In related art, material spreaders such as a side discharge spreader, include a discharge device and a shroud to convey materials from a container of the side discharge spreader and out through a discharge opening. The discharge device may include a plurality of material conveying components that are rotatably secured to a drive shaft. During operation, the material conveying components may rotate about a central axis and swing downward into the material, peeling it off, pulverizing it, and slinging it underhand laterally out the discharge opening. As a result, an even and controlled spread pattern of the material may be achieved. Over time, however, the plurality of material conveying components begin to wear due to use and a gap distance between an end of the material conveying components and the shroud begins to increase. As the gap distance increases, spread performance of the material conveying components decreases. In an attempt to address this issue, the shrouds in related art may include a single pivot to help bring the shroud closer to the material conveying components. However, the single pivot design causes some portions of the shroud to be closer to the material conveying components than other portions of the shroud. In operation, the varying gap distance causes the material conveying components to follow a path that is non-concentric with the shroud. The non-concentric gap distance results in a less than optimal spread performance and accelerates wear on components. Moreover, additional power is required to rotate the material conveying components to compensate for the larger gap distance between the plurality of material conveying components and the shroud. SUMMARY According to an embodiment of the present disclosure, a discharge device of a material spreader may be provided with a plurality of material conveying components and a corresponding adjustable shear ledge and adjustable shroud. The adjustable shroud may be pivotably mounted to the adjustable shear ledge and the adjustable shear ledge may in turn be attached to the material spreader so as to be movable along a first axis and a second axis to bring both the adjustable shear ledge and the adjustable shroud closer to the plurality of material conveying components. By providing the adjustable shear ledge, the gap distance between the top surfaces of the adjustable shear ledge and the adjustable shroud can be maintained substantially concentric with the swing of the material conveying components, enabling the discharge device to maintain a consistent spread pattern. Additionally, by maintaining a substantially concentric gap distance, both power consumption and wear of components is reduced. According to an embodiment of the present disclosure, a discharge device of a material spreader may be provided with a plurality of material conveying components mounted on a drive shaft that may be adjusted to move relative to a center of a material holding container. A mounting position of the drive shaft may be adjusted by at least one hydraulic system, which may provide a corresponding adjustment of a position of the plurality of conveying components. The at least one hydraulic system may be used with an adjustable shear ledge and/or an adjustable shroud, or may be used with a fixed position shear ledge and/or fixed position shroud. The drive shaft may be adjusted toward or away from the adjustable shear ledge and/or the adjustable shroud, or the fixed position shear ledge and/or the fixed position shroud. BRIEF DESCRIPTION OF THE DRAWINGS The characteristics and advantages of exemplary embodiments are set out in more detail in the following description, made with reference to the accompanying drawings. FIG. 1A depicts a top perspective view of an exemplary embodiment of a material spreader according to the present disclosure. FIG. 1B depicts a side view of the exemplary embodiment of the material spreader of FIG. 1A . FIG. 1C depicts a bottom view of the exemplary embodiment of the material spreader of FIG. 1A . FIG. 2A depicts a front elevation view of an exemplary embodiment of a discharge device with an adjustable shear ledge and an adjustable shroud. FIG. 2B depicts a close up view of the exemplary embodiment of the discharge device of FIG. 2A . FIG. 3A depicts a front elevation view of an exemplary embodiment of a discharge device with an adjustable shear ledge, an adjustable shroud, and a pivot bracket. FIG. 3B depicts another front elevation view of the exemplary embodiment of the discharge device of FIG. 3A without the pivot bracket. FIG. 4 depicts a perspective view of an exemplary embodiment of a discharge device with material conveying components passing over a top surface of an adjustable shear ledge and a top surface of an adjustable shroud. FIG. 5 depicts a perspective view of an exemplary embodiment of a discharge device. FIG. 6 depicts a side exploded view of an exemplary embodiment of a discharge device. FIG. 7 depicts a bottom exploded view of an exemplary embodiment of a discharge device. FIG. 8 depicts another bottom perspective view of an exemplary embodiment of a discharge device. FIG. 9A depicts a perspective view of an exemplary hydraulic system for adjusting a position of an adjustable shear ledge and an adjustable shroud. FIG. 9B depicts another perspective view of the exemplary hydraulic system of FIG. 9A . FIG. 10A depicts a perspective view of an exemplary hydraulic system for adjusting a position of a drive shaft supporting a plurality of material conveying components. FIG. 10B depicts another perspective view of the exemplary hydraulic system of FIG. 10A . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Objects, advantages, and features of the exemplary adjustable shear ledge and shroud for a material spreader described herein will be apparent to one skilled in the art from a consideration of this specification, including the attached drawings. Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views. It is noted that as used in the specification and the appending claims the singular forms “a,” “an,” and “the” can include plural references unless the context clearly dictates otherwise. As shown in FIGS. 1A-1C , a material spreader 1 of the present disclosure may include a material holding container 10 , a hitch 20 , a power take-off 30 , a drive enclosure 40 , at least one auger (not shown), and a discharge device 50 . The container 10 of the material spreader 1 may include angled sidewalls 12 to allow materials stored in the container 10 , such as manure or fertilizer, to be conveyed downwards toward a bottom 14 of the container 10 . The discharge device 50 may be disposed on a side surface of one of the angled sidewalls 12 . Additionally, the at least one auger may be housed near the bottom 14 of the container 10 , along a portion of one of the angled sidewalls 12 . Referring to FIGS. 2A and 2B , the discharge device 50 may include a discharge inlet 52 , a discharge outlet 54 , and a housing 56 . The discharge inlet 52 may include a discharge door 58 located between the discharge device 50 and the container 10 . The discharge door 58 may control the amount of material entering the discharge device 50 from the container 10 or may prevent any material from entering the discharge device 50 . Using rotational power received from the power take-off device 30 , the drive enclosure 40 may then convert the power received from the power take-off 30 to an appropriate rotational speed in order to drive the at least one auger. During operation, the at least one auger may be rotatably actuated in order to convey materials located within the container 10 towards the discharge inlet 52 . The discharge device 50 may then convey the materials out of the housing 56 via the discharge outlet 54 laterally outward from the discharge device 50 , as will be described in further detail below. As shown in FIGS. 2A and 2B , the discharge device 50 may include an adjustable shear ledge 60 and an adjustable shroud 70 . As shown in FIGS. 3A and 3B , the discharge device 50 may include a drive shaft 80 and a plurality of material conveying components 82 which may be attached to the drive shaft 80 . The drive shaft 80 may be mounted to the housing 56 of the discharge device 50 , and the housing 56 may be attached to a side surface of one of the angled sidewalls 12 . Each of the plurality of material conveying components 82 may include a front face 84 and a bottom surface 86 . The drive enclosure 40 may convert power received from the power take-off 30 to an appropriate rotational speed in order to drive the drive shaft 80 . During operation, the drive shaft 80 may be rotatably actuated and the plurality of material conveying components 82 are correspondingly rotated about a center of the drive shaft 80 in a counter-clockwise manner (R), as shown in FIG. 3A . In one embodiment, the center of the drive shaft 80 may be configured to move towards or away from the adjustable shear ledge 60 and/or the adjustable shroud 70 in order to adjust a gap distance between the plurality of material conveying components 82 and at least one of the adjustable shear ledge 60 and the adjustable shroud 70 . In one embodiment, as shown in FIG. 4 , the adjustable shear ledge 60 of the discharge device 50 may include a shear top surface 62 . The adjustable shear ledge 60 may also include a shearing edge 64 . The adjustable shroud 70 of the discharge device 50 may be disposed adjacent to the adjustable shear ledge 60 . The adjustable shroud 70 may include a shroud top surface 72 . When the plurality of material conveying components 82 are rotated, a portion of the materials located near the discharge inlet 52 may be scooped up by the front surface 84 of one of the plurality of material conveying components 82 . Subsequently, as the front surfaces 84 of the plurality of material conveying components 82 nears the adjustable shear ledge 60 , a portion of materials is separated and peeled from the remainder of the materials as other portions of the materials contact the shearing edge 64 located near the discharge inlet 52 . The portion of the materials may then be guided along the shear top surface 62 . After passing along the shear top surface 62 of the adjustable shear ledge 60 , the portion of the materials may then be guided along a shroud top surface 72 and then slung underhand laterally out the side of the discharge outlet 54 . In one embodiment, as shown in FIG. 5 , the adjustable shear ledge 60 may include a plurality of reinforcing tabs 66 . The plurality of reinforcing tabs 66 may be disposed on an underside of the adjustable shear ledge 60 , opposite of the shear top surface 62 , in order to provide structural strength to the adjustable shear ledge 60 . Each of the plurality of reinforcing tabs 66 may also include a mounting hole 68 disposed on an end opposite of the shearing edge 64 . The adjustable shear ledge 60 may also include a plurality of mounting brackets 63 having mounting members 65 disposed thereon. The mounting members 65 may be in the form of a longitudinal slot or a longitudinal rail. The plurality of mounting brackets 63 may be provided on opposite lateral ends of the adjustable shear ledge 60 . The mounting members 65 of the mounting brackets 63 may be parallel with a rear surface 67 of the shearing edge 64 . In one embodiment, each of the plurality of mounting brackets 63 includes at least two mounting members 65 . In one embodiment, the shearing edge 64 moves along a plane that passes substantially through a center of the shaft 80 . The adjustable shroud 70 may include a plurality of longitudinal ribs 74 and a plurality of lateral ribs 76 on a side opposite of the shroud top surface 72 in order to provide structural rigidity to the adjustable shroud 70 . One end of the longitudinal ribs 74 may include a through hole 78 . The adjustable shroud 70 may include a plurality of external mounting plates 71 disposed on each lateral end of the adjustable shroud 70 . A shroud mounting hole 73 may also be provided on each of the external mounting plates 71 . In one embodiment, the adjustable shear ledge 60 and adjustable shroud 70 may be assembled adjacent to each other. The adjustable shear ledge 60 may be pivotably connected to the adjustable shroud 70 . A fastener or bearing (not shown) may be provided to couple the mounting hole 68 of the adjustable shear ledge 60 to the through hole 78 of the adjustable shroud 70 . In operation, the adjustable shroud 70 may pivot relative to the adjustable shear ledge 60 . In one embodiment, the fastener or bearing securing the adjustable shear ledge 60 to the adjustable shroud 70 may be designed to fail, when a predetermined load is applied to the adjustable shear ledge 60 and/or the adjustable shroud 70 , in order to provide overload protection for the other components of the discharge device 50 . For example, overload protection may be required when an unusually large object attempts to pass through the discharge device 50 and would otherwise become stuck or cause damage to critical, expensive, or hard to replace components of the discharge device. As shown in FIGS. 6-8 , the adjustable shear ledge 60 and the adjustable shroud 70 may be mounted to the bottom 14 of the container 10 . The adjustable shear ledge 60 may be a self-contained structure, or the adjustable shear ledge 60 may be integral with the container 10 . In one embodiment, outer mounting beams 16 may be positioned on opposite sides of the shaft 80 as shown in FIGS. 6 and 7 . The outer mounting beams 16 may be attached to inner mounting beams 18 positioned below the bottom 14 of the container 10 . A first outer mounting beam 16 a may be disposed closer towards a front end of the material spreader 1 . As shown in FIGS. 6 and 7 , the first outer mounting beam 16 a may be formed to correspond to a portion of the drive enclosure 40 so as to fit around a side 40 a and a bottom portion 40 b of the drive enclosure 40 . A second outer mounting beam 16 b may be disposed closer towards a rear end of the material spreader 1 . The outer mounting beams 16 may each include a shroud adjusting port 15 . The outer mounting beams 16 may each include at least one first shear adjustment port 17 , or at least one shear adjusting track (not shown). Each first shear adjustment port 17 may be attached by a bolt or other fastener to at least one of a plurality of second adjustment ports 19 , or one of a plurality of second shear adjusting tracks (not shown), formed in the inner mounting beams 18 . In one embodiment, the mounting members 65 may be provided on the mounting beams 16 , 18 , and corresponding adjustment ports, or adjustment tracks, may be provided on the mounting brackets 63 . In one embodiment, as shown in FIGS. 7 and 8 , each of the mounting brackets 63 of the adjustable shear ledge 60 may be attached to a respective inner mounting beam 18 , and a respective one of the first outer mounting beam 16 a and the second outer mounting beam 16 b . By lining up the mounting members 65 with the first shear adjustment ports 17 and the second shear adjustment ports 19 , a bolt and/or another fastener system may be used to secure the adjustable shear ledge 60 to the mounting beams ( 16 , 18 ). In one embodiment, as shown in FIG. 9A , the fastener system may include, on one side, at least one bolt 102 and at least one washer 104 secured to least one nut 106 on an opposite side of the a respective mounting beam ( 16 a , 16 b , or 18 ) to lock the adjustable shear ledge 60 in a desired position. In one embodiment, the at least one bolt 102 may be designed to fail, when a predetermined load is applied to the adjustable shear ledge 60 and/or the adjustable shroud 70 , to provide overload protection for the other components of the discharge device 50 . In one embodiment, the at least one bolt 102 , the at least one washer 104 , and the at least one nut 106 may be forcibly slid along the slots or rails provided by the mounting members 65 , while being secured to one of the first shear adjustment ports 17 and/or one of the second shear adjustment ports 19 , when a predetermined load is applied to the adjustable shear ledge 60 and/or the adjustable shroud 70 , to provide overload protection for the other components of the discharge device 50 . In one embodiment, the adjustable shear ledge 60 may be provided with a guide system, and the mounting beams ( 16 , 18 ) may be provided with a corresponding follower system to follow the guide system. In one embodiment, the adjustable shear ledge 60 may be provided with a follower system and the mounting beams ( 16 , 18 ) may be provided with a guide system. The guide system and the follower system may enable the adjustable shear ledge 60 to be repositioned relative to the plurality of material conveying components 82 by way of repositioning the adjustable shear ledge 60 on the mounting beams ( 16 a , 18 ). In one embodiment, the guide system may be in the form of a track, groove, rail, etc., and the corresponding follower system may be in the form of a peg, wheel, ball joint, etc. For example, the peg of the follower system may follow along a track of the guide system. In one embodiment, fasteners may be used to set and hold a current location of the follower system relative to the guide system. In one embodiment, a set screw or a bolt and nut combination may be used to secure and lock the follower system at a particular location on the guide system to lock a position of the adjustable shear ledge 60 in place. In one embodiment a shock absorption system may be disposed between the adjustable shear ledge 60 and the mounting beams ( 16 , 18 ) in order to provide overload protection for the adjustable shear ledge 60 . In one embodiment, a shock absorption system may be interposed between the guide system and the follower system. The shock absorption system may include a spring-loaded mount or an elastomeric mount. In one embodiment, the shock absorption system may enable the adjustable shear ledge 60 to move relative to the mounting beams ( 16 , 18 ) and away from the plurality of material conveying components 82 . In one embodiment, the shock absorption system may provide overload protection by enabling large objects or obstructions to pass through the discharge device 50 by temporarily increasing an operating clearance between the plurality of material conveying components 82 and the adjustable shear ledge 60 , and/or between the plurality of material conveying components 82 and the adjustable shroud 70 . Once the large object or obstruction has passed, the shock absorption system may return the adjustable shear ledge 60 and/or the adjustable shroud 70 back to a normal or previously set location and operating clearance. The overload protection may thereby prevent damage to the discharge device and reduces operating down time. In one embodiment, adjustments to the adjustable shear ledge 60 and/or the adjustable shroud 70 may be performed manually by an operator loosening/tightening bolts and/or fasteners and then shifting a current position of the adjustable shear ledge 60 to a new position. In one embodiment, adjustments to the adjustable shear ledge 60 and/or the adjustable shroud 70 may be implemented using a hydraulic system or a mechanical linkage. In one embodiment, a shroud mounting port 15 may be formed in each of the outer mounting beams 16 as shown in FIG. 8 . With the shroud mounting port 15 , respective mounting plates 71 may be attached to each of the outer mounting beams 16 . Specifically, by lining up each shroud mounting hole 73 with a portion of a respective shroud adjusting port 15 , a bolt and/or other fastener may be used to secure the adjustable shroud 70 to a respective outer mounting beam ( 16 a , 16 b ). In one embodiment, as shown in FIGS. 8, 9A, and 9B , an opening of the shroud adjusting port 15 may be sized larger than an opening of the mounting hole 73 . In this configuration, the mounting hole 73 can be moved vertically and/or horizontally into an infinite number of positions, with respect to the shroud adjusting port 15 , while still remaining within a boundary of the opening of the shroud adjusting port 15 . A bolt and/or other fastener together with a washer or a movable installation plate may be used to secure the adjustable shroud 70 to the outer mounting beams 16 . In one embodiment, as shown in FIG. 9A , a bolt 91 , a washer 92 , an eccentric plate 93 , and a nut 94 may be provided to secure the external mounting plates 71 to the outer mounting beams 16 . The eccentric plate 93 may be provided to prevent the bolt 91 from passing through the opening of the adjusting port 15 while enabling the bolt 91 to be secured to the nut 94 in a plurality of positions. In one embodiment, a bracket 95 and a set screw adjustment 96 which may include an eyebolt, may be provided to assist in aligning the adjustable shroud 70 . By adjusting the location of where the adjustable shroud 70 is secured with respect to the outer mounting beams 16 , a gap distance between the shroud top surface 72 and the plurality of material conveying components 82 may be adjusted to achieve a desired gap distance and to promote concentricity. In one embodiment, the bolt 91 may be designed to fail when a predetermined load is applied to provide overload protection for the other components of the discharge device 50 . In one embodiment, the bolt 91 , the washer 92 , the eccentric plate 93 , and the nut 94 may be forcibly repositioned with respect to the opening of the adjusting port 15 , while being secured to one of the shroud mounting holes 73 , when a predetermined load is applied to provide overload protection for the other components of the discharge device 50 . In one embodiment, the external mounting plates 71 of the adjustable shroud 70 may be provided with a guide system, and the outer mounting beams 16 may be provided with a corresponding follower system to follow the guide system. The guide system may be in the form of a track, groove, rail, etc. In one embodiment, the external mounting plates 71 of the adjustable shroud 70 may be provided with a follower system, and the outer mounting beams 16 may be provided with a corresponding guide system to guide the follower system. The guide system and the follower system may enable the adjustable shroud 70 to be repositioned relative to the plurality of material conveying components 82 by way of repositioning the adjustable shroud 70 on the outer mounting beams 16 . In one embodiment, the guide system may be in the form of a track, groove, rail, etc., and the corresponding follower system may be in the form of a peg, wheel, ball joint, etc. For example, the peg of the follower system may follow along a track of the guide system. In one embodiment, fasteners may be used to set and hold a current location of the follower system relative to the guide system. In one embodiment, fasteners may be used to set and hold a current location of the follower system with respect to the guide system. In one embodiment, a set screw or a bolt and nut combination may be used to secure the follower system at a particular location on the guide system to lock a position of the adjustable shear shroud 70 in place. In one embodiment a shock absorption system may be disposed between the adjustable shroud 70 and the outer mounting beams 16 in order to provide overload protection for the adjustable shroud 70 . In one embodiment, a shock absorption system may be interposed between the guide system and the follower system. The shock absorption system may include a spring-loaded mount or an elastomeric mount. In one embodiment, the shock absorption system may enable the adjustable shroud 70 to move relative to the outer mounting beams and away from the plurality of material conveying components 82 . In one embodiment, the shock absorption system may provide overload protection by enabling large objects or obstructions to pass through the discharge device 50 by temporarily increasing an operating clearance between the plurality of material conveying components 82 and the adjustable shear ledge 60 , and/or between the plurality of material conveying components 82 and the adjustable shroud 70 . Once the large object or obstruction has passed, the shock absorption system may return the adjustable shear ledge 60 and/or the adjustable shroud 70 back to a normal or previously set location and operating clearance. The overload protection may thereby prevent damage to the discharge device and reduces operating down time. In one embodiment, both the adjustable shear ledge 60 and the adjustable shroud 70 may both be moved with respect to the mounting beams ( 16 , 18 ) to achieve a desired gap distance and promote concentricity with the plurality of material conveying components 82 . Additionally, while the adjustable shear ledge 60 and adjustable shroud 70 are being moved, the adjustable shroud 70 may also be pivoted with respect to the adjustable shear ledge 60 , thus enabling the entire shroud top surface 72 to be brought closer towards the plurality of material conveying components 82 to promote concentricity. In one embodiment as shown in FIGS. 9A and 9B , a hydraulic system 110 may be provided to adjust a position of the adjustable shear ledge 60 and the adjustable shroud 70 . The hydraulic system 110 may include a first hydraulic actuator 111 secured at a first end 112 to the bottom of the container 14 or to the housing 56 of the discharge device 50 . The hydraulic actuator 111 may be secured at a second end 113 to a bracket 114 of the adjustable shear ledge 60 . In one embodiment, the hydraulic actuator 111 may be installed parallel with or substantially parallel with the bottom of the container 14 to laterally adjust a position of the adjustable shear ledge 60 , or both the adjustable shear ledge 60 and the adjustable shroud 70 . In one embodiment, the adjustable shear ledge 60 and/or the adjustable shroud 70 may be repositioned laterally away from a center of the container 10 as the hydraulic actuator 111 is extended, or towards the center of the container 10 as the hydraulic actuator 111 is retracted. The hydraulic system 110 may include a second hydraulic actuator 115 with a first end 116 secured to the bracket 114 of the adjustable shear ledge 60 . The second hydraulic actuator 115 may include a second end 117 secured to a bracket 119 of the adjustable shroud 70 . In one embodiment, the second hydraulic actuator 115 may extend at an angle, downward from the first hydraulic actuator 111 , in order to rotatably adjust the adjustable shroud 70 with respect to the adjustable shear ledge 60 . In one embodiment, the adjustable shroud 70 may be rotated upward towards the plurality of material conveying components 82 as the second hydraulic actuator 115 is extended, or rotated downward away from the plurality of material conveying components 82 as the second hydraulic actuator 115 is retracted. In one embodiment, the first hydraulic actuator 111 and/or the second hydraulic actuator 115 may be adjusted to extend or retract on demand in response to a predetermined load applied to the adjustable shear ledge 60 and/or adjustable shroud 70 to provide overload protection for the other components of the discharge device 50 . In one embodiment, the adjustable shear ledge 60 may be provided with a guide system, and the mounting beams ( 16 , 18 ) may be provided with a corresponding follower system to follow the guide system, or vice versa. The guide system and the follower system, together with the hydraulic system, may be used to adjust a position of the adjustable shear ledge 60 and/or the adjustable shroud 70 relative to the plurality of material conveying components 82 by way of repositioning the adjustable shear ledge 60 and/or the adjustable shroud 70 on the mounting beams ( 16 , 18 ). The first hydraulic actuator 111 may be used to set and hold a position of the adjustable shear ledge 60 relative to the mounting beams ( 16 , 18 ). The guide system and the follower system, together with the hydraulic system 110 , may be used to adjust a position of the adjustable shear ledge 60 and/or the adjustable shroud 70 relative to the plurality of material conveying components 82 by way of repositioning the adjustable shroud 70 and/or the adjustable shear ledge 60 on the mounting beams ( 16 , 18 ). The second hydraulic actuator 115 may be used to set and hold a position of the adjustable shroud 70 and/or the adjustable shear ledge 60 on the mounting beams ( 16 , 18 ). In one embodiment, a shock absorption system may be installed in series or in parallel with the first hydraulic actuator 111 and/or the second hydraulic actuator 115 . The shock absorption system may provide overload protection by enabling large objects or obstructions to pass through the discharge device 50 by temporarily increasing an operating clearance between the plurality of material conveying components 82 and the adjustable shear ledge 60 , and/or between the plurality of material conveying components 82 and the adjustable shroud 70 . Once the large object or obstruction has passed, the shock absorption system may return the adjustable shear ledge 60 and/or the adjustable shroud 70 back to a normal or previously set location and operating clearance. In one embodiment, the shock absorption system may be spring loaded device. In one embodiment, the shock absorption system is actuated when a predetermined force is applied on the adjustable shear ledge 60 and/or the adjustable shroud 70 . In one embodiment, when the shock absorption system is actuated, a distance between the first end 112 and the second end 113 of the first hydraulic actuator 111 may be extended or shortened as needed to allow the obstruction to pass. In one embodiment, when the shock absorption system is actuated, a distance between the first end 116 and the second end 117 of the second hydraulic actuator 115 may be extended or shortened as needed to allow the obstruction to pass. In one embodiment, as shown in FIGS. 10A and 10B , at least one hydraulic system 120 may be provided to adjust a mounting position of the drive shaft 80 with respect to the housing 56 . The at least one hydraulic system 120 may be used with one of the adjustable shear ledge 60 and/or the adjustable shroud 70 , or may be used with a fixed position shear ledge and/or fixed position shroud. The drive shaft 80 may support the plurality of material conveying components 82 and the adjustment of the mounting position may correspondingly adjust a position of the plurality of material conveying components 82 with respect to an installed shear ledge and shroud to improve a swing path of the plurality of material conveying components 82 . In one embodiment, the hydraulic system 120 may be provided on either side of the housing 56 to support at least both ends of the drive shaft 80 . The hydraulic system 120 may include a support column 121 that is rotatable and secured to a pivot 122 which may be attached to the housing 56 . The hydraulic system 120 may include a collar mechanism 123 that may be slidably supported on the support column 121 . In one embodiment, a first hydraulic actuator 124 may be provided to adjust an axial position of the collar mechanism 123 along a length of the support column 121 . A bearing support member 130 may be attached to the collar mechanism 123 to secure the drive shaft 80 to the housing 56 . The first hydraulic actuator 124 may be attached at a first end 125 to the pivot 122 and at a second end 126 to the collar mechanism 123 . In one embodiment, the drive shaft 80 may be adjusted towards the adjustable shear ledge 60 and/or the adjustable shroud 70 as the first hydraulic actuator 124 is extended, or adjusted away from the adjustable shear ledge 60 and/or the adjustable shroud 70 as the first hydraulic actuator 124 is retracted. In one embodiment, the collar mechanism 123 may include a plurality of circular rings sized to receive the support column 121 along their respective inner circumference. A beam member may be provided to connect the plurality of circular rings to one another. The circular rings may include mounts for attaching the bearing support member 130 thereto. In one embodiment, a second hydraulic actuator 127 may be provided to adjust an angle A of the support column 121 with respect to the pivot 122 . The second hydraulic actuator 127 may be attached at a first end 128 to an end of the support column 121 , opposite from the pivot 122 . The second hydraulic actuator 127 may be attached to a second end 129 that is secured to a side of the housing 56 or the container 10 . In one embodiment, the drive shaft 80 may be swung laterally away from a center of the container 10 as the second hydraulic actuator 127 is extended, or swung toward a center of the container 10 as the second hydraulic actuator 127 is retracted. In one embodiment, the first hydraulic actuator 124 and/or the second hydraulic actuator 127 may be adjusted to extend or retract on demand in response to a predetermined load applied to the adjustable shear ledge 60 , adjustable shroud 70 , and/or the plurality of material conveying components 82 to provide overload protection for the other components of the discharge device 50 . In one embodiment, a shock absorption system may be installed in series or in parallel with the first hydraulic actuator 124 and/or the second hydraulic actuator 127 to provide overload protection by enabling large objects or obstructions to pass through the discharge device 50 by temporarily adjusting a position of the drive shaft 80 . Once the large object or obstruction has passed, the shock absorption system may return the drive shaft 80 back to a normal or previously set position. In one embodiment, the shock absorption system may be a spring loaded device. In one embodiment, the shock absorption system is actuated when a predetermined lateral force is applied to the drive shaft 80 . In one embodiment, adjustments may be made by an operator based on visual inspection of the discharge device 50 . As shown in FIG. 3B , a sensor 90 to measure a gap distance and/or to measure torque of the material conveying components 82 may be provided to give a reading of the measurement to the operator, whereby the operator can adjust the gap distance between the adjustable shear ledge 60 and/or the adjustable shroud 70 with the plurality of material conveying components 82 to a desired gap distance. In one embodiment, the sensor 90 may be provided to measure a gap distance between the plurality of material conveying components 82 and the adjustable shear ledge 60 and/or the adjustable shroud 70 to determine whether the gap distance is in an appropriate operating range, and to automatically adjust the gap distance using the hydraulic system 120 [LJW1] . In one embodiment, a sensor measuring a torque of the material conveying components 82 may be provided to detect whether the discharge device 50 is in an appropriate operating range and to automatically adjust the gap distance between the adjustable shear ledge 60 and/or the adjustable shroud 70 with the plurality of material conveying components 82 using the hydraulic system 120 . In one embodiment, each of the mounting members 65 is a longitudinal opening (e.g. slot) that extends towards the shear top surface 62 . In this configuration, the adjustable shear ledge 60 may be positioned or repositioned along a vertical axis and a horizontal axis, both the vertical axis and the horizontal axis being perpendicular to an axis of the drive shaft 80 . By positioning or repositioning the adjustable shear ledge 60 , a gap distance between the shear top surface 62 and the plurality of material conveying components 82 may be adjusted to achieve a desired gap distance and to promote concentricity. In one embodiment, the gap distance may be between 0.05 and 0.25 inches. In another embodiment, the gap distance may be between 0.10 and 0.15 inches. It is understood that the adjustable shear ledge and shroud of the present disclosure is not limited to the particular embodiments disclosed herein, but embraces much modified forms thereof that are within the scope of the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/803,120, filed by Bob Cook on Mar. 9, 2001. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. BACKGROUND OF THE INVENTION [0003] 1. Field of Invention [0004] This invention relates to a weighted exercise glove. Specifically, the invention describes a glove that is shaped, supported and padded like a boxing glove, with integral weight uniformly distributed over the generally dorsal (back) side of the glove and/or the wrist, allowing the palm of the glove to remain flexible to allow hinged motion of the thumb and finger portions of the glove. The glove may extend beyond the fingertips to completely cover the fingers, such as in a traditional boxing glove, or the fingertips may extend beyond the glove, as in a fingerless glove. [0005] The invention allows the user to wear resistance weight applied to the upper extremities without having to grasp the weight. Rather than having to grasp resistance weight, such as a dumbbell, the user wears the weighted gloves. This prevents strain on the wrists, since there is no requirement to grasp and hold the weight. Rather, the weight is evenly distributed in a balanced manner across the distal portion of the arm, generally from the fingers to the forearm. [0006] The invention is useful for those unable to grasp objects, heavy or light, due to wrist injuries, neurological injury or other diseases or injuries having such a condition. Since the user wears rather than holds the weight on his lower arms, resistance training is still possible for functional muscle groups, such as biceps, deltoids, trapezius, and other upper body and arm structures. [0007] Even for exercisers not injured, the invention provides several advantages over conventional free and fixed station weights. Since the weight is not grasped, strain to the wrists is removed, even when a portion of the weight is distributed about the wrist, since tendons, ligaments and muscles in and about the wrist are not being used to affect hand and finger grip of the weight. Thus, the user is able to isolate and focus her strength training on the targeted muscle group, without having to provide energy and support to the wrists for the grip/grasp. This provides a more efficient workout while reducing the potential of acute or repetitive trauma wrist injury from hyperextension or other strain. [0008] Other advantageous uses include those when performing shoulder shrugs, lunges, rows and lower body workouts where resistance weight is needed. As the weight is always being applied to the wearer's arms in a glove (which is preferably padded), there is less likelihood of bumping the body with a weight such as a dumbbell. This allows the user to focus on his form and targeted muscle groups affected by the exercise, rather than concentrating on the position of a free weight held in the hands or keeping the wrist straight. When using traditional free weights (dumbbells or barbells), the user is often directing a major portion of his attention, energy and effort towards maintaining proper wrist position to prevent injury from wrist strain and/or hyperextension. The present invention allows the user to focus instead on the targeted muscle group receiving resistance. [0009] Additionally, the invention is useful as a boxing training aid. The shape and feel of the device are very similar to a traditional boxing glove. The extra weight allows the user to improve muscle mass while maintaining flexibility and range of motion during the workout. When the gloves are removed and replaced by traditional boxing gloves, the user is typically able to have greater hand speed since wearing the invention has strengthened the exact muscles used in boxing. In addition, when hitting a heavy bag with the preferred embodiment in which the gloves extend beyond the fingertips, the user feels less impact shock in his arms since the weight about the glove both disperses shock load and minimizes bounce-back from the bag due to inertial forces of the gloves. [0010] When used for heavy weight training, the invention takes strain off the lower back because the hands are in a natural position. This is especially true when performing overhead military presses, since the body does not have to be tilted to clear the chin as required when lifting a barbell. With the present invention, the wearer if so desired can simply raise her hands straight up over her head with the palms facing forward to isolate and strengthen the deltoid muscle group. This is not possible with dumbbells, which requires the palms to be facing inward when lifting overhead in order to prevent the ends of the dumbbells from striking the sides of the user's head. [0011] In the alternative embodiment, the gloves are weighted with replaceable water. This embodiment allows some flexibility in determining the weight of the gloves, and is especially useful if the gloves are transported, such as in the suitcase of a business traveler. The weighted gloves allow the traveler to have a full resistance weight workout in his room without carrying heavy weight in his luggage. Since water weighs approximately eight pounds per gallon (1.0 gm/ml) and is readily available, it can be filled into integral chambers of the gloves to provide the needed weight. Preferably, the water chambers are baffled to minimize sloshing and related fluid inertial forces. [0012] 2. Related Art [0013] Weighted exercise gloves are found in the prior art. Some, such as Walker '433 (U.S. Pat. No. 4,911,433, issued Mar. 27, 1990) and Fredenhagen '853 (U.S. Pat. No. 3,838,853, issued Oct. 1, 1974) are for developing finger strength. These patents disclose weights on fingers of a glove, in order to increase finger strength for piano playing (Fredenhagen '853) or grasping a baseball bat (Walker '433). Neither is capable of supported heavy weights, and both create stress on the wrists. [0014] Other weighted gloves include Guthrie '706 (U.S. Pat. No. 4,326,706, issued Apr. 27, 1981) and Schwartz '097 (U.S. Pat. No. 4,247,097, issued Jan. 27, 1981). These gloves have pockets for inserting weights. The main disadvantage of such designs is that in their disclosed embodiments the weights break out of their pockets, either from the pockets opening or the retaining material tearing, especially in fast exercises such as aerobic dancing and shadow boxing. More significantly, such devices still require, or at least encourage the user to grip palm weights, thus placing strain on the wrist, especially the carpal tunnel. [0015] It would therefore be useful improvement of the prior art for a weight resistance glove to not have the limitations of the prior art, including those described above. Specifically, such a glove would conform comfortably and naturally to the neutral position of the hands, without requiring the user to grip the glove and its integrated weight. BRIEF SUMMARY OF THE INVENTION [0016] Accordingly, the objectives of this invention are to provide, inter alia, a new and improved weighted glove that: [0017] provides upper body weight resistance without the need to grip the weight; [0018] has weights that are integral, preferably permanently, to the glove to minimize breakage or disengagement of the weight from the glove; [0019] has weight uniformly distributed across the hand and forearm to minimize wrist strain; [0020] can alternatively be constructed to use water or other similar available fluids as weight; and [0021] is cost effective. [0022] These objectives are addressed by the structure and use of the inventive device. Other objects of the invention will become apparent from time to time throughout the specification hereinafter disclosed. BRIEF DESCRIPTION OF THE DRAWINGS [0023] [0023]FIG. 1 depicts the palm side of the weighted glove, showing securement straps and the flexible palm. [0024] [0024]FIG. 2 depicts the inventive glove with integral molded weights in two sections, on the dorsal side of the glove and along the thumb. [0025] [0025]FIG. 3 depicts the preferred embodiment of the glove, with a unitary molded weight integral with the glove, preferably under the outer skin of the glove. [0026] [0026]FIG. 4 depicts an alternative embodiment of the glove, having a chambered fluid container on the dorsal side of the glove and along the thumb. [0027] [0027]FIG. 5 depicts an alternative embodiment of the glove, having a continuous fluid chamber or weighted material surrounding the glove. [0028] [0028]FIG. 6 depicts an alternative embodiment of the glove, having additional weight about the wrist. [0029] [0029]FIG. 7 depicts an alternative embodiment of the glove, having a unitary molded weight, including weight about the wrist area, which is integral with the glove, preferably under the outer skin of the glove. [0030] [0030]FIG. 8 depicts an alternative embodiment of the glove, wherein the fingers and thumb extend beyond the distal end of the glove. DETAILED DESCRIPTION OF THE INVENTION [0031] The present invention is described as a weighted glove 10 , depicted in FIGS. 1 through 8. [0032] As seen in FIG. 1, the shape of glove 10 is preferably that of a boxing glove, preferably a non-Corbett style of glove, having a mitten type area for the fingers and a separate thumb area. However, any shape glove providing natural support and shape for the hand is appropriate for the invention. The preferred glove 10 shown in FIG. 1 extends from past the wearer's fingertips (a first position distal the wearer's fingertips) to the forearm (a second position proximal the wearer's wrist) typically three or four inches to the proximal side of the wrist. The interior of the glove is preferably shaped and padded to provide a slight natural curve of the fingertips when the had is inserted. The glove preferably attaches to the hand with securements 42 , which are Velcro™ type straps in the preferred embodiment. Alternatively, any securement method known in the art of athletic gloves may be used as securement 42 , including but not limited to lacing, buckles, an elastic sleeve or zippers. Alternatively, no securement 42 may be used, and glove 10 stays on the user's hand due to the shape of the interior of glove 10 molding to the natural curvature and shape of the user's hands. Glove palm 40 comprises the portion of the exterior of glove 10 proximate the user's palm. [0033] One embodiment of glove 10 is shown in FIG. 2, having a dorsal weight 30 covering dorsal side 36 and a separate thumb weight 32 covering thumb dorsal area 31 . Each weight is preferably a solid weight, preferably a singular flexible rubberized weight, preferably permanently secured under outer skin 38 of glove 10 . Alternatively, dorsal weight 30 and thumb weight 32 may each comprise a plurality of smaller weights, secured in separate closed compartments (not shown) of skin 38 . Alternatively, dorsal weight 30 and thumb weight 32 may be removable, by being secured in a pocket or other similar restraint (not shown) of glove 10 . These removable weights may be a singular flexible rubberized weight or its equivalent, or the removable weights may be a plurality of smaller weights. [0034] The preferred embodiment of glove 10 is shown in FIG. 3. A single unitary weight 50 is molded about dorsal side 36 of glove 10 , also covering thumb dorsal area 31 . Analogous to the weight described in FIG. 2, unitary weight 50 is preferably a singular flexible rubberized weight, secured under outer skin 38 of glove 10 . Unitary weight 50 is preferably permanently secured under outer skin 38 , but may be removable in an alternate embodiment. Alternatively, unitary weight 50 , while still unitary in that it contiguously molds about dorsal side 36 of glove 10 , may comprise a plurality of smaller weights secured in closed compartments (not shown) of skin 38 . These closed compartments are typically sewn pockets that are stitched closed, to prevent the release of unitary weight 50 , whether a single piece of weight or a plurality of smaller weights. Alternatively, these closed compartments may be pockets or similar compartments that can be accessed to remove and replace different amounts of weights in glove 10 . Unitary weight 50 is shown covering only a portion of dorsal side 36 and thumb dorsal area 31 . However, it is understood that weight 50 can cover all of the area of dorsal side 36 and thumb dorsal area 31 in this preferred embodiment. [0035] An alternative embodiment of glove 10 is shown in FIG. 4, where dorsal weight 30 and thumb weight 32 are replaced with dorsal fluid chamber 60 and thumb fluid chamber 62 respectively. These chambers are capable of being filled with fluid, such as water, through at least one fill tab 64 . Fill tabs 64 are any type of valve known in the art for allowing fluid to be selectively filled into or drained out of the fluid chambers. The chambers preferably have internal baffles 65 , to prevent the fluid from sloshing and creating fluid inertial forces when the gloves are moved quickly. The chambers are depicted in FIG. 4 as segregated units. However, dorsal fluid chamber 60 and thumb fluid chamber 62 may combine and join to form a unitary fluid chamber (not shown) that covers all or part of dorsal side 36 and thumb dorsal area 31 . Typically, the interior of this unitary fluid chamber is all in fluid communication within itself. [0036] Another preferred embodiment of glove 10 is shown in FIG. 5. In this embodiment, unibody fluid chamber 66 is the full weight 68 , which covers the entire glove 10 under skin 38 , including dorsal side 38 , thumb dorsal area 31 and glove palm 40 . The hand of the user fits into the interior of glove 10 , which is surrounded by unibody fluid chamber 66 . This embodiment allows an additional fluid capacity of glove 10 , but limits its flexibility. The interior of glove 10 is still shaped to fit the natural contour of the user's hand. Alternatively, full weight 68 of glove 10 can be provided by a single flexible solid weight (not shown) that surrounds dorsal side 36 , thumb dorsal area 31 and glove palm 40 and is secured, permanently or removably, under skin 38 . While such an embodiment further limits the flexibility of the glove, this additional weight is uniformly supported about the glove. [0037] Alternatively, glove 10 may include wrist weight 52 , which forms around the wrist area of the user, as depicted in FIGS. 6 and 7. In these embodiments, either with segregated weights (FIG. 6) or a unitary weight 50 (FIG. 7), there is still minimal strain on the wrist, since the wrist is not being required to support the biomechanics required for grasping/gripping a weight. However, in these embodiments, it is still preferred that glove palm 40 (shown in other figures) remain flexible, to allow glove thumb 25 and glove fingers area 27 to hinge in conformance to the natural curvature and movement of the user's hand, especially his fingers and thumb. This natural hinging position keeps the glove on the hand without extra gripping/grasping by the user. Therefore, although wrist weight 52 may obstruct and even prevent securement 42 , glove 10 stays on the user's hands due to the natural curvature of the hands mating with the hinged curvature of glove 10 . [0038] Alternatively, glove 10 can have user fingers 70 and user thumb 72 extend beyond glove distal end 75 , to allow the user to flex his digits and keep them cooler, such that glove 10 is oriented between a first position anatomically proximal to user's fingertips 71 and/or user thumb end 73 , and a second position anatomically proximal the wearer's wrist (not shown). Weight is distributed across the user's hand as in other embodiments, and the user still does not have to grip or grasp the weight of glove 10 , since glove 10 conforms to the natural shape of the user's hand as above. Glove 10 in this embodiment may also incorporate wrist weight 52 (not shown in this figure), and/or may utilize the unitary weight 52 and/or unibody fluid chamber 66 described above. [0039] In all embodiments, glove 10 is preferably padded both inside glove 10 as well as under skin 38 . The interior padding aids in shaping the hand of the wearer to a natural position, preferably with the fingers slightly bent. The exterior padding under skin 38 provides additional safety if the gloves 10 should be dropped on the user when removed, or if they should be bumped against the wearer during the workout routine. OPERATION [0040] While all gloves 10 depicted are a single left-handed glove, it is understood that it is the intention of the inventor that gloves typically come in and are used in matching right and left handed pairs, assuming the wearer is capable and so desires such bilateral use. [0041] The user places one or both hands in a corresponding glove 10 . The gloves are secured to the hands and lower forearms of the user by engaging securement 42 . Additional securement is afforded by the curved and slightly padded shape of glove palm 40 . Alternatively, the user does not use or glove 10 does not have securement 42 , but glove 10 remains on the user's hands due to the natural mating together of the user's hand and the interior of glove 10 . As the user slips her hands into the glove, the interior cavity of glove 10 forms around the hands to hold gloves 10 on even when the hands are held in the downward position. If the user chooses to flex glove palm 40 , she may do so, but this is typically not necessary to hold gloves 10 on. [0042] The user then exercises in the same way she would exercise with dumbbells or barbells. For example, bicep curls are performed by lifting the arms upward as if holding a barbell or dumbbells. However, the hands do not have to grip gloves 10 , since they are strapped onto the hands and lower forearms. The hands should remain in an ergonomically neutral position, with the fingers slightly curled. The wrist is held straight by the shape of and support provided by glove 10 . [0043] Lunges are likewise performed as if holding dumbbells. The gloves 10 do not pose striking hazards to the user, unlike dumbbells, which may hit the user when exercising. Likewise, exercises that traditionally use barbells, such as overhead military presses or bench presses, can be performed with gloves 10 on and simply pushing the weighted gloves 10 away. This provides a safer exercise, since the weights can not be dropped. [0044] Boxer training is also improved with gloves 10 . The user can shadow box or even hit a speed bag with gloves 10 on. These routines use the same muscles and range of motion of boxing, thus targeting the specific muscles that need to be strengthened for the sport. By increasing the muscle strength while maintaining the muscle flexibility offered by the range of motion of the shadow boxing routine, the boxer's speed will be increased as muscle strength increases without loss of flexibility. In the preferred embodiment, the weights are integral to gloves 10 and are not in pockets that may open, thus the weights remain firmly secured to gloves 10 . Thus there is minimal danger of the weights flying out of gloves 10 during rapid movement, such as in shadow boxing or aerobic dancing. In addition, when hitting a heavy bag, the user feels less impact shock in his arms since the weight about glove 10 both disperses shock load and minimizes bounce-back from the bag due to inertial forces of the gloves. If the weights are replaceable in pockets (not shown) about gloves 10 , the pockets preferably are secured firmly to prevent inadvertent release of the weights. [0045] The foregoing disclosure and description of the invention is illustrative and explanatory thereof. Various changes in the details of the illustrated construction may be made within the scope of the appended claims without departing from the spirit of the invention. The present invention should only be limited by the following claims and their legal equivalents.

1a

This is a continuation of copending application(s) International Application PCT/SE02/00309 filed on 21 Feb. 2002 and which designated the U.S. TECHNICAL FIELD The present invention relates to process for the extraction of soluble proteins, non-starch carbohydrates, and optionally oils from commercially available cereal bran. It also allows the production of cell wall-derived materials and less accessible proteins from cereal brans that are substantially free of soluble compounds, the compounds thus recovered as well as their use. BACKGROUND OF THE INVENTION Bran is defined as the seed coat of cereal grains such as wheat, barley, rye, triticale, oat or rice. Anatomically, bran comprises the outer layers of the seed, known as the pericarp-testa and an inner layer known as the aleurone layer, which is often classified as the outermost layer of the endosperm. However, from the practical point of view cereal bran is herein defined as the remaining material after the conventional milling or polishing of cereal grains and contains primarily pericarp-testa and aleurone layer components, along with the cereal germ and residual parts of the endosperm. The relative amounts of each component will depend upon the type of cereal and milling technique applied. Within this definition, bran therefore contains all of the pericarp-testa components, the aleurone layer, the germ components including germ proteins and oils, along with a residual amount of endosperm starch, gluten and pentosans. U.S. Pat. No. 4,361,651 describes a process for making fermentable sugars and high protein products from grain, mainly maize. In this method, grain is steeped for 10-30 h, prior to milling and separation of the germ component, saccharification of carbohydrates (mainly starch), and separation of fibre. The yield of starch is maximised for fermentation to alcohol. Within the described process there is no specific fractionation of the bran component, separation of protein types or consideration of the germ component. U.S. Pat. No. 5,312,636 discloses a process for fractionating crop into industrial raw material. This is focused on oat grain and incorporates bran fractionation procedures that involve the extraction of more hydrophobic components such as lipids in polar organic solvents prior to the alkaline extraction of residual bran to produce beta-glucan, protein and degummed fibres. The use of the organic solvent is a key step in the process and hydrolysing enzymes are not utilised during the fractionation procedure. Two related US patents (U.S. Pat. Nos. 4,171,383 and 4,171,384) disclose dry and wet milling procedures for refining whole wheat grain. U.S. Pat. No. 4,171,383 focuses on wet milling of the whole kernel. The bran produced is mixed with a separated (mainly) endosperm protein fraction to produce animal feed. U.S. Pat. No. 4,171,384 describes dry milling of the whole kernel to produce an endosperm fraction, a germ fraction and a bran fraction. The endosperm fraction is then subjected to wet milling and separation of starch-rich and protein-rich fractions. The protein rich fraction is added to the bran to produce an animal feed. There is no description of a specific wet fractionation of the bran itself within either patent. Patent application WO 99/11672 discloses a process that uses selective enzymes, such as acetyl xylan esterase and ferulic acid esterase, to both facilitate the removal of hemicellulose from various plant materials and alter its degree of phenolic ester substitution. Despite the fact that functional hemicellulose with high solubility and gelling strength can be produced yields are rather low. In fact, the inventors reported a 3 and 6% yield of arabinoxylan ferulate (hemicellulose), when wheat bran was treated with acetyl xylan esterase for 90 and 180 min, respectively. Furthermore, the invention does not make any reference to the use of xylanases, or its combination with wet milling in order to overcome the low yields reported. U.S. Pat. No. 5,308,618 discloses a process to extract soluble dietary fibre hemicelluloses from wheat bran by applying a heat pre-treatment in aqueous solution. Further processing such as filtration, salting out, dialysis, ultrafiltration, reverse osmosis, gel filtration and precipitation in order to remove contaminants from the hemicellulose fraction, follows this. The inventors make no claims with regards to the use of enzymes and production of products streams other than hemicellulose. Furthermore, the invention highlights the need of run costly procedures to remove contaminants, which were once present in the original wheat bran. The bran is extracted at high temperatures and pressures in water (180-200° C.), producing a glucose rich dietary fibre component in the water phase. The process specifically targets the production of dietary fibre and is not really/strictly a fractionation procedure in that other products is largely ignored. U.S. Pat. No. 3,879,373 discloses a process to extract hemicelluloses from wheat bran by applying alkali treatment to dissolve hemicelluloses and other bran components followed by ethanol extraction to separate the hemicelluloses. Alkali (sodium hydroxide) extraction of hemicellulose has also been disclosed in U.S. Pat. No. 5,174,998 as an intermediate step to produce controlled-release compositions containing the said alkali-extracted hemicellulose and an active substance. Similar alkali-extraction procedure is disclosed in U.S. Pat. No. 4,927,649 to produce hemicellulose, which is then used in coating compositions containing insoluble dietary fibre. WO 00/04053 patent application describes a chemical process using alkaline peroxide treatment to produce high yields of light coloured gelling hemicelluloses from products derived from flour, husk or bran. Another chemical extraction process of hemicellulose from wheat bran has been disclosed in WO98/31713 patent application, whereby the inventors combine a washing procedure to remove the starch fraction followed by an alkaline treatment with sodium hydroxide to extract the hemicellulose from the starch-free raw material. It appears from above-described prior art on alkali extraction of hemicellulose that this is an old, proven and effective way to yield high quantities of soluble hemicellulose with interesting functionalities such as gelling, dietary fibre and as an inert material for controlled-release compositions. The drawback of such technology is the associated problems of utilising chemicals. Firstly, chemicals eventually become contaminants in various product streams, and therefore require additional purification. This normally has significant cost implications. Secondly, innovative industrial processes based on chemical extraction are not always attractive from the marketing point of view, particularly in food applications. Production of insoluble dietary fibres from oats is disclosed in U.S. Pat. No. 5,023,103, which describes a chemical procedure (alkali and bleaching treatment) for the production of insoluble dietary fibre with high water holding capacity and non-gritty mouth feel. A water holding capacity of 6.9 g watering oat fibre has been reported. Other references have disclosed processes for the extraction of proteins from cereal brans. U.S. Pat. No. 4,746,073 discloses a physical process to separate aleurone cell particles and pericarp-testa particles from commercial wheat bran. The process consists of milling the bran particles to a specific particle size distribution, electrostatically charge the said particles and then pass the said charged particles through a magnetic field, which separates aleurone from pericarp-testa particles. The separation is achieved by hammer-milling the bran and then subjecting the resultant particles to a physical separation regime achieve the separation. No aqueous wet processing is employed during the fractionation procedure described therein. This is a rather different concept from the current invention, which is based upon the use of enzymes and aqueous wet milling. Waszczynskyj et al. (1981) have proven that protein extraction rate of alkali-treated full fat wheat bran can be increased from 30% up to 38.5% when it is preceded by polysaccharidase treatment. The above-mentioned figures are significantly lower than those described in the present invention whereby up to 60% protein extraction rates were achieved without using alkali treatment. Furthermore, U.S. Pat. No. 5,622,738 discloses a method to extract soluble hemicelluloses, for use as a source of dietary fibre, from various fibrous materials including cereal brans using alkali digestion followed by xylanase treatment. As in other prior art, Waszczynskyj et al made use of alkali digestion to improve extraction rates. Additionally, the residence time for the enzymatic treatment was rather long (3 to 96 h), which makes the process not very attractive from a production cost point of view. WO 01/60180 relates to process for separating oil from rice bran, whereby bran having a suitable particle size in a slurry is subjected to an enzymatic treatment, and subjecting the enzymatically treated slurry for a separation to recover an oil phase for further isolation of specific lipids. The process is carried out under alkaline conditions for a considerable time period, normally 15 hours. As no degradation of starch present, about 15% of the ingoing bran, takes place, any end product will be heavily contaminated with starch. It is clear that the above-mentioned prior art has not succeeded to arrive at a process of cereal bran fractionation, which is both chemical-free and yields different food-grade fractions and simultaneously yield aleurone proteins, oligosaccharides and hemicelluloses, and yet produce insoluble dietary fibre from previously cleaned cereal bran, i.e. substantially free of soluble components, using xylanases and/or beta-glucanases in combination with wet milling. SUMMARY OF THE PRESENT INVENTION The main objectives of the present invention are to: 1. Arrive at an efficient and cost effective industrial wet process to extract and yield germ-, endosperm- and aleurone-rich fractions, glucose, soluble hemicellulose, soluble oligosaccharides, insoluble fibre, and optionally oils from cereal bran. 2. Combine the use of enzymatic treatment with wet milling to improve the efficiency of extraction and separation in an industrial process. 3. Ensure that in the fractionation process protein fractions of distinct physical properties and therefore functionalities were obtained. 4. Ensure that the intermediate fibre raw material contains the least amount of readily extractable components, hence solubles, so that contamination with the said solubles in the end products is kept to a minimum. 5. The process is carried out in such a way so that use of chemical extraction procedures are avoided and that, preferably food grade and non-genetically modified (non-GMO), xylanases and/or beta-glucanases are used in order to broaden the market opportunities for the end products. In this description, the term cereal bran substantially free of soluble compounds or “cleaned bran” refers to any cereal bran, which has been processed, after conventional milling or polishing, by any means, so as to remove substantial amounts of soluble components, which are extracted by water or less polar solvents. The resulting material, hereafter referred to as cleaned bran, should contain rather limited amounts of soluble sugars, starch and gluten (less than 1%), but it may still contain some proteins and fats, which are less accessible and/or soluble. The cleaned bran consists primarily of cell wall components, of which hemicellulose is the most abundant. The invention relates to methods, procedures and an industrial process for the wet-fractionation of cereal bran into two protein rich fractions, one of which contains the germ oils and related components, a fibre fraction, which also retains most of the aleurone proteins, and a sugar syrup fraction. The invention is centred around the wet-milling of cereal bran in the presence of enzymes: a) starch degrading enzymes of the group amylases, and amyloglucosidases, and optionally b) non-starch degrading enzymes (polysaccharidases) and optionally a phytase, under appropriate conditions of temperature, i.e. from 50 to 90° C., more preferably from 50 to 75° C., and pH from 4 to 7.5. This is followed by the separation of the above listed components from aqueous suspension using mainly centrifugal separation methods. The pH when using an alpha amylase is normally around 7, and when using an amyloglucosidase it is around 4.5. The enzymes are used normally in a cocktail comprising 200 to 1500 IU/g of substrate, but should contain at least 1 IU/g of substrate. This invention also relates to methods, procedures and an industrial process for the wet-fractionation of cleaned bran into one protein rich fraction, which contains primarily proteins from the aleurone cells, a soluble hemicellulose fraction, a soluble oligosaccharide fraction and an insoluble fibre fraction. This invention further aims at the fractionation of cleaned bran by combining wet-milling and enzymatic hydrolysis specifically with food grade xylanases and/or beta-glucanase under well-controlled conditions of temperature, such as i.e. from 35 to 80° C., more preferably from 40 to 50° C., and pH from 4 to 7, preferably 4.5 to 5.5. Nowhere during the degradation of the bran and bran components pH exceeds 7.5 as alkaline hydrolysis seems to have a detrimental effect on the fractionation and the end products. A further effect of the present invention is that the end products will contain no, or substantially no starch, starch derivates, or starch fragments due to the primary hydrolysis using a starch hydrolysing enzyme treatment. This step is followed by the separation of insoluble fibre and protein fractions from aqueous suspension using centrifugal separation methods while both hemicellulose and oligosaccharide fractions are separated by size exclusion techniques such as ultrafiltration. Presently there exist no commercial enzyme-based methods for wet-fractionating of cereal bran, which is capable of extracting the above-mentioned fractions. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a set-up for carrying out a preferred embodiment of the invention. FIG. 2 shows the fractionation of the cereal bran in an over-view. DETAILED DESCRIPTION OF THE PRESENT INVENTION It has now surprisingly been shown possible to solve the problems identified above and meet the objectives by means of the present invention which is characterized in that bran is first subjected to a combination of enzymatic treatment with enzymes of the group starch- and optionally phytate-hydrolysing enzymes, and aqueous wet milling, followed by an optional step of enzyme inactivation by wet heat treatment, and a subsequent step whereby the insoluble phase containing a cleaned bran consisting of both pericarp and aleurone fractions are separated by centrifugal forces into an aqueous phase containing a germ-rich fraction and an aqueous phase containing residual endosperm components, and that the proteins contained in the endosperm-rich fraction are concentrated. In a preferred embodiment cereal brans are the fibrous-residue resulting from a primary grain milling, i.e. after the separation of the endosperm fraction, of wheat, rice, barley, oat, rye and triticale, and having variable chemical compositions, presence of anti-nutritive factors, and presence of various anatomical fractions, i.e. pericarp, germ, and residual endosperm. In a preferred embodiment the enzymatic treatment is accomplished using a starch degrading enzyme in the form of a polysaccharidase of amylases and/or amyloglucosidases. In a preferred embodiment a further enzymatic treatment is carried out using at least one non-starch degradable polysaccharidase in the form of cellulases, hemicellulases mainly xylanases, beta-glucanases, and pectinases, and/or phytases. In a preferred embodiment such cleaned bran is subjected to a combination of enzymatic treatment with specific enzymes of the group xylanase and/or beta-glucanase under strictly controlled hydrolysis conditions, and intermittent wet milling, followed by an optional step of enzyme inactivation by wet heat treatment. In a preferred embodiment the inactivated hydrolysate is then fractionated by centrifugal forces into an insoluble phase containing primarily cellulose, lignin, less accessible hemicellulose, residual aleurone cells and cell wall bound proteins, and an aqueous phase containing soluble hemicellulose, oligosaccharides, sugars and proteins, and that the aqueous phase is further separated by centrifugal force into protein-rich fraction and a carbohydrate-rich fraction, and that the carbohydrate-rich fraction is further separated by size exclusion technique into a hemicellulose-rich fraction (medium molecular size) and an oligosaccharide-rich fraction (small molecular size). In a preferred embodiment cereal bran substantially free of both in water or less polar solvents soluble compounds are derived from wheat, rice, barley, oat, rye or triticale. In a preferred embodiment the combination of intermittent wet milling with enzymatic treatment is arranged to increase substrate accessibility to the cell wall degrading enzymes thereby improving the overall hydrolysis performance and the subsequent separation of the various fractions by density/solubility and molecular size. In a preferred embodiment the enzymatic treatment is carried out using at least one non-starch degradable polysaccharidase in the form of cellulases, hemicellulases mainly xylanases, beta-glucanases, and pectinases, and optionally phytases. In a preferred embodiment the enzymatic treatment is accomplished by using xylanases with high beta 1-4-xylanase (pentosanase) and/or beta-glucanase activity. In a preferred embodiment the said fraction contains at least 35% protein and 10% oil on dry matter basis and exhibits a high emulsifying capacity and an increased shelf life with regards to resistance to oxidation compared to the original bran, and that the said fraction contains less than 5% fibre. In a preferred embodiment the said fraction contains at least 25% protein and 10% sugar and less than 3% oil and 3% fibre, and at least 25% soluble high-molecular weight non-starch polysaccharides of the groups beta-glucans for barley and oat and arabinoxylans for wheat, rice, rye and triticale. In a preferred embodiment liquid whey is incorporated in to the said fraction at levels varying from 20 to 80% by weight on dry matter basis, and that the final mixture is dried. A further aspect of the invention comprises an insoluble fibre fraction produced wherein the said fraction consists of cell wall components of bran (>85%) and aleurone proteins (>10%), and substantially free of gluten and starch, and with a high water holding capacity (>6 g water/g dry product). A still further aspect of the invention encompasses a sugar fraction wherein the said fraction is originated primarily from the residual endosperm and it contains more than 65% sugars (such as glucose, maltose and maltotriose) on dry matter basis. A further aspect of the invention encompasses a protein fraction derived substantially from the aleurone cells, wherein the said fraction contains at least 35% protein and 10% oil, less than 5% insoluble fibre on dry matter basis, substantially free of gluten and starch and with a high emulsifying capacity. A still further aspect of the invention encompasses an insoluble fibre fraction, wherein the said fraction consists primarily of cell wall components with a relative lower hemicellulose content compared to the original cleaned cereal bran, substantially free of gluten and starch (<1% on dry matter basis) and with a high water holding capacity (>6 g watering dry product). A further aspect of the invention relates to a soluble hemicellulose fraction, wherein the said fraction consists primarily of medium molecular weight hemicellulose preferably above 20 kDa (>40%) of the groups arabinoxylans from wheat, rye, rice and triticale, and beta-glucans from oat and barley, which also contains proteins (<10%) and monosaccharides (<10%), and is substantially free of gluten and starch (<1% on dry matter basis). A still further aspect of the invention relates to a soluble oligosaccharide fraction, wherein the said fraction consists primarily of low molecular weight hemicellulose sub-units of below about 20 kDa (>40%) of the groups arabinoxylans from wheat, rye, rice and triticale, and beta-glucans from oat and barley, which also contains proteins (<10%), monosaccharides (<20%), lignans and related phenolics (<5%), and is substantially free of gluten and starch (<1% on dry matter basis). A further aspect of the invention relates to a protein fraction, wherein the oil can be optionally removed by conventional organic solvent extraction or preferably by supercritical carbon dioxide extraction to yield an oil fraction and a defatted protein fraction. A still further aspect of the invention relates to a protein fraction, wherein the oil can be optionally removed by conventional organic solvent extraction or preferably by supercritical carbon dioxide extraction to yield an oil fraction and a defatted protein fraction. A further aspect of the invention relates to an insoluble dietary fibre used for recovery of cellulose, hemicellulose, lignin and lignans. A still further aspect of the invention relates to a germ containing sterols known to reduce the uptake of cholesterol in humans and intact vitamin E complex, sterols, lecithins, phospholipids and glycolipids. A further aspect of the invention relates to a defatted germ rich protein produced in accordance with the invention. A still further aspect of the invention relates to an aleurone-rich oil produced in accordance with the invention. A further aspect of the invention relates to a defatted aleurone-rich protein produced. A still further aspect of the invention relates to a protein fraction, wherein proteases are incorporated in to the said fraction in wet state and at controlled temperature and pH conditions, and the resulting protein hydrolysate has enhanced functionalities such as solubility, emulsifying and foaming capacities. A further aspect of the invention relates to a use of a protein fraction, as described in feed and food applications to replace other protein products from vegetable and animal sources. A still further aspect of the invention relates to a use of a protein fraction, as described, in food application as a texturizer, emulsifier, fat binder and fat replacer. A further aspect of the invention relates to a use of a protein fraction, as described, as a raw material for the extraction of soluble high-molecular weight non-starch polysaccharides. A still further aspect of the invention relates to a use of a protein fraction, as described, in food applications as a foam stabilising agent, whipping agent, water binder, gelling agent, and as a dietary supplement rich in soluble dietary fibre (beta-glucans and arabinoxylans) with associated health benefits such as cholesterol-reducing effects of the beta-glucans. A further aspect of the invention relates to a use of a protein fraction, as described, as an additive or ingredient in foods such as baked products, processed meats, dairy products, soups and sauces, high protein drinks and health drinks. A still further aspect of the invention relates to a use of a fibre fraction, as described, in feed and food applications to replace other insoluble fibrous products as a texturizing and water binding additive in processed foods particularly meat products, and as a source of dietary fibre in breakfast cereals, baked products and health products, or as a raw material for further processing to extract remaining cellulose, hemicellulose, lignin and lignans. A further aspect of the invention relates to a use of a soluble hemicellulose, as described, in feed and food applications as a gellant, thickener, foam stabilizer, emulsifier, water binder, and as a dietary supplement rich in soluble dietary fibre, and in chemical applications, or as a raw material for further processing to obtain other functional hemicelluloses. A still further aspect of the invention relates to a use of a soluble hemicellulose, as described, as an additive or ingredient in foods such as baked products, processed meats, dairy products, soups and sauces, high protein drinks and health drinks. A further aspect of the invention relates to a use of a soluble oligosaccharide, as described, in feed and food applications as a functional soluble dietary fibre or low calorie sweetener, or as a raw material for further processing to extract lignans and associated phenolics such as ferulic acid, or as a feedstock for industrial fermentation. A still further aspect of the invention relates to a use of a soluble oligosaccharide, as described, in confectionery formulations in combination with glucose or other sugar syrups and further concentrated to produce moisture stable products. A further aspect of the invention encompasses use of a soluble oligosaccharide, as described in claim 19 , in food and biomedical applications as a combined source of lignans and fermentable oligosaccharides for the conversion of lignans into active cancer-reducing agents such as enterolactones. A still further aspect of the invention relates to a use of a sugar fraction, as described, in feed, food and industrial fermentation applications as an energy source, flavouring agent and binding agent. A further aspect of the invention relates to a set up for carrying out the process, wherein it comprises a hydrolysis vessel, a wet mill, a heat exchange for enzymatic inactivation, decanters, a holding tank, an ultra-filter, and optionally at least an evaporator, and dryers. A still further aspect of the invention relates to a set up for carrying out the process, wherein it comprises a hydrolysis vessels, a wet mill, a heat exchange for enzymatic inactivation, decanters, a holding tank, an ultra-filter, and optionally evaporators, and dryers. In a further embodiment of the process of the invention, the enzymatic treatment is carried out at a pH of 4 to 7.5 and at a temperature of from 50 to 90° C., at an enzymatic activity of 200 to 1500 IU/g of substrate. In a further embodiment of the process the enzymatic treatment is carried out at a pH of 4 to 7, preferably 4.5-5.5, and at a temperature of from 35 to 80° C., at an enzymatic activity of at least 1 IU/g of substrate, preferably 200 to 1500 IU/g of substrate. DESCRIPTION OF THE PREFERRED EMBODIMENTS It is widely known and accepted that when cereals are milled with the purpose of producing flour the most nutritious part of the grain is diverted into the by-product, i.e. cereal bran. Despite the fact that cereal brans are rich in proteins, oils, vitamins and minerals its use in the food industry and high value feed industry is rather limited. There is now developed an industrial process, which makes possible the separation of fractions of different nature from various cereal bran, produce high value protein, soluble non-starch carbohydrates, and optionally oil fractions, and extract virtually all insoluble fibre as a separate fraction. The resulting low-fibre protein and sugar fractions as well as the insoluble fibre fraction have much broader market applications and greater value than the original bran. Various methods of extraction and fractionation of hemicelluloses from cereal brans have been developed in the past. Equally, various methods for the extraction of valuable proteins and insoluble dietary fibre from cereal brans have been disclosed. The problem is that when one combines the use of commercial cereal brans, which contain large quantities of soluble components such as starch, soluble proteins, pentosans, oils, etc, and a simple extraction process such solubles eventually become contaminants of the main product streams, and therefore have to be removed. This is a costly procedure and in many cases jeopardizes the market value of the non-hemicellulose components. By utilising previously cleaned bran as the preferred raw material, the inventors have overcome many important production constraints and created interesting opportunities to extract and separate new components from cereal brans. Furthermore, the inventors have developed a simple method in which wet milling is combined with enzymatic treatment using food grade commercial xylanases and/or beta-glucanases, and cheap industrial separation processes. Essentially, this invention allows one to economically produce fractions derived substantially from the germ, endosperm and aleurone cells, hemicellulose, oligosaccharide and insoluble dietary fibre. EXAMPLE 1 Wheat bran produced from short milling (SMB) and conventional milling (CMB) processes were used in this trial. Bran sample of 25 kg was transferred to a mixing tank and sequentially hydrolysed at temperatures varying from 70° C. at the first stage with α-amylase to 60° C. in the second stage with amyloglucosidase for a total hydrolysis time of 3 h. During this period the reaction mixture was intermittently wet milled to increase in surface area and dispersion of soluble components. The pH of the reaction mixture was set at neutral initially and then decreased down to 4.5 with acetic acid in the second stage. In addition of maximising the enzymatic activity the acidic pH allowed partial solubilization of the phytates present in the bran. At the end of the enzymatic hydrolysis and wet milling step the enzymes contained in the reaction mixture were inactivated by wet heating through a heat exchange and quickly cooled down to room temperature. The hydrolysed bran solution was then put through a two-phase decanter to separate the insoluble (fibre and aleurone fractions) from the soluble fraction. The soluble fraction was fed to a separator so that the heavy phase containing mostly the germ components could be separated from the light phase containing mainly components from the remaining endosperm found in the bran. The light fraction, which was contained high levels of sugar, was processed in an ultrafilter having a 50 kDa membrane in order to separate low molecular weight sugars and a protein fraction. All soluble protein fractions, i.e. heavy and light phases, were blended together and finally processed through spray drying. The sugar fraction was concentrated by vacuum evaporation at mild temperature (40 to 60° C.) until a 75% sugar concentration was achieved. The fibre fraction was dried in a conventional laboratory oven, but in an industrial process this can be carried out by a number of different dryers, i.e. tumble drier, ring drier, fine grinder, etc. Average chemical composition of the brans and their respective fractions are shown below in Table 1. TABLE 1 Dry Sample matter Protein Oil Fibre Ash NNE*** CMB* 90.8 15.7 4.1 45.4 5.5 29.3 CMB fractions of the process Protein phase 92.9 31.8 7.7 1.1 7.9 51.5 Fibre 92.8 13.6 3.0 76.9 4.1 2.4 SMB** 89.1 14.3 2.3 23.7 3.2 56.5 SMB fractions of the process Protein phase 93.9 27.8 1.5 0.9 3.4 66.4 Fibre 94.3 22.5 4.1 64.8 1.6 7.0 *Conventional milling bran **Short milling bran ***Non-nitrogen extracts EXAMPLE 2 Wheat bran produced from conventional milling was subjected to enzymatic treatment and wet milling as described in Example 1. The hydrolysed bran was fractionated using a two-phase decanter into an insoluble (combined fibre and aleurone) and a soluble fraction. The soluble fraction was fed into a separator for fractionation using centrifugal forces thus producing two phases. The germ-rich phase was washed with water and fed again to the separator to remove the excess solubles. The resulting protein fraction was kept as such or mixed with evaporated liquid whey on a 1:1 ratio (dry matter basis). The endosperm-rich wheat fraction, which contained high levels of sugar, was processed in to an ultrafilter in order to separate low molecular weight sugars and a protein fraction. All soluble protein fractions, i.e. germ and endosperm-rich phases and the mixtures with whey, were spray dried separately. The sugar fraction was concentrated by vacuum evaporation at mild temperature (t=60° C.) until 75°Brix was achieved. The fibre fraction was oven dried. The additional washing carried out on both germ-rich protein and fibre fraction was very effective to decrease the amount of light soluble contaminants from each fraction, and therefore increase the relative content of valuable components. Compositional data indicates that germ and endosperm-rich protein fractions have a different relative content of protein and oil. Protein and oil content from the former were 48.6 and 18.6%, respectively and those from the latter were 28.7% and 1.5%, respectively. The insoluble phase containing primarily the bran pericarp (fibre) and the aleurone proteins had 86.4% fibre and 12.6% protein. The chemical composition of the germ-rich phase—whey mix was 31.5% protein, 9.8% oil and 37% lactose. A further important observation was that the spray dried germ-rich fraction containing 18.6% oil was substantially more resistant to oxidation (rancidification) compared to the original wheat bran. The original wheat bran started getting rancid after 3 weeks of storage. Despite the fact that no exogenous anti-oxidants were added to the germ-rich fraction it only started going off after 12 weeks of storage. EXAMPLE 3 Previous examples illustrate the use of starch-hydrolysing enzymes and wet milling followed by various separation steps in order to yield both protein, sugar and fibre fractions, the latter still containing substantially high amounts of aleurone proteins. It could be of interest for same applications to separate, at least partly, the aleurone proteins from the bran pericarp (fibre) and recover such proteins in the same fraction as the endosperm-rich fraction for instance. A trial was set up in the same way as described in EXAMPLE 2, except that a cocktail of polysaccharidases containing both high cellulase and xylanase activities was added together with the amyloglucosidases, and let to work for 3 h. Temperature and pH conditions were kept unchanged. The resulting reaction mixture was further treated exactly as described in EXAMPLE 2. The inclusion of polysaccharidase during the hydrolysis step had a positive effect with regards to aleurone protein extraction and protein recovery as measured by the mass balance and protein content. The protein content in the endosperm-rich fraction increased from 28.7% (without polysaccharidases) to 34.7% (with polysaccharidases) and the overall protein recovery was increased by 35% when polysaccharidase was added. EXAMPLE 4 The colour of protein ingredients can be of importance particularly in some food and feed applications. Milk products such as caseinates, whey powder and whey protein concentrate has a light colour and soy protein concentrate have a light brown colour. These products are the main ingredients in high value feeds such as calf milk replacer. But, in same food applications such as sausage and hamburger despite the fact the inclusion level is much lower, colour can still play an important role in the product acceptability. The technical feasibility of bleaching the germ-rich fraction was assessed by two means. 1. Solely alkali and hydrogen peroxide bleaching, and 2. Alkali-free peroxidase and hydrogen peroxide bleaching. 1. 10 (ten) g samples of germ-rich fraction were incubated in 1 L beakers containing 100 ml water. Samples were dispersed with stirring and ca. 0.25 ml NaOH added until pH 12 was reached. Solutions were warmed at 50° C. and 3.5, 5 and 10 ml of 30% H 2 O 2 were added to different flasks to provide uptake levels 10, 15 and 30% H 2 O 2 on weight basis of germ-rich fraction. Mixtures were stirred for 1 h and neutralise with acetic acid. Full bleaching was achieved with 15 and 30% H 2 O 2 . Sample treated with 10% H 2 O 2 was only partly bleached. All alkali bleached samples became darker with drying. 2. 10 (ten) g sample of germ-rich fraction was incubated in 1 L beaker containing 100 ml water. Samples were dispersed with stirring and ca. 0.25 ml NS 51004 Novozymes per-oxidase was added. Solution was warmed at 50° C. and 3.5 of 30% H 2 O 2 was added to the flask, i.e. 10% H 2 O 2 on weight basis of germ-rich fraction, and the mixture stirred for 2 hrs. The peroxidase—hydrogen peroxide bleaching was effective, consumed less chemicals and no darkening of the sample was observed after drying. EXAMPLE 5 Amongst the various end-uses of the germ-rich fraction of EXAMPLES 1-4 one could describe meat products such as hamburgers, sausages and meatballs. In such end-uses germ-rich fraction could replace meat, soy protein concentrate and isolate, but also milk casein and caseinates, to mention just a few. It is therefore important to test the overall performance of the germ-rich fraction with regards to emulsifying and binding capacity, taste, etc. A trial set up to test the feasibility of incorporating various germ-rich fractions extracted from wheat bran into a traditional meat ball recipe consisted of meat, garlic, premix and water. The following spray dried fractions were tested: Germ-rich fraction extracted from short milling wheat bran—(I) Germ-rich fraction extracted from conventional milling wheat bran—(II) 1:1 mix of whey and II, on dry matter basis—(III). Meatball recipes were tested without germ-rich fraction (control recipe) or with 2.5% inclusion of samples I, II or III. Meatballs were analysed for weight loss, taste, texture and colour after frying. The results are described in the table 2 below. TABLE 2 Weight loss after frying Recipe tested (%) Colour Texture Control (meat, garlic, 23.4 Reference Reference premix and water) Control + 2.5% of I 21.3 Slightly Slightly tougher darker Control + 2.5% of II 20.8 Similar Similar Control + 2.5% of III 18.0 Similar Slightly more tender The overall conclusion was that the samples performed well as additives in a meat ball recipe, and were particularly interesting as they all decreased the weight loss after frying. EXAMPLE 6 Laboratory scale trials were carried out on cleaned wheat bran to test extraction rates using xylanase treatment. The cleaned wheat bran used as a raw material contained less than 1% starch and at least 50% and 70% of the protein and oil, respectively, originally found in the starting material had been removed. Ten (10) g of cleaned bran were incubated in 150 ml water, the pH adjusted to 5.5 with acetic acid and an enzyme cocktail containing pentosanase and hemicellulase activities was added at the following concentrations: 0 (control), 0.1, 0.25, 0.5, 1 and 2% (w/w basis). Reaction mixtures were kept at 40° C. for 120 min. The treatment was terminated by inactivating the enzymes at 80° C. for 30 min. Results indicated relatively high extraction rates compared to the control treatment (no enzyme added) despite the amount of enzyme used. Extraction rates of 3.1, 32.0, 32.8, 33.1, 33.8 and 34.2%, respectively, were obtained from control, 0.1, 0.25, 0.5, 1 and 2% treatments, respectively. EXAMPLE 7 A similar trial to that described above was carried out with a purified endo 1,4-beta xylanase (pentosanase) at two levels of inclusion: 0.25 and 0.5% (w/w basis). Extraction rates were also high, and increased from 3.1 (control treatment—no enzyme) to 28.6 and 26.1%, when 0.25 and 0.5% pentosanases were added, respectively. EXAMPLE 8 Cleaned bran with the same specification as described in Examples 6 and 7 was used in a large-scale trial. The objective was to validate a process using standard industrial equipments, quantify process parameters, determine extraction rates of the various fractions, and ultimately characterize the end products. Cleaned bran (80 kg) was incubated in hydrolysis tanks containing 500 L water. The pH was adjusted to 5.5 and a purified endo 1,4-beta xylanase (pentosanase) was added at 0.5% (w/w basis). The reaction mixture was continuously stirred and intermittently wet milled while kept at 40° C. for 90 min. The hydrolysis/wet milling treatment was terminated by heating up the reaction mixture to 90° C. for 2 min in a heat exchange device. The inactivated hydrolysate was pumped through a commercial two-phase decanter where the insoluble phase (insoluble dietary fibre) was separated from the solubles. The insoluble phase was dried and further milled in a commercial fine grinder using indirect heat. The solubles were then pumped through another two-phase decanter where a heavy phase (aleurone protein-rich fraction) was separated from a light phase containing the extracted hemicellulose fraction in the form of both soluble hemicelluloses and oligosaccharides. The protein-rich phase was spray dried. The hemicellulose fraction was further separated by size exclusion using an ultrafiltration unit whereby the large molecular size fraction (soluble hemicellulose) was separated from the small molecular size fraction (oligosaccharides and sugars). The resulting fractions were further processed by spray drying into a fine powder or alternatively evaporating the excess water until 25% water content was achieved. The following yields of insoluble dietary fibre, hemicellulose, oligosaccharides and protein-rich fractions were obtained from cleaned wheat bran: 51.0, 26.1, 17.3 and 7.7%, respectively. EXAMPLE 9 An insoluble fibre fraction extracted according to the procedure described in Example 8 was characterized with focus on its potential use as a source of dietary fibre and texturizer in food applications. Typical composition was as following: dry matter 95%, cell wall components 75%, protein 11%, soluble sugars 3% (of which at least 75% is glucose), fat 4% and minerals 1.5%. The water holding capacity (WHC), of primary importance when assessing the usefulness of insoluble dietary fibres, of the above-described product was 8.6 g of water/g sample on dry basis. For comparison purposes the WHC of wheat bran in the range of 3.5 g/g and that of cleaned wheat bran is 7.5 g/g. This indicates the improved water absorption of the fibre after cell wall components have been partly removed. Other commercial dietary fibres extracted from wheat straw and sugar beet have WHC of 6.3 and 7.9 g/g, respectively. EXAMPLE 10 The protein fraction, which contains substantial amounts of aleurone proteins, produced as described in Example 8, have a very interesting chemical composition, functionality and is an Ideal raw material for further processing. A typical composition of the protein fraction is: dry matter 98%, protein 40%, sugar 3%, fat 18%, non-sugar carbohydrates 32% and minerals 5%. In order to determine the effect of protease treatment on the functionalities of the protein fraction, a protein sample was subjected to a mild protease treatment and the samples analysed for dry matter and protein solubility, emulsifying capacity and emulsifying stability. The results are shown in Table 3, and clearly indicate the possibilities to further improve some important functionalities of the protein fraction. TABLE 3 Protein fraction treated Parameters analysed Protein fraction with protease Dry matter solubility (%) 19.7 38.1 Protein solubility (%) 18.4 55.5 Emulsifying capacity (%) 52.5 90.6 Emulsifying stability (%) 47.5 86.0 CHARACTERIZATION & END-USES Germ-Rich Fraction The high protein content of the germ-rich fractions makes it an ideal substitute for existing expensive proteins from animal and vegetable origin. Additionally, the germ-rich fraction because of the nature of its protein, the presence of high quality oil, phospholipids and sterols also exhibit interesting functionalities such as emulsification, texture and binding, and health benefits associated with cholesterol control in humans. One can list, as examples, the following existing products, which can be replaced by the germ-rich fraction in the food industry: Animal protein: casein and caseinates, plasma protein and egg white Vegetable proteins: soy protein concentrates and isolates, texturized soy, hydrolysed gluten and potato protein. Generally, the above products can be used as meat extenders and texturizer ingredients in hamburger, sausage, and meat balls production to mention a few. The products can be used as a casein replacer in the production of sausage, spreads, dressings, etc., as well. In the feed industry, the germ-rich fraction is an ideal ingredient for high value feeds such as calf milk replacer, starter feeds for calves, piglets and chicks, fish feeds and pet food. In food applications it can substantially replace the use of soy proteins (texturized soy, concentrate and isolate), potato protein, hydrolysed gluten, high quality fishmeal, plasma protein, and dry milk products such whey protein concentrate, whey and skimmed milk. The germ rich protein is of great interest as a functional food ingredient, especially in the case of rye, primarily because it contains rye germ oil. Endosperm-Rich Fraction This protein fraction is mainly derived from the residual endosperm proteins in cereal bran. It contains 25-40% protein, much of which is highly soluble. It is also particularly rich in soluble dietary fibre pentosans (>35%), has a high water holding capacity and has a light colour. The endosperm-rich fraction can be used in the food industry in baked products, processed meats, dairy products, soups and sauces, high protein drinks and health drinks. It is a valuable source of non-starch polysaccharides, which are excellent soluble dietary fibre and water-binding materials. In feed applications, it can partly replace gluten, soy and milk proteins as an ingredient to calf milk replacer, piglet started feed and fish feed. The emulsifying, water binding and foam stabilising properties are equivalent or better than those of other commercial proteins like caseinates, soy protein concentrate and modified wheat gluten. The endosperm-rich protein is very suitable to be used as an ingredient in milk replacer formulae (both for humans and calves), sauces, mayonnaise, dressings etc. Because it contains high amounts of pentosans and associated ferulic acid there are extra health and functional benefits. In the cosmetic industry the stabilising, emulsifying and water holding properties are ideal. A combination of the endosperm rich protein and soluble hemicellulose is interesting in a number of food and biomedical applications, because of the emulsifying effect of the endosperm rich protein and the soluble pentosans and the thickening effects of the soluble hemicellulose. The endosperm-rich fraction is high in pentosan hemicelluloses, mainly arabinoxylans in rye and wheat, or beta-glucans in the case of oat and barley. The claimed health benefits are therefore as described for arabinoxylans and beta-glucans (see below). Aleurone-Rich Fraction This is the protein that is derived primarily from the aleurone cell layer and is both a functional and nutritionally valuable material, rich in essential amino acids. In the food business it would be used as an emulsifier, foam stabilizer and texturiser. In addition there is high potential as a protein supplement. Insoluble Fibre Fraction The insoluble fibre fraction can be used as an interesting source of fibre in food applications. The main end-uses as food would be as a texturizing and water binding additive in processed foods particularly meat products, and as a source of dietary fibre in breakfast cereals, baked products and health products. Specifically the high water binding capacity and beneficial effect on bowel function makes it an interesting product for the biomedical market. This is the remaining fibre after the soluble components (first step process) and a proportion of hemicellulose (second step process) has been removed from cereal bran. The insoluble fibre fraction is a cleaned cereal fibre containing low levels of phytic acid. Because the fibre has already been partially “digested” enzymatically, many beneficial compounds derived from the cell wall are available to the gut for absorption. The insoluble fibre has high water binding capacity, i.e. typically 100% higher than that of wheat bran. This provides increased gut transit (digesta flow). The remaining pentosans are more accessible to the gut wall (cholesterol reducing) due to the fractionation process. Because of the increased availability of lignin type materials and other antioxidants within the fibre, various health benefits can be claimed. Specifically the lignans and polyphenolics from rye are known to mimic estrogens (female hormones), and more recently have been found to help preventing various types of cancers. This has been verified for rye products. Additionally the insoluble fibre is also a good raw material for the further extraction (enzymatically) of lignins, ferulic acids, lignans etc., which are natural antioxidants and potential anticancer agents. These can be used in many biomedical and “cosmetic pharmaceutical” applications such as lotions, creams and moisturizers. The ferulic acid is an effective UV absorber and as such can be used in a sunscreen. Insoluble dietary fibres are rich in accessible lignans and residual pentosans/hemicelluloses. Bacteria present in the colon convert plant lignans to mammalian lignan, enterolactone, using hemicelluloses as a fermentation medium. These compounds mimic estrogens and appear to have a tangible, demonstrable effect on the suppression of hormone related cancers, e.g., breast, ovarian and prostrate cancers. Rye insoluble dietary fibre specifically contains the lignans secoisolariciresinol (SECO) and matairesinol (MAT), which are known precursors of enterolactone. The insoluble dietary fibre from wheat also contains these lignans, but the effect is not demonstrated in wheat. It is important to state that in this fraction the lignans are supplied in an accessible form, as the cell wall is already partially enzymatically digested, along with their natural synergistic partners, the arabinoxylan hemicelluloses remaining on the fibre. Sugar Fraction This is the glucose produced from enzymatic degradation of residual starch of the bran and is a more pure product compared to molasses. It can be used in feed and food applications as an energy source, flavouring agent and binding agent. Alternatively, it is ideal as a feedstock for industrial fermentation since it produces fewer waste products. Ethanol and citric acid industries are therefore ideal consumers of very large quantities of such a product. The production of single-cell protein for the feed and food markets can also be considered. Soluble Hemicellulose This is the major cell wall non-cellulose polysaccharide in cereal bran. It can be produced with a medium to high molecular weight and high solubility (the combination of these two properties is the powerful aspect). Because the product is a pentosan (arabino-xylan) it is low calorie and beneficial for gut health. The product can be produced with or without ferulate side chains or free ferulic acid and other antioxidants and is a free flowing cream powder. Due to its composition and high water binding capacity it is ideal to use as a thickener, gellant, stabilizer, soluble dietary fibre and fat replacer. A non-gellant form of soluble hemicellulose can also be produced. As a thickener and gellant it is interesting in the food industry as an additive in soups, margarine, deserts, pâtés, sauces etc. As a stabilizer it is a cheaper alternative or modified starch (made from wheat, maize etc), modified cellulose, gums (guar gum and carrageenan gum), alginates (seaweed), gelatin (cheap but problem with BSE) and pectin (fruit peel & sugar beet). Finally, it has a good potential in drinks because it is an excellent source of soluble dietary fibre alongside its stabilizing properties. It is possible to supply the pentosan with ferulate side chains, and in this form the substance will gel in combination with oxygen and enzyme. As such it is an interesting material, for example, for wound dressings as it will keep the skin in a hydrated state and therapeutic agents can be added. From rye and wheat, this is almost exclusively arabino-xylan (pentosan) hemicellulose. This is readily fermented in the colon, is low calorie to the human and is reported to generate butyrate as a short chain fatty acid (SCFA) end product after fermentation. This is the most “healthy” SCFA according to recent studies as it is a preferred source of energy to epithelial cells lining the colon. The health benefits of adding an enriched, available source of arabinoxylan to the diet may therefore be far-reaching. This fraction is a perfect soluble dietary fibre, with all of the concomitant health benefits. Arabinoxylans are also thought to be excellent binding sites for secondary bile acids, as a consequence of the rigidity of parts of the molecular chain and the occurrence of relatively hydrophobic domains on the polymer. This is thought to reduce any potential carcinogenic effects. In addition, this fraction contains ferulic ester side chains to a proportion of the polymer, with concomitant free radical stabilising and anti-oxidant properties. It is important to emphasise that the arabinoxylan concentrated in this fraction is not normally available to the gut and colon if presented as a part of a normal diet or even from conventional bran. In oat and barley, this fraction is rich in beta-glucan with all of the documented beneficial effects of this polysaccharide. There is a tangible benefit in supplying a concentrated beta-glucan of this nature as the normal ingestion of oats does not supply sufficient material for the full effects to be realised. Purified beta-glucan can be purchased but is very expensive because of the extensive purification regime. It is important to realise that this high purification is required to remove the chemicals utilised in the extraction process. It is suspected that natural synergistic partner compounds are removed in such a process, whilst these materials should still be present in the present process fraction. Oligosaccharide Syrup This is derived from the hemicellulose fraction and is a 100% soluble dietary fibre of low molecular weight and low viscosity. The oligosaccharide syrup can be produced with lignans, ferulic acid and other antioxidants and is extremely soluble and hygroscopic. It has a high potential in the drinks industry as it has low viscosity, is a good source of dietary fibre and gives good mouth feel and texture. In combination with glucose syrup it could be used as a sweetener and energy source for drinks, cereal bars etc. As it is rich in ferulic acid, pentosans and solubilised lignans, one can also claim the related health benefits. It is very important to supply lignans in the presence of pentosan oligomers if the full cancer prevention effect is to be expressed and realised: precisely the situation in this fraction. The combination of glucose syrup and oligosaccharide syrup is also ideal in applications where one requires increased dietary fibre content and increased water binding capacity without thickening. Soluble oligosaccharide can also be used in confectionery formulations in combination with glucose or other sugar syrups and further concentrated to produce moisture stable products. The oligosaccharide syrup is the low molecular weight fraction of the solubilised arabinoxylans along with other low molecular weight components solubilised from the cell wail. This includes dissolved lignin fragments, phenolic compounds such as ferulic acid and lignans. As with the insoluble dietary fibre, the presence of lignans with arabinoxylan gives rise to claims for cancer preventative roles for rye and wheat derived fractions. In this case, the arabinoxylans are present as oligomers and the lignans are very available in the syrup with a potential high accessibility for the gut. This should increase the rate of conversion of the plant lignans to enterolactone with a potentially larger impact on cancer prevention. Furthermore, the presence of high concentrations of oligomeric arabinoxylan provides a ready fermentation substrate for the production of beneficial SCFAs such as butyrate, with benefits as described for the hemicellulose fraction. This fraction, especially in the case of rye, is probably the most interesting in the present context being an excellent source of arabinoxylans, lignans and phenolic antioxidants in very accessible forms along with relevant synergistic partner compounds. In oat and barley, it is a good source of low molecular weight beta-glucan fragments. Germ Oil The germ oil is derived from the germ rich protein and is a high quality food grade oil and ingredient. It can be extracted without using any solvent, and it contains no preservatives or additives. It is a good source of poly and mono unsaturated fat, has a good flavour, is rich in vitamin E and can be suspended easily. As a flavouring component it is good in wheat or rye based products (cereals, baking goods, biscuits etc), deserts, ice creams etc. It can also be useful as an ingredient in fat and oil formulations, juices etc. with natural vitamin E. Rye germ oil is particularly rich in naturally occurring β-sitosterol, a cholesterol lowering compound and tocotrienol, a cholesterol “burner”. These materials can be classified as “natural synergistic partners”, an important factor in the functional food area. This massively increases the potential of the oil as a value-added neutraceutical ingredient in foods such as margarines and spreads. Germ oil is also a good UV blocker and therefore together with ferulic acid it can be ideal as a component of a sun tan lotion. Its emulsifying properties make it very suitable as an emulsion stabilizer and as an emollient ingredient for skin creams. Defatted Protein Fractions This is the protein that remains after the oil has been extracted from full fat germ- and aleurone-rich fractions and has at least 60% protein content. It is also a good functional protein, has an extremely high fat binding capacity and can be easily upgraded enzymatically to increase solubility, emulsion and foam stabilisation properties. The product is an excellent stabiliser for water in oil emulsions and is interesting as a meat texturiser or extender in sausages, burgers, patées etc. The defatted protein fraction is a functional protein that can easily replace soya proteins and contains phospholipids, natural lecithins and glycolipids. It has a high potential in cosmetic formulation as an emulsion stabiliser because it contains natural lecithins. One preferred embodiment of a plant for carrying out the invention on cereal bran is shown in the attached drawing, wherein FIG. 1 shows a set-up for carrying out a preferred embodiment of the invention; and FIG. 2 shows the fractionation of the cereal bran in an over-view. One preferred embodiment of a plant for carrying out the invention related to separation of cereal bran or cleaned cereal bran is shown in the attached drawing, FIG. 1 wherein 1 denotes a suspension and hydrolysis vessel to which a wet mill 2 is connected. The reaction mixture is intermittently pumped through the wet mill 2 (from 1 to 3 times). The hydrolyzate is then optionally inactivated in a heat exchange 3 and transferred to a two-phase decanter 4 , which decanter 4 separates the insoluble (insoluble fibre) from the soluble phase. The insoluble phase having a dry matter content of about 35% is dried to approximately 95% dry matter in a ring drier 5 . The soluble phase, having a dry matter content of approximately 3%, is pumped through another two-phase decanter 7 , or optionally a separator, via a holding tank 6 , in which two-phase decanter 7 protein-rich fraction is separated off. The protein-rich fraction is optionally enzymatically treated for improved functionality in hydrolysis vessel 8 , and then dried to about 95% dry matter in spray drier 9 . The soluble (liquid) phase from the two-phase decanter 7 , having a dry matter content of approximately 3%, is allowed to pass an ultra filter 10 having a molecular cut between 20 and 100 kD, preferably between 20 and 50 kD, which will depend on different product requirements. The retentate (fraction retained in the ultrafilter) from ultrafilter 10 is optionally enzymatically treated for improved functionality in hydrolysis vessel 11 , and then dried to about 95% dry matter in spray drier 12 or optionally evaporated to a syrup concentration of at least 75% solids in an evaporator. The permeate fraction (not retained in the ultrafilter) from ultrafilter 10 is preferably evaporated to a syrup concentration of at least 75% solids in an evaporator 13 .

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62/114,166, filed on Feb. 10, 2015, entitled “HEADREST TILT MECHANISM.” This application also claims the benefit of U.S. Provisional Application No. 62/055,771, filed on Sep. 26, 2014, entitled “HEADREST TILT MECHANISM”. The teachings of U.S. Application Nos. 62/114,166 and 62/055,771 are hereby incorporated by reference in their entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. TECHNICAL FIELD Embodiments of the present invention relate to headrest mechanisms, and particularly to headrest mechanisms for use on reclining seating units. BACKGROUND OF THE INVENTION Conventional recliner chairs typically incorporate mechanisms to move the chair into three basic positions: closed, with the footrest retracted and the back generally upright, a “TV position” with the footrest extended and the back generally upright, and reclined, with the footrest extended and the back in a reclined position. One feature that may add to the comfort of users of these conventional recliners is a moveable headrest. The moveable headrest feature allows the head portion of the chair back to pivot with respect to the remainder of the back. This may increase the comfort of a person, especially in the reclined position, as rotation of the headrest provides supports the head of the user and can be adjusted to the most-comfortable position. While moveable headrests have been provided, it is desirable to provide a simplified structure, capable of installation on any number of styles of chairs, while still providing the adjustment needed to enhance the comfort of those using the chair. BRIEF DESCRIPTION OF THE INVENTION A simplified headrest tilt mechanism is disclosed that is operable to move a headrest portion of a chair back between a closed position generally in line with a chair back, and an open position in which the headrest is pivoted with respect to the chair back. Additional objects, advantages, and novel features of the invention will be set forth in part in the description that follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS The present invention is described in detail below with reference to the attached drawing figures, wherein: FIG. 1 is a perspective view of an exemplary headrest tilt mechanism in a closed position, with only a portion of a chair frame shown for clarity, in accordance with an embodiment of the invention; FIG. 2 is a perspective view similar to FIG. 1 , from a different angle; FIG. 3 is a perspective view similar to FIG. 1 , with the mechanism in an open position, and with the back frame post removed to show the pivot point; FIG. 4 is a perspective view similar to FIG. 3 , but showing the release mechanism in a released condition; FIG. 5 is an enlarged view showing the relationship of the motor slide hinge, the motor slide bracket and the cam; FIG. 6 is a perspective view showing an embodiment using a different motor; FIG. 7 is a view similar to FIG. 6 , from a different angle; FIG. 8 is a perspective view of an exemplary headrest tilt mechanism in a closed position, with only a portion of a chair frame shown for clarity, in accordance with a different embodiment of the invention; FIG. 8A is an enlarged view of a portion of FIG. 8 to show particular details of construction; FIG. 9 is a perspective view of the headrest tilt mechanism of FIG. 8 , with additional parts removed for clarity; FIG. 10 is a perspective view of the headrest tilt mechanism of FIG. 8 , shown in the open, or tilted, position; FIG. 11 is a view of the headrest tilt mechanism of FIG. 10 , shown as a perspective view from a different angle; FIG. 12 is a perspective view of one side of an exemplary headrest tilt mechanism in a closed position, with only a portion of a chair frame shown for clarity, in accordance with a different embodiment of the invention; FIG. 13 is a view of the headrest tilt mechanism of FIG. 12 , shown from a different angle, and with portions shown as “see through” for clarity; FIG. 14 is a side view of FIG. 13 ; and FIG. 15 is a perspective view of an exemplary headrest tilt mechanism in a closed position, with only a portion of a chair frame shown for clarity, in accordance with a different embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION Embodiments of the present invention generally relate to a moveable headrest or head tilt mechanism for use on a recliner chair or other item of furniture. With initial reference to FIG. 1 , an exemplary headrest tilt mechanism 10 is shown that moves the head portion of the chair between the closed position, shown in FIGS. 1 and 2 , to the open position, shown in FIG. 3 . The mechanism 10 is installed into the chair by mounting it to a back frame post 12 that forms the frame for the back of the chair. Only one back frame post 12 is shown in the figures for clarity, but in practice, a second back frame post will be present to support the other side of the chair back. Only a portion of the chair frame is shown, but those with skill in the art would readily understand that back frame post 12 forms only a part of the entire chair frame. Mechanism 10 is mounted to back frame post through a back post spacer block 14 . Block 14 is rigidly secured to the inner face of the back frame post 12 . A back bracket 16 is then rigidly secured to the back post spacer block 14 , such as by screws or bolts, although other methods of attachment would work. Back bracket 16 extends forwardly and upwardly. A stop 18 is either formed in, or coupled to, back bracket 16 at the lower end of the back bracket 16 . A headrest tilt 20 is pivotally coupled to the upper end of back bracket 16 at pivot 22 (as shown in FIG. 3 ). Headrest tilt 20 is shaped as shown with an upwardly extending leg 24 and an inwardly extending leg 26 . As shown, there are two headrest tilts 20 , one a minor-image of the other. A top connector tube 28 is coupled to each inwardly extending leg 26 to secure the two headrest tilts 20 together. The connector tube 28 may include a series of spaced holes along its length to allow for width changes in the chair back to which mechanism 10 is attached. A back insert 30 is coupled between the upwardly extending legs 24 of the headrest tilts 20 . The back insert 30 is a rigid frame that, in practice, will be finished with support, padding and a cover. A bottom bracket 32 is coupled to the back frame post 12 , spaced downwardly from back bracket 16 . As shown, the mechanism 10 includes two bottom brackets 32 , each a minor-image of the other. A bottom connector tube 34 is rigidly secured to each bottom bracket 32 and forms a lower brace for the mechanism 10 . More specifically, a clevis 36 is coupled to the connector tube 34 such as by bolts, rivets or welding. The shaft 38 of a motor 40 is then pivotally coupled to the clevis 36 . The motor shown in the figures could also be any other type of motor, linear actuator or gas spring, capable of the movements described below. The upper end of motor 40 is pivotally coupled to back area of a motor slide hinge 42 at pivot 44 . Motor slide hinge 42 has an upper surface with a locating notch 46 , as best seen in FIG. 5 . Additionally, motor slide hinge 42 includes a retaining finger 48 that extends upwardly. The retaining finger 48 operates to prevent the mechanism geometry from entering an over-center condition, retaining the stop pin 54 in the desired area. The forward area of motor slide hinge 42 is pivotally coupled to a motor slide bracket 50 at pivot 52 . Motor slide bracket 50 is generally L-shaped. One leg of the L is pivotally coupled to the motor slide hinge 42 . The other leg of the L is rigidly secured to the adjacent inward leg 26 of the headrest tilt 20 through connector tube 28 . A stop pin 54 is rigidly secured to the motor slide bracket 50 . Stop pin 54 is located to correspond with the notch 46 in the motor slide hinge 42 . At least one of the inward legs 26 (or the top connector tube 28 ) is connected to at least one of the bottom brackets 32 (or the bottom connector tube 34 , or the back post 12 ) with an extension spring 56 . Spring 56 biases the mechanism 10 to the closed position shown in FIG. 1 . The motor 40 is sized to overcome this spring force to move the mechanism 10 from the closed position to the open position. More specifically, if a user desires to move the mechanism from the closed position of FIG. 1 to the open position of FIG. 3 , he or she will engage the motor 40 . While not shown, the motor 40 is operably connected to a switch or control that is operable by the user. The control for the motor 40 may be separate from, or integrated with, other controls associated with the chair. The shaft 38 of the motor extends, overcoming the biasing force of spring 56 and causing an upward force at pivot 44 . This upward force moves the motor slide hinge 42 upwardly. As the motor slide hinge 42 moves upwardly, the stop pin 54 is rotated rearwardly and upwardly, caused by the upward force of motor slide hinge 42 and the pivot point 52 . This movement also results in the corresponding movement of the motor slide bracket 50 . The rotation of the motor slide bracket 50 operates to rotate the headrest tilt 20 about pivot 22 . So, the motor 40 is used to provide selected adjustment of the angular position of the headrest tilt 20 with respect to the back frame post 12 . To move the headrest tilt to the closed position, the motor controls are used to retract the shaft 38 , and the spring 56 operates to pull the headrest tilts 20 to the closed position, until the headrest tilt 20 abuts stop 18 . Another feature of the mechanism 10 is the release configuration. As the headrest tilts 20 are moving to the closed position, objects may have moved into place behind the back insert 30 . If an object is present, the pivotal coupling of the motor 40 , motor slide hinge 42 and motor slide bracket 50 cooperate to allow the motor 40 to continue to operate, without imparting continued force to the rotation of the headrest tilts 20 . More specifically, if an object is behind the back insert 30 , it will operate to block movement of the headrest tilts 20 , effectively preventing rotation about pivot 22 . The motor 40 can continue to operate, moving pivot 44 downwardly. With the headrest tilts 20 prevented from movement, the motor slide bracket 50 will remain in place. The motor slide hinge 42 is still allowed to move, pivoting about pivot 52 . This effectively moves the motor slide hinge 42 away from the stop pin 54 , as seen in FIG. 4 . The only remaining force acting against the object behind back insert 30 is imparted by the spring 56 . The mechanism 10 has been described above in a “frame-within-a-frame” environment. In other words, the back insert 30 nests within or between the back frame posts 12 . The mechanism 10 could also be used in an environment where the back frame posts 12 extend only to approximately the area of pivot 22 , with the back insert configured to extend essentially across the width of the chair on which it is placed. An embodiment of the mechanism 10 showing the use of a different motor 40 A is shown in FIGS. 6 and 7 . The clevis 36 A is configured differently from clevis 36 to accommodate the motor 40 A. The remainder of the components of mechanism 10 is the same. As noted above, other motors, gas springs, or linear actuators could also be used in mechanism 10 . As would be understood by those in the art, each different motor, gas spring or actuator may require slight modification in the mounting arrangement. A different embodiment of the mechanism 10 showing a slightly different configuration is shown in FIGS. 8-11 . With initial reference to FIG. 8 , the mechanism 10 is again mounted between a back frame post 12 and a back insert 78 . More specifically, a motor bracket 60 is coupled to the frame post 12 , such as by bolts, adhesives or screws, although other attachment mechanisms could certainly be used. Bracket 60 extends inwardly from the frame post 12 and has an upwardly extending tab that is coupled to a clevis 62 of a motor 64 at pivot 66 . The opposite end of motor 64 has an extending shaft 68 that is pivotally coupled to a motor slide hinge 70 at pivot 72 . Motor slide hinge 70 is shaped as shown and has a retaining notch 82 , as best seen in FIG. 8A (similar to retaining notch 46 of FIGS. 1-5 ), and a retaining finger 84 (similar to retaining finger 48 of FIGS. 1-5 ). The motor slide hinge 70 is pivotally coupled to a back bracket 74 at pivot 76 . Although not shown, the pivotal coupling can be made with a bolt, rivet or other pivotal attachment mechanism. Near this pivotal coupling, a cam 80 is fixed to the back bracket 74 . The cam 80 generally rests within the retaining notch 82 . The upper end of the back bracket 74 is fixedly coupled to the back insert 78 , such that movement of the back bracket 74 results in movement of the back insert 78 . As best seen in FIG. 9 , the back bracket 74 is pivotally coupled to a side bracket 86 at pivot 88 . Note that side bracket 86 has an unused hole spaced from pivot 88 . Having two holes positioned in this location and geometry allows side brackets 86 to be used as either left-side or right-side interchangeably. With continued reference to FIG. 9 , a locating stop 92 is coupled to back bracket 74 and protrudes outwardly toward side bracket 86 . In the closed position, stop 92 rests within a notch 94 in side bracket 86 . As best seen in FIG. 9 , a side bracket 86 and a back bracket 74 are used to pivotally couple back frame post 12 to back insert 78 on the side opposite motor 64 . A spring 96 extends from back bracket 74 to a mounting tab 98 coupled to back frame post 12 . The operation of the mechanism 10 shown in FIGS. 8-11 operates substantially similarly to the operation described with respect to FIGS. 1-5 above, including the operation of the motor and spring return, use of the retaining finger, and the release operation. FIGS. 12-14 show a mechanism 10 that is similar to that described above with respect to FIGS. 8-11 , but showing a “split-back” configuration. The mechanism 10 of FIGS. 12-14 has many of the same components as those described in FIGS. 8-11 . In this configuration, however, the back frame is split into a lower back frame post 100 and an upper head rest frame 102 . The motor bracket 60 is coupled to the lower back frame post 100 . Instead of the back bracket 74 being coupled to the back insert 78 , the back bracket 74 is coupled to the upper head rest frame 102 via a spacer block 104 . This embodiment illustrates the use of mechanism 10 in a split-back configuration, as opposed to the frame within a frame configuration of FIGS. 8-11 . The principle operation of the mechanism remains the same, but offers furniture manufacturers additional choices in styling. FIG. 15 illustrates the basics of mechanism 10 as shown and described with reference to FIGS. 8-14 , but showing the use of a different motor 110 (which is the same motor as shown and described with respect to FIGS. 6 and 7 above). FIG. 15 illustrates that a number of different motors can be used while retaining the majority of the mechanism. As shown, a different motor bracket 112 is used to mount motor 110 to the back frame post 12 . Additionally, the coupling between the motor 110 and motor slide hinge 70 may be slightly different, depending on the shaft configuration of the motor. From the foregoing, it will be seen that this invention is one well adapted to attain all the ends and objects hereinabove set forth together with other advantages, which are obvious and inherent to the structure. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims. Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.

1a

PRIORITY CLAIM [0001] The present application is a continuation of U.S. patent application Ser. No. 14/872,326 filed Oct. 1, 2015, which is a continuation of U.S. Pat. No. 9,173,937 filed Feb. 25, 2011 as U.S. patent application Ser. No. 13/000,670, which is a National Stage of International Application No. PCT/EP09/057474 filed Jun. 16, 2009, which claims priority to European Application No. 08158833.7 filed Jun. 24, 2008, the entire contents of each incorporated herein by reference. BACKGROUND [0002] The present invention relates generally to the field of nutrition, health and wellness. In particular the present invention relates to probiotics and ways to increase their effectiveness. One embodiment of the present invention relates to a combination of probiotics with secretory IgA and possible uses of this combination. [0003] An infection is the detrimental colonization of a host organism by foreign species. Usually, the infecting organism attempts to utilize the host's resources to promote its own multiplication. Thereby, the infecting organism, or pathogen, may interfere with the normal functioning of the host and can lead to more infection related disorders that may have a varying severity and that may lead in the worst case to death. [0004] If there is a synergy between infecting organism and host, whereby the relationship is beneficial for the infecting organism but detrimental to the latter, is characterised as parasitism. [0005] The list of disease linked to infection is huge and the costs associated with the treatment and prevention of infections are significant. [0006] The market for antibacterial agents in the US alone is considered to be around 26 bn US-Dollars. [0007] Infection can be treated today by proper medication. However, the selection of a proper medication requires defining the type of infection to be treated. Bacterial infections are often treated with antibacterial antibiotics. Taking the wrong antibacterial antibiotics in error for treating a specific non-viral infection won't treat the infection and may even be harmful. Further, such medication may always result in unwanted side effects and often requires the supervision of medical personnel. [0008] Additionally, an extensive usage of antibiotics might contribute to the generation of antibiotic resistant infectious species. The Forbes Magazine states in June 2006 that drug resistant infections kill more Americans than AIDS and breast cancer combined. [0009] Hence, the development of compositions that may contribute to reduce the need for antibiotics in society, is presently a key research focus. [0010] Consequently, there is a need in the art for non-antibiotic compositions that can be administered, preferably on a day-to-day basis -without unwanted side effects and that can be used safely to treat or prevent infections, without the need to define the exact nature of the causative agent first. [0011] One way to achieve this object is to administer a food composition comprising probiotics. [0012] Probiotic micro-organisms are known to have a beneficial effect on the health and well-being of the host. In the last few decades, the use of probiotic bacteria has gained considerable attention as a safe and accessible form of treatment for example for gastrointestinal diseases (Isolauri E, et al., Dig Dis Sci 1994,39:2595-2600). Typical probiotic bacteria that have been employed in this respect belong to the Lactobacillus or the Bifidobacterium genus. [0013] The effectiveness of probiotics depends, in part, on their ability to resist to digestive tract conditions and adhere to intestinal epithelium. Moreover, a critical aspect conditioning their potential benefit to the host is the probiotic cross-talk with the host's environment and their impact on epithelium barrier and its function. [0014] While some probiotics already achieve very respectable result in terms of colonization of the gastrointestinal tract, it would be desirable to have available a tool to further improve the effectiveness with which the probiotic micro-organisms colonize the gut. SUMMARY [0015] It was consequently the object of the present invention to provide the art with a composition that has the same advantages as the administration of probiotics to a subject in need thereof but that is even more effective in treating or preventing infections than the administration of probiotics alone. [0016] The present inventors have addressed this need and found that they could achieve this object by a method and a food composition in accordance with the claims. [0017] The present invention relates hence to a composition comprising antibodies, in particular secretory IgA, and at least one probiotic and to its use to treat, modulate, reduce and/or prevent infections. [0018] Antibodies are often glycoproteins, which specifically recognise antigens. In vertebrates five immunoglobulin classes are described, including IgG, IgM, IgA, IgD and IgE, all of which differ in their function in the immune system. Secretory IgA (SIgA), which is the predominant and more stable immunoglobulin in intestinal mucosal secretions, was found to be in particular effective for the purpose of the present invention. [0019] Without wishing to be bound by theory, the inventors believe that SIgA and probiotics may form complexes that may potentiate the interaction of probiotics with the host and improving their health benefit. [0020] The suggested mechanism of interaction of this combination with the intestinal mucosa of the host is presented in FIG. 1 . [0021] The first interaction of probiotics with the host occurs at the level of the gut mucosa. Among the key criteria for the selection of a probiotic micro-organism is its capacity to adhere to intestinal mucosa. [0022] This adhesion seems to be required to block pathogen entry and to contribute to modulate protective immune functions, for example. [0023] One of the most characteristic features of the mucosal immune system in most mammals is the dominant presence of secretory antibodies, particularly secretory IgA (SigA), an antibody class unique to mucosae. [0024] Biosynthesis of polymeric IgA takes place in the mucosal lamina propria, and its transport across the epithelium lining the mucosal surfaces is ensured by the polymeric Ig receptor (pIgR) expressed by crypt and columnar epithelial cells. [0025] In secretions, a significant portion of the pIgR termed the secretory component (SC) remains associated with polymeric IgA, releasing SIgA. [0026] The release of SIgA into the lumen is dependent on the production of SC, whose expression is up-regulated after birth. pIgR appears to be critical to the stability and mucosal anchoring of the antibody (Phalipon et al. (2002) Secretory component : A new role in secretory IgA-mediated immune exclusion in vivo. Immunity 17:107-115). [0027] Neonates, in which SIgA antibodies are barely detectable, depend on maternal IgG transferred through the placenta, and an exogenous supply of SIgA abundantly found in breast milk. [0028] Together, this confers passive immunization in the gut essential to the protection of the host during the phase of shaping and maturation of the gastrointestinal immune system. [0029] Hence the composition of the present invention will be in particular beneficial for newborns and infants (up to 2 years old), since they do not produce SIgA in sufficient amounts but rely on external supply. [0030] The inventors presently believe that it is this association of SIgA with probiotics that potentiates the interaction of probiotics with the host, so that the resulting health benefits for the host are improved. [0031] The present inventors have identified secretory IgA antibodies capable of associating with strains of commensal bacteria. [0032] The present inventors have used in vitro Caco-2 epithelial cell monolayers to examine how SIgA favours the cross-talk between non-pathogenic bacteria and the epithelial surface. Two probiotic strains representative of the two main genders Lactobacilli and Bifidobacteria were evaluated as proof of principle, i.e. Lactobacillus rhamnosus NCC4007 (LPR) and Bifidobacterium lactis NCC2818 (BL818). [0033] It was found that SIgA and/or SC, when associated with probiotics, promotes the interaction of probiotics with the host and modulates downstream processes involved in defense mechanisms. [0034] This contributes to enhance the health benefits of probiotics. Through their combination with probiotics, SIgA and/or SC could optimally help trigger efficient protective host defense reactions, including responses against infections by various pathogens. Given their homeostatic effect, SIgA, combined with probiotics, will help to trigger an immune boosting effect against infections while preventing any potential damaging inflammatory process. [0035] Consequently, one embodiment of the present invention is a composition comprising secretory IgA and at least one probiotic for the preparation of a product to treat or prevent non-viral infections. [0036] The present invention also relates to the use of a composition comprising secretory IgA and at least one probiotic for the preparation of a product to treat or prevent non-viral infections. [0037] The present invention additionally relates to a composition comprising SIgA and at least one probiotic for use in the treatment and/or prevention of non-viral infections. [0038] The present invention extends to a composition comprising SIgA and at least one probiotic for treating and/or preventing non-viral infections. [0039] The treatment of non-viral infections includes the reduction of non-viral infections. [0040] “Probiotic” means microbial cell preparations or components of microbial cells with a beneficial effect on the health or well-being of the host. (Salminen S, Ouwehand A. Benno Y. et al “Probiotics: how should they be defined” Trends Food Sci. Technol. 1999:10 107-10). [0041] All probiotic micro-organ isms may be used in accordance with the present invention. Preferably, they are selected from the group consisting of Bifidobacterium, Lactobacillus, Streptococcus and Saccharomyces or mixtures thereof, in particular selected from the group consisting of Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus johnsonii, Lactobacillus plantarum, Lactobacillus salivarius, Enterococcus faecium, Saccharomyces boulardii and Lactobacillus reuteri or mixtures thereof, preferably selected from the group consisting of Lactobacillus johnsonii (NCC533; CNCM 1-1225), Bifidobacterium longum (NCC490; CNCM 1-2170), Bifidobacterium longum (NCC2705; CNCM 1-2618), Bifidobacterium lactis (2818; CNCM 1-3446), Lactobacillus paracasei (NCC2461; CNCM I-2116), Lactobacillus rhamnosus GG (ATCC53103), Lactobacillus rhamnosus (NCC4007; CGMCC 1.3724), Enterococcus faecium SF 68 (NCIMB10415), and mixtures thereof. [0042] The composition of the present invention may also contain prebiotics. The addition of prebiotics is beneficial as it can, when combined with probiotics delivers synergistic effects in terms of the health benefits. A composition comprising a combination of prebiotics and probiotics is commonly known as a symbiotic composition. [0043] “Prebiotic” means food substances that promote the growth of probiotics in the intestines. They are not broken down in the stomach and/or upper intestine or absorbed in the GI tract of the person ingesting them, but they are fermented by the gastrointestinal microflora and/or by probiotics. Prebiotics are for example defined by Glenn R. Gibson and Marcel B. Roberfroid, Dietary Modulation of the Human Colonic Microbiota: Introducing the Concept of Prebiotics, J. Nutr. 1995 125: 1401-1412. [0044] The prebiotics that may be used in accordance with the present inventions are not particularly limited and include all food substances that promote the growth of beneficial bacteria such as bifidobacteria or lactobacilli, and/or probiotics in the intestine. Preferably, they may be selected from the group consisting of oligosaccharides, optionally containing fructose, galactose, mannose; dietary fibers, in particular soluble fibers, soy fibers; inulin; or mixtures thereof. Preferred prebiotics are fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), isomalto-oligosaccharides, xylo-oligosaccharides, oligosaccharides of soy, glycosyl sucrose (GS), lactosucrose (LS), lactulose (LA), palatinose-oligosaccharides (PAO), malto-oligosaccharides, pectins and/or hydrolysates thereof. [0045] The non-viral infection of the present invention may be a bacterial and/or a parasite infection. It may also be a fungal infection. [0046] The non-viral infection may be a bacterial infection selected from an Escherichia coli infection, an Vibrio cholerae infection, a salmonella infection, a clostridia infection, a shigella infection, a parasite infection, including Giardia lamblia, Entamoeba histolytica and Cryptosporidium spp or mixtures thereof. [0047] Typical bacterial infectious diseases that can be treated or prevented by the present invention include salmonellosis, shigellosis, typhoid fever, bacterial meningitis, anthrax, botulism, brucellosis, campylobacteriosis, cat scratch disease, cholera, diphtheria, epidemic typhus, gonorrhea, impetigo, legionellosis, leprosy (Hansen's Disease), leptospirosis, listeriosis, lyme disease, melioidosis, rheumatic fever, MRSA infection, nocardiosis, pertussis (whooping cough), plague, pneumococcal pneumonia, psittacosis, Q fever, Rocky Mountain Spotted Fever (RMSF), scarlet fever, syphilis, tetanus, trachoma, tuberculosis, tularaemia, typhus, and/or urinary tract infections [0048] Typical parasitic infectious diseases that can be treated or prevented by the present invention include african trypanosomiasis, amebiasis, ascariasis, babesiosis, Chagas disease, clonorchiasis, cryptosporidiosis, cysticercosis, diphyllobothriasis, dracunculiasis, echinococcosis, enterobiasis, fascioliasis, fasciolopsiasis, filariasis, free-living amebic infection, giardiasis, gnathostomiasis, hymenolepiasis, isosporiasis, kala-azar, leishmaniasis, malaria, metagonimiasis, myiasis, onchocerciasis, pediculosis, pinworm infection, scabies, schistosomiasis, taeniasis, toxocariasis, toxoplasmosis, trichinellosis, trichinosis, trichuriasis, trichomoniasis, and/or trypanosomiasis. [0049] Typical fungal infectious diseases that can be treated or prevented by the present invention include aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis, histoplasmosis, and/or tinea pedis. [0050] The product prepared by the use of the present invention may be a food product, an animal food product or a pharmaceutical composition. For example, the product may be a nutritional composition, a nutraceutical, a drink, a food additive or a medicament. [0051] A food additive or a medicament may be in the form of tablets, capsules, pastilles or a liquid for example. Food additives or medicaments are preferably provided as sustained release formulations, allowing a constant supply of SIgA and probiotics for prolonged times. [0052] The product is preferably selected from the group consisting of milk powder based products; instant drinks; ready-to-drink formulations; nutritional powders; nutritional liquids; milk-based products, in particular yoghurts or ice cream; cereal products; beverages; water; coffee; cappuccino; malt drinks; chocolate flavoured drinks; culinary products; soups; tablets; and/or syrups. [0053] Milk may be any milk obtainable from animal or plant sources and is preferably cows milk, human milk, sheep milk, goat milk, horse milk, camel milk, rice milk or soy milk. [0054] Instead of milk, also milk derived protein fractions or colostrum may be used. [0055] The composition may further contain protective hydrocolloids (such as gums, proteins, modified starches), binders, film forming agents, encapsulating agents/materials, wall/shell materials, matrix compounds, coatings, emulsifiers, surface active agents, solubilizing agents (oils, fats, waxes, lecithins etc.), adsorbents, carriers, fillers, co-compounds, dispersing agents, wetting agents, processing aids (solvents), flowing agents, taste masking agents, weighting agents, jellifying agents, gel forming agents, antioxidants and antimicrobials. They may also contain conventional pharmaceutical additives and adjuvants, excipients and diluents, including, but not limited to, water, gelatine of any origin, vegetable gums, ligninsulfonate, talc, sugars, starch, gum arabic, vegetable oils, polyalkylene glycols, flavouring agents, preservatives, stabilizers, emulsifying agents, buffers, lubricants, colorants, wetting agents, fillers, and the like. Further, they may contain an organic or inorganic carrier material suitable for oral or enteral administration as well as vitamins, minerals trace elements and other micronutrients in accordance with the recommendations of Government bodies such as the USRDA. [0056] The composition of the present invention may contain a protein source, a carbohydrate source and/or a lipid source. [0057] Any suitable dietary protein may be used, for example animal proteins (such as milk proteins, meat proteins and egg proteins); vegetable proteins (such as soy protein, wheat protein, rice protein, and pea protein); mixtures of free amino acids; or combinations thereof. Milk proteins such as casein and whey, and soy proteins are particularly preferred. [0058] If the composition includes a fat source, the fat source more preferably provides 5% to 40% of the energy of the formula; for example 20% to 30% of the energy. DHA may be added. A suitable fat profile may be obtained using a blend of canola oil, corn oil and high-oleic acid sunflower oil. [0059] A source of carbohydrates may more preferably provide between 40% to 80% of the energy of the composition. Any suitable carbohydrate may be used, for example sucrose, lactose, glucose, fructose, corn syrup solids, maltodextrins, and mixtures thereof. [0060] The product prepared by the present invention may be administered to humans or animals, in particular companion animals, pets or livestock. It has beneficial effects for any age group. Preferably, the product is intended in for infants, juveniles, adults or elderly. It may however also be administered to mothers during pregnancy and lactation to treat the infant. [0061] The composition of the present invention will be effective as long as probiotics and SIgA are administered simultaneously, briefly one after the other in a maximal timeframe of less than 60 minutes, preferably less than 30 minutes, more preferred less than 15 minutes and most preferred less than 5 minutes, and/or are combined prior to administration as already present in the food product. [0062] However, it was found that the combination of probiotics and SIgA is in particular effective, if SIgA and probiotics are combined in complexes prior to administration. This has the advantage that the beneficial complexes do not need to form after consumption of the product, but that they are already present in the food product. [0063] Consequently, one embodiment of the present invention relates to the use of a composition comprising SIgA and probiotics, wherein the SIgA molecule and at least one probiotic are at least partially associated in the composition. [0064] SIgA and at least one probiotic are preferably present as immune complexes, for example in a way that at least 90%, more preferably at least 95%, even more preferred all probiotic bacteria are present as immune complex in association with at least 1 SIgA molecule, for example with at least 5 SIgA molecules. [0065] The composition may also contain at least one other kind of other food grade bacteria, preferably selected from the group consisting of lactic acid bacteria, bifidobacteria, enterococci or mixtures thereof. These other food grade bacteria may contribute to obtain a healthy gut microflora and will hence contribute to achieve the object of the present invention even more effectively. [0066] The present invention also relates to a food composition comprising SIgA and at least one probiotic micro-organism. The SIgA and the probiotic micro-organism may preferably be combined as a complex in the food composition. SIgA and the probiotic micro-organism may preferably be present in a stoichiometric ratio of at least 10:1, preferably at least 100:1, most preferably at least 2000:1 to 100000:1. The upper limit of SIgA saturation is determined by the surface of the probiotic micro-organisms and by the number of available binding sites for SIgA. [0067] Typically, the probiotics will be effective in a large range amount. If the bacteria reach the intestine alive, a single bacterium can be sufficient to achieve a powerful effect by persisting in the gut and multiplication. However, in general, it is preferred if the product comprises between 102 and 1010 cells of probiotics per daily dose. [0068] The amount of SIgA required to achieve an effect, is equally not limited. In principle one SIgA molecule combined with one probiotic micro-organism, preferably in the form of a complex, will be effective for the present invention. However, it is in generally preferred if the product comprises between 0.0001 mg secretory SIgA and 10 mg SIgA per daily dose. [0069] Those skilled in the art will understand that they can freely combine all features of the present invention described herein, without departing from the scope of the invention as disclosed. In particular, features described for the uses of the present invention may be applied to the composition, e.g. the food composition, of the present invention and vice versa. [0070] Further advantages and features of the present invention are apparent from the following Examples and Figures. BRIEF DESCRIPTION OF THE DRAWINGS [0071] FIG. 1 shows schematically how SIgA is believed to improve the effects of commensal bacteria, when associated with them by increasing the interaction with the intestinal mucosa of the host. [0072] FIG. 2 shows the result of experiments testing the binding properties of two probiotic strains, Lactobacillus rhamnosus NCC4007 (LPR) and Bifidobacterium lactis NCC2818 (BL818), representative for the two main genders Lactobacilli and Bifidobacteria to epithelial cells. Data are expressed as means CFU per 100 Caco-2 cells ±SEM. [0073] FIG. 3 shows the result of experiments testing the binding properties of two probiotic strains, Lactobacillus rhamnosus NCC4007 (LPR) and Bifidobacterium lactis NCC2818 (BL818), representative for the two main genders Lactobacilli and Bifidobacteria to epithelial cells and the influence of secretory IgA (SIgA) or secretory component (SC). Data are expressed as means CFU per 100 Caco-2 cells±SEM. [0074] FIG. 4 shows the result of an experiment testing the effect of two probiotic strains, Lactobacillus rhamnosus NCC4007 (LPR) and Bifidobacterium lactis NCC2818 (BL818), representative for the two main genders Lactobacilli and Bifidobacteria, alone or in combination with SIgA or SC, on transepithelial electrical resistance (TER) measuring epithelial permeability. Data are expressed as means ohms per cm 2 ±SEM. [0075] FIG. 5 shows the result of an experiment testing the effect of LPR, combined or not with SIgA or SC, on NF-κB activation in Caco-2 cell monolayer. Decrease in NF-κB binding activity is indicative of attenuated inflammatory pathway(s) within the Caco-2 cell. [0076] FIG. 6 shows the result of an experiment testing the effect of LPR, combined or not with SIgA or SC, on S. flexneri invasion of Caco-2 cell. Two monoclonal SigA molecules were used: a non-specific SIgA (SlgAnon-spec) recognizing a Salmonella epitope, and the specific anti- S. flexneri SIgAC5. Data are expressed as means CFU per Transwell filter±SEM. [0077] FIG. 7 shows the result of an experiment testing the effect of probiotics on polymeric Ig receptor (pIgR) expression in a Caco-2 monolayer. Different treatments tested at 16 h, including combination of probiotics with non-specific SIgA and combination of S. flexeneri with specific anti- S. flexneri SIgA. (A) Different treatments tested at 16 h, including combination of probiotics with non-specific SIgA and combination of S. flexneri with specific anti- S. flexneri SIgA. The presence of pIgR was assessed by western blot, as was β-actin. (B) Semi-quantitative analysis of pIgR expression levels normalized to β-actin by densitometric analysis of the bands identified in the gels in A. (C) Kinetics of pIgR expression over 24 h incubation of Caco-2 cells with various preparations, as measured by ELISA. DETAILED DESCRIPTION EXAMPLE 1 [0078] Binding to Epithelial Cells [0079] Approximately 10 6 Caco-2 cells were seeded per 1 cm 2 Transwell filter. Cells were incubated for 16 h at 37° C. in absence of antibiotic or FCS with different doses of bacteria, as indicated in the figure legend. Fresh overnight cultures of LPR, BL818 and E. coli TG-1 bacteria were used. Cells were then washed prior to enumeration. Bound bacteria were counted by plating on MRS or LB plates. For each experiment, triplicate tests were performed. Data were expressed as means of bound bacteria per 100 Caco-2 cells±SEM. Triplicates were performed for each experiment. In a subsequent experiment, cells were incubated with 2×10 7 bacteria for 16 hours at 37° C., in the presence of increasing doses of either SIgA or SC as indicated in the legend to FIG. 3 . Cells were then washed prior to enumeration. Bound bacteria were counted by plating on MRS or LB plates. For each experiment, triplicate tests were performed. Data were expressed as means of bound bacteria per 100 Caco-2 cells±SEM. Triplicates were performed for each experiment. [0080] A preferential binding to polarized Caco-2 cells of LPR or BL818 is observed in comparison to E. coli TG-1 ( FIG. 2 ). There is a dose-dependent binding capacity of probiotics to intestinal epithelial cells. It can be observed that binding properties could be differentiated between the two strains. [0081] For subsequent experiments, 2×10 7 CFU of probiotics were used, as this amount did not lead to any pH change in the medium on one hand, and showed an efficient binding ratio on the other hand. [0082] Increasing the dose of monoclonal SIgA potentiated the capacity of both LPR and BL818 to bind to polarized Caco-2 cell monolayers. When associated with the 20 bacteria, secretory component did not exhibit such properties ( FIG. 3 ). The 1 μg dose of SIgA that confers a significant improvement in probiotic binding capacity was selected for subsequent experiments. This dose leads to the formation of a final complex constituted of approximately 50′000 to 100′000 units of SIgA for 1 bacterium. [0083] Results are shown in FIGS. 2 and 3 . EXAMPLE 2 [0084] Barrier Function in Polarized Caco-2 Cell Monolayer [0085] Approximately 10 6 Caco-2 cells were seeded per 1 cm 2 Transwell filter. Cells were incubated for 24 h at 37° C. with 2×10 7 CFU of bacteria in absence of antibiotic or FCS. Bacteria were tested either alone or in combination with SIgA or SC at concentrations indicated in the legend to FIG. 4 . Transepithelial electrical resistance (TER) was measured at 3, 6, 9, 15 and 24 h. Controls include incubation with SIgA and SC alone. Triplicates were performed for each experiment. [0086] A 20-25% increase in transepithelial electrical resistance (TER) resulted from the incubation of polarized Caco-2 cell monolayer with LPR or BL818 alone, suggesting that probiotics potentiated epithelial barrier function. This remained true when the bacteria were combined with SIgA or SC ( FIG. 4 ). SIgA or SC by themselves did not lead to any TER change. [0087] Results are shown in FIG. 4 . EXAMPLE 3 [0088] NF-κB Activation in Polarized CACO-2 Cell Monolayer [0089] Approximately 10 6 Caco-2 cells were seeded per 1 cm 2 Transwell filter. Cells were incubated for 16 h at 37° C. with 2×10 7 CFU of LPR in absence of antibiotic or FCS. Bacteria were tested either alone or in combination with SIgA or SC at concentrations indicated in the legend to FIG. 5 . S. flexneri, S. typhi and H. pylori (2×10 7 CFU) were used as pro-inflammatory pathogens in control experiments. Nuclear extracts were prepared and analysed by electrophoretic mobility shift assay (EMSA) to examine the binding of NF-κB to a specific DNA probe. Cytoplasmic extracts were obtained in parallel and the presence of IκBα was analyzed by Western blot using an anti-IκBα-specific monoclonal antibody to the protein. [0090] Exposure of polarized Caco-2 cell monolayers to pathogenic bacteria led to a much more pronounced activation of nuclear NF-κB compared to non-pathogenic bacteria ( FIG. 5 ). [0091] Disappearance of IκBα (lower panel) reflects activation of the pathway leading to nuclear translocation of NF-κB. In that respect, while LPR alone has a mild effect on NF-κB activation, combination of LPR with SIgA or SC reduced NF-κB activation in Caco-2 cells (BL818 not tested). As expected, incubation of epithelial cells with pathogenic S. flexneri led to a complete disappearance of IκBα expression. [0092] Results are shown in FIG. 5 . EXAMPLE 4 [0093] Anti-Pathogenic Activity [0094] Approximately 10 6 Caco-2 cells were seeded per 1 cm 2 Transwell filter. Cells were incubated for 16 h at 37° C. with 2×10 7 CFU of LPR in absence of antibiotic or FCS. LPR was tested alone or in combination with with either 0.2 μg of SC, 1 μg of polyclonal SIgA or 1 g of specific anti- S. flexneri LPS SIgAC5. After incubation with LPR cells were washed and then incubated with 10 7 S. Flexneri for 6 hours, washed again and incubated with 50 g/ml gentamycin for 45 min. Finally, cells were lysed and intracellular S. flexneri were enumerated on LB agar plates. Triplicates were performed for each experiment. [0095] Addition of LPR reduced infection of polarized Caco-2 cell monolayer by S. flexneri in a dose dependent manner. The effect was highly enhanced upon combination with SIgA. Full prevention of infection was achieved when S. flexneri LPS-specific SIgAC5 antibody was used ( FIG. 6 ). [0096] Results are shown in FIG. 6 . EXAMPLE 5 [0097] Expression of Polymeric Ig Receptor in Polarized Caco-2 Cell Monolayer [0098] Approximately 10 6 Caco-2 cells were seeded per 1 cm 2 Transwell filter. Cells were incubated for 16 h at 37° C. with 2×10 7 CFU of LPR or BL818 in absence of antibiotic or FCS. Probiotics were tested alone or in combination with with either 0.2 μg of SC or 1 μg of polyclonal SIgA. Control S. flexneri was tested alone or in combination with 1 μg of specific anti- S. flexneri LPS SIgAC5. After washing, Caco-2 cells were directly recovered from the Transwell filters and lysed. Nuclei were removed and cell debris as well as cytoplasms were analyzed by Western blot using anti-pIgR antibody and antisera to human SC and β-actin as controls. Triplicates were performed for each experiment. [0099] In a subsequent experiment cells were incubated following the same procedure and then recovered from the Transwell filter after 8, 16 and 24 h of incubation. Quantitative analysis of pIgR was performed by ELISA on cell debris/cytoplasms fractions. Total proteins were determined by the BCA protein assay. Values were normalized to protein content and data expressed as means of ng pIgR/mg of total protein±SEM. [0100] pIgR expression in epithelial cells was normalized to β-actin expression. As revealed by Western blot (upper panel) and densitometric analysis of the respective signals (lower panel), there was an increase of pIgR level following overnight exposure of polarized Caco-2 monolayers to combinations of LPR or BL818 with either SIgA or SC compared to probiotics alone ( FIG. 7 a ). Specific anti- S. flexneri LPS SIgAC5 prevented interaction of the pathogen with the Caco-2 cell polarized monolayer, thus explaining the decrease in pIgR expression when compared to S. flexneri treatment alone. [0101] The results further showed a time-dependent increase of polymeric 1 g receptor (pIgR) level following exposure of polarized Caco-2 cell monolayers to probiotic combinations with SIgA or SC ( FIG. 7 b ). [0102] Results are shown in FIG. 7 .

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Korean Patent Application No. 10-2012-0036139, filed on Apr. 6, 2012 in the Korean Intellectual Property Office, the disclosure of which is incorporated herein by reference. BACKGROUND 1. Field One or more embodiments relate to a robot cleaner that automatically removes dust accumulated on a floor while navigating a cleaning area and a method of controlling the robot cleaner. 2. Description of the Related Art A robot cleaner refers to a device that automatically cleans a cleaning area by absorbing foreign substances such as dust from a floor while navigating a cleaning area without a user's manipulation. A robot cleaner includes a main brush for removing dust accumulated under a main body of the robot cleaner, and an auxiliary cleaning tool for cleaning a near-wall portion or the like to improve cleaning performance. The auxiliary cleaning tool of the robot cleaner protrudes outward from the main body of the robot cleaner and removes dust or the like on a floor, particularly, on the near-wall portion. However, when the auxiliary cleaning tool has an error and thus fails to operate normally, since a conventional robot cleaner does not include a unit for detecting an error of the auxiliary cleaning tool, an abnormal state of the auxiliary cleaning tool may remain for a predetermined period of time. An abnormal operation of the auxiliary cleaning tool may be caused by a collision with an obstacle that is disposed adjacent to the conventional robot cleaner or by a material of the floor with high resistance, or may be caused when a user arbitrarily lifts up the conventional robot cleaner that is navigating. In this case, since the abnormal state of the auxiliary cleaning tool remains for a predetermined period of time, the conventional robot cleaner may no longer efficiently clean the floor. SUMMARY The foregoing described problems may be overcome and/or other aspects may be achieved by one or more embodiments of a robot cleaner that detects an abnormal operation of an auxiliary cleaner, classifies causes of the abnormal operation, and performs an operation in response to the abnormal operation, and a method of controlling the robot cleaner. Additional aspects and/or advantages of one or more embodiments will be set forth in part in the description which follows and, in part, will be apparent from the description, or may be learned by practice of one or more embodiments of disclosure. One or more embodiments are inclusive of such additional aspects. In accordance with one or more embodiments, a robot cleaner may include: a main body that navigates a floor; a first detector that detects an obstacle getting closer to the main body; an auxiliary cleaner that is mounted on the main body to protrude and retract; a second detector that detects a protrusion state or a retraction state of the auxiliary cleaner; and a controller that determines an abnormal operation of the auxiliary cleaner based on a result of the detection of the second detector and controls a protrusion operation or a retraction operation of the auxiliary cleaner according to a result of the determination. The second detector may detect whether the auxiliary cleaner performs a protrusion operation or a retraction operation, detect a protrusion degree or a retraction degree of the auxiliary cleaner, and detect whether the protrusion operation or the retraction operation of the auxiliary cleaner is completed. The controller may calculate a number of times a driving unit that drives the auxiliary cleaner rotates based on the result of the detection of the second detector, and when the number of times the driving unit rotates for a preset period of time is less than a critical value, may determine that an error has occurred in an operation of the auxiliary cleaning unit. the controller may calculate a number of times a driving unit that drives the auxiliary cleaner rotates based on the result of the detection of the second detector, and when the number of times the driving unit rotates for a preset period of time is greater than a critical value even though there is no protrusion or retraction command for the auxiliary cleaner, may determine that an error has occurred in an operation of the auxiliary cleaning unit. The controller may calculate an amount of current supplied to a driving unit that drives the auxiliary cleaner based on the result of the detection of the second detector, and when the amount of current supplied to the driving unit for a preset period of time is less than a critical value, may determine that an error occurs in an operation of the auxiliary cleaning unit. The controller may calculate an amount of current supplied to a driving unit that drives the auxiliary cleaner based on the result of the detection of the second detector, and when the amount of current supplied to the driving unit for a preset period of time is greater than a critical value even though there is no protrusion or retraction command for the auxiliary cleaner, may determine that an error occurs in an operation of the auxiliary cleaning unit. The controller may estimate a position of the auxiliary cleaner based on the result of the detection of the second detector, and when the auxiliary cleaner is not located at a predicted position within a preset period of time, may determine that an error has occurred in an operation of the auxiliary cleaning unit. The controller may estimate a position of the auxiliary cleaner based on the result of the detection of the second detector, and when there is a change in the position of the auxiliary cleaner even though there is no protrusion or retraction command for the auxiliary cleaner, may determine that an error has occurred in an operation of the auxiliary cleaning unit. When an obstacle is detected in a protrusion or retraction direction of the auxiliary cleaner based on the result of the detection of the first detector, the controller may determine the auxiliary cleaner has operated abnormally due to the obstacle. The controller may perform a protrusion or retraction operation of the auxiliary cleaner or change a navigation direction and a navigation pattern of the main body in response to the obstacle. When no obstacle is detected in a protrusion or retraction direction of the auxiliary cleaner based on the result of the detection of the first detector, the controller may determine that the auxiliary cleaner has operated abnormally due to a change in a floor surface. The controller may perform a protrusion or retraction operation of the auxiliary cleaner or adjusts an operation strength of the auxiliary cleaner in response to the change in the floor surface. When a protrusion or retraction operation of the auxiliary cleaner is detected based on the result of the detection of the second detector even though there is no operation command for the auxiliary cleaner, the controller may determine that an undesired operation has occurred. The controller may determine that the undesired operation has been caused by an external force, and control the auxiliary cleaner to resist the external force in order to maintain a previous state. In accordance with another aspect of the present invention, a method of controlling a robot cleaner that may include a main body that navigates a floor, a first detector that detects an obstacle getting closer to the main body, an auxiliary cleaner that is mounted on the main body to protrude and retract, and a second detector that detects a protrusion or retraction state of the auxiliary cleaner, may include: determining an abnormal operation of the auxiliary cleaner based on a result of the detection of the second detector; and controlling a protrusion or retraction operation of the auxiliary cleaner according to a result of the determination. The controlling of the protrusion or retraction operation of the auxiliary cleaner may include: determining whether an obstacle is detected in a protrusion or retraction direction of the auxiliary cleaner; determining whether the auxiliary cleaner operates abnormally due to the obstacle when it is determined that the obstacle is detected; and performing a protrusion or retraction operation of the auxiliary cleaner or changing a navigation direction and a navigation pattern of the main body in response to the obstacle. The controlling of the protrusion or retraction operation of the auxiliary cleaner may include: determining whether an obstacle is detected in a protrusion or retraction direction of the auxiliary cleaner; determining that the auxiliary cleaner operates abnormally according to a change in a floor surface when the obstacle is not detected; and performing a protrusion or retraction operation of the auxiliary cleaner or adjusting an operation strength of the auxiliary cleaner in response to the change in the floor surface. The method may further include determining whether there exists an operation command for the auxiliary cleaner, wherein the determining of the abnormal operation of the auxiliary cleaner includes determining whether a protrusion or retraction operation of the auxiliary cleaner is detected based on the result of the detection of the second detector even though there is no operation command for the auxiliary cleaning unit. The controlling of the protrusion or retraction operation of the auxiliary cleaner may include: when a protrusion or retraction operation of the auxiliary cleaner is detected, determining that an undesired operation occurs; and determining that the undesired operation is caused by an external force and controlling the auxiliary cleaner to resist the external force in order to maintain a previous state. According to the present invention, since an abnormal operation of an auxiliary cleaner may be detected and a response operation may be performed by classifying causes of the abnormal operation, an error of the auxiliary cleaner may be corrected and cleaning may be performed. BRIEF DESCRIPTION OF THE DRAWINGS These and/or other aspects will become apparent and more readily appreciated from the following description of embodiments, taken in conjunction with the accompanying drawings of which: FIG. 1 is a perspective view illustrating an outer appearance of a robot cleaner according to one or more embodiments; FIG. 2 is a cross-sectional view illustrating a structure of a bottom surface of a robot cleaner according to one or more embodiments, such as the robot cleaner of FIG. 1 ; FIG. 3 is a cross-sectional view illustrating a structure of an auxiliary cleaner that protrudes or retracts, according to one or more embodiments; FIG. 4 is a cross-sectional view illustrating a structure of an auxiliary cleaner that protrudes or retracts, according to one or more embodiments; FIG. 5 is a view illustrating a structure of an auxiliary cleaning tool, according to one or more embodiments; FIG. 6 is a view illustrating a structure of an auxiliary cleaning tool, according to one or more embodiments; FIG. 7 is a block diagram illustrating a control structure of a robot cleaner, according to one or more embodiments; FIG. 8 is a block diagram illustrating a control structure of a controller of a robot cleaner, according to one or more embodiments; FIG. 9 is a perspective view illustrating a structure of detecting an operation of the auxiliary cleaner, according to one or more embodiments; FIG. 10 is a perspective view illustrating a structure of detecting an operation of the auxiliary cleaner, according to one or more embodiments; FIG. 11 is a diagram for explaining a method of detecting an error of the auxiliary cleaner, according to one or more embodiments, such as the embodiments shown in FIG. 9 or 10 ; FIG. 12 is a block diagram illustrating a structure of detecting an operation of the auxiliary cleaner, according to one or more embodiments; FIG. 13 is a graph for explaining a method of detecting an error of the auxiliary cleaner, according to one or more embodiments, such as the embodiment shown in FIG. 12 ; FIGS. 14 and 15 are views illustrating a structure of detecting an operation of the auxiliary cleaner, according to one or more embodiments; FIG. 16 is a flowchart illustrating a method of controlling the robot cleaner in a case where an error occurs when the auxiliary cleaner protrudes, according to one or more embodiments; and FIG. 17 is a flowchart illustrating a method of controlling the robot cleaner in a case where an error occurs when the auxiliary cleaning retracts, according to one or more embodiments. DETAILED DESCRIPTION Reference will now be made in detail to one or more embodiments, illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. In this regard, embodiments of the present invention may be embodied in many different forms and should not be construed as being limited to embodiments set forth herein, as various changes, modifications, and equivalents of the systems, apparatuses and/or methods described herein will be understood to be included in the invention by those of ordinary skill in the art after embodiments discussed herein are understood. Accordingly, embodiments are merely described below, by referring to the figures, to explain aspects of the present invention. FIG. 1 is a perspective view illustrating an outer appearance of a robot cleaner 1 according to one or more embodiments. Referring to FIG. 1 , the robot cleaner 1 may include a main body 10 that forms the outer appearance and auxiliary cleaners 100 a and 100 b (collectively denoted by 100 ) that clean a near-wall portion and a corner portion. Various sensors for detecting an obstacle may be coupled to the main body 10 and may include a proximity sensor 61 and/or a vision sensor 62 . For example, when the robot cleaner 1 navigates in an arbitrary direction without a determined path, that is, in a cleaning system with no map, the robot cleaner 1 may detect an obstacle by using the proximity sensor 61 and may navigate a cleaning area. By contrast, when the robot cleaner 1 navigates along a determined path, that is, in a cleaning system requiring a map, the vision sensor 62 that receives position information of the robot cleaner 1 and generates a map may be provided, and other various methods may be used. Also, a display unit 70 may be coupled to the main body 10 and may display various states of the robot cleaner 1 . The display unit 70 may display, for example, a battery state of charge, whether a dust-collecting device is full, or a cleaning mode of the robot cleaner 1 . A structure of each auxiliary cleaner 100 will be explained below in detail with reference to FIGS. 3 through 6 . FIG. 2 is a cross-sectional view illustrating a structure of a bottom surface of a robot cleaner according to one or more embodiments, such as the robot cleaner 1 of FIG. 1 . Referring to FIGS. 1 and 2 , the robot cleaner 1 may include a main brush unit 30 , a power supply 50 , driving wheels 41 and 42 , a caster 43 , and the auxiliary cleaners 100 a and 100 b. The main brush unit 30 may be mounted in an opening formed in a rear portion R of the bottom surface of the main body 10 . The main brush unit 30 may sweep dust accumulated on a floor on which the main body 10 is put into a dust inlet 33 . The opening of the bottom surface of the main body 10 in which the main brush unit 30 may be mounted is the dust inlet 33 . The main brush unit 30 may include a roller 31 and a main brush 32 on an outer surface of the roller 31 . As the roller 31 rotates, the main brush 32 may sweep dust accumulated on the floor into the dust inlet 33 . Although not shown in FIG. 2 , a ventilation device that generates a suction force may be provided in the dust inlet 33 and may transfer the dust swept into the dust inlet 33 to the dust collecting device. The power supply 50 may supply driving power for driving the main body 10 . The power supply 50 may include various driving devices for driving various parts mounted on the main body 10 and a battery that may be electrically connected to the main body 10 and may supply driving power. The battery may be a rechargeable secondary battery. When a cleaning process is completed and the main body 10 is coupled to a charger or a discharge station, the battery may be supplied with power from the charger or the discharge station to be charged. The driving wheels 41 and 42 may be symmetrically disposed on left and right edges of a central area of the bottom surface of the main body 10 . While the robot cleaner 1 performs the cleaning process, the driving wheels 41 and 42 may navigate forward or backward, or rotate. The caster 43 may be provided on a front edge of the bottom surface of the main body 10 in a navigation direction of the robot cleaner 1 , to help the main body 10 to maintain a stable posture. The driving wheels 41 and 42 and the caster 43 may constitute one assembly and may be detachably mounted on the main body 10 . Openings may be formed at both sides of a front portion F of the bottom surface of the main body 10 , and the auxiliary cleaning units 100 a and 100 b may be provided to cover the openings. A structure of the auxiliary cleaner 100 will be explained in detail with reference to FIGS. 3 through 6 . The auxiliary cleaner 100 may be mounted to the bottom surface of the robot cleaner 1 to protrude and retract from and to the robot cleaner 1 . The auxiliary cleaner 100 may have any of various structures, and two structures according to one or more embodiments will be explained, but the structure of the auxiliary cleaner 100 is not limited thereto. FIG. 3 is a cross-sectional view illustrating a structure of the auxiliary cleaner 100 that protrudes or retracts, according to one or more embodiments. Referring to FIG. 3 , the auxiliary cleaner 100 may include a side arm 102 , a rim cover 103 , and an auxiliary cleaning tool 110 . The side arm 102 may be coupled to a lower portion of a front side of the main body 10 , and an arm motor (not shown) that may drive the side arm 102 may be located in an upper portion of the side arm 102 . The arm motor may be connected to a rotating shaft (not shown) via a predetermined gear that may transmit a driving force to the side arm 102 , and the rotating shaft may be mounted in a coupling groove 101 formed in one end of the side arm 102 . Accordingly, when the arm motor is driven, the rotating shaft may rotate and the side arm 102 may pivot about the coupling groove 101 . In this case, as the side arm 102 pivots to the outside of the main body 10 , the rim cover 103 may no longer cover the opening of the main body 10 and may no longer form a side rim of the main body 10 . A coupling groove 104 to which the auxiliary cleaning tool 110 may be coupled may be formed in the other end of the side arm 102 . A rotary motor (not shown) that drives the auxiliary cleaning tool 110 may be located in an upper portion of the other end of the side arm 102 , and the auxiliary cleaning tool 110 may rotate about the coupling groove 104 due to a driving force of the rotary motor. FIG. 4 is a cross-sectional view illustrating a structure of an auxiliary cleaner 100 that protrudes or retracts, according to one or more embodiments. Referring to FIG. 4 , the auxiliary cleaner 100 may include a side arm 106 , a rim cover 108 , and the auxiliary cleaning tool 110 . The side arm 106 may be coupled through a coupling groove 105 to a lower portion of a front side of the main body 10 , and an extension arm 107 that may slidably extend to the outside of the side arm 106 may be received in the side arm 106 . The extension arm 107 may move forward and backward in a longitudinal direction of the side arm 106 in the side arm 106 . To this end, a rail may be formed in the side arm 106 , a guide loop (not shown) may be formed on the extension arm 107 , and the extension arm 107 may slidably move along the rail while being fixed to the rail. Also, another extension arm that may slidably extend to the outside of the extension arm 107 may be received in the extension arm 107 . The other extension arm may move in the same manner, and the number of extension arms is not limited. An arm motor (not shown) that drives the extension arm 107 may be received in an upper portion of the side arm 106 . The arm motor may transmit a driving force to the extension arm 107 . When the arm motor is driven, the extension arm 107 may slide to the outside of the side arm 106 and may protrude to the outside of the main body 10 . In this case, the rim cover 108 may no longer cover the opening of the main body 10 and may no longer form a side rim of the main body 10 . A coupling groove 109 to which the auxiliary cleaning tool 110 may be coupled may be formed in an end of the extension arm 107 . A rotary motor (not shown) that drives the auxiliary cleaning tool 110 may be received in an upper portion of the end of the extension arm 107 , and the auxiliary cleaning tool 110 may rotate about the coupling groove 109 due to a driving force of the rotary motor. In the auxiliary cleaner 100 , the auxiliary cleaner 100 may protrude by receiving a force from, for example, a spring instead of a motor. Also, as described above, a rotating shaft of the auxiliary cleaning tool 110 may not be the same as a rotating shaft of the motor and may be connected, for example, by a gear, a belt, or the like. The auxiliary cleaner 100 may include the auxiliary cleaning tool 110 , and the auxiliary cleaning tool 110 may clean a near-wall portion. The auxiliary cleaning tool 110 may include a brush that collects or scatters foreign substances such as dust, a dustcloth that cleans a floor, and an absorber that absorbs foreign substances such as dust. However, the auxiliary cleaning tool 110 is not limited to a specific type. FIG. 5 is a view illustrating a structure of the auxiliary cleaning tool 110 , according to one or more embodiments. Referring to FIG. 5 , the brush arm 113 may extend outward in a radial direction of the auxiliary cleaning tool 110 . An auxiliary brush 112 may be coupled to the brush arm 113 , and a rotating shaft 111 that may protrude from the brush arm 113 may be coupled to the side arm 102 or the extension arm 107 through a coupling groove. When the auxiliary cleaning tool 110 rotates, the auxiliary brush 112 may sweep dust accumulated on a near-wall portion toward the central area of the main body 10 . FIG. 6 is a view illustrating a structure of an auxiliary too, such as the auxiliary cleaning tool 110 , according to one or more embodiments. Referring to FIG. 6 , a dustcloth holder 116 may be formed in a radial direction of the auxiliary cleaning tool 110 , and an auxiliary dustcloth 115 may be mounted in a radial direction of the dustcloth holder 116 on the dustcloth holder 116 . A rotating shaft 114 that may receive a driving force of the rotary motor and may rotate the auxiliary cleaning tool 110 may protrude from the center of the dustcloth holder 116 , and the rotating shaft 114 may be coupled to the side arm 102 or the extension arm 107 through a coupling groove. When the auxiliary cleaning tool 110 rotates, the auxiliary dustcloth 115 may clean a near-wall portion. When the auxiliary cleaning tool 110 of FIG. 6 is applied to the auxiliary cleaner 100 of FIG. 4 , a cleaning operation of the auxiliary cleaner 100 may be performed when the auxiliary cleaning tool 110 rotates and the extension arm 107 repeatedly protrudes and retracts. Also, a cleaning operation may be performed when only the extension arm 107 repeatedly protrudes and retracts without any rotation of the auxiliary cleaning tool 110 . The auxiliary brush 112 may be formed of any of various elastic materials, and the auxiliary dustcloth 115 may be formed of any of various materials such as, for example, a fibrous material. Since a cleaning area may be widened due to the auxiliary cleaner 100 that protrudes to the outside of the main body 10 , the robot cleaner 1 may clean even a near-wall portion or a corner portion of the floor. Although two auxiliary cleaning units 100 a and 100 b may be provided on both side portions of the robot cleaner 1 in FIGS. 1 through 6 , the present embodiment is not limited thereto and a number and positions of the auxiliary cleaning units 100 are not limited. However, for convenience of explanation, in the following description, it is assumed that two auxiliary cleaning units 100 may be provided on both side portions of the robot cleaner 1 as shown in FIGS. 1 through 6 . In the following description, it is assumed that a cleaning process may be basically performed by the main brush unit 30 while the robot cleaner 1 navigates. Also, for convenience of explanation, it is assumed that the auxiliary cleaning tool 110 may be a brush type. FIG. 7 is a block diagram illustrating a control structure of a robot cleaner, according to one or more embodiments. Referring to FIG. 7 , the robot cleaner 1 may include a first detector 60 that may detect an environment of the robot cleaner 1 , a second detector 300 that may detect an operation of the auxiliary cleaner 100 , an input unit 80 that may receive a command related to navigation or a cleaning operation of the robot cleaner 1 from a user, a controller 200 that may control the navigation and/or the cleaning operation of the robot cleaner 1 according to the command input to the input unit 80 or a result of the detection of the first and second detection units 60 and 300 , the main brush unit 30 and the auxiliary cleaner 100 that may perform the cleaning operation of the robot cleaner 1 , and a navigation unit 40 that may be in charge of the navigation of the robot cleaner 1 . The first detector 60 may detect an obstacle. Examples of the first detector 60 that detects an obstacle may include, for example, an ultrasonic sensor, a light sensor, or a proximity sensor, etc. When the first detector 60 is an ultrasonic sensor, the first detector 60 may detect an obstacle by transmitting ultrasound waves to a navigation path and receiving reflected ultrasound waves. When the first detector 60 is a light sensor, an infrared light-emitting element may emit infrared rays, and an infrared receiving element may receive reflected infrared rays to detect an obstacle. In addition, the first detector 60 may be, for example, a proximity sensor, a contact sensor, or a vision sensor. As long as the first detector 60 may detect an obstacle, the first detector 60 is not limited to a specific construction. The second detector 300 may detect whether the auxiliary cleaner 100 performs a protrusion operation or a retraction operation. Also, the second detector 300 may detect a protrusion degree or a retraction degree of the auxiliary cleaner 100 , and may detect whether the protrusion operation or the retraction operation of the auxiliary cleaner 100 is completed. In order to detect a protrusion or retraction state of the auxiliary cleaner 100 , the second detector 300 may include a contact sensor such as a micro-switch, a circuit that detects a counter-electromotive force of an arm motor, a hall sensor that detects a number of times the arm motor rotates, or a photo sensor. A detailed structure of the second detector 300 will be explained below in detail when a structure of detecting an operation of the auxiliary cleaner 100 is described. The input unit 80 may receive a command related to a cleaning operation or a navigation of the robot cleaner 1 from the user. Basically, a cleaning start command or a cleaning end command may be input by inputting an on/off signal, and a command related to a navigation mode and a cleaning mode may be input. The input unit 80 may be provided on the main body 10 of the robot cleaner 1 as a button type, or may be provided on the display unit 70 as a touch panel type, for example. The controller 200 may detect an error of the auxiliary cleaner 100 and accordingly may control the robot cleaner 1 to clean and navigate. To this end, the controller 200 may include an error detector 210 that may detect an error of the auxiliary cleaner 100 , a cleaning controller 220 that may control the main brush unit 30 and the auxiliary cleaner 100 for a cleaning operation of the robot cleaner 1 , and a navigation controller 230 that may control the navigation unit 40 for a navigation of the robot cleaner 1 . A structure and an operation of the controller 200 will be explained in detail below. The main brush unit 30 may include the roller 31 and the main brush 32 placed into the outer surface of the roller 31 as described above. When the cleaning controller 220 transmits a control signal to a driving motor that drives the roller 31 , the roller 31 may begin to rotate according to the control signal. As the roller 31 rotates, the main brush 32 may sweep dust accumulated on the floor into the dust inlet 33 and a cleaning operation of the main brush unit 30 may be performed. The auxiliary cleaner 100 may clean a corner portion which the main brush unit 30 may not reach. The term ‘corner portion’ used herein refers to a portion formed when an obstacle including a wall and a floor contact each other. The auxiliary cleaner 100 may clean a corner portion which the main brush unit 30 may not reach. The auxiliary cleaner 100 may include the side arms 102 and 106 and/or the extension arm 107 which may be in charge of a protrusion operation and a retraction operation of the auxiliary cleaner 100 , a rotary motor that may rotate the auxiliary cleaning tool 110 , and an arm motor that may drive the side arms 102 and 106 and/or the extension arm 107 . The navigation unit 40 may include the driving wheels 41 and 42 , the caster 43 , and a driving unit that may drive the driving wheels 41 and 42 and the caster 43 as described above. The navigation controller 230 may transmit a control signal to the driving unit to drive the driving wheels 41 and 42 forward or backward, and thus may move the robot cleaner 1 forward or backward. When the driving wheel 41 as a left driving wheel is moved backward and the driving wheel 42 as a right driving wheel is moved forward, the robot cleaner 1 may rotate leftward. By contrast, when the driving wheel 41 is moved forward and the driving wheel 42 is moved backward, the robot cleaner 1 may rotate rightward. FIG. 8 is a block diagram illustrating a control structure of the controller 200 of a robot cleaner, according to one or more embodiments. The first detector 60 , the second detector 300 , the input unit 80 , the main brush unit 30 , the auxiliary cleaner 100 , and the navigation unit 40 have already been described and thus an explanation thereof will not be given. Referring to FIG. 8 , the error detector 210 may determine whether the auxiliary cleaner 100 operates abnormally based on a result of a detection of the second detector 300 . When the cleaning controller 220 transmits a protrusion or retraction command to the auxiliary cleaner 100 but a result of the detection of the second detector 300 indicates that the auxiliary cleaner 100 does not normally protrude or retract, the error detector 210 may determine that an error has occurred in an operation of the auxiliary cleaner 100 . The cleaning controller 220 may control the main brush unit 30 and the auxiliary cleaner 100 to perform a cleaning operation according to the user's input or a program that is previously stored. In detail, the cleaning controller 220 may generate a cleaning command and may control a motor that drives the main brush unit 30 to be driven, and may generate a protrusion command or a retraction command and may control a motor that drives the auxiliary cleaner 100 to be driven. The navigation controller 230 may control a navigation path and a navigation speed of the robot cleaner 1 by controlling the navigation unit 40 according to the user's input or a program that is previously stored. A protrusion or retraction operation of the auxiliary cleaner 100 and a rotation operation of the auxiliary cleaning tool 110 in one or more embodiments may be the same as those described with reference to FIGS. 3 through 6 . That is, a protrusion or retraction operation of the auxiliary cleaner 100 may be performed as the arm motor that drives the side arm 102 or the extension arm 107 rotates, and a rotation operation of the auxiliary cleaning tool 110 may be performed as the rotary motor rotates. A structure of detecting an operation of the auxiliary cleaner 100 and a method of detecting an error of the auxiliary cleaner 100 will be explained in detail. In the following description, a driving unit may include an arm motor that drives a side arm or an extension arm of the auxiliary cleaner 100 . FIG. 9 is a perspective view illustrating a structure of detecting an operation of an auxiliary cleaner, such as the auxiliary cleaner 100 , according to one or more embodiments. Referring to FIG. 9 , a magnet plate 340 may rotate by being coupled to a rotating shaft of a driving unit 120 . Two or more permanent magnets 330 are mounted on the magnet plate 340 . The number of the permanent magnets 330 mounted on the magnet plate 340 may vary according to sizes of the permanent magnets 330 . Hall sensors 311 and 312 may be provided on a side of an outer peripheral surface of the driving unit 120 . A plurality of the hall sensors 311 and 312 may be provided on the outer peripheral surface of the driving unit 120 with a phase difference of, for example, 120 or 90 degrees. As the magnet plate 340 rotates, a magnetic field generated by the permanent magnets 330 may be detected by the hall sensors 311 and 312 , and the hall sensors 311 and 312 may transmit a square-wave signal to the error detector 210 according to the detected magnetic field. In this case, the magnet plate 340 may rotate forward or backward according to a rotation direction of the driving unit 120 . The error detector 210 may determine the rotation direction of the driving unit 120 according to the magnetic field detected by the plurality of hall sensors 311 and 312 . FIG. 10 is a perspective view illustrating a structure of detecting an operation of an auxiliary cleaner, such as the auxiliary cleaner 100 , according to one or more embodiments. Referring to FIG. 10 , a rotary plate 350 in which a plurality of slits may be formed to block or pass light may be coupled to the rotating shaft of the driving unit 120 . A light-emitting unit 360 that emits light toward the rotary plate 350 may be provided, and a light-receiving unit 313 that receives light may be provided on a side of the outer peripheral surface of the driving unit 120 . The light-emitting unit 360 may be, for example, a light-emitting diode (LED), and the light-receiving unit 313 may be, for example, a photo sensor. As the rotary plate 350 rotates, the light-receiving unit 313 may receive light that has been emitted from the light-emitting unit 360 and has been transmitted through the slits formed in the rotary plate 350 . Accordingly, whether the light-receiving unit 313 receives light may be related to whether the driving unit 120 rotates, and a number of times the light-receiving unit 313 receives light may be related to a number of times the driving unit 120 rotates. The light-receiving unit 313 may transmit a square-wave signal to the error detector 210 according to whether light is received. FIG. 11 is a diagram for explaining a method of detecting an error of an auxiliary cleaner according to one or more embodiments, such as the auxiliary cleaner 100 of FIG. 9 or 10 . Referring to FIG. 11 , the error detector 210 may receive a square-wave signal from the hall sensors 311 and 312 or the light-receiving unit 313 . The error detector 210 may determine a rotation direction of the driving unit 120 according to from which hall sensor a square-wave signal is first received from among the plurality of hall sensors 311 and 312 . Accordingly, the error detector 210 may determine whether the auxiliary cleaner 100 performs a protrusion operation or a retraction operation according to whether the rotation direction of the driving unit 120 is a forward direction or a backward direction. The error detector 210 may calculate a rotation speed of the driving unit 120 according to a cycle of a signal received from the hall sensors 311 and 312 or the light-receiving unit 313 . When a signal is received from the hall sensors 311 and 312 , a cycle of the signal is inversely proportional to a rotation speed of the driving unit 120 and a number of the permanent magnets 330 mounted on the magnet plate 340 . When a signal is received from the light-receiving unit 313 , a cycle of the signal is inversely proportional to a rotation speed of the driving unit 120 and a number of the slits formed in the rotary plate 350 . The error detector 210 may calculate a number of times the driving unit 120 rotates by analyzing a square-wave signal received for a preset period of time, and may determine a protrusion or retraction degree of the auxiliary cleaner 100 based on the number of times the driving unit 120 rotates. For example, the error detector 210 may calculate a number of times the driving unit 120 rotates based on a number of times a low level or a high level of a signal is changed. For example, when a rotation speed of the driving unit 120 is a first speed (1×) as shown in FIG. 11 , a number of times a low level or a high level of a signal is changed for a preset period of time may be 5. Likewise, when a rotation speed of the driving unit 120 is a second speed (2×), a number of times a low level or a high level of a signal is changed for a preset period of time may be 10. For example, when a cycle of a signal is repeated 5 times, the rotating shaft of the driving unit 120 may rotate by 45°, and when a cycle of a signal is repeated 10 times, the rotating shaft of the driving unit 120 may rotate by 90°. That is, the error detector 210 may calculate a number of times the driving unit 120 rotates by analyzing a number of times a cycle of a signal is repeated for a preset period of time. When a number of times a cycle of a signal is changed for a preset period of time is less than a critical value, that is, when a number of times a low level or a high level of a signal is changed is less than a critical value, the error detector 210 may determine that an error has occurred in a protrusion or retraction operation of the auxiliary cleaner 100 . The preset period of time may be the same as a time taken for the auxiliary cleaner 100 to normally protrude or retract or a value obtained by adding or subtracting a predetermined period of time to or from the time taken for the auxiliary cleaner 100 to normally protrude or retract. The error detector 210 may determine whether a protrusion operation or a retraction operation of the auxiliary cleaner 100 is completed based on an accumulated number of times the driving unit 120 rotates. When a square-wave signal is received from the hall sensors 311 and 312 or the receiving unit 313 and a number of times a cycle of a signal is repeated for a preset period of time is greater than a critical value even though there is no protrusion command or retraction command for the auxiliary cleaner 100 , the error detector 210 may determine that the auxiliary cleaner 100 has performed an undesired protrusion operation or retraction operation. FIG. 12 is a block diagram illustrating a structure of detecting an operation of an auxiliary cleaner, such as the auxiliary cleaner 100 , according to one or more embodiments. Referring to FIG. 12 , a first detection circuit 314 and a second detection circuit 315 may be provided in the driving unit 120 , and each of the first and second detection circuits 314 and 315 may detect a counter-electromotive force generated when the arm motor or the rotary motor rotates. The first detection circuit 314 and the second detection circuit 315 may be provided at different positions in order to distinguish counter-electromotive forces according to a rotation direction of the driving unit 120 . The error detector 210 may determine whether the auxiliary cleaner 100 performs a protrusion operation or a retraction operation according to whether current corresponding to a forward rotation of the driving unit 120 is detected or current corresponding to a backward rotation of the driving unit 120 is detected. FIG. 13 is a graph for explaining a method of detecting an error of an auxiliary cleaner according to one or more embodiments, such as the auxiliary cleaner 100 of FIG. 12 . Referring to FIG. 13 , a current may be supplied from a power supply circuit to the driving unit 120 according to a protrusion command or a retraction command for the auxiliary cleaner 100 , and the first detection circuit 314 or the second detection circuit 315 may detect an amount of current generated as the arm motor or the rotary motor supplied with the rotates. Current supplied to the arm motor or the rotary motor may be proportional to current detected by the first detection circuit 314 or the second detection circuit 315 . Since an amount of current detected by the first detection circuit 314 or the first detection circuit 314 may be proportional to a protrusion degree or a retraction degree of the auxiliary cleaner 100 , the error detector 210 may determine the protrusion degree or the retraction degree by using the amount of current detected by the first detection circuit 314 or the second detection circuit 315 . For example, current values i 1 and i 2 may need to be supplied in order to drive and rotate the arm motor or the rotary motor as shown in FIG. 13 , and amounts of current S 1 and S 2 supplied to the arm motor or the rotary motor may be set according to a desired protrusion degree or a desired retraction degree of the auxiliary cleaner 100 . Here, the current values i 1 and i 2 and the amounts of current S 1 and S 2 supplied to the arm motor or the rotary motor may vary according to a type of the arm motor or the rotary motor, and the amounts of current S 1 and S 2 supplied to the arm motor or the rotary motor may correspond to values obtained by integrating current values supplied to the arm motor or the rotary motor for periods of time t 1 and t 2 taken for the auxiliary cleaner 100 to operate normally. When an amount of current detected by the first detection circuit 314 or the second detection circuit 315 for a preset period of time is less than a critical value, the error detector 210 may determine that an error has occurred in a protrusion or retraction operation of the auxiliary cleaner 100 . The preset period of time may be the same as a time taken for the auxiliary cleaner 100 to normally protrude or retract or a value obtained by adding or subtracting a predetermined period of time to or from the time taken for the auxiliary cleaner 100 to normally protrude or retract. The error detector 210 may determine whether a protrusion operation or a retraction operation of the auxiliary cleaner 100 is completed based on an accumulated amount of current detected by the first detection circuit 314 or the second detection circuit 315 . When current is detected by the first detection circuit 314 or the second detection circuit 315 and an amount of current detected for a preset period of time is greater than a critical value even though there is no protrusion command or retraction command for the auxiliary cleaner 100 , the error detector 210 may determine that the auxiliary cleaner 100 has performed an undesired protrusion operation or retraction operation. FIGS. 14 and 15 are diagrams illustrating a structure of detecting an operation of an auxiliary cleaner, such as the auxiliary cleaner 100 , according to one or more embodiments. Referring to FIGS. 14 and 15 , in order to protrude or retract the auxiliary cleaner 100 , a contact detection sensor such as, for example, a micro-switch or a contact switch may be provided in a path through which a predetermined mechanism moves. Examples of a contact detection sensor include a sensor that indirectly detects a contact such as a photo interrupter as well as a sensor that physically detects a contact. When it is assumed that a predetermined mechanism pivots about a predetermined rotating shaft as shown in FIG. 14 , a plurality of contact detection sensors 316 may be provided in a radial direction of a mechanism 370 . When it is assumed that a predetermined mechanism linearly moves in a predetermined direction as shown in FIG. 15 , a plurality of the contact detection sensors 316 may be provided in a movement direction of a mechanism 390 . Accordingly, the error detector 210 may indirectly estimate a position of the auxiliary cleaner 100 by using a contact position between a predetermined mechanism and the contact detection sensors 316 . Although a micro-switch is used as only an example in the following description for convenience of explanation, the present embodiment is not limited thereto. Also, the number of the contact detection sensors 316 may vary according to an accuracy in detecting an operation of the auxiliary cleaner 100 , and a resistor 380 may be connected to an end of each of the contact detection sensors 316 . A plurality of micro-switches may be provided to contact a predetermined mechanism in a path through which the predetermined mechanism moves. As the predetermined mechanism moves, a specific micro-switch of the micro-switches may detect a contact, and the error detector 210 may determine whether the auxiliary cleaner 100 performs a protrusion operation or a retract operation based on a position of the specific micro-switch detecting the contact and an order in which contacts are detected. The error detector 210 may calculate an operation speed of the auxiliary cleaner 100 by using a time and a position of a micro-switch detecting a contact, and may determine whether a protrusion operation or a retraction operation of the auxiliary cleaner 100 is completed based on a final position of a micro-switch detecting a contact. When a contact between a mechanism and a micro-switch of a predicted position within a preset period of time is not detected, the error detector 210 may determine that an error occurs in a protrusion or retraction operation of the auxiliary cleaner 100 . The preset period of time may be the same as a time taken for the auxiliary cleaner 100 to normally protrude or retract or a value obtained by adding or subtracting a predetermined period of time to or from the time taken for the auxiliary cleaner 100 to normally protrude or retract as described above. When a position of the auxiliary cleaner 100 is changed and a contact between a mechanism and a micro-switch of a specific position is detected even though there is no protrusion command or retraction command for the auxiliary cleaner 100 , the error detector 210 may determine that the auxiliary cleaner 100 performs an undesired protrusion operation or retraction operation. A method of controlling the robot cleaner 1 according to the structures of detecting an error of the auxiliary cleaner 100 will be explained. FIG. 16 is a flowchart illustrating a method of controlling a robot cleaner in a case where an error occurs when an auxiliary cleaner, such as the auxiliary cleaner 100 , protrudes, according to one or more embodiments. Referring to FIG. 16 , in operation 511 , the controller 200 may determine whether a protrusion command for the auxiliary cleaner 100 is generated. When it is determined in operation 511 that there is a protrusion command for the auxiliary cleaner 100 , the method may proceed to operation 512 . In operation 512 , the controller 200 may determine whether an error is detected in a protrusion operation of the auxiliary cleaner 100 based on a result obtained when the second detector 300 detects the auxiliary cleaner 100 . When it is determined in operation 512 that an error is detected in a protrusion operation of the auxiliary cleaner 100 , the method may proceed to operation 513 . In operation 513 , the first detector 60 may determine whether an obstacle is detected in the protrusion direction of the auxiliary cleaner 100 . When it is determined in operation 513 that an obstacle is detected in the protrusion direction of the auxiliary cleaner 100 , the method may proceed to operation 514 . In operation 514 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by the obstacle (for example, a state where the auxiliary cleaner 100 fails to protrude due to a collision with the obstacle). In operation 515 , the controller 200 may perform an operation in response to the obstacle. In this case, the controller 200 may perform a retraction operation of the auxiliary cleaner 100 in response to the obstacle. Also, the controller 200 may change a navigation direction and a navigation pattern of the robot cleaner 1 in response to the obstacle. When it is determined in operation 513 that an obstacle is not detected in the protrusion direction of the auxiliary cleaner 100 , the method may proceed to operation 516 . In operation 516 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by a change in a floor surface (for example, a state where the floor surface is changed to a floor surface formed of a material with high resistance such as a carpet). In operation 517 , the controller 200 may perform an operation in response to the change in the floor surface. In this case, the controller 200 may perform a retraction operation of the auxiliary cleaner 100 in response to the change in the floor surface. Also, the controller 200 may adjust a protrusion strength of the auxiliary cleaner 100 in response to the change in the floor surface. To this end, the controller 200 may adjust current supplied to the arm motor that protrudes the auxiliary cleaner 100 . When it is determined in operation 511 that there is no protrusion command for the auxiliary cleaner 100 , the method may proceed to operation 518 . In operation 518 , the controller 200 may determine whether an error is detected in a protrusion operation of the auxiliary cleaner 100 based on a result obtained when the second detector 300 detects the auxiliary cleaner 100 . In this case, the controller 200 may additionally determine whether the robot cleaner 1 is in a navigation mode. When it is determined in operation 518 that an error is detected in a protrusion operation of the auxiliary cleaner 100 , the method may proceed to operation 519 . In operation 519 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by an undesired protrusion (for example, a state where the robot cleaner 1 is lowered by the user and the auxiliary cleaner 100 protrudes downward). In operation 520 , the controller 200 may determine that the undesired protrusion is caused by an external force applied by the user, and may control the driving unit 120 to resist the external force in order to maintain a previous state. FIG. 17 is a flowchart illustrating a method of controlling a robot cleaner in a case where an error occurs when an auxiliary cleaner, such as the auxiliary cleaner 100 retracts, according to one or more embodiments. Referring to FIG. 17 , in operation 611 , the controller 200 may determine whether a retraction command for the auxiliary cleaner 100 is generated. When it is determined in operation 611 that there is a retraction command for the auxiliary cleaner 100 , the method may proceed to operation 612 . In operation 612 , the controller 200 may determine whether an error is detected in a retraction operation of the auxiliary cleaner 100 based on a result obtained when the second detector 300 detects the auxiliary cleaner 100 . When it is determined in operation 612 that an error is detected in a retraction operation of the auxiliary cleaner 100 , the method may proceed to operation 613 . In operation 613 , the first detector 60 may determine whether an obstacle is detected in the retraction direction of the auxiliary cleaner 100 . When it is determined in operation 613 that an obstacle is detected in the retraction direction of the auxiliary cleaner 100 , the method may proceed to operation 614 . In operation 614 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by the obstacle (for example, a state where the auxiliary cleaner 100 fails to retract due to the obstacle disposed between the auxiliary cleaner 100 and the main body 10 ). In operation 615 , the controller 200 may perform an operation in response to the obstacle. In this case, the controller 200 may maintain a protrusion state of the auxiliary cleaner 100 for a predetermined period of time in response to the obstacle. Also, the controller 200 may change a navigation direction and a navigation pattern of the robot cleaner 1 in response to the obstacle. When it is determined in operation 613 that an obstacle is not detected in the retraction direction of the auxiliary cleaner 100 , the method may proceed to operation 616 . In operation 616 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by a change in a floor surface (for example, a state where the floor surface is changed to a floor surface formed of a material with high resistance such as a carpet). In operation 617 , the controller 200 may perform an operation in response to the change in the floor surface. In this case, the controller 200 may perform a protrusion operation of the auxiliary cleaner 100 in response to the change in the floor surface. Also, the controller 200 may adjust a retraction strength of the auxiliary cleaner 100 in response to the change in the floor surface. To this end, the controller 200 may adjust current supplied to the arm motor that retracts the auxiliary cleaner 100 . When it is determined in operation 611 that there is no retraction command for the auxiliary cleaner 100 , the method may proceed to operation 618 . In operation 618 , the controller 200 may determine whether an error is detected in a retraction operation of the auxiliary cleaner 100 based on a result obtained when the second detector 300 detects the auxiliary cleaner 100 . In this case, the controller 200 may additionally determine whether the robot cleaner 1 is in a navigation mode. When it is determined in operation 618 that an error is detected in a retraction operation of the auxiliary cleaner 100 , the method may proceed to operation 619 . In operation 619 , the controller 200 may determine that the error of the auxiliary cleaner 100 is caused by an undesired retraction (for example, a state where the user arbitrarily presses down the auxiliary cleaner 100 that is protruding. In operation 620 , the controller 200 may determine that the undesired retraction is caused by an external force applied by the user, and may control the driving unit 120 to resist the external force in order to maintain a previous state. Although two auxiliary cleaning units 100 may be provided on both side portions of the robot cleaner 1 in the above-mentioned embodiments, the embodiments are not limited thereto, and a number and positions of the auxiliary cleaning units 100 are not limited. Each of the auxiliary cleaning units 100 may protrude or retract, and a method of controlling the robot cleaner 1 which may be performed when an error occurs in an operation of each of the auxiliary cleaning units 100 may be applied to each of the auxiliary cleaning units 100 . In one or more embodiments, any apparatus, system, element, or interpretable unit descriptions herein include one or more hardware devices or hardware processing elements. For example, in one or more embodiments, any described apparatus, system, element, retriever, pre or post-processing elements, tracker, detector, encoder, decoder, etc., may further include one or more memories and/or processing elements, and any hardware input/output transmission devices, or represent operating portions/aspects of one or more respective processing elements or devices. Further, the term apparatus should be considered synonymous with elements of a physical system, not limited to a single device or enclosure or all described elements embodied in single respective enclosures in all embodiments, but rather, depending on embodiment, is open to being embodied together or separately in differing enclosures and/or locations through differing hardware elements. In addition to the above described embodiments, embodiments can also be implemented through computer readable code/instructions in/on a non-transitory medium, e.g., a computer readable medium, to control at least one processing device, such as a processor or computer, to implement any above described embodiment. The medium can correspond to any defined, measurable, and tangible structure permitting the storing and/or transmission of the computer readable code. The media may also include, e.g., in combination with the computer readable code, data files, data structures, and the like. One or more embodiments of computer-readable media include: magnetic media such as hard disks, floppy disks, and magnetic tape; optical media such as CD ROM disks and DVDs; magneto-optical media such as optical disks; and hardware devices that are specially configured to store and perform program instructions, such as read-only memory (ROM), random access memory (RAM), flash memory, and the like. Computer readable code may include both machine code, such as produced by a compiler, and files containing higher level code that may be executed by the computer using an interpreter, for example. The media may also be any defined, measurable, and tangible distributed network, so that the computer readable code is stored and executed in a distributed fashion. Still further, as only an example, the processing element could include a processor or a computer processor, and processing elements may be distributed and/or included in a single device. The computer-readable media may also be embodied in at least one application specific integrated circuit (ASIC) or Field Programmable Gate Array (FPGA), as only examples, which execute (e.g., processes like a processor) program instructions. While aspects of the present invention has been particularly shown and described with reference to differing embodiments thereof, it should be understood that these embodiments should be considered in a descriptive sense only and not for purposes of limitation. Descriptions of features or aspects within each embodiment should typically be considered as available for other similar features or aspects in the remaining embodiments. Suitable results may equally be achieved if the described techniques are performed in a different order and/or if components in a described system, architecture, device, or circuit are combined in a different manner and/or replaced or supplemented by other components or their equivalents. Thus, although a few embodiments have been shown and described, with additional embodiments being equally available, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the claims and their equivalents.

1a

FIELD OF THE INVENTION [0001] The present invention pertains to a resilient, flexible, compressible, bio-compatible prosthesis insertable into the stomach to effect weight loss over a controlled period. BACKGROUND OF THE INVENTION [0002] The incidence of obesity and its associated health-related problems have reached epidemic proportions in the United States. See, for example, P. C. Mun et al., “Current Status of Medical and Surgical Therapy for Obesity” Gastroenterology 120:669-681 (2001). Recent investigations suggest that the causes of obesity involve a complex interplay of genetic, environmental, psycho-behavioral, endocrine, metabolic, cultural, and socioeconomic factors. Severe obesity is frequently associated with significant comorbid medical conditions, including coronary artery disease, hypertension, type II diabetes mellitus, gallstones, nonalcoholic steatohepatitis, pulmonary hypertension, and sleep apnea. [0003] Estimates of the incidence of morbid obesity are approximately 2% of the U.S. population and 0.5% worldwide. Current treatments range from diet, exercise, behavioral modification, and pharmacotherapy to various types of surgery, with varying risks and efficacy. In general, nonsurgical modalities, although less invasive, achieve only relatively short-term and limited weight loss in most patients. Surgical treatments include gastroplasty to restrict the capacity of the stomach to hold large amounts of food, such as by stapling or “gastric banding.” Other surgical procedures include gastric bypass and gastric “balloons” which, when deflated, may be inserted into the stomach and then are distended by filling with saline solution. [0004] The need exists for cost effective, less invasive interventions for the treatment of morbid obesity. SUMMARY OF THE INVENTION [0005] The present invention provides a novel system for treatment of morbid obesity by use of a bioabsorbable gastric prosthesis placed in the stomach through a minimally invasive procedure. The prosthesis takes up space in the stomach so that the stomach can hold a limited amount of food, and preferably exerts pressure on the upper fundus to create a sensation of being full. The material of the prosthesis can be selected to degrade over a predetermined period and pass out of the patient without additional intervention. [0006] In the preferred embodiment, the prosthesis is a porous weave of bioabsorbable filaments having an open mesh configuration. The prosthesis can be formed from a cylindrical stent, such as by reverting the ends of the cylinder and joining them at the center. The filaments preferably have memory characteristics tending to maintain an oblate shape with sufficient resiliency and softness so as not to unduly interfere with normal flexing of the stomach or cause abrasion of the mucus coat constituting the inner lining of the stomach. The prosthesis may be free floating in the stomach, but is shaped so as to be biased against the upper fundus, or it may be tacked in position adjacent to the fundus by bioabsorbable sutures. BRIEF DESCRIPTION OF THE DRAWINGS [0007] The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: [0008] [0008]FIG. 1 is a somewhat diagrammatic elevation of a stomach and adjacent parts of the alimentary canal, with the wall adjacent to the viewer partially broken away to reveal an intragastric prosthesis in accordance with the present invention; [0009] [0009]FIG. 2 is a side elevation of a cylindrical stent from which a prosthesis in accordance with the present invention may be formed; [0010] [0010]FIG. 3 is a side elevation of a prosthesis in accordance with the present invention, formed from the stent of FIG. 2; and [0011] [0011]FIG. 4 is a diagrammatic elevation corresponding to FIG. 1, illustrating insertion of a prosthesis in accordance with the present invention through the esophagus and into the stomach. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0012] The present invention provides a volume-filling prosthesis insertable into the stomach for treatment of morbid obesity by taking up space in the stomach to reduce its capacity and by exerting pressure to create a sensation of being full, particularly on the upper fundus. [0013] [0013]FIG. 1 illustrates a central portion of the alimentary canal including the distal segment of the esophagus 10 , the stomach 12 , and the duodenum 14 (proximate segment of the small intestine). The esophagus 10 opens into the stomach 12 toward the top of the lesser curvature 16 adjacent to the fundus 18 . The pyloric part 20 of the stomach leads to the duodenum by way of the gastric outlet or pylorus 22 which forms the distal aperture of the stomach and has an enclosing circular layer of muscle which is normally contracted to close the aperture but which relaxes to provide an open but restricted passage. Although subject to substantial variation in different individuals, representative dimensions for the stomach are approximately 8 cm long (fundus to pylorus) by 5 cm wide (greatest distance between lesser and greater curvatures), with the esophageal opening being approximately 2 cm in diameter and the pylorus having a maximum open diameter of about 2 cm. [0014] In accordance with the present invention, an oblate, volume-filling prosthesis 24 is held within the stomach, sized for reception in the proximate portion adjacent to the opening of the esophagus and fundus. Such prosthesis preferably is a porous body formed of a loose weave of thin polymer filaments 26 , having large spaces between filaments for an open area of at least about 80%, preferably more than 90%, so as not to impede the flow of gastric juices or other functioning in the stomach. The filaments 26 have substantial memory characteristics for maintaining the desired oblate shape and size. However, the filaments preferably are sufficiently soft and flexible to avoid abrasion of the mucus coat forming the inner lining of the stomach and to enable normal flexing and shape changes. The size of the prosthesis 24 is substantially greater than the opening of the esophagus, at least about 3 cm in the narrowest dimension, preferably at least about 4 cm. The longer dimension of the oblate prosthesis is greater than 4 cm, preferably at least about 5 cm to prevent the prosthesis from free movement within the stomach. The size and shape of the prosthesis tend to maintain it in the position indicated in FIG. 1, adjacent to the fundus 18 and remote from the pyloric part 20 . Thus, while the prosthesis occupies a substantial portion of the volume of the stomach, preferably approximately one-half the volume, the prosthesis does not interfere with normal digestion of food, such as by gastric juices (hydrochloric acid and digestive enzymes) nor with passage of food through the pyloric part 20 and its opening 22 to the duodenum 14 . [0015] With reference to FIG. 2, the prosthesis can be formed from a substantially cylindrical stent 28 having the desired porous weave and large open area. The filaments 26 and weave pattern are selected to achieve memory characteristics biasing the prosthesis to the cylindrical condition shown. In the preferred embodiment, the opposite ends 30 of the stent are reverted, the end portions are rolled inward, and the ends are secured together such as by suturing. Alternatively, a disk of the same pattern and material can be used in securing the reverted ends together. The resiliency of the filaments tends to bulge the resulting prosthesis 26 outward to the desired oblate shape. [0016] Prior to reversion of the ends, stent 28 in the condition shown in FIG. 2 can be approximately 2-3 cm in diameter and approximately 8-10 cm long, in a representative embodiment. The filaments can have a diameter of about 0.010 inch to about 0.25 inch. The filaments may be coated or impregnated with other treating agents, such as appetite suppressants, or agents to decrease the likelihood of gastric problems, such as ulcers, due to the presence of a foreign object. However, such problems are unlikely due to the biocompatible nature and the resilient flexibility of the prosthesis. [0017] It is preferred that the filaments 26 be formed of a bioabsorbable polymer such as a polyglycolic acid polymer or polylactic acid polymer. Similar materials are used for some bioabsorbable sutures having “forgiving” memory characteristics and sufficient “softness” that tissue abrasion is inhibited. The absorption characteristics of the filaments 26 can be selected to achieve disintegration of the prosthesis 26 within the range of three months to two years, depending on the severity of obesity. In the preferred embodiment, the prosthesis will absorb and pass naturally from the stomach approximately 6 months after deployment. [0018] Nonbioabsorbable materials may be used, such as Nitinol, which exhibit the desired springiness but which would require that the prosthesis be retrieved. An advantage of the preferred, bioabsorbable embodiment of the invention is that delivery can be through the esophagus, with no additional intervention being required. [0019] With reference to FIG. 4, preferably from the condition shown in FIG. 3, the prosthesis 26 can be compressed to a generally cylindrical shape having a diameter of no more than about 2 cm such that the compressed prosthesis can be carried in a short (approximately 5 cm to 6 cm long) loading tube 32 . The loading tube can be advanced along the esophagus by a central tube 34 of smaller diameter, under the visualization allowed by a conventional endoscope 36 . The tube 34 can enclose a core wire 38 to actuate a pusher mechanism 40 for ejecting the prosthesis 26 when the opening of the esophagus into the stomach has been reached. The endoscope and deployment mechanism can then be retracted. [0020] While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. For example, while it is preferred that the prosthesis be sized for self-retention in the desired position in the stomach, it also may be secured in position by a few sutures applied endoscopically, preferably in or adjacent to the fundus area of the stomach.

1a

FIELD OF THE INVENTION The present invention relates to a puncture resistant material for use in a garment where the garment is intended to offer a significant level of protection against puncture from alien objects. BACKGROUND ART Materials offering varying degrees of such protection for different applications are known, for example those used in items such as bullet resistant vests, surgical and garden gloves etc. The principal requirement of such materials is that they safely perform the function for which they are intended, i.e. that they afford at least the required degree of protection. With garden gloves for example, the gloves are intended to offer the wearer sufficient protection against injury from for example thorns. With a bullet resistant vest, clearly the vest must be able to prevent penetration from bullets. In all cases, the item should ideally not detrimentally affect the activities of the wearer and be as comfortable as possible to wear. Thus for garden gloves, as well as providing protection to the wearer, the gloves should be sufficiently flexible and offer adequate sensitivity so as not to inhibit the gardening activities of the wearer. The flexibility and sensitivity of a garment will depend on the characteristics and dimensions of the material from which it is made. Generally speaking a thicker material will offer less flexibility and sensitivity than a thinner material. In certain applications there is therefore often a compromise between protection and flexibility/sensitivity with regard to the material thickness. For example for surgical gloves the requirements of flexibility and sensitiveness are paramount, bearing in mind the delicate operations a surgeon has to perform. Ideally therefore the material should be as thin as possible. In this connection most surgical gloves currently in use are made from latex, an elastic material which can be made sufficiently thin so as to offer the required degree of flexibility and sensitivity for delicate operative techniques. The choice of latex for surgeon's gloves has in the past arisen predominantly out of the flexibility and sensitivity necessities and has in a protection point of view been in the patient's rather than the surgeon's interests, i.e. for the purpose of maintaining as sterile conditions as possible for the patient so as to minimise the risks of infection. However the use of surgical gloves is now also becoming vital in the role of providing protection for the surgeon against accidental self inflicted injuries that regularly occur by way of so-called `needle stick` accidents. Such accidents occur for example when a surgeon inadvertently stabs himself or herself with a needle or scalpel blade that is being used. Protection in the form of gloves is thus utilised by surgeons and other health workers to reduce the risk of infection to themselves in such circumstances. The puncture resistance of latex gloves is however minimal such that with current concerns in relation to accidental infection of diseases such as HIV (human immunodefeciency virus) and Hepatitis A,B,C,D and E and in the absence of any better alternative, surgeons are often `double gloving`, namely wearing two latex gloves on each hand, one on top of another, to reduce the risks of glove puncture and thus infection. Clearly the use of two gloves in this way can only detrimentally lessen the flexibility and touch sensitivity of the glove to the wearer. There are known materials in the field of armoured clothing, for example as disclosed in co-pending application No. WO 93/21492, which are puncture resistant and are directed to affording protection from projectiles, e.g. bullets. However such materials are generally heavy duty and cannot by virtue of their interlocking construction provide the degree of flexibility required for delicate applications. There are also materials available which are primarily cut or slash resistant in that they offer the wearer of a garment made from such a material increased protection against cuts and slashes made across the material. This is useful for providing protection against, say scalpel wounds. Such materials are however not notably puncture resistant. US-A-5200263 and US-A-5138719 both disclose puncture resistant materials which comprise a plurality of flat platelets formed either of metal discs or carbon fibres which are disposed within the material. Such materials are made by dipping a former into a polymeric material, for example, a latex usually used for glove formation into which has been disposed a plurality of platelets. By virtue of the dipping procedure the platelets to a certain extent orientate in the latex material, but always at the junction of overlaying layers of latex. Materials such as those disclosed in these citations do in fact increase penetration resistance to needle stick but not to the necessary degree, due possibly to a failure of the dipping process to reliably align the platelets, particularly when these are of small size, parallel to the plane of the material. Latex gloves such as those commonly used by surgeons have relatively low puncture resistance. As shown in FIG. 5 which follows, for example, single glove thicknesses have a penetration resistance of about 20 grams and double gloves tend to have a penetration resistance of 40 grams. By way of comparison, leather with an equivalent thickness will have a static load resistance of a little over 200 grams while a Medak glove which is some six times thicker and hence is quite unsuited to surgical use other than for orthopaedic procedures will resist a little over 600 grams static load. SUMMARY OF THE INVENTION The present invention seeks to provide in one aspect a puncture resistant sheet material able to reliably withstand 1000 grams static loading while still maintaining flexibility, sensitivity, and impermeability. The applicants have found that this may be achieved by using pressure-forming techniques since it is believed these act upon the platelets in an unformed polymer mix to orientate them more precisely parallel to the plane of the material in the overlapped condition. Accordingly therefore, the present invention provides a puncture resistant polymeric sheet material comprising a plurality of discrete platelets disposed substantially parallel to the plane of the sheet material in an overlapping orientation; characterised in that the orientation of the platelets in the sheet material has been effected by aligning platelets within the polymeric material by subjecting it to positive or negative pressure when plastic during the forming process. By this means, at least a majority of the platelets are aligned so as to be substantially parallel to the opposed surfaces of the sheet material and in an overlapped position such that the sheet material can reliably resist penetration. The puncture resistant polymeric sheet material is preferably formed into its final shape by stretch blow moulding and hence is particularly suited to the production of gloves, although other blow moulded items may similarly be formed. In a preferred form of the invention, the material has a thickness of more than 200 μm and can withstand a needle point loading above 500 grams. At least the majority of platelets are provided in overlapping interrelation. It is nevertheless desirable for a small proportion, for example, less than 10% to be angled to the plane of orientation of the majority of the platelets. The reason for this is to assist in the prevention of a needle suture point sliding on the high aspect ratio surface of the platelets disposed in the material and hence causing penetration by sliding between adjacent platelets. The angled platelets tend to resist this lateral movement and hence resist tearing of the material. The puncture resistant qualities of the material depend to an extent upon the geometry of the platelets. These may be apertured (e.g. doughnut shaped) allowing a needle tip to locate therein to effectively increase the needle tip load distribution. Alternatively or additionally the platelets may have a contoured surface, with ridges or dimples for example, to reduce the skidding of the needle tip in use. The platelets need not be uniform in size or shape and particularly short reinforcement fibres may be added to the material to increase its tensile strength. Although any suitable platelets may be used, for example metal platelets, in a preferred embodiment, the platelets comprise a high aspect ratio ceramic material. The polymer is preferably an elastomer such as a polyurethane or a polyalkylene, styrene block copolymers or a synthetic rubber such as nitrile rubber. According to a second aspect of the present invention, there is a provided a method of manufacturing a puncture resistant sheet or article of clothing comprising the steps of: (a) mixing discrete platelets with a polymer to form a mixture wherein the platelets are randomly orientated, (b) curing the mixture optionally with pressure and/or heat to form a parison, and subsequently, (c) heating the parison and subjecting it to positive or negative pressures, e.g. blow moulding or vacuum moulding, to form a sheet or article of clothing in which at least a majority of the platelets are pressure orientated so as to be aligned in an overlapping relationship and generally parallel to the opposed faces of the material forming the sheet or article of clothing. The parison may be moulded by injection or indeed extrusion moulding so long as the final product is made by for example vacuum forming or blow moulding. In a preferred form of the invention, a compatible polymer is co-extruded on at least one surface of the parison. According to a final form of the invention, there is provided a parison for a puncture resistant article, said parison comprising an elastomer formed with 10-30% or even up to 60% by weight of ceramic platelets and overlayed on one surface by a compatible polymeric material by coextrusion. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the present invention will now be described by way of illustration only, with reference to FIGS. 1 to 5 of the accompanying drawings in which: FIG. 1 shows in a sectional view as a photo-micrograph of the material in accordance with a preferred embodiment of the present invention, FIG. 2 shows a schematic view of a method of manufacture in accordance with the preferred embodiment in the invention, FIG. 3 shows in perspective a pair of hands showing areas venerable to needles to injury, FIG. 4 shows the material of FIG. 1 made into the shape of a surgeon's glove, and FIG. 5 shows a graph of loadings withstood by various puncture resistant materials at various thicknesses. FIGS. 6a and 6b show in vertical cross-section a mould and a preform for use therewith, and FIGS. 7a and 7b show in vertical cross-section a second stage of the pressure-forming process. DESCRIPTION OF THE PREFERRED EMBODIMENTS The pressure-forming steps of the invention may be effected by blow moulding or vacuum forming. (a) Extrusion Blow Moulding--is a process whereby a cylindrical parison of polymer in its hot, plastic state is introduced into a two piece tool that when closed, simultaneously seals the bottom of the parison and creates the means at the top of the tool for air to be blown into the top of the parison so that the parison inflates to follow the shape of the inner cavity of the tool. This type of blow moulding will result in a seam where the parison is sealed by the tool. The process allows for single layer or multi-layer structures to be formed (co-extrusion). (b) Stretch Blow Moulding--is similar to conventional Extrusion Blow Moulding but a mechanism is incorporated into the tooling that mechanically stretches the parison along its length prior to the blowing stage. This mechanical stretching ensures bi-axial orientation of the polymer with associated improvements in the mechanical properties of the end product. (c) Pre-Form Blow Moulding--is a process whereby a preformed shape is made by injection moulding or polymer dipping or similar and in a secondary process, the pre-form is heated and blown within a cavity mould into the required end product. Vacuum forming requires the provision of negative pressure to the opposed surface of the parison and has the advantage of producing a seamless product. FIG. 1 shows a cross-section through a material 1 according to an embodiment of the invention. The material comprises a plurality of platelets 2 suspended in an elastomer 3. The platelets are dispersed in a generally homogenous manner in the elastomer. Whilst the platelets may be formed of any suitable material, e.g. metal or plastics, FIG. 1 shows ceramic material and in particular, a ceramic silicate. Aluminia silicates are also a preferred choice. The elastomer may be any suitable material for example, polyethylene, polypropylene and polyurethane. The elastomer provides the material with a degree of flexibility in all directions and should have a flexural modulus of <300 MPa and preferably <30 MPa. It will be noted that the platelets are generally aligned in the material such that at least a majority lie parallel to the upper and lower surfaces 4 and 5, also at least the majority of the platelets overlap one another so as to form a continuous barrier across the material. The overlapped nature of the platelets strengthens the barrier against puncture. The thickness or density of the material can be varied to meet particular anti-puncture requirements as desired. For the preferred embodiment of surgeon's glove as shown in FIG. 1, the material is arranged to be of the order of 250 microns thick thereby giving the required flexibility and touch sensibility. The high aspect platelets themselves are preferably 10 to 15 microns across and 1 to 5 microns deep. With these characteristics, the material can withstand an OS4 cutting suture needle, for example 50 mm long and 0.4 mm diameter, loading of 600 to 1200 grams. Of course for different applications, e.g. garden gloves, etc., these variables can be altered as required. As shown in FIG. 1, there are a number of horizontally extending voids. These would normally be occupied by ceramic platelets but these were removed during preparation by polishing of the material for photomicrography. The material may be provided at specific areas only of a garment. For example a glove may be provided with more or less reinforcement only at certain areas. Preferably an entire garment can be manufactured from the material but by means of co-extrusion, certain areas only may be provided with the ceramic reinforcement. A preferred method of production of the glove is shown schematically in FIG. 2. As shown, the liquid elastomer 3 has mixed into it microsized, preferably high aspect ratio, ceramic platelets 2 in powdered form. The resulting mixture is poured into a plug-shape mould 6 such that the mixture can initially set in the shape of a thin wall tube. Of course, any suitable shape may be formed. Thereafter a setting pressure P is preferably applied to the tube at a suitable pressure, such pressure preferably having a preliminary effecting in aligning the platelets so that they begin to become aligned substantially parallel to the surface of the material. The application of pressure to align the platelets of course could be provided as a completely separate step to that of the forming of the parison. In this regard, it will be appreciated that the method of manufacture may include curing the parison by any suitable means. These may include the inclusion of an additive, e.g. an accelerating agent and/or by use of heat and/or pressure. Use of heat and/or pressure may however may have the above-mentioned advantageous effect in preliminarily aligning the platelets. The shaped tube is then heated with heater 7 and blow moulded via mould 12 into the shape of a glove 8. During the blow moulding treatment, the material is compacted a second time under pressure to ensure alignment of at least a majority of the platelets. Whilst a method of manufacturing a glove is described above, the same method can of course be used to produce alternative items. In an alternative method of producing articles of clothing in the present invention, the parison manufactured as produced above may be collapsed to form a substantially flat envelope of material. The profile of the desired article, e.g. a glove, can then be cut from the envelope using any suitable means, for example a laser. The use of a laser is particularly advantageous in that the edges of the opposed faces of the clothing article are fused together along the profile whilst being cut from the collapsed parison. EXAMPLE 1 In a preferred method for the production of a glove in accordance with the present invention, the method of manufacture may be as follows: mixture of polyurethane polymer (Estane; Registered Trade Mark) is admixed with various mixes of Ceramic platelets for example, 0%, 10%, 20% and most preferably 30% by weight. The resultant mixture is then heated and formed into rods and the rods are cut into pellets for further processing. Using other polymers, it is possible to load the material with up to 60% by weight or even higher if the base polymer is highly elastermeric. This is because the lower the flexural modulus of the polymer, the higher the loading of platelets which is possible. These are all then melted and passed through a conventional screw extruder to form a tube shaped parison. The parison may alternatively be made by injection moulding. The so formed parison may be stored as such for future use for a considerable period. Subsequently the final shape, in this case a surgeon's glove, can be formed by moulding. To this end, the parison is subjected to a primary formation step in which the tubular parison is closed at its remote end and a glove-shaped pre-form is formed. The glove-shaped pre-form is then introduced into a final blow moulding step and subjected to biaxial stretch blow moulding by heat and pressure to form the final glove shape, before being removed from the mould for cooling. As the step of blow moulding materials such as bottles is well known, the discovery by the applicant that significantly improved products could be produced by using blow moulding techniques for the formation of a product such as puncture resistant gloves incorporating ceramic particles is a significant advance since it leads to the production of articles having very much improved puncture resistant properties. The materials formed by the above process were then tested against a commercially available latex glove, again the Du Puy (Medak) glove mentioned previously and against a glove material formed by traditional extrusion moulding techniques. The results are shown in FIG. 5. From this figure it will be seen that at 20% ceramic platelets, a blow moulded Estane glove having a final thickness of about 200 μm withstood a loading of between 600 to 800 grams while at the same thickness and using the same starting material, an extruded product could only withstand a static loading of the order of 100-200 grams. The "Medak" glove product had a thickness of about 1200 μm and withstood a loading of 600 grams, while at that thickness the product in accordance of the present invention withstood a loading of between about 800 and 1400 grams. Whereas at 1200 μm the thickness of the inventive glove material is too great for surgical use, it is useful for gardening and industrial gloves and at that thickness is roughly twice as penetration resistant as the Medak glove. At 400 μm, the efficiency of the inventive product is of the order of four times that of the prior art result. The gloves as shown in FIG. 5 are made in accordance with the product as shown in FIG. 1. On the scale shown in FIG. 1, a suture needle tip is in excess of one half of the horizontal transverse section as shown. It follows that the penetration of such a needle, however sharp, must be resisted by a significant number of horizontally overlapping platelets. One of the problems however with the inventive glove product is that at the material surface the ceramic platelets tend to be dislodged. This happens because the platelets are either at the surfaces or immediately adjacent to them. This results in "dusty" surfaces which can become semi-porous. This does not matter for a material intended for industrial gloves for example, which has a thickness of 1200 μm, but it could be a significant feature with regard to the surfaces of gloves having an overall thickness of 250 to 400 μm. To address this, it is often desirable to overlay the parison with a layer of the same or a compatible polymer or elastomer simultaneously with parison formation by, coextrusion. This allows a fine layer of polymeric material of about 5 to 10 μm to overlay the inventive material. It will also be appreciated that for different purposes, the relative thickness and purpose of the layers can be altered at will to provide, for example, a relatively thick platelet free outer layer (or vice-versa). For example the inner and outer surfaces of the puncture resistant material in accordance with the present invention can thus be sealed and the outer surface can be made to have different characteristics than the inner surface. Thus the outer surface may be made to assist gripping whereas the inner surface may be made with a low friction surface to allow the hand to easily don the glove. FIG. 3 shows in perspective a pair of surgeon's hands, namely left hand 9 and right hand 10. On each hand there are shown a number of dots representing areas particularly vulnerable to needlestick injury. In this connection it has been reported that of all hospital related injuries to employees, the highest percentage (35%) is caused by needlestick and other sharp object (sharps) injuries, (British Journal of Nursing, 1992, Vol 1, No 8, Pages 389 to 390). Furthermore form a study reported in the publication British Journal of Surgery 1988, Vol 75, April, pages 314 to 316, the overall perforation rate of surgical gloves used in general surgical procedures was 37.5%. FIG. 4 shows a glove made according to the preferred method described in relation to FIG. 2. Hatched areas 11 represent portions on such a glove which may be additionally reinforced, bearing in mind the vulnerable areas shown in FIG. 3. These areas may alternatively represent portions of material according to the preferred embodiments of the invention, which are applied to existing gloves to increase their resistance to puncture in the vulnerable areas. EXAMPLE 2 The production of a seamless pre-form and a glove formed therefrom was effected as shown in FIGS. 6 and 7 by: (1)Creating a one piece female tool (20) into which the pre-form is blown. This does not create seams or flash. The tool can be cast and not machined and therefore is relatively inexpensive to produce. (2) A pre-form male tool (22) is used to create a pre-form (21) of the polymer/platelet composite from either a hot melt or solvented polymer base. The pre-form (21) is of a size, relative to the female tool (20), that will allow suitable biaxial orientation of the platelet/polymer composite to occur during the blowing or vacuum forming phase, thus the allowed extension should be equal to, or exceed 1.25. (3) When the pre-form (21), still attached to the pre-form tool (22), is inserted into the female tool, an air seal is formed at the neck (23) of the female tool (wrist end) and the pre-form is inflated via a device in the pre-form tool. A vent for air trapped in the cavity of the female tool is provided if necessary. Since the pre-form and the pre-form tool extend into the female tool to a point where the pre-form finger (24) and thumb (25) sections extend into the top of their respective finger (26) and thumb (27) cavities of the female tool, when the pressure applying phase commences, inflation of the pre-form must occur with the fingers and thumb extending into their respective cavities. Thus the need to stretch blow is eliminated. (4) After forming, the pre-form tool (22) is withdrawn (since it is of smaller diameter) through the neck (23) of the female tool. The formed glove is then sucked out of the female tool ready for packaging etc. Since the only flash generated is at the wrist end of the glove that can be quickly removed before the glove is sucked out of the tool. The invention applies therefore to a method for the manufacture of a puncture resistant sheet, to a puncture resistant article formed thereby and to a parison therefor.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a prosthesis inserter which is particularly, although not exclusively, applicable for use for inserting a femoral stem prosthesis. 2. Description of the Prior Art It is difficult, when inserting certain types of prosthesis into a bone cavity, to judge the position and depth of the prosthesis in the bone and this is particularly so when inserting a femoral prosthesis of the collarless type. When a femoral stem prosthesis is inserted into the cement in the prepared socket in the femur it is essential to maintain pressure on the cement while it sets. It is also essential that the stem be seated in the intended position according to alignment and depth. To maintain pressure on the cement, a collarless stem requires a temporary proximal seal. There are many kinds of prosthesis inserters but, in general, they are used to grip the prosthesis to assist the surgeon in implanting it into the prepared opening. It is particularly difficult to grip the femoral component of a total hip prosthesis without damaging the stem. Damage to a femoral component in the region of the neck may lead to a reduction in the fatigue life of the component since the damage may lead to the initiation of cracks. Furthermore, damage to the spigot or trunion of a modular design, that is a stem component in which heads of different sizes or shapes can be fitted to a spigot, may lead to problems with the engagement of the prosthetic femoral head on the stem. Consequently there are many designs of stem introducing instruments which employ protection of the spigot and the neck of the stem. It has also been found with earlier designs which clamp only the spigot, that although the inserter may be tightly clamped to the spigot, there can be rotary movement. The rotary movement can be a nuisance during insertion and can result in an incorrect and misaligned insertion. In many cases it has been found necessary to include a feature on the stem, such as a dimple or a depression into which the stem introducing instrument engages to provide a secure attachment of the stem to the introducer. With such a design of stem introducing instrument, it is usual to achieve engagement onto the stem by advancing an attachment element which engages with the stem. In previous designs the method of advancement has required the surgeon to use two hands to advance the attachment element to secure the stem and, more importantly, has required two hands to be used to effect release. The use of two hands is indicative of the complexity of the methods of engagement and, for a cemented stem, the action to disengage the stem introducing instrument may lead to a disruption of the partially cured cement mantle which may impair the long term result of the implantation. It is therefore desirable to achieve a design of prosthesis inserter which enables the stem to be released with one hand with the minimum disturbance to the cement mantle. SUMMARY OF THE INVENTION Although the present invention can be used with various types of stem introducers it is particularly effective when it can be used with a single handed operating device and where it is possible to release the attachment device of the inserter but without removing it from the prosthesis to be inserted. According to the present invention a prosthesis inserter adapted for use with a prosthesis which is to be held in place with cement in an opening in a bone. The inserter comprises an attachment device for securing and holding the prosthesis to be implanted and includes a pressurizer to bear against a seal which is adapted to surround at least part of the outer circumference of the prosthesis to be implanted. The seal is designed to prevent escape of and to maintain pressure on the cement surrounding the prosthesis at the mouth of the opening in the bone when the prosthesis has been placed in position with respect to the cut bone. Preferably the inserter also includes pressure means to bear against a seal which is adapted to surround at least part of the outer circumference of the prosthesis to be implanted to prevent escape of and to maintain pressure on the cement surrounding the prosthesis at the mouth of the opening in the bone when the prosthesis has been placed in position with respect to the cut bone. Thus, the inserter itself carries the seal and the means to bear against the seal to maintain the pressure in the cement. A stop can also be included to control the position and depth of the prosthesis when it has been placed in position with respect to the cut bone. If this seal is attached to the inserter and is aligned in a defined way corresponding to the cut bone at the opening of the socket, the seal will serve not only to pressurize cement but also to control the stem position as it docks with the cut bone. By using different thicknesses of resilient seal, the depth of insertion of the stem may also be controlled. In one preferred embodiment the seal is secured to the pressure means but in another the sealing means is detachable from the pressure means. In another alternative arrangement the sealing means may not be attached to the pressure means. Preferably the pressure means are in the form of a backing plate carried on a body portion of the inserter and the sealing means are carried on the backing plate. The sealing means can be in the form of a substantially flat pad adapted to surround the prosthesis when in position. The pressurizer can be mounted to enable pressure to be maintained on the seal when the attachment device for holding the prosthesis has been disconnected. This enables the surgeon to disconnect the attachment device but maintain the pressure on the cement through the inserter. In a preferred construction the inserter includes a retractable locator spaced away from the attachment device and adapted to engage the prosthesis to prevent axial and angular movement thereof in relation to the insertion axis of the inserter and release means adapted to release the attachment means or the location means or both. The release means can be adapted for single handed operation. The construction may be arranged so that the implantation loads applied to the inserter are transmitted to the prosthesis to be implanted through the attachment device. Alternatively the construction can be such that implantation loads applied to the inserter are transmitted to the prosthesis to be implanted through the retractable locator. The attachment device is preferably adapted to attach to the head spigot of a femoral component to be inserted and may include a resilient adapter shaped to surround the spigot of the prosthesis and the provision of engagement element which grasp the resilient adapter. Thus, the resilient adapter may include an engagement claw or claws which locate in the engagement element. In another embodiment the attachment device can include an attachment element adapted to attach to the head spigot of the femoral component and to also receive the locator. With this arrangement the attachment element has means for firm attachment to the inserter and thus it may have a tapered socket dimensioned to co-operate with the spigot of the prosthesis and a tapered socket to co-operate with the suitable portion of the inserter adjacent the locator. The attachment element can be adapted to engage the proximal shoulder of the femoral component to be implanted or it may be clear of it. The element can be made from any suitable material, for example a synthetic plastics material such as polycarbonate. In a convenient construction the attachment element can carry means for releasably attaching the means to control the position and depth of the prosthesis when placed in position in the bone and with this arrangement the attachment element can be provided with a pair of supports on which the means to control the position and depth of the prosthesis are carried. Means can be included for adjusting the position of the means to control the position and depth of the prosthesis and in construction where an attachment element is used, as set forth above, the means to control the position and depth of the prosthesis can be provided by a clamp which is tightened when the means to control the position and depth of the prosthesis is fitted. Thus, the clamp can comprise a location member which is clamped between the supports. In another construction the resilient adapter can be in the form of a collet having a flange which is adapted to engage beneath the head spigot of the prosthesis to be implanted and releasable means is provided for retaining the collet in place. If desired the collet can be split. With this construction an operating rod can be included for simultaneously actuating the releasable collet retaining and the releasable locator. The locator can be adapted to engage a location feature on the prosthesis to be implanted and such a feature can be provided by a side or sides of the prosthesis. With this arrangement the locator can be in the form of a retractable bifurcated portion which engages the sides of the prosthesis. Alternatively or additionally the locator may include a retractable pin adapted to engage a location opening in the prosthesis. The device may include a body portion which extends along the axis of insertion, a handle and a trigger for operating the retractable locator. The releasable locator acts to lock the prosthesis in position to prevent rotation and the device can thus easily be removed from the prosthesis once it has been inserted by simple operation of the operating trigger which acts to remove all the connections. With this arrangement it is therefore possible to release the attachment device and locator but to retain the inserter in position on the implant so that pressure can continue to be applied to it and thus to the seal. In the earlier construction referred to above in which the resilient adapter includes a claw or claws the operation is again single handed because the locator can be withdrawn and the attachment device simply disconnected. If desired means can be included to hold the retractable locator in a withdrawn position thus assisting removal. BRIEF DESCRIPTION OF THE DRAWINGS The invention can be preformed in various ways and some embodiments will now be described by way of example and with reference to the accompanying drawings in which: FIG. 1 is a cross sectional side elevation of a first construction of prosthesis inserter embodying pressurizer to bear against the seal according to the invention; FIG. 2 is a plan view from below of the attachment device carried on the inserter; FIG. 3 is a plan view of the pressurizer and seal shown in FIG. 1 and detached from the main part of the inserter; FIG. 4 is an isometric view of an adapter for use with the inserter shown in FIG. 1; FIG. 5 is a end elevation of the adapter shown in FIG. 4; FIGS. 6, 7 and 8 show alternative forms of the locator; FIG. 9 is a side elevation of an alternative construction of adapter embodying the invention; FIG. 10 is an enlarged cross-sectional side elevation of part of the construction shown in FIG. 9; FIG. 11 is a plan view from below of the construction shown in FIG. 10; FIG. 12 is a side elevation of a two part split collet for use in the construction shown in FIGS. 9, 10, and 11; FIG. 13 is an end elevation on the lines XII--XII of FIG. 12 showing one of the collet parts; FIG. 14 is a plan view from above of the collet shown in FIG. 12; FIG. 15 is a cross-sectional side elevation of part of another construction according to the invention. FIG. 16 is a part cross-sectional side elevation showing another alternative construction; FIG. 17 is an isometric view of the attachment element used in the construction shown in FIG. 16; FIG. 18 is an isometric view of the inserter without the attachment element; FIG. 19 is an exploded cross-sectional view of the construction shown in FIG. 16; FIG. 20 is an isometric view of a two-part attachment element with the parts separated; FIG. 21 is a cross-sectional side elevation of an alternative construction of one of the parts shown in FIG. 20; FIG. 22 is a part cross-sectional elevation of an alternative construction of one of the parts shown in FIG. 20; and, FIG. 23 is an isometric view of an alternative construction of two parts of an alternative adjustable two-part attachment element construction. DESCRIPTION OF THE PREFERRED EMBODIMENT As shown in FIGS. 1 to 5 the preferred prosthesis inserter according to the present invention comprises a main body component I having a longitudinal axis and which is the insertion axis, indicated by broken line 2. The main body component 1 includes an angled extension 3 on which is mounted an attachment device 4 for holding a femoral prosthesis component indicated by broken lines 5. The main body component 1 has a cylindrical support 6 on which is carried a compression spring 7 which bears against a sliding collar 8 also mounted on the cylindrical support 6. The collar 8 is provided with a circumferential groove 9 and is connected to an operating rod 10. The spring 7 is housed within a casing 11 having a cylindrical bore 12 to enable it to be carried on the cylindrical support 6 and the end of this support has a square section portion 33 and a screw threaded extension 33a on which is located a rotatable locating disc 13 and a screw threaded lock knob 14. The end of the bore 12 is of square cross-section to locate on the square section 33 of the support 6. The lower part of the casing 11 is extended to form a handle 15 and a guide slot 16 is provided between the handle and the main part of the casing to house a trigger 17. The trigger has an upstanding abutment 18 which locates in the annular groove 9 and is also provided with an extension 19 which is shaped to fit into an opening 20 provided on the outer circumference of the disc 13. The end of the rod 10 spaced away from the handle 15 is guided in an extended bore 31 located in a projecting boss 21 on the extension 3 and the outer end 22 of the rod 10 is shaped, in this example, in the form of a truncated cone, to fit closely into a location feature in the form of a location opening 23 in the prosthesis 5. The prosthesis is of modular design, that is a stem component on which heads of different sizes or shapes can be fitted to a spigot 24. In order to prevent damage to the spigot an adapter 25 is provided which is shown in FIGS. 4 and 5. This adapter can be made from any suitable material, for example metal or a plastics material such as a resilient polycarbonate, and is in the form of a collar 26 one side of which is split to provide an opening 27. A pair of claws 28 extend one on each side of the opening 27 and their outer faces 29 are chamfered, as is most clearly shown in FIG. 5. The internal bore 30 of the collar is slightly less that the outer circumference of the tapered spigot 24 so that it is a push fit onto it, the natural resilience of the material allowing the collar to be placed in position. The attachment device 4 is in the form of a substantially square tray, as is mostly clearly shown in FIG. 2. The tray has three upstanding side walls 34 the upper portions of which are chamfered at 35. The remaining side is open apart from a bar 36 which extends between the two parallel side walls 34 and leaves beneath it an opening 37 to the flat floor 38 of the tray. The angle of the base of the tray is appropriate for the angle of the neck to the stem of the prosthesis to be inserted. To attach a femoral component to be inserted, a collar 25 is first placed over the spigot 24. The claws 28 are then pushed into the tray and rotated about the bar 36 so that they extend into the opening 37. The dimensions of the claws and the distance from their front faces to the outer circumference of the collar is arranged so that the collar together with the femoral component is locked between the bar 36 and the opposed end wall 34 within the portion of the wall beneath the chamfer 35. Moreover, the width between the parallel walls 34 and the distance between the chamfered faces 29 and the remainder of the walls of the claws relative to the two parallel walls 35 is arranged so that there is a constricting effect tending to close the gap in the collar so that the spigot of the femoral component is tightly clamped. With the femoral component located on this attachment device it will be seen that the center line of the femoral component, indicated by reference numeral 40, and the broken line 2 of the inserter are substantially in axial alignment. In the embodiment being described the alignment is slightly displaced but the displacement or the alignment could be as desired. If this were the only means of holding the prosthesis onto the inserter then there is the possibility of the spigot rotating in the collet, despite the clamping effect. The prosthesis is however provided with the location feature in the form of the location opening 23 in the shoulder of the prosthesis. As the prosthesis is rotated into the attachment means the trigger 18 is retracted thus compressing the spring 7 and moving the rod 10 rearwardly. Once the locking pin is approximately in position the trigger can be released and slight further movement will allow the engagement locking pin to move into place. Thus the prosthesis is now held by the attachment device 4 and the retractable locator provided by the pin 10 engage the prosthesis at a point spaced away from the attachment means and prevent axial and angular movement in relation to the insertion axis 2 of the inserter. Because the pin 10 is biased into the location opening 23 any downward insertion load by the surgeon while the prosthesis is being implanted will not be carried by the rod 10 but by the end 32 of the boss 21 bearing against the shoulder of the prosthesis and is also partly carried by the angled stem 3 which transfers the load to the prosthesis through the attachment device 4. The pin 10 merely acts to prevent axial and angular movement. Once the surgeon has completed the insertion and provided the loading on the cement the inserter can be removed by one hand, merely by operating the trigger 17 to remove the rod 10 from the location opening 23 to release the locator and by then simply rotating the inserter about the pin 36 so that the attachment device is also released without unnecessarily disturbing the implanted prosthesis and without having to use both hands. FIGS. 6, 7 and 8 show various alternative embodiments to provide the locator and which can be employed in any of the construction described herein. Thus, FIG. 6 shows an embodiment in which the end of the rod 10 has a single taper 42 and a rounded end 43 which mate with an appropriately shaped opening in the prosthesis 5. FIG. 7 shows a construction in which the end of the rod has a semi circular shape 44 with an appropriate opening in the prosthesis 5 and FIG. 8 shows the end of the rod 10 carrying a bifurcated head 45 which is shaped and dimensioned to fit over the shoulder 46 of the prosthesis 5. In this case the location feature is formed by the sides 47 and 48 of the prosthesis. The angular position of the handle 15 in relation to the angled extension 3 can be altered by relocating it on the square section portion 33 of the support 6. In order to rotate the handle to a different angular position the lock knob 14 is released by unscrewing it sufficiently to move the casing 11 to the right with respect to the support 6 to disengage the square section. The handle is then moved to the desired angular position and slid back onto the square section being subsequently clamped in position by the lock knob 14. The inserter is also provided with pressurizer 50 which bears against a seal 51 which is adapted to surround at least part of the outer circumference of the prosthesis 5 to be implanted to prevent escape of and to maintain pressure on cement (not shown) surrounding the prosthesis at the mouth of the opening in the femur when the prosthesis has been placed in position. The femur of the patient is indicated by reference numeral 52 and it will be seen that the seal, which is in the form of a flat pad of resilient material, for example polyurethane foam can bear against the resected end surface 53 of the femur to form a seal around the prosthesis 5. As will be seen from FIG. 3 the pressurizer 50 is in the form of a U-shaped plate 54 which has a central slot 55. This rigid plate is held by angled support struts 56 to the boss 21 and by further struts 57 to the end of the angled extension 3. These struts and pressure plate are not shown in FIG. 2 in order to make the construction shown in that in that figure more clear. The pressure plate 54 has raised side walls 58 on the surface which faces the seal 53 in order to provide a location for the seal. The seal in the form of the pad 53 is of substantially the same shape in plan as the pressurizer but is split, as indicated at 59, along a portion of its length which is equivalent to the length of the slot 55. The pad 53 can be secured to the pressure plate 54, for example by adhesive, or it can merely be located by the side walls 58 so that it can be easily replaced. Again, if desired, it may not be attached to the pressure plate. Thus it can be placed in position and the plate then applied to it when the plate is pressurized by the surgeon. The construction shown can not only be used to seal and pressurize the cement around the inserted prosthesis but it may also be used to control the position of the prosthesis stem, given the precise resection of the neck of the femur. The seal will prevent cement from escaping from the opening around the neck thus assisting pressurization of the cement and by using different thickness of resilient seal next to the resected femur the intended depth of insertion of the prosthesis will be achieved. The resilient seal can therefore act as means to control the position and depth of the prosthesis in the bone. When locating the stem on the inserter it is slid down the slot 55, the split sides 59 of pad 53 maintaining a tight fit around the sides of the prosthesis. When the prosthesis has been inserted the surgeon can, if he desires, operate the trigger 17 but he can maintain the pressure on the cement merely by continuing to push along the axis of insertion using the inserter itself to thus maintain a steady pressure around most of the circumference of the implant. The inserter is detached from the prosthesis in the manner referred to above. FIGS. 9 to 14 show another embodiment according to the invention in which a retractor is included for retaining a spigot adapter in the form of a split collet in place and an operator is included for simultaneously actuating the retractable spigot adapter retainer and retractable locator. In this construction the device comprises an open framed body 100 in which a sliding rod 101 is mounted. The axis of the rod 101 which also forms the insertion axis is indicated by reference numeral 102. The rod carries a rigidly attached collar 103 on one side of which is located a compression spring 104 the other end of which bears against the frame of the main body 100 so that the rod is biased towards the right, as shown in the drawing. Located on the other side of the collar 103 is a loosely mounted short spring 105 the operation of which will be described hereafter. A third compression spring 106 is also carried on the rod one end of which bears against a frame member 107 and the other end of which acts against an actuator 108 which is also carried on the rod and is in the form of a plate the upper end of which is provided with a slot 109 which can slide along a guide 110 in the upper part of the body frame. The lower part of the actuator 108 is cut away to provide a further guide surface 111 which can slide along a lower frame portion 112. A first operating trigger 113 is also carried on the lower frame 112 by a pivot 114. The lower part of the first trigger 113 is formed as an operating lever 115 and the upper part 116 is shaped to engage the lower part of the actuator 108. An extension of the lower part of the frame 112 is shaped to form a handle 117 on which is pivoted a second operating lever 118 the upper part of which is in the form of a hook 119 which engages the lower part of a locking member 120. The locking member is freely mounted on the rod 101 and the upper part is provided with a yoke 121 which engages on both sides of a retaining ridge 122 on the main body 100. A fourth compression spring 123 is carried on the rod 101 between a rear frame member 124 through which the rod 101 passes and the locking member 120. The rod 101 passes from the body 100 through a tubular extension 125 and emerges as a locating pin 126 which provides locating means. A bracket 127 is carried on the end of the extension 125, and has a socket 128 which forms part of the attachment device. The construction of the attachment device is most clearly shown in FIGS. 10 and 11. The side of the socket 128 is cut away to provide a slot 129 which extends through the bracket 127 and into the cylindrical extension 125 as indicated by reference numeral 130. A collet retainer is provided in the form of a collet lock provided by a flat locking plate 131 which is located in the slot 129 and pivoted by a pin 132. The locking plate is bifurcated at 133 to provide a pair of arms which pass each side of a reduced portion 134 of the rod 101. The reduced portion 134 terminates at one end in an abutment ridge 135 and at the other in an enlargement 136 as is most clearly shown in FIG. 10. The locking plate 131 also carries a locking hook 137 having an engagement face 138 and an engagement wall 140 (most clearly shown in FIG. 10). The socket 128 is dimensioned to receive a split collet of the kind shown in FIGS. 12, 13 and 14. This collet comprises two collet portions 66 and 67 which are made from a resilient plastics material, for example polypropylene. Each of the portions 66, 67 is substantially semi circular and has a closed end provided by an upper wall 68 and a semi circular cavity 69. The cavity is shaped to correspond to the neck 70 and head 71 of the modular prosthesis 72 shown in FIGS. 9, 10 and 11. The collet portion 67 has a flat 73 on one side and as will be seen from the drawings each of the collet portions do not extend around a full half circumference of the spigot but leave a gap between them. The collet and socket 128 are dimensioned so that the collet and spigot are a push fit into the socket which is sufficient to firmly secure and hold the spigot in place, but allowing the spigot and collet to be easily withdrawn. The shaped end 22 of the rod 101 is adapted to engage in a location opening 23 on the shoulder of the prosthesis 72 in a similar manner to the construction shown in FIG. 1 but in this construction it will be seen from FIG. 9 that the insertion axis 102 is not axially aligned with the axis 79 of the prosthesis although it could be if desired. In FIGS. 9, 10 and 11 the inserter is shown in the position in which both the locating pin 126 and locking plate 131 are in the retracted positions they take up when a prosthesis is being attached to the inserter that is, the trunion 71 is located in place in the socket 128 but the location pin 126 is not yet located in the shoulder of the implant. In this position the rod 101 is in its right hand position in the body portion 100 and the first compression spring 104 is not compressed. It will also be seen that the bifurcated portion 133 of the locking plate is against the abutment ridge 135 of the rod 101 and the engagement face 138 of the locking hook 137 is clear of the end of the socket 128. From FIG. 9 it will be seen that in this retracted position the second spring 105 is free on the rod 101 and the third spring 106 is uncompressed and is holding the plate 108 against the trigger 113. The fourth spring 123 is still acting against the locking member 120. Referring to FIGS. 9 and 10, the opening in the locking member 120 is slightly larger than the diameter of the operating rod 101 but because the spring 123 pushes the lever outwardly away from the frame member 124 the lever tends to rotate about the retaining ridge 122 so that the opening operates to jam against the rod 101 and prevent movement. When the second operating lever 118 is operated it rotates and the hook 119 presses against the lower end of the locking lever so that it rotates against the action of the spring 123 and thus frees the rod 101. With the rod freed from the locking member the compression spring 104 when compressed can act against the collar 103 to push the operating rod 101 to the right and into a retracted position as shown in FIG. 9. This position is determined by the enlargement 136 on the rod 101 engaging the bifurcated end 133 of the locking plate which not only causes the locking plate to rotate about the pivot 132 to a retracted position where the hook 137 and engagement wall 140 are clear of the socket 128 but acts to restrain the retracting movement of the rod 101. In the drawing the rod has been moved to the right from this position so that the abutment ridge 135 is engaging the bifurcated portion 133 ready to act against and rotate the locking plate into its locking position. The actuator plate 108 is loosely fit on the rod 101 so that although it can tilt under the action of the trigger 113 it then locks onto the rod 101 and acts to move it against the action of the third spring 106. Thus, the trigger can move the actuating plate to provide an "inching" movement or as a single or separate movements to advance the rod to the operating position where the location pin 126 can engage the location opening 50 in the prosthesis 72. After each movement of the trigger, and when the trigger is relaxed, the third spring 106 pushes the actuating plate 108 to the position shown in FIG. 9 so that the plate always returns to this position after use of the trigger irrespective of the position of the rod 101. This movement of the rod 101 also causes the abutment ridge 135 to engage the locking plate 131 and cause it to rotate to a locking position and the hook 137 overlaps and engages the end of the collet to hold it in position. It also causes the engagement wall 140 to extend slightly into the general curvature of the socket 128 to engage against the flat 73 on the collet part 68 to compress the collet and firmly hold it in position in the socket 128. In order to use the inserter shown in FIGS. 9, 10 and 11 the two piece collet 68 is first placed in position on the neck and tapered spigot of the prosthesis. With the rod 101 in the retracted position as shown in the drawing the collet is placed in position on the spigot 71 and the collet and prosthesis are inserted into the socket 128. The first trigger 113 is operated to move the rod 101 into its operative position with the locating pin entering the location opening 23 in the shoulder of the prosthesis and the hook 137 engaging over the end of the collet, at the same time slightly compressing the collet to hold it firmly in the socket. The prosthesis can now be inserted by the surgeon holding the handle 117 and once the insertion has been completed the inserter can simply be removed by one hand by operating the lever 118 which releases both the locator and the attachment device provided by the locking hook 137 and wall 140 acting on the collet. With these released the inserter can be easily removed, the whole operation being carried out by one hand. In this construction the inserter is also provided with pressure means which are similar to those shown in FIGS. 1 and 3 and the same reference numerals are used to define similar parts. Thus the pressurizer 50 which bears against seal 51 which is adapted to surround at least part of the outer circumference of the prosthesis 72 to be implanted to prevent escape of and to maintain pressure on cement (not shown) surrounding the prosthesis at the mouth of the opening in the bone when the prosthesis has been placed in position. The femur of the patient is again indicated by reference numeral 52 and it will be seen that the seal, which is in the form of a flat pad of resilient material, for example polyurethane form can bear against the resected end surface 53 of the femur to form a seal around the prosthesis 72. The pressurizer 50 are in the form shown in FIG. 3 and comprise a U-shaped plate 54 which has a central slot 55. This rigid plate is held by angled support struts 56 to the extension 125 and by further struts 57 to the bracket 127. The seal in the form of the pad 51 is of substantially the same shape in plan as the pressurizer but is split, as indicated at 59 (see FIG. 3), along a portion of its length which is equivalent to the length of the slot 55. When locating the prosthesis on the inserter it is slid down the slot 55, the slot 59 maintaining a tight fit around the sides of the prosthesis. When the prosthesis has been inserted the surgeon can operate the second trigger 118 to release the attachment device and locator but he can maintain the pressure on the cement merely by continuing to push along the axis of insertion using the inserter itself to thus maintain a steady pressure around most of the circumference of the implant. Because the attachment device and locator are released the pressure on the cement can be maintained with the possibility of interfering with the location of the prosthesis in the cement in the bone. The inserter is detached from the inserted prosthesis by merely sliding the spigot and collet out of the socket 128 and subsequently removing the split collet. Again the removal can be achieved with one hand. FIG. 15 shows another embodiment according to the invention which is somewhat similar to that shown in FIGS. 9 to 11 but in which the locator does not retract. The same reference numerals are used to indicate similar parts to those shown in FIGS. 9 to 11 and a split collet similar to that shown in FIGS. 12 to 13 is employed. In this embodiment rod 101 is provided with a groove 150 and the outer end 151 of the rod is carried in a blind bore 152 provided in a housing 153. This housing is screw threaded at 154 into the outer end of the tubular extension 125. The housing is shaped to provide a locating pin 155 which is appropriately shaped to engage the location opening 23 in the prosthesis. Although it will be appreciated that the shape of this locator could be in any of the forms shown in FIGS. 6, 7 and 8. With this construction the bifurcated part 133 of the locking plate which provides the pair of arms engage in the groove 150 and are acted upon by the abutment ridge 135 provided by one side of the groove. A second abutment ridge 156 is provided by the other side of the groove. The triggers 113 and 117 (not shown in FIG. 15) are operated in a similar manner to that described with regard to FIGS. 9 to 11 but it will be seen that when the rod 101 is advanced it only operates on the locking plate 131, the outer end 151 of the rod 101 sliding in the blind bore 152. Retraction of the locking plate 131 is again achieved in a similar manner to operation of the construction shown in FIGS. 9 to 11 but in this case the second abutment ridge 156 acts against the bifurcation 133 to move the locking plate 131 to its retracted position. This construction is used in a similar manner to that described with regard to FIGS. 9 to 11 but in this case the locator provided by the location pin 155 is pushed into position and the trigger 113 is operated to lock the spigot into the attachment device. In order to remove the inserter the trigger 118 is operated to release the locking plate 131 so that the inserter can be removed. Once again it will be appreciated that all the actions can be carried out with one hand and this construction demonstrates a device in which the release acts only on the locator. It will be appreciated that although various forms of the locator can be employed, for example as shown in FIGS. 6, 7 and 8, there are others which could be equally effective. For example, a locating means can be used which only engages one side wall of the prosthesis to be inserted, the device employing a flat surface which has sufficient length to effectively prevent angular rotation of the prosthesis about its spigot in both directions. In the embodiment shown in FIGS. 16 to 19 another alternative prosthesis inserter according to the present invention comprises a prosthesis holder which includes a tubular main body component 201 having a longitudinal axis co-axial with the insertion axis the distal end of which is attached by a fixing screw 215 which bears on a section of reduced diameter 216 to an operating handle 202. The handle 202 houses a pivotal lever 203 which rotates around pivot 214, and one end of which bears upon one end of an operating rod 204 which can travel along the insertion axis. The operating rod 204 is mounted coaxially with the main body component 201 in a bore and a spring 205 is provided between the distal end of the operating rod 204 and the distal end of the main body component 201 to bias the rod 204 towards a rest position. The proximal end of the operating rod arm 204 has a shaped end 206 of reduced diameter for limited insertion into the femoral prosthesis 207. The proximal end of the main body component 201 has tapered flats 208 shown in FIG. 18 to produce a tapering effect when inserted into a tapered socket 210 of an attachment element 209 the flats precluding torsional movement of the main body component 201 in the element 209. The tapered socket 210 allows limited entry of the main body component 201 while allowing full passage of the operating rod 204. The attachment element 209 also has an additional tapered socket 211 which fits over the tapered spigot 212 of the femoral prosthesis 207 to co-operate therewith and to firmly locate thereon. An engagement feature 213 is provided on the shoulder of the prosthesis 207 for locating the shaped end of the operating rod 204 so that when engaged it ensures that the entire assembly is held rigid. In this construction the attachment element 209 also carries a pressurizer 250 in a similar manner to that described with regard to the earlier constructions described herein. The seal 251 is again adapted to surround at least part of the outer circumference of the prosthesis 207 to prevent escape of and to maintain pressure on cement (not shown) surrounding the prosthesis at the mouth of the opening in the bone when the prosthesis has been placed in position. The seal 251 is again in the form of a flat pad 253 of resilient material, for example polyurethane foam. The pressurizer 250 is again in the form of a U-shaped plate 254 which has a central slot 255. This rigid plate is held by angled support struts 256 which provide supports integral with the attachment element 209. It will be appreciated that the plate 254 again acts as means to control the position and the depth of the prosthesis when it has been placed in position with respect to the cut bone. The attachment element 209 can be made of any convenient material, for example a synthetic plastics material such as polycarbonate. The construction of the seal which is in the form of a pad 253 is a similar construction to that described with regard to the construction shown in FIG. 1 and if desired side walls (not shown) can be provided again as described above. The parts are assembled by firstly firmly inserting the tapered spigot 212 of the femoral prosthesis 207 into the tapered socket 211 of the attachment element 209, then by firmly inserting the tapered end 208 of the tubular main body component into the tapered socket 210 of the attachment element 209 and the shaped end 206 of the operating rod 204 into the engagement feature 213 of the prosthesis 207. To release the femoral prosthesis 207 the pivotal lever 203 is rotated about the pivotal 214 which causes one end of the lever to bear upon the distal end of the operating rod. This causes the spring 205 to be compressed allowing the operating rod 204 to travel within the tubular main body component 201. The shaped end 206 of the operating rod 204 is now caused to bear upon the femoral prosthesis 207 to release the tubular main body component 201 from the attachment element 209 and allowing the attachment 209 to be released from the tapered spigot 212 of the femoral prosthesis 207. FIGS. 20 and 21 show two-part construction of attachment element. In this construction the same reference numerals are used to indicate similar parts to those shown in FIGS. 16 to 19 but in this arrangement the tapered sockets 210 and 211 are interconnected by a bridge 231 which has a slight amount of flexibility. Thus, when the parts are assembled and are in place on the prosthesis 207, the slight amount of flexibility allows the front face 232 of the portion providing the socket 210 to bear against the shoulder of the prosthesis and when the rod 204 is released to move away thus facilitating release. The construction shown in FIGS. 20 and 21 is also provided with a pair of spaced apart supports 233 to allow the connection of means to control the position and depth of the prosthesis when it is placed in position with respect to the bone into which it is to be inserted in the form of a detachable U-shaped pressure plate 234 which is a similar shape to pressure plate 254 described above with regard to the construction shown in FIGS. 16 to 19. This plate 234 however carries a pair of spaced apart rails 235 each of which is provided with a groove 236. Each of the supports 233 has a lip 237 which is dimensioned to slide into grooves 236 when the supports 233 are compressed towards each other thus creating a friction grip in the grooves 236. The grip is insufficient to hold the plate 234 in position and stops (not shown) can be provided if required. This construction is used in the same way as those described above. FIG. 21 shows another embodiment of attachment element, indicated by reference numeral 240, which is similar to that shown in FIGS. 20 and 22 but in which the closed end of the socket 210 is deleted. Thus, the socket is replaced by a tapered bore 241 so that the end of the main body component 201 can pass through it and directly engage the shoulder of the prosthesis 218. In certain requirements there are advantages with this construction in as much the axial forces applied to the handle through the main body component 201 can be directly transferred to the shoulder of the prosthesis. For fitting and removal the apparatus works in the same way as that described with regard to the other constructions. FIG. 23 shows an embodiment somewhat similar to that shown in FIGS. 20 and 21 and, if desired, FIG. 22 but in this arrangement means are provided for adjusting the position of the means to control the position and depth of the prosthesis by adjusting the position of the pressure plate. The attachment element again has tapered sockets 210 and 211 which are interconnected by a bridge 231 but in this construction the tapered socket 211 is provided in a boss 260 which has a slightly raised rim 261. The boss is dimensioned to co-operate with an attachment clip 262 which has a pair of spaced apart supports 263 which have curved internal surfaces 264. These internal surfaces are provided with serrations 265. The other end of the clip is cylindrical as indicated by reference numeral 266 and has an end opening 267. The ends of the supports 263 each carry an engagement ridge 268. To assemble this construction the clip 262 is pushed over the boss 260, the rim 261 engaging the serrations 265. The plate 234 is connected to the ridges 268 in a similar manner to that described with regard to FIG. 20 and the squeezing effect of the rails 235 on the ends of the supports 263 acts to clip the supports in a desired position on the boss 260, the affect of the compression of the supports acting as a clamp. Thus, the position of the pressure plate 234 can be adjusted and set as desired by the surgeon. The boss 260 and its rim 261 acting as a location member for the plate 234. Once again the apparatus can be used in the manner described above with regard to the other FIGS.

1a

RELATED APPLICATION [0001] This application claims benefit of priority from U.S. Provisional Patent Application No. 61/530,695, filed Sep. 2, 2011, TECHNICAL FIELD [0002] The present invention relates to a pulmonary air leakage occluding agent comprising a self-assembling peptide hydrogel. BACKGROUND OF THE INVENTION [0003] Pulmonary air leaks due to thoracic trauma, thoracic and pulmonary surgery, lung cancer, and pyothorax remain challenging clinical problems. Lung surgeries include open surgery, thoracoscopic surgery, and bronchoscopic surgery. Lung surgeries also include lung transplants. During and following lung surgery, air often leaks for sutured sites, resected surfaces of lungs, bronchial anastomosis sites, and sites of bronchorrhaphy (suture of a wound of a bronchus). Such air leaks cause collapse of the lungs (pneumothorax) and empyema. [0004] Traditionally, pulmonary air leaks have been treated with the insertion, through the chest wall, of chest tubes through which vacuum is applied to maintain lung volume until the air leak has sealed. More recently, products have been developed and used in the treatment of pulmonary air leaks. These products include oxidized cellulose, polyglycolic acid, and fibrin glues. Such products are typically applied directly to the site or sites of air leakage. [0005] Existing products for the treatment of pulmonary air leaks have certain disadvantages. For example, fibrin glue, consisting of a biological substance, presents a risk of infection. Moreover, fibrin glue frequently solidifies during its application, thereby limiting its efficacy and ease of use. Both oxidized cellulose and polyglycolic acid have been found to have only limited efficacy. [0006] US 2011/0002880 and US 2011/0201541 disclose certain self-assembling peptides useful for wound healing, skin reconstruction, and tissue occlusion to prevent leakage of body fluids (e.g., to achieve hemostasis). SUMMARY OF THE INVENTION [0007] The present inventors have completed this invention upon finding that a pulmonary air leakage occluding effect equivalent to or greater than that of existing pulmonary air leakage occluding agents is exhibited when a self-assembling peptide hydrogel utilized as a scaffold for cell culture is applied for pulmonary air leakage occlusion. [0008] Specifically, the invention relates to a pulmonary air leakage occluding agent containing a peptide, wherein the peptide is an amphiphilic peptide having 8-200 amino acid residues with the hydrophilic amino acids and hydrophobic amino acids alternately bonded, and is a self-assembling peptide exhibiting a beta-sheet structure in aqueous solution in the presence of physiological pH and/or in the presence of a cation. [0009] In one embodiment, the peptide is 16 amino acid residues long. [0010] In one embodiment, the peptide comprises a repeated sequence arginine-alanine-aspartic acid (RAD). In one embodiment, the peptide consists essentially of a repeated sequence arginine-alanine-aspartic acid (RAD). In one embodiment, the peptide is a repeated sequence arginine-alanine-aspartie acid (RAD). [0011] In one embodiment, the peptide comprises a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). In one embodiment, the peptide consists essentially of a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). In one embodiment, the peptide is a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). [0012] In one embodiment the peptide has the amino acid sequence Ac-(RADA,) 4 -CONH 2 (SEQ ID NO:1), Ac-(IEIK) 3 I-CONH 2 (SEQ ID NO:2), or Ac-(KLDL) 3 -CONH 2 (SEQ ID NO:3). [0013] In one embodiment, the peptide has the amino acid sequence (RAD) 5 R (SEQ ID No:4), (ADR) 5 A (SEQ ID NO:5), or (DRA) 5 ) (SEQ ID NO:6). [0014] In one embodiment, the peptide is provided as an aqueous solution of about 0.5% to about 3% (weight of peptide to volume). [0015] An aspect of the invention is a method of occluding a pulmonary air leak. The method includes the step of applying to a site of pulmonary air leak an effective amount of an amphiphilic peptide having 8-200 amino acid residues with the hydrophilic amino acids and hydrophobic amino acids alternately bonded, and is a self-assembling peptide exhibiting a beta-sheet structure in aqueous solution in the presence of physiological pH and/or in the presence of a cation. [0016] In one embodiment, the peptide is 16 amino acid residues long. [0017] In one embodiment, the peptide comprises a repeated sequence arginine-alanine-aspartic acid (RAD). In one embodiment, the peptide consists essentially of a repeated sequence arginine-alanine-aspartic acid (RAD). In one embodiment, the peptide is a repeated sequence arginine-alanine-aspartic acid (RAD). [0018] In one embodiment, the peptide comprises a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). in one embodiment, the peptide consists essentially of a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). In one embodiment, the peptide is a repeated sequence arginine-alanine-aspartic acid-alanine (RADA). [0019] In one embodiment the peptide has the amino acid sequence Ac-(RADA) 4 -CONH 2 (SEQ ID NO:1), Ac-(IEIK) 3 I-CONH 2 (SEQ ID NO:2), or Ac-(KLDL) 3 -CONH 2 (SEQ ID NO:3). [0020] In one embodiment, the peptide has the amino acid sequence (RAD) 5 R (SEQ ID NO:4), (ADR) 5 A (SEQ ID NO:5), or (DRA) 5 D (SEQ ID NO:6). [0021] In one embodiment, the peptide is provided as an aqueous solution of about 0.5% to about 3% (weight of peptide to volume). [0022] In one embodiment, the peptide is applied to lungs. [0023] In one embodiment, the peptide is applied to a bronchus. [0024] In one embodiment, the peptide is applied thoracoscopically. [0025] In one embodiment, the peptide is applied bronchoscopically. [0026] In certain embodiments the pulmonary air leak occluding agent also includes at least one small molecule drug useful to treat a condition selected from cancer, inflammation, and infection. BRIEF DESCRIPTION OF THE FIGURES [0027] FIG. 1 is a group of three chest X-rays of a mini-pig obtained before (left), immediately after (middle), and 10 days after treatment of a surgically created pulmonary air leak with a self-assembling peptide hydrogel of the invention. [0028] FIG. 2 is a pair of photomicrographs depicting histopathologic appearance of lung tissue with a surgically created puncture and occlusion by self-assembling peptide hydrogel. The image on the right is a detail of the circled portion of the image on the left. Self-assembling peptide hydrogel is indicated by a circle in the image on the right. DETAILED DESCRIPTION OF THE INVENTION [0029] Self-assembling peptides have a property whereby the peptide molecules form regularly arranged self-assemblies according to their amino acid sequence. In recent years, these have attracted much attention as novel materials because of their physical, chemical, and biological properties. [0030] Self-assembling peptides of the invention have an alternating structure of electrically charged hydrophilic amino acids and electrically neutral hydrophobic amino acids, and alternating distribution of positive charge and negative charge, whereby they adopt a beta-sheet structure at physiological pH and salt concentration. [0031] Hydrophilic amino acids that can be used include acidic amino acids such as aspartic acid and glutamic acid, and basic amino acids such as arginine, lysine, histine, and ornithine. [0032] As hydrophobic amino acids there may be used alanine, valine, leucine, isoleucine, methionine, phenylalanine, tyrosine, tryptophan, serine, threonine, or glycine. [0033] The self-assembly of such peptides occurs under the following conditions. [0034] (1) The peptide molecules adopt a beta-sheet structure in aqueous solution, wherein the charged hydrophilic amino acids and electrically neutral hydrophobic amino acids are maldistributed on the two sides of the peptide molecules. [0035] (2) The beta-sheet structure results in a complementary electrical distribution between adjacent molecules. [0036] (3) The beta-sheet structure leads to sufficient hydrophobic bonding between adjacent molecules. [0037] (4) The electrical charge of the amino acid side chains is screened by monovalent inorganic salts. [0038] (5) The molecules are electrostatically neutral near the isoelectric point of the peptide. [0039] It is believed that self-assembly occurs by the following mechanism when these conditions are all satisfied. [0040] (1) The alternating distribution of positive charge and negative charge in the peptide molecules causes attraction between the molecules. [0041] (2) Hydrophobic bonds are formed between the neutral amino acid side chains of adjacent molecules. [0042] (3) The positive/negative electrical distribution results in complementary alignment between adjacent molecules, and associative force between the molecules is strengthened. [0043] (4) The molecular aggregates gradually extend, forming nanofibers. [0044] The nanofibers are superfine fibers with thicknesses of about 10 nm to 20 nm, and they aggregate to form meshwork and exhibit a macroscopically gel-like form. [0045] The gel network structure strongly resembles a natural extracellular matrix (ECM) in terms of its fiber size and pore size, and its use as a scaffold for cell culture is being studied. [0046] Since the peptide hydrogel is biodegradable and its decomposition product does not adversely affect tissue, while it is also highly bioabsorbable, it is suitable for cellular engraftment and growth. [0047] Because self-assembling peptides are chemical synthetic products, rather than products isolated from biological sources, they do not carry the risk of infectious disease from animal-derived products, including animal viruses and other infectious agents such as the agent of mad cow disease (bovine spongiform encephalopathy, BSE). [0048] In this pulmonary air leakage occluding agent, the peptide is preferably a self-assembling peptide having a repeating sequence arginine-alanine-aspartic acid-alanine (RADA); a repeating sequence isoleucine-glutamic acid-isoleucine-lysine (IEIK); or a repeating sequence lysine-leucine-aspartic acid-leucine (KLDL). In one embodiment, it is a self-assembling peptide comprising the amino acid sequence Ac-(RADA) 4 -CONEH 2 (SEQ ID NO:1). In one embodiment, it is a self-assembling peptide comprising the amino acid sequence Ac-(IEIK) 3 I-CONH 2 (SEQ ID NO:2). In one embodiment, it is a self-assembling peptide comprising the amino acid sequence Ac-(K1 DL) 3 -CONH 2 (SEQ ID NO:3). [0049] The pulmonary air leakage occluding agent of the invention will now be explained in detail. [0050] The main component of the pulmonary air leakage occluding agent of the invention is a self-assembling peptide which is an amphiphilic peptide having 8-200 amino acid residues with the hydrophilic amino acids and hydrophobic amino acids alternately bonded, and it exhibits a beta-sheet structure in aqueous solution in the presence of physiological pH and/or a cation. [0051] According to the invention, physiological pH is pH 6-8, preferably pH 6.5-7.5 and more preferably pH-1 7.3-7.5. [0052] A “cation” as used herein is a positively charged ion, for example, sodium ion (Na + ) or potassium ion (K + ). In one embodiment, the cation is present at a concentration of about 5 mM to 5 M. A cation can be a single cation or any combination of cations. [0053] Self-assembling peptides used for the invention can be represented by the following four general formulas. [0000] ((XY) l -(ZY) m ) n   (I) [0000] ((YX) l -(YZ) m ) n   (II) [0000] ((ZY) l -(XY) m ) n   (III) [0000] ((YZ) l -(YX) m ) n   (IV) [0054] In formulas (I)-(IV), X represents an acidic amino acid, Y represents a hydrophobic amino acid, Z represents a basic amino acid, and l, m, and n are all integers, wherein n×(1+m)<200. [0055] Of course, it is not required that a peptide of the invention begin and end with complete repeating unit. That is, only a portion of any given repeating unit may be present at either one or both ends of a peptide of the invention. For example, a peptide made up primarily of RADA repeating units may begin with N-terminal A, DA, or ADA; likewise, a peptide made up primarily of RADA repeating units may end with C-terminal R, RA, or RAD. [0056] The N-terminals may be acetylated, and the C-terminals may be amidated. [0057] Hydrophilic amino acids that can be used include acidic amino acids such as aspartic acid and glutamic acid, and basic amino acids such as arginine, lysine, histidine and ornithine. As hydrophobic amino acids there may be used alanine valine, leucine, isoleucine, methionine, phenylalanine, tyrosine, tryptophan, serine, threonine or glycine. [0058] Preferred among these self-assembling peptides are self-assembling peptides having the repeating sequence arginine-alanine-aspartic acid-alanine (RADA), and such peptide sequences are represented by Ac-(RADA) p -CONH 2 (p=2-50) (SEQ ID NO:7). There are also preferred self-assembling peptides having the repeating sequence isoleucine-glutamic acid-isoleucine-lysine (IEIK), and such peptide sequences are represented by Ac-(IEIK) p I-CONH 2 (p=2-50) (SEQ ID NO:8). There are additionally preferred self-assembling peptides having the repeating sequence lysine-leucine-aspartic acid-leucine (KLDL), and such peptide sequences are represented by Ac-(KLDL) p -CONH 2 (p=2-50) (SEQ ID NO:9). These self-assembling peptides may be composed of 8-200 amino acid residues, with 8-32 residue self-assembling peptides being preferred, and self-assembling peptides having 12-16 residues being more preferred. In one embodiment, the peptide is 16 amino acid residues long. [0059] As specific examples of self-assembling peptides according to the invention there may be mentioned peptide RAD 16-I having the sequence Ac-(RADA) 4 -CONH 2 (SEQ ID NO:1), peptide IEIK13 having the sequence Ac-(IEIK) 3 I-CONH 2 (SEQ ID NO:2), and peptide KLD having the sequence Ac-(KLDL) 3 -CONH 2 (SEQ ID NO:3). A 1% aqueous solution of RAD16-I is available as the product PuraMatrix™ by 3D-Matrix Co., Ltd. PuraMatrix™ contains 1% peptide having the sequence Ac-(RADA) 4 -CONH 2 (SEQ ID NO:1), with hydrogen ion and chloride ion. [0060] In one embodiment, the peptide has the amino acid sequence (RAD) 5 R (SEQ ID NO:4), (ADR) 5 A (SEQ ID NO:5), or (DRA) 5 D (SEQ ID NO:6). The N-terminals may be acetylated, and the C-terminals may be amidated, similar to SEQ ID NOs:1-3. [0061] Peptides in accordance with the invention can be prepared using standard peptide synthetic methods and apparatus, e.g., using a programmable automated peptide synthesizer. Peptide synthesizers and reagents for use with same are readily available from any of a number of commercial suppliers, e.g., Applied Biosystems. [0062] PuraMatrix™, IEIK13, and KLD are oligopeptides of 12-16 amino acid residues and having a length of about 5 nm. Although their solutions are liquid at acidic pH, at a concentration of at least about 0.1% (w/v) the peptides undergo self-organization upon change to neutral pH, forming nanofibers with diameters of about 10 nm, causing gelling of the peptide solutions. [0063] PuraMatrix™ is an amphiphilic peptide having an amino acid sequence with alternate repeats of positively charged arginine and negatively charged aspartic acid as hydrophilic amino acids, and alanine as a hydrophobic amino acid. IEIK13 is an amphiphilic peptide having an amino acid sequence with alternate repeats of positively charged lysine and negatively charged glutamic acid as hydrophilic amino acids and isoleucine as a hydrophobic amino acid. KLD is an amphiphilic peptide having an amino acid sequence with alternate repeats of positively charged lysine and negatively charged aspartic acid as hydrophilic amino acids and leucine as a hydrophobic amino acid. The self-assembly of these peptides is due to hydrogen bonding and hydrophobic bonding between the peptide molecules by the amino acids composing the peptides. [0064] In the self-assembling peptides used for the invention, the nanofiber diameter is 10-20 nm and the pore size is 5-200 nm, as averages. These numerical value ranges are approximately the same as collagen, which is a natural extracellular matrix. [0065] Physiological pH and salt concentration are conditions for self-assembly of the self-assembling peptides of the invention. The presence of a monovalent alkali metal ion promotes gelling. Once gelling has occurred, the gel does not decompose, even under common protein-denaturing conditions such as exposure to high temperature or denaturing agents such as acids, alkalis, proteases, urea, guanidine hydrochloride or the like. [0066] These self-assembling peptides, such as PuraMatrix™, are peptide sequences lacking a distinct physiologically active motif, and therefore intrinsic cell function is not impaired. Physiologically active motifs control numerous intracellular phenomena such as transcription, and the presence of physiologically active motifs can lead to phosphorylation of intracytoplasmic or cell surface proteins by enzymes that recognize the motifs. When a physiologically active motif is present in a peptide agent, transcription of proteins with various functions can be activated or suppressed, The self-assembling peptides, such as Pura Matrix™, lack such physiologically active motifs and therefore do not carry this risk. [0067] Furthermore, a self-assembling peptide composed of natural amino acids also has satisfactory biocompatibility and biodegradability, and it has been reported that infusion of PuraMatrix™ into murine cardiac muscle, for example, results in infiltration of cells into the PuraMatrix™ and formation of normal tissue. The decomposition time diMrs depending on the conditions such as the location of infusion, but the fibers decompose and are excreted by about 2 to 8 weeks after infusion. [0068] The pulmonary air lelikage occluding agent of the invention may further contain one or more small molecule drugs. As used herein, a small molecule drug is an organic molecule of up to 1 kDa molecular weight having pharmaceutical activity. [0069] There are no particular restrictions on such small molecule drugs, and these may include, without limitation, glucose, saccharose, purified saccharose, lactose, maltose, trehalose, dextran, iodine, lysozyme chloride, dimethylisopropyiazulene, tretinoin tocoferil, povidone iodine, alprostadil alfadex, anise alcohol, isoamyl salicylate, alpha, alpha-dimethylphenylethyl alcohol, bacdanol, sulfazin silver, bucladesine sodium, alprostadil alfadex, gentamycin sulfate, tetracycline hydrochloride, sodium fusidate, mupirocin calcium hydrate and isoamyl benzoate. [0070] The small molecule drug can be an anti-cancer agent. As used herein, an anti-cancer agent refers to a chemotherapeutic agent or other small molecule or radionuclide useful for killing cancer cells. Examples of chemotherapeutic agents include 13-cis-Retinoic Acid, 2-Chlorodeoxyadenosine, 5-Azacitidine, 5-Huorouracil, (5-FU), 6-Mercaptopurine, (6-MP), 6-Thioguanine (6-TG), Abraxane, Accutane®, Actinomycin-D, Adriamyein®, Adrucil®, Afinitor®, Agrylin®, Ala-Cort®, Aldesleukin, ALIMTA, Alitretinoin, Alkaban-AQ®, Alleran®, All-Transretinoic Acid, Altretamine, Amethopterin, Amifostine, Aminoglutethimide, Anagrelide, Anandron®, Anastrozole, Arabinosylcytosine, Ara C, Aranesp®, Aredia®, Arimidex®, Arranon®, Arsenic Trioxide, Arzerra 1 ™, Asparaginase, ATRA, Avastin®, Azacitidine, BCG, BCNU, Bendamustine, Bexarotene, BEXXAR®, Bicalutamide, BiCNU, Blenoxane®, Bleomycin, Busulfan, Busulfex®, C225, Calcium Leucovorin, Camptosar®, Camptothecin-11, Capecitabine, Carac™, Carboplatin, Carmustine, Carmustine Wafer, Casodex®, CC-5013, CCI-779, CCNU, CDDP, CeeNU, Cerubidine®, Chlorambucil, Cisplatin, Citrovorum Factor, Cladribine, Cortisone, Cosmegen®, CPT-11, Cyclophosphamide, Cytadren®, Cytarabine, Cytarabine Liposomal, Cytosar-U®, Cytoxan®, Dacarbazine, Dacogen, Dactinomycin, Darbepoetin Alfa, Dasatinib, Daunomycin, Daunorubicin, Daunorubicin Hydrochloride, Daunorubicin Liposomal, DaunoXome®, Decadron, Decitabine, Delta-Cortef®, Deltasone®, Denileukin, Diftitox, DepoCyt™, Dexamethasone, Dexamethasone Acetate, Dexamethasone Sodium Phosphate, Dexasone, Dexrazoxane, DHAD, DIC, Diodex, Docetaxel, Doxil®, Doxorubicin, Doxorubicin Liposomal, Droxia™, DTIC, DTIC-Dome®, Duralone®, Efudex®, Eligard™, Ellence™, Eloxatin™, Elspar®, Emcyt®, Epirubicin, Erbitux, Erlotinib, Erwinia, L-asparaginase, Estramustine, Ethyol, Etopophos®, Etoposide, Etoposide Phosphate, Eulexin®, Everolirnus, Evista®, Exemestane, Fareston®, Faslodex®, Femara®, Filgrastim, Floxuridine, Fludara®, Fludarabine, Fluoroplex®, Fluorouracil, Huoxymesterone, Flutamide, Folinic Acid, FUDR®, Fulvestrant, Gefitinib, Gemcitabine, Gemzar, Gleevec™, Gliadel® Wafer, Goscerelin, Halotestin®, Herceptin®, Hexadrol, Hexalen®, Hexamethylmelamine (HMM), Hycamtin®, Hydrea®, Hydrocort Acetate®, Hydrocortisone, Hydrocortisone Sodium Phosphate, Hydrocortisone Sodium Succinate, Hydrocortone Phosphate, Hydroxyurea, Tiuxetan, Idamycin®, Idarubicin, Ifex®, Ifosfamide, Imatinib mesylate, Imidazole Carboxamide, Introit A®, Iressa®, Irinotecan, Isotretinoin, Ixabepilone, Ixempra™, Kidrolase (t), Lanacort®, L-asparaginase, LCR, Lenalidomide, Letrozole, Leucovorin, Leukeran, Leukine™, Leuprolide, Leurocristine, Leustatin™, Liposomal Ara-C, Liquid Pred®, Lomustine, L-PAM, L-Sarcolysin, Lupron®, Lupron Depot®, Matulane®, Maxidex, Mechlorethamine, Mechlorethamine Hydrochloride, Medralone®, Medrol®, Megace®, Megestrol, Megestrol Acetate, Melphalan, Mercaptopurine, Mesna, Mesnex™, Methotrexate, Methotrexate Sodium, Methylprednisolone, Meticorten®, Mitomycin, Mitomycin-C, Mitoxantrone, M-Prednisol®, MTC, MTX, Mustargen®, Mustine, Mutamycin®, Myleran®, Mylocel™, Mylotarg®, Navelbine®, Nelarabine, Neosar®, Neulasta™, Neumega®, Neupogen®, Nexavar®, Nilandron®, Nitotinib, Nilutamide, Nipent®, Nitrogen Mustard, Novaldex®, Novantrone®, Nplate, Octreotide, Octreotide acetate, Oncospar®, Oncovin®, Ontak®, Onxal™, Oprelvekin, Orapred®, Orasone®, Oxaliplatin, Paclitaxel, Pamidronate, Panretin®, Paraplatin®, Pazopanib, Pediapred®, Pegaspargase, Pegfilgrastim, PEG-L-asparaginase, PEMETREXED, Pentostatin, Phenylalanine Mustard, Platinol®, Platinol-AQ®, Prednisolone, Prednisone, Prelone®, Procarbazine, Prolifeprospan 20 with Carmustine Implant, Purinethol®, Raloxifene, Revlimid®, Rheumatrex®, Romiplostim, Rubex®, Rubidomycin hydrochloride, Sandostatin®, Sandostatin LAR®, Sargramostim, Solu-Cortef®, Solu-Medrol®, Sorafenib, SPRYCEL™, STI-571, Streptozocin, SU11248, Sunitinib, Sutent®, Tamoxifen, Tarceva®, Targretin®, Tasigna®, Taxol®, Taxotere®, Temodar®, Ternozolomide, Ternsiroiimus, Teniposide, TESPA, Thalidomide, Thalomid®, TheraCys®, Thioguanine, Thioguanine Tabloid®, Thiophosphoamide, Thioplex®, Thiotepa, TICE®, Toposar®, Topotecan, Toremifene, Torisel®, Treanda®, Tretinoin, Trexall™, Trisenox®, TSPA, TYKERB®, VCR, Vectibix™, Velban®, Velcade®, VePesid®, Vesanoid®, Viadur™, Vidaza®, Vinblastine, Vinblastine Sulfate, Vincasar Pfs®, Vincristine, Vinorelbine, Vinorelbine tartrate, VLB, VM-26, Vorinostat, Votrient, VP-16, Vumon®, Xeloda®, Zanosar®, Zevalin™, Zinecard®, Zoladex®, Zoledronic acid, Zolinza, and Zometa®. [0071] The small molecule drug can be an anti-inflammatory agent. Anti-inflammatory agents include corticosteroids (e.g., prednisone, cortisone, methylprednisolone) and non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, celecoxib, diclofenc sodium, flurbiprofen, fenoprofen calcium, ibuprofen, indomethacin, ketoprofen, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tolmetin sodium, and valdecoxib). [0072] The small molecule drug can be an anti-infective agent. Anti-infective agents include antibacterial antibiotics, antivirals, and antifungals, and paraciticides. [0073] A sugar may be added to the pulmonary air leakage occluding agent of the invention to improve the osmotic pressure of the solution from hypotonicity to isotonicity without reducing the pulmonary air leakage occluding effect, thereby allowing the biological safety to be increased. [0074] The pulmonary air leakage occluding agent of the invention may be in the form of a powder, a solution, a gel, or the like. Since the self-assembling peptide gelates in response to changes in solution pH and salt concentration, it can be distributed as a liquid drug that gelates upon contact, or shortly following contact, with the body during application. [0075] Formulations for clinical use can include cylinder-equipped syringes or pipettes that are prefined with chemical solution containing components such as self-assembling peptides (prefilled syringes), or methods of supplying a chemical solution to a syringe or pipette chip by means that supplies the components through the opening of the syringe or pipette chip (an aspirator or valve), and applying it to the affected area through the discharge section. A construction with two or more syringes or pipettes is sometimes used. [0076] The components may be used as a coating on an instrument such as a stent or catheter, to suppress pulmonary air leakage. [0077] Also, the components may be anchored on a support such as gauze or a bandage, or a lining, that is commonly used in the field. The components may also be soaked into a sponge for use. [0078] In addition, an atomizing sprayer filled with a powder or solution of the components may be prepared. When such a spray is used fbr spraying onto an affected area, the pH and salt concentration increase upon contact with the Indy, thereby causing gelling, and therefore this form can be applied for a great variety of sites and conditions. [0079] An aspect of the invention concerns a method of treating a pulmonary air leak. The method includes the step of applying to a site of pulmonary air leak an effective amount of a peptide in accordance with the invention, i.e., an amphiphilic peptide having 8-200 amino acid residues with the hydrophilic amino acids and hydrophobic amino acids alternately bonded, and is a self-assembling peptide exhibiting a beta-sheet structure in aqueous solution in the presence of physiological pH and/or in the presence of a cation. [0080] As used herein, a “pulmonary air leak” refers to any situation in which air abnormally escapes from airways of the lung, for example, into the extra-alveolar spaces. Pulmonary air leaks can occur spontaneously in conditions such as emphysema, in which blebs rupture. Pulmonary air leaks also can occur as a result of trauma (penetrating or non-penetrating) to the chest, as well as surgical procedures (and complications thereof) involving the lungs. In one embodiment, a pulmonary air leak may present as pulmonary interstitial emphysema, pneumomediastinum, pneumothorax, pneumopericardium, pneumoperitoneum, subcutaneous emphysema, or any combination thereof. In one embodiment, a pulmonary air leak may occur in association with surgical biopsy or resection of lung tissue, for example, resection of small cell lung cancer, carcinoid tumor, non-small cell lung cancer, adenocarcinoma, nroquunzoum cell carcinoma. [0081] As used herein, “applying” is locally administering, for example by soaking, dripping, painting, spraying, or otherwise contacting a tissue site to be treated. In one embodiment the site is lung parenchymal tissue, e.g., at a site of resection, In one embodiment the site is a trachea, bronchus, bronchiole, or other airway. In one embodiment the site is a bronchus. [0082] In one embodiment the peptide is applied thoracoscopically, i.e., via a thoracoscopic instrument, Such instruments are well known in the art and need not be described further here. In one embodiment, the peptide is applied during thoracoscopic surgery. [0083] In one embodiment the peptide is applied bronchoscopically, i.e., via a bronchoscopic instrument. Such instruments are well known in the art and need not be described further here. In one embodiment, the peptide is applied during bronchoscopic surgery or during a bronchoscopic procedure such as a bronchoscopic examination, bronchoscopic biopsy, bronchoscopic brushing, or bronchoscopic alveolar lavage. [0084] The peptide is applied in an effective amount to treat the pulmonary air leak. As used herein, the term “treat” means to reduce, ameliorate, or cure a condition of a subject. A “subject” as used herein refers to a mammal, specifically including but not limited to a human. [0085] An “effective amount” as used herein is an amount that is sufficient to bring about a desired biological result. Persons skilled in the art will have no difficulty ascertaining what constitutes an effective amount, based on conventional animal studies (such as described below) and/or clinical experience. An effective amount may vary depending on the particular lesion to be treated. For example, an effective amount may vary depending on factors such as the site of the lesion, the size of the lesion, the condition of the subject, and other factors readily recognized by ordinarily skilled practitioners. [0086] In one embodiment, the peptide can be provided as an aqueous solution. In one embodiment the aqueous solution of peptide is about 0.5% to about 3% (w/v). The solvent for the aqueous solution can be water alone, physiologically isotonic dextrose (e.g. 5% dextrose in water), physiologic saline, Ringer's solution, or the like. Other physiologically acceptable aqueous solvents are also embraced by the invention. [0087] An aspect of the invention is a pharmaceutical composition comprising a peptide of the invention and a pharmaceutically acceptable carrier. A pharmaceutical composition can be made by combining a peptide of the invention and a pharmaceutically acceptable carrier. In one embodiment, the pharmaceutical composition is sterilized by any suitable method, e.g., sterile filtering. In one embodiment, the pharmaceutically acceptable carrier is selected from water alone and physiologically isotonic dextrose (e.g. 5% dextrose in water). In one embodiment, the pharmaceutical composition further includes at least one additional agent, for example a preservative, a stabilizing agent, or a coloring agent. [0088] An aspect of the invention is a kit. The kit includes a peptide of the invention, an applicator, and instructions for use of the peptide and the applicator to occlude a pulmonary air leak. In one embodiment, the peptide of the invention is provided as a powder. In one embodiment, the peptide of the invention is provided as a powder and the kit further includes an aqueous solvent for the peptide. In one embodiment, the peptide is provided as an aqueous solution. In one embodiment, the applicator is a sponge. In one embodiment, the applicator is a dropper, for example with a deformable bulb and a tip through which a solution of the peptide can be drawn up and dispensed. In one embodiment the applicator is constructed and arranged to dispense a solution of the peptide as a spray. [0089] The pulmonary air leakage occluding agent of the invention will now be explained in greater detail through the following example, but the invention is not limited thereto so long as its gist and range of application is maintained. EXAMPLE Effects of 2.5% Aqueous Peptide Solution in Miniature Swine Model [0090] A miniature swine model of pulmonary air leak was used in an experiment to determine if a 2.5% (w/v) aqueous solution of peptide could occlude the air leak. A pulmonary air leak was surgically created in at least one miniature swine (“mini-pig”). A 2.5% aqueous solution of a self-assembling peptide in accordance with the invention was topically applied to the site of the air leak. Evaluation of the air leak showed it was occluded following application of the peptide solution. [0091] The body weight of miniature swine (Gottingen) receipt ranged from 21.4 to 22.6 kg. Animals were quarantined for 7 days and acclimatized for 2 days. The animal room was maintained at temperature 23° C., 55% humidity, lighting period of 12 hours (6:00 to 18:00), and ventilation 10 complete exchanges/hour (fresh air through filter). Study Design [0092] [0000] Number of animals Animal number Observation Group 3 M00001, M00002, M00003 Necropsy in surgery 1 — Diet [0093] Animals were supplied with 500 g±5 g/day of pellet diet (manufactured within 5 months, Nisseiken, Ltd.) by using metal feeder in morning. [0000] Drinking water [0094] Animal has free access to tap water using an automatic watering system. Anesthesia and Treatment of Pre-Operation [0095] Animals were anesthetized by intramuscular injection of 0.05 mg/kg atropine sulfate and 15 mg/kg ketamine hydrochloride in cervical back. A tracheal cannula (PORTEX) was inserted under general anesthesia provided as N 2 O:O 2 =1:1 mixture gas±0.5% isoflurane using inhalation apparatus (Vigor21 II, ACOMA Medical Industry Co., Ltd). Artificial respiration was carried out as follows: 10-15 mL/kg, 18-22 breaths/minute using artificial respirator (PRO-V mkII, ACOMA Medical Industry Co., Ltd), Further, Ampicillin+glucose lactated Ringer's solution (1 drop/second) was administered intravenously from pre-operation until closing of the chest. Thoracotomy and Surgical Creation of Lung Injury [0096] Animals treated as above were positioned in left side lying position and lung was exposed by thoracotomy from the right side. An air leak was created by the perpendicular puncture in pulmonary lobe using 18 G injection needle (TERUMO Ltd.). Confirmation of pulmonary air leakage was carried out with physiological saline solution that filled thoracic cavity. Then 10-15 mL of 2.5% (w/v) self-assembling peptide hydrogel RADA16 was applied several times until the air leakage was stopped. Due to dispersion of the peptide by inflation and deflation of the lung, the self-assembling peptide was applied to the lesion with the assistance of the grip of tweezers to help localize the gel on the surface of the lung at the site of the puncture lesion. This procedure was effective to occlude the pulmonary air leakage. [0097] The occlusion of pulmonary air leakage was initially checked by raising the internal pressure of the artificial respiration system. Then, the occlusion was finally confirmed by gradual increase of air pressure to 20 cm H 2 O of internal pressure. [0098] A lung sample was obtained from an animal which underwent necropsy in the surgery and fixed with 10 vol % neutralize buffered formal in to confirm the pulmonary air leak occlusion by self-assembling peptide hydrogel during the surgery. In the other three animals, the chest was sewed up with a chest tube temporarily left in place until extraplural air was fully evacuated. [0099] A catheter (12 G cannula, LCV-UK kit, Nippon Sherwood Ltd) was inserted into cranial sinus of venae cava for post-operative monitoring. Animals were recovered from anesthesia after the cannula was installed. Histopathological Examination [0100] The lung sample from the animal which underwent necropsy in surgery was fixed with formalin, sectioned, stained with hematoxylin and eosin, and examined by light microscopy in order to evaluate the site that had been punctured and then sealed with peptide. Postoperative Care [0101] 500 mL of Viccillin+LactecD was administered twice daily (morning and afternoon) for 3 days from 1 day after operation. Ampicillin was administered by intramuscular injection in cervical back on day 4 after operation. Buprenophine (0.01 mg/kg) as a painkiller was injected intramuscularly into cervical back for 4 days following the operation. Evaluation [0102] Chest X-ray examinations were conducted in pre-operation, post-operation and pre-necropsy using surgical x-ray TV equipment (DHE-105CX-PC, Hitachi Medico Ltd.). [0103] All animals were observed for general appearance and death once a day from the day of experiment to the day of necropsy. [0104] All animals were weighed with a digital platform scale (DUE600ST/M3s-A, Mettler Toledo Ltd.) on the day of operation, 5 days post-operation, and the day of autopsy. [0105] Food consumption was checked every day. Any remaining amount of food was weighed with a digital platform scale (DUE600ST/ID3s-A, Mettler Toledo Ltd.) when present. If there was no uneaten diet, food consumption was recorded as 500 g. [0106] Blood for hematological examination was collected by catheter on the day of operation, 3 days after operation, and 7 days after operation, and the day of necropsy. Blood was collected into EDTA-2K coated blood collection tubes (VP-DK052K05, TERUMO Ltd.). Red blood cell count (RBC), white blood cell count (WBC), hemoglobin concentration (HGB), hematocrit (HCT), and platelet count (PLT) were measured using a multi-channel blood cell counter (Sysmex K-4500, Sysmex [0107] Blood for biochemical examination was centrifuged at 3,000 rpm at 4° C. for 15 min to obtain serum samples used to measure AST, ALT, ALP, total protein (TP), albumin (Alb), protein fraction (alb), alpha 1 globulin (α 1 -glb), alpha 2 globulin (α-glb), beta globulin (β-glb), gamma globulin (γ-glb), albumin/globulin ratio (A/G), total bilirubin (T-Bil), urea nitrogen (UN), creatinine (CRE), glucose (Glu), total cholesterol (T-Cho), triglycerides (TG), sodium, potassium, chloride, calcium, inorganic phosphate (IP), and C-reactive protein (CRP). Necropsy [0108] Animals were anesthetized by injection of 6.4% pentobarbital sodium into auricular veins. Then, animals were euthanized by exsanguination by cutting the carotid artery. RESULTS [0109] Pulmonary air leak was not found in any of the animals during and following treatment with peptide. Representative results of X-ray examination are shown in FIG. 1 . As shown in FIG. 1 , no abnormality was found in lung from the day of operation to the day of necropsy. Representative results of histopathological examination are shown in FIG. 2 . As shown in FIG. 2 , occlusion of pulmonary air leak by self-assembling peptide hydrogel was identified in histopathological examination. [0110] All animals remained in good general condition throughout the experiment. Animals generally maintained body weight and trod intake. [0111] Results of hematological examination are shown in Table 1. All animals showed elevated level of WBC on day 3 after operation, and M 0001 showed the high WBC on the day of necropsy. However, these changes were considered to be due to the open surgery but not due to the self-assembling peptide hydrogel. [0112] Results of biochemical examination are shown in Table 2. An elevated level of CRP was evident on day 3 after operation. The changes in CRT and in other parameters were considered to be due to the open surgery but not due to the self-assembling peptide hydrogel, [0000] TABLE 1 Hematological findings in mini-pigs. RBC HGB HCT PLT WBC Animal 10 4 /μL g/dL % 10 4 /μL 10 2 /μL No. Pre AD3 AD7 NE Pre AD3 AD7 NE Pre AD3 AD7 NE Pre AD3 AD7 NE Pre AD3 AD7 NE M00001 738 804 661 620 11.9 13.1 10.7 10.1 39.2 43.4 33.6 31.4 47.0 50.8 79.5 103.1 106 113 118 161 M00002 773 712 656 641 13.2 11.9 11.0 10.7 40.4 36.8 33.9 33.1 39.2 45.8 69.5 82.7 90 135 82 91 M00003 705 649 611 638 12.4 11.5 10.7 11.2 38.0 34.7 32.7 34.0 55.4 51.8 83.6 86.0 83 126 99 83 Number 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 of animals Mean 739 722 643 633 13.0 12.2 10.8 10.7 39.2 38.3 33.4 32.8 47.2 49.5 77.5 90.6 93 125 100 112 Pre: Before treatment, AD3: 3 days after treatment, AD7: 7 days after treatment, NE: Necropsy day (10 days after treatment). [0000] TABLE 2 Hematological findings in mini-pigs. Animal No. Pre AD3 AD7 NE Pre AD3 AD7 NE Pre AD3 AD7 NE Pre AD3 AD7 NE AST ALT ALP TP IU/L IU/L IU/L g/dL M00001 20.1 69.5 23.1 19.7 30.3 85.2 49.8 37.2 318.3 279.0 215.0 216.5 7.24 7.97 6.76 6.99 M00002 16.8 26.1  9.3 15.3 23.0 58.7 37.8 29.6 322.7 416.2 235.8 221.5 6.06 6.57 5.95 6.30 M00003 19.6 26.4 17.5 15.8 26.2 47.7 36.1 31.6 357.9 330.7 248.4 241.3 6.24 6.81 6.39 6.44 Number  3  3  3  3  3  3  3  3  3  3  3  3 3 3 3 3 of animals Mean 18.8 40.7 16.6 16.9 27.0 63.9 41.2 32.8 333.0 342.0 233.1 226.4 6.51 7.12 6.37 6.58 Alb alb α 1 -glb α 2 -glb g/dL % % % M00001 4.34 3.80 3.78 3.59 60.0 47.7 55.9 51.3 0.9 0.7 0.9 0.8 17.7 19.5 21.5 19.8 M00002 3.90 3.21 3.17 3.18 64.4 48.9 53.3 50.5 0.8 0.7 0.9 0.7 15.7 19.6 22.9 20.7 M00003 3.80 3.31 3.52 3.62 60.9 48.6 55.1 56.2 0.8 0.7 0.9 0.8 15.8 19.7 20.5 19.9 Number 3 3 3 3  3  3  3  3 3 3 3 3  3  3  3  3 of animals Mean 4.01 3.44 3.49 3.46 61.8 48.4 54.8 52.7 0.8 0.7 0.9 0.8 16.4 19.6 21.6 20.1 β-glb γ-glb T-Bil % % A/G mg/dL M00001 15.0 28.3 16.7 24.5 6.4 3.8 5.0 3.6 1.50 0.91 1.27 1.06 0.09 0.09 0.10 0.08 M00002 12.9 27.1 17.3 24.0 6.2 3.7 5.6 4.1 1.81 0.96 1.14 1.02 0.09 0.09 0.09 0.08 M00003 14.1 26.2 16.4 16.4 8.4 4.8 7.1 6.7 1.55 0.95 1.23 1.28 0.14 0.08 0.09 0.08 Number  3  3  3  3 3 3 3 3 3 3 3 3 3 3 3 3 of animals Mean 14.0 27.2 16.8 21.6 7.0 4.1 5.9 4.8 1.62 0.94 1.21 1.12 0.11 0.09 0.09 0.08 UN CRE Glu T-Cho mg/dL mg/dL mg/dL mg/dL M00001 15.5 9.9 10.1 7.6 1.35 1.40 1.03 0.99 87.9 97.9 74.9 73.6 85.2 96.8 67.2 59.8 M00002  4.6 5.9  7.4 7.0 1.21 0.96 0.94 0.89 86.4 93.6 79.3 68.6 45.4 53.2 47.9 41.2 M00003  4.5 6.0  5.8 8.1 1.44 0.99 1.03 1.04 69.1 82.0 67.7 64.7 39.2 48.3 51.5 36.4 Number  3 3  3 3 3 3 3 3  3  3  3  3  3  3  3  3 of animals Mean  8.2 7.3  7.8 7.6 1.33 1.12 1.00 0.97 81.1 91.2 74.0 69.0 56.6 66.1 55.5 45.8 TG Na K Cl mg/dL mEq/L mEq/L mEq/L M00001 43.8 40.6  9.4 23.7 157.9 a) 168.7 a) 144.6 141.9 3.66 4.17 3.84 4.13 107.9 123.0 100.4 98.8 M00002 18.5 23.9 13.2 27.5 142.2 143.5 140.7 140.7 3.67 4.15 4.20 4.05 103.0 102.5  99.0 99.0 M00003 17.8 23.6 13.0 27.1 142.3 145.2 142.4 141.2 3.66 4.33 4.07 4.06 101.1 105.2 101.2 98.6 Number  3  3  3  3  3  3  3  3 3 3 3 3  3  3  3  3 of animals Mean 26.7 29.4 11.9 26.1 147.5 152.5 142.6 141.3 3.66 4.22 4.04 4.08 104.0 110.2 100.2 98.8 Ca IP CRP mg/dL mg/dL mg/mL M00001 11.5 11.4 11.0 11.2 6.7 5.8 6.0 6.0 30.1 88.3 33.7 16.0 M00002 10.3 10.8 10.4 10.6 5.4 5.4 6.1 6.0 20.8 67.9 36.2 37.5 M00003 10.2 10.9 10.7 10.6 6.0 5.2 6.0 6.2 14.4 63.3 26.0 19.4 Number  3  3  3  3 3 3 3 3  3  3  3  3 of animals Mean 10.7 11.0 10.7 10.8 6.0 5.5 6.0 6.1 21.8 73.2 32.0 24.3 Pre: Before treatment, AD3: 3 days after treatment, AD7: 7 days after treatment, NE: Necropsy day (10 days after treatment). a) Obtained in the scheduled measurement (1st measurement); the value, which is markedly higher than that in other animals, was confirmed to be correct in the 2nd measurement. INCORPORATION BY REFERENCE [0113] The entire contents of all patents and published patent applications cited in this application are incorporated by reference herein.

1a

CROSS REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of prior application Ser. No. 14/575,698, filed Dec. 18, 2014, entitled “Computer-Implemented Methods and Systems Enabling Fan Participation in Calling Plays at Sporting and Other Events,” which claims benefit of U.S. Provisional Application No. 61/918,350, filed Dec. 19, 2013, entitled “Computer-Implemented Methods and Systems Enabling Fan Participation in Calling Plays at Sporting and Other Events,” each of which is incorporated herein by reference. BACKGROUND [0002] The present application relates generally to live events and, more particularly, methods and systems for enabling fans or audience members to participate in calling plays at football games and other events. [0003] While traditional applications of technology for user participation in live events exist, they are generally passive forms of user participation. For example, some traditional entertainment shows allow fans to vote for a winner, but results are not shown until the end of a show, or days or weeks later. Fans can help decide which entertainer ‘wins’, but fans do not decide what activity occurs from minute-to-minute. Fans have minimal real-time impact on the real-time action. [0004] In the context of sporting events, traditional applications allow users to participate in a fantasy game, where they can choose players and teams, and compete based on statistics corresponding to real time events in the sporting events. While real time events can affect a user's score or standing in traditional applications, the user has no ability to participate or influence real time events. SUMMARY [0005] Systems and methods are disclosed for facilitating state-based participation in calling plays in a football game thereby allowing fans to proactively participate in real-time in the game with players, referees and coaches. In some aspects, the systems and methods comprise receiving, by a computing device, a user profile, the user profile corresponding to a user registered to vote in a real-time football game, the user profile comprising a coach score. In some aspects, the systems and methods comprise initiating, by the computing device, a sequence of states in response to a start of a play during the real-time football game. In some aspects, the sequence of states comprise a poll creation state for a first time period, the poll creation state comprising receiving, by the computing device, a submission of a set of plays from a computing device associated with a coach at a time corresponding to a time prior to an execution of a play in the real-time football game; a notification state for a second time period, the notification state comprising sending, by the computing device, the set of plays to a computing device associated with a registered user in a format such that the sets of plays automatically display upon the registered user device; a fan voting state for a third time period, the fan voting state comprising receiving, by the computing device, a vote from the registered user device, the vote corresponding to one play from the set of plays; a notification state for a fourth time period, the notification state comprising sending, by the computing device, a winning play to the registered user device and the coach device, the winning play based on results of the vote, such that a sum of the first time period, second time period, third time period, and fourth time period is equal to or less than 100 seconds; and a play in action state for a fifth time period, the play in action state comprising receiving, by the computing device, a result of a real-time play based on the winning play from a computing device associated with at least one of a referee and an administrator. In some aspects, the systems and methods comprise updating, by the computing device, the user score by comparing the vote with the winning play and with the result of the real-time play; and outputting, by the computing device, content to the registered user device related to the coach score. [0006] In some aspects, the sequence of states terminates upon the start of a subsequent state. In some aspects, the submission of the set of plays further comprises a coach override, the coach override comprising a winning play selected by the coach. In some aspects, the poll creation state further comprises creating at least one of: a random set of plays, a set of plays based on prior game statistics, and a set of plays based on current game statistics, when the submitted set of plays comprises no plays. In some aspects, the content comprises a winning play score, the winning play score corresponding to a number of times a play selected by the user, from the set of plays associated with the poll creation state, is the winning play. In some aspects, the content further comprises at least one of a participation score and a scoring play score, the participation score corresponding to a number of plays where the user submits a vote, the scoring play score corresponding to a number of times a play selected by the user results in a team associated with the voting scoring a goal or preventing the scoring of a goal. In some aspects, the content comprises at least one of voting information, challenges, and education information, the voting information comprising a record corresponding to how a user earned the coach score, the challenges comprising comparing the coach score with coach scores corresponding to other user profiles, the education information comprising at least one of information and an activity to improve the coach score. In some aspects, the systems and methods comprise sending, by the computing device, state information to the referee device. In some aspects, the systems and methods comprise receiving, by the computing device, a duration of at least one of the first time period, second time period, third time period and fourth time period from the referee device. In some aspects, the systems and methods comprise outputting, by the computing device, live game information to at least one of the user device, the coach device, and the referee device. In some aspects, the sum of the time periods ranges from 30 seconds to 60 seconds. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is a simplified block diagram illustrating an exemplary network in which a live-game engine or system may be implemented, according to some embodiments of the present disclosure. [0008] FIG. 2 is a block diagram illustrating system architecture, according to some embodiments of the present disclosure. [0009] FIGS. 3 and 4 are flow diagrams illustrating an exemplary play voting cycle, according to some embodiments of the present disclosure. [0010] FIGS. 5-74 are exemplary screenshots illustrating operation of the live-game system, according to some embodiments of the present disclosure. [0011] FIG. 75 is a simplified diagram illustrating an exemplary game engine finite state machine, according to some embodiments of the present disclosure. DETAILED DESCRIPTION [0012] When football fans watch a football game, either live or on television, they have no involvement in how the game is played. They know little about the plays the coach of their team is picking to execute on the field, and have no ability to influence the coach's play choices. Various embodiments disclosed herein are directed to computer-implemented methods and systems for increasing fan involvement in games by enabling fans to actively participate in calling plays at football games. [0013] As will be discussed in greater detail below, in accordance with various embodiments, a computer-implemented live-game system or engine is provided that enables fans of a team to collectively decide in real-time which plays should be executed by their team during a game. For each play, the coaches of the teams pick a set of possible plays, which the fans vote on. The system tabulates the fan votes, and the winning play can be executed on the field in real-time. The system provides users with access to a wide variety of information needed to participate in the system including information on plays, player rosters, teams, stats etc. The system also tracks each fan's coaching performance (e.g., the % of times the fan's play choice was the winning play, the % of times the fan's play succeeded (scored, achieved first down, gained certain yardage), or the % of times the fan's play selection likely would have been a better choice given the poor performance of the actual play run on the field, etc.). The system also enables fans to compete against one another, individually or in leagues, in their coaching skills. [0014] While the exemplary embodiments illustrated herein relate to the game of American football, this is by way of example only. It should be understood that the methods and systems for increasing fan participation are not limited to football, and may also be applied to other live events such as, e.g., soccer, baseball, golf, hockey, basketball, movie screenings, game shows, award shows, sales meetings, political events, and business conferences. [0015] FIG. 1 illustrates an exemplary network, in which a live-game system 100 may be implemented, according to some embodiments of the present disclosure. The live-game system 100 can be implemented in a computer server system, which communicates with a plurality of client devices operated by the users of the system 100 , including fans 102 , the coaches/coordinators 104 , 106 of the teams playing the game, referees 108 , and system administrators 110 . Other users of the system can include production staff 112 and product marketing/customer service staff 114 . [0016] The client devices communicate with the system 100 over a communications network 116 . The communications network 116 can include any network or combination of networks including, without limitation, the Internet, a local area network, a wide area network, a wireless network, and a cellular network. [0017] The client devices operated by users to access the live-game system 100 can include any computing device that can communicate with the computer server system including, without limitation, personal computers (including desktop, notebook, and tablet computers), smart phones (e.g., Apple-based smart phones and Android-based smart phones), wearable computer devices (e.g., smart watches and smart glasses), cell phones, personal digital assistants, and other mobile devices. The client devices include operating systems (e.g., Android, Apple iOS, and Windows Phone OS, among others) on which applications run. The operating systems allow programmers to create applications (often called “Apps”) to provide particular functionality to the devices. [0018] A representative client device can include at least one computer processor and a storage medium readable by the processor for storing applications and data. The client device also can include input/output devices, one or more speakers for acoustic output, a microphone for acoustic input, and a display for visual output, e.g., an LCD or LED display, which may have touch screen input capabilities. [0019] FIG. 2 is a block diagram illustrating system architecture, according to some embodiments of the present disclosure. FIG. 2 shows a message listener 202 , record manager 204 , score manager 206 , poll manager 208 , Advanced Message Queuing Protocol (AMQP) 210 , game manager 212 , engagement service 214 , coach manager 216 , vote manager 218 , information service 220 , referee application 222 , moderator devices 224 , coach devices 226 , fan devices 228 , database 230 , and fan connections. [0020] Message listener 202 is active software built into the system. It provides asynchronous event handling that defines the initial action to be taken as each message arrives. Different actions may be defined for different message types. [0021] Record manager 204 includes a database for storing user voting records (e.g., votes during a game). The database can include any physical database or cloud-based data storage (e.g., Mongo database instance). [0022] Score manager 206 includes a database for storing game statistics (e.g., wins, losses, play executed during a game). The database can include any physical database or cloud-based data storage (e.g., Mongo database instance). [0023] Poll manager 208 controls state logic for polling. As described in more detail, polling can include a series of discrete states. [0024] AMQP 210 comprises an Advanced Message Queuing Protocol (e.g., RabbitMQ). AMQP can support a variety of protocols and includes message orientation, queuing, and routing. [0025] Game manager 212 includes a database for storing real-time events and statistics during a game. The database can include any physical database or cloud-based data storage (e.g., Mongo database instance). Game manger 212 can communicate with Ref App 222 . As described in more detail below, game manager 212 can send Ref App 222 real-time data corresponding to a game. Ref App 222 can send instructions to Game Manager 212 , based on the real-time data, to update state information (e.g., state information for polling) and information for display on one or more coach device 226 or fan device 228 . [0026] Engagement service 214 represents multiple discreet services that coordinate elements of the game experience. These services include a user interface, logic, and storage. One of the services, FanScore Moderator 224 , stores the data behind multiple question-and-answer games (e.g., the name of each game, one to one-thousand questions, timing logic associated with answers for each of the questions, and tips for each of the questions). A person operating the FanScore Moderator can define a game, initiate a game, and trigger the delivery of each question (e.g., the first question is sent 10 minutes before kickoff, the second question during the first timeout), and identify the recipients of each question (e.g., all registered fans or fans voting with only one of the two teams). Another service, CoachScore Moderator 224 , allows an operator to evaluate the results of plays run on the field in real time (e.g., declaring an error on a play and assessing the success of the play run on the field). These evaluations are then used to create each Fan's CoachScore. [0027] Coach manager 216 includes a database for storing coaching records (e.g., information about plays, players, scheduling) and other data that is used in multiple devices across the system. The database can include any physical database or cloud-based data storage (e.g., Mongo database instance). Coach manager 216 is in communication with a coach application 226 . Coach manager 216 can display information in the database to the coach device and receive edits and changes from the coach device to information in the database. [0028] Vote manager 218 coordinates voter polling. Vote manager 218 maintains the logic for communication and controls that communication with fan devices 228 via fan connections 240 . Fan Connections 240 declares and manages the communication channel used with fan devices. Vote manager 218 , through a fan connection module, can push a poll to fan device 228 and receive results from the poll. [0029] Fan device 228 represents the mobile devices used by fans to participate in calling plays. The Info Service 220 includes web services that execute key processes (e.g., retrieving fan profile information, updating playbook information in fan apps, etc.). The information service refers to a fast, in-memory data store 230 (e.g., Redis). [0030] FIGS. 3 and 4 are flow diagrams illustrating an exemplary play voting cycle, according to some embodiments of the present disclosure. Referring to FIG. 4 , prior to a game, each of the entities in the system logs in once to backend service 420 . Backend service is described in more detail above in FIG. 2 . The entities include admin 410 , a voter 412 , offensive coordinator 413 , and defensive coordinator 414 . Admin, at the start of the game, can send an instruction to the backend service 420 to start the game 411 . For each play, the process starts with the administrator starting a play clock 301 . In some embodiments, an administrator starts each game, starts each play clock, and identifies each possession switch (e.g., when possession of the ball transfers from one team to the other). The coaches of each team are given a predetermined amount of time (e.g., 1-60 seconds, preferably 7 seconds) to pick a set of possible plays to be voted on by the fans. The offensive coordinator can select a set of plays 302 , and a defensive coordinator can select a set of plays 303 . In some embodiments, the offensive coordinator and defensive coordinator each select 3 plays. The plays are pushed out via push technology (preferably no manual refresh on the fans app is needed) to fans who have registered with the system. Fans are then able to view the poll 304 . Fans are then given a preset time period (e.g., 1 to 60 seconds, preferably 10 seconds) to vote on the play they want their team to execute 305 . The fan votes are sent to a system database and tabulated. The winning results are sent to the coaches 306 . The results can also be sent to the fans at the same time, again preferably via push technology 308 . Coaches then radio or otherwise communicate the winning play to the personnel on the field, and the fans and coaches get to see the winning play executed on the field in real-time. The process described above can then start again for a subsequent play. [0031] The system provides users with access to a wide variety of information needed to participate in the system including information on plays, player rosters, teams, stats etc. Fans [0032] In one or more embodiments, fans can download a Fan App on their client devices to access the system. FIG. 5 shows an exemplary screenshot from the Fan App enabling users to register and login 503 to the system, according to some embodiments of the present disclosure. A user can access a unique URL 501 and sign in using his/her username and password by clicking a “sign in” button 502 . During the registration process, a user will enter his or her name and choose a user name and password that will identify the user whenever using the system. Users can also enter in secure information, including a credit card and billing address information if they are going to sign up for a premium or paid product. Users can click on a “get in the action” button 504 to be directed to a team page where they will also be asked to choose which team they are a fan of 505 , or they can go in and look at team information before they decide. They can click a button 506 to decide on a team once they review team information. [0033] Fans who are registered and logged in can enter a Fan App Dashboard as illustrated in the exemplary screenshot of FIG. 6 . The dashboard provides fans with access to a variety of content items (illustrated in FIGS. 7-14 ) they can use to participate in the live-game system. For example, Fan App Dashboard can include a header 601 , which displays details about a coming game before the start of a game. As described in more detail below, Fan App Dashboard can also include rattlers den 602 , team banter 603 , playbook 604 , injury report 605 , weekly recap 606 , player roster 607 , my stats 608 , and my achievements 609 . [0034] Fans can access team information 700 , including coach and player videos and talk sessions as illustrated in the exemplary screenshot of FIG. 7 . Also known as rattlers den, a repository of player videos and talk sessions can be branded for each team. Fans can be asked to choose and confirm a team selection 800 , as illustrated in the exemplary screenshot of FIG. 8 . In some embodiments, a fan has up until game time to change which team they vote for in any given game. Fans can also access a team page, as illustrated in the exemplary screenshot of FIG. 9 . The team page can display various details about a team, including coach videos, player videos and talk sessions 900 . Fans can also access a team match-up page, as illustrated in the exemplary screenshot of FIG. 10 . To help fans determine which team to vote with, the team matchup page can include a comparison of game statistics for both teams, such as running and passing 1000 . The team match-up page can also display voting statistics and averages. Fans can also access a team list, as illustrated in the exemplary screenshot of FIG. 11 . In some embodiments, the team page lists all teams, their conference, rank, record, coach and next game 1101 . Fans can access chat discussions 1202 and Twitter (or proprietary chat-based service) feeds 1203 as illustrated in the exemplary screenshot of FIG. 12 . Also known as team banter, discussion and twitter feeds can be displayed alongside an icon of a fan displayed with their achievement level 1201 . FIG. 13 is an exemplary screenshot illustrating fan access to injury reports 1301 . FIG. 14 is an exemplary screenshot illustrating fan access to information 1401 on each player on the team roster. [0035] Along with this content, the system also offers fans functionalities to track their performance—My Stats 1501 shown in the exemplary screenshot of FIG. 15 and My Achievements 1601 shown in the exemplary screenshot of FIG. 16 . My Stats 1501 details the Fan Coach Scores. The Coaching game logic engine of the live-game system scores the fan's Coaching or play calling performance. Participation 1502 indicates the % of plays that have been voted on by the fan. Winning plays 1503 indicates the % of times the fan's play choice was the winning play and run by the team. Scoring plays 1504 indicates the % of times a fan's play scored. My Achievements 1601 can indicate achievement levels earned by each fan. Achievements can include Grid-Iron Ruler 1602 (e.g., voting on a certain number of plays), Primetime Picker 1603 (e.g., picking a certain number of plays that have been executed), Captain Endzone 1604 (e.g., picking a certain number of plays that score), and Move the Chains 1605 (e.g., having a certain percentage of 3 rd down conversion). [0036] In some embodiments, Coach Score can be displayed on a user device, as shown in the exemplary screenshot of FIG. 17 . The main page can include a fan Coach Score season average 1701 , a voting section 1702 , results for each week 1704 , and results for each game 1705 . In some embodiments, voting section 1702 includes a breakdown of how a fan earns a Coach Score. The breakdown can include details of Coaching game logic engine, described in more detail below. The Coach Score page can also include a challenges section, as shown in the exemplary screenshot of FIG. 18 . Challenges can allow fans to see their performance within head to head challenges 1800 , as described in more detail below. The Coach Score page can also include an education section, as shown in the exemplary screenshot of FIG. 19 . The education section can include articles and activities to allow fans to learn more about play calling 1900 . In some embodiments, articles and activities that are displayed in the education section are selected based on a fan's Coach Score. [0037] FIG. 20 shows screenshot of a Fan Score page, according to some embodiments of the present disclosure. A Fan Score page can show points fans earn by participating in events hosted by the system 2000 . A Fan Score page can include an Achievements Section, showing fans how they have earned points 2002 . [0038] A FanScore page can also include an Events section, as shown in the exemplary screenshot of FIG. 21 . An Events section can include links to activities where fans can earn additional points 2100 . Activities can include fan contests, finding a fan voting party, subscribing to fan alerts, and tuning into coach picks. Activities can also include answering trivia or other questions, as shown in the exemplary screenshot of FIG. 22 . Trivia allows fans to participate in real-time trivia and related contests 2200 . In some embodiments, each question has a time limit 2202 , and a fan can choose one of three answers 2203 . A fan can gather points that contribute to FanScore points 2204 . A fan is delivered a Trivia Answer page after answering a trivia question, as shown in the exemplary screenshot of FIG. 23 . A fan can be shown a correct answer, their answer, and an explanation of the correct answer 2300 . FIG. 24 shows a screenshot of a rewards page, in accordance with certain embodiments. Fan Points can be accumulated and redeemed for real merchandise and digital goods 2400 . [0039] Fans may participate in Challenges, as shown in the exemplary screenshot of FIG. 25 . Fans can initiate challenges 2501 and define a type of challenge 2502 . Challenges may be decided by CoachScore, a measure of effective play-calling. Challenges may also be decided by FanScore earned by answering trivia or other questions 2200 . Challenges can involve individual players or player-defined leagues. The duration of a challenge can last any amount of time (e.g., single game, weekend, or season). A Challenges Page, as shown in the exemplary screenshot of FIG. 26 , can also include real time requests for challenges 2600 . Fans can choose either to accept or reject a real time challenge 2601 . [0040] Fans can also access real-time results on the system, as shown in the exemplary screenshot of FIG. 27 . Real time results include allowing fans to see in real-time how they are performing in their CoachScore and FanScore challenges as well as any pending invites 2700 . Real time results can also include rankings, as shown in the exemplary screenshot of FIG. 28 . Fans can see in real-time where they are ranked for both CoachScore and FanScore 2800 . [0041] FIG. 29 is a screenshot illustrating a coach score engine, according to some embodiments of the present disclosure. Coaching game logic engine (also referred to in the present disclosure as “CoachScore Engine”) can determine each player's CoachScore. In some embodiments, coach score ranges from 50-100. Unlike traditional “fantasy” points, Coach Score is not merely additive. Each player's Coach Score can be calculated after each drive and can naturally vary through the course of each game. CoachScore Engine first receives a coach bundle, which can include 3 plays. CoachScore Engine assigns a historical “Adjusted Yardage” 2900 based on data from prior games. The historical Adjusted Yardage 2900 can be calculated automatically from the data from prior games, as described in more detail below. The play run on the field is then scored on the yards gained on the field, augmented by positive modifiers for good results (e.g., earning a first down or scoring) or negative modifiers (e.g., resulting in a sack of the quarterback or lost yards) 2901 . The three plays' Adjusted Yardage scores (two historical, one actual) are then ranked, highest to lowest, 1 st , 2 nd , and 3 rd . Each play is then assigned points 2902 based on its ranking. The points are continuously summed and adjusted for tempo 2903 . Tempo adjustments 2903 allow scoring to be consistent, whether the game is partially complete or complete and whether a team runs a fewer number or a greater number of plays (e.g., 65 plays or 85). [0042] FIG. 30 is a screenshot illustrating a coach score engine moderator, according to some embodiments of the present disclosure. The moderator application can rate the play actually run on the field versus the historical expectations of the other two non-winning plays. The coach score moderator application can rank (e.g., good, neutral, bad or 1 st , 2 nd , 3 rd ) the play result seen on the field relative to the historical expectations of the two plays not selected, and submit any additional factors, especially errors (dropped pass, fumble, etc.), that impact the assessment of the play 3002 . The application can display which plays are suggested by a coach and which play was run on a field 3000 3001 . The ranking can come from a human operator or can be determined by a computing device. [0043] FIG. 31 is a screenshot illustrating the calculation of historical Adjusted Yardage within a coach score engine, according to some embodiments of the present disclosure. Each play can have a stored adjusted yardage value calculated from historical data and the adjusted yardage algorithm. In both pre-time and real-time, the system can calculate historical Adjusted Yardage from historical results 3100 . This calculation starts by identifying all plays previously run, noting their results (e.g. yardage gained, 1 st downs gained, scoring, game, play #, etc.), annotating each play with additional scenario identifiers (e.g., team, defense faced, game #, field position, time, down, distance, play type, in-game play #, etc.), grouping these play-scenario combinations, calculating typical yardage gained for each play-scenario combination 3100 , and, finally, enhancing typical yardage with 1 st -down and scoring trending 3101 to produce a historical Adjusted Yardage number for each play in each scenario. The adjusted yardage calculation weighs results from the current game, current teams, and more recent games more heavily than results from less current and less pertinent teams. [0044] The Playbook section of the Fan App is indicated by way of example in the screenshot of FIG. 32 . The playbook details the plays for the fan's team 3200 . The fan can sort by Play Type Formation 3201 . Each play includes a Detailed diagram, Simple Name, Coach Name, etc. 3202 . The Playbook section can also include Playbook Detail, as shown in the exemplary screenshot of FIG. 33 . Every play in a team's playbook can be clicked on to offer more detail, past performance, and video to illustrate the play and its performance history 3300 . [0045] The content items discussed above are live and active content during an actual game. When a game starts, the Fan App automatically changes to a gamecasting/push app determined by a League Official as shown in the exemplary screenshots of FIGS. 34 and 35 . During the game, the Fan App automatically displays game information 3400 3500 such as the teams playing, which quarter, the time/game clock, the score, which team has possession, and down and distance. [0046] Once a game is in progress and a fan is logged in correctly, the system automatically pushes a vote to the app as shown in the exemplary screenshots of FIGS. 36 and 37 . Fans can see a push of the vote of coaches play choices visually through the voting screen, manually through a buzz, and/or aurally through a tone 3600 3700 . The screen displays down, distance, field position, and game time in real time 3601 . The screen can also display play choices as graphical renditions of the plays as well as text 3701 . Visually through graphical renditions of plays, fans can see the three coach choices 3602 . Fans can also choose to Skip Vote 3603 by clicking an “x” button 3702 or clicking a “close” button 3703 , if desired. [0047] Once fans receive a poll from the system as illustrated in the exemplary screenshots of FIGS. 38 and 39 , they can vote with a single touch of the play of their choice 3800 3900 . In one embodiment, their chosen play is marked 3801 and automatically sent to be tabulated to the back-end service of the system. In another embodiment, fans can choose to change their vote by clicking a “change vote” button 3901 . Fans then watch the winning play executed on the field. As shown in the exemplary screenshots of FIGS. 40 and 41 , the Fan App shows fans when their play has been selected to be run on the field 4100 and what % of fans voted for each play 4000 4101 . As shown in the exemplary screenshot of FIG. 42 , the Fan App can also show fans when their play has not been selected to be run on the field 4200 . When a fan's play is not selected, they are also shown the winning play 4201 . [0048] In addition to the live football game, fans can compete against other fans and other groups of fans on their coaching expertise. Fans can choose and structure the ways in which they want to compete 4300 as shown in the exemplary screenshot of FIG. 43 . Game dimensions can include, e.g., Single game vs. season, Player vs. player, Intra and Extra-team leagues, Player-defined leagues, and League vs. league. Fans can compete using their Coaching Score in additional to their Achievements as shown in the exemplary screenshot of FIG. 44 . A coach score is derived from the actual and typical results of the plays voted on by fans 4400 . Scores are normalized to adjust for differences in team styles and results. Coaches/Coordinators [0049] The system allows coaches/coordinators to enter plays or formations to facilitate player coaching, game planning, and play selection. As shown in the exemplary screenshot of FIG. 45 , coaches/coordinators can enter multiple name types 4501 and a description 4502 for new plays and formations. Coaches/coordinators can apply standard tags to each play 4503 including, e.g., “opening script”, “short yardage”, “medium yardage”, “long yardage”, “pass”, “run”, “game 1”, “game 2”. Coaches/coordinators can define new tags 4504 and can attach images to each play 4505 . [0050] As shown in the exemplary screenshot of FIG. 46 , coaches/coordinators can manage playbooks. They can search for plays by multiple categories 4601 and edit play names, tags, formations, etc. 4602 . [0051] Coaches/coordinators can build scripts of plays that can be used for game planning, coaching, and easy selection as shown in the exemplary screenshot of FIG. 47 . Coaches/coordinators can select and/or create script names/tags 4701 . They can create poll names 4702 and assign plays to poll names 4703 . [0052] As shown in the exemplary screenshot of FIG. 48 , coaches/coordinators can organize and present plays in various fashions 4801 , view plays on screen 4802 , and print plays for game day 4803 . [0053] As shown in the exemplary screenshot of FIG. 49 , production team members can manage plays for presentation to fans. They can enter multiple name types for plays 4901 and a fan playbook description 4902 , and attach a simple play diagram 4903 . [0054] Coaches/coordinators can pick plays to be voted on by fans as shown in the exemplary screenshot of FIG. 50 . Coaches/coordinators can access the screen from a unique URL of the coach application 5000 . Coaches/coordinators log in, click on 3 plays 5001 , and click on a Commit Plays button 5002 to confirm the choice. If no plays are committed, the system automatically assigns 3 plays after a given period of time (e.g., 7 seconds). The Coach receives the play that won the highest percentage of votes 5100 as shown in the exemplary screenshot of FIG. 51 . [0055] FIG. 52 shows a screenshot of a coach application, according to some embodiments of the present disclosure. Coach application can communicate game status 5200 . Game status can include a game quarter, a score, location of the ball, team with possession, and down information. Coach application also allows a coach to choose plays sent to fans 5202 . Plays sent to fans can include either pre-defined bundles of plays (e.g., in bundles of three) or individually-selected plays 5204 . Coach application can include a visual depiction of selected plays to the coach 5205 . Coach application can also allow the coach to override and select a singular play for a number of times a game 5206 . [0056] As shown in FIG. 53 , in accordance with one or more embodiments, a coach can also elect to override the vote and select the play himself or herself. Coaches can be allowed a certain number of overrides per half (e.g., 4 ), and users can be notified immediately with a push notification on their device. Coach Management System [0057] According to some embodiments, a Coach Management System allows coaches to select their plays during games and coordinate other aspects of planning and executing plays during a game. An interface allows coaches to pick a set of plays offered to fans during each play, to see the winning play selected by fans, and to call “overrides” when they have to get their play run. [0058] In some embodiments, the Coach Management System allows football coaches to manage everything about a football team, as described in more detail below. Briefly, a roster module can store the names, profiles, and video of all players. Scouting can keep the profiles and assessments of all potential draftees and opposing players. Medical Manager can track all injuries, readying them for the injury report. Playbook can give coaches a place to create any play they want, to organize each play by any attribute, and to create installs, scripts, and game plans for any situation. Calendar can allow assistant coaches to structure daily coaching plans that roll up into weekly and seasonal plans managed by head coaches. Analytics can allow coaches to understand the performance of all plays by situation, package and player. [0059] FIG. 54 is a screenshot illustrating a coaching management system overview, according to some embodiments of the present disclosure. The Coaching Management System can enable efficient, data- and system-driven management of most aspects of a football team, including: Personnel management, Playbook management, Game plan management, Player education, Scouting and Injuries 5400 . For personnel management, the system will capture past and current of player(s), plays the player partakes in and the performance of that player in given situations—home, away, etc. For Playbook management, the system will capture all aspects of the playbook from individual plays, video links of the play, players associated with the play etc. For Game Plan Management, the system will allow the coaching staff to detail out all aspects of the upcoming opponent and plan out the game by quarter, by player personnel, by situations like down and distance etc. For Scouting and Injuries, the system would like with scouting reports, interface with video footage of scouting sessions and offer real-time insights on injuries directly from the training and strength and conditioning staff. [0060] FIG. 55 is a screenshot illustrating a play section within a coaching management system playbook, according to some embodiments of the present disclosure. From the play section, a coach can store plays 5500 , filter plays by situation (e.g., down, distance, zone, game time, etc.) 5501 , filter plays by package 5502 (an indicator of the number of running backs, tight ends, and receivers on the field), filter plays by type (e.g., run, pass, play action, special teams, etc.) 5503 , and add plays 5504 . Adding a new play involves entering a play name, illustrating the action of the play, and attaching the appropriate filters to the play. [0061] FIG. 56 is a screenshot illustrating a bundles section within a coaching management system playbook, according to some embodiments of the present disclosure. In the bundles section, plays can be organized into bundles of multiple plays (e.g., three plays) that can be selected by a coach 5601 . Each bundle represents a reasonable set of plays for a given game scenario—a set that makes sense for the coach and the fan. Organizing plays into bundles makes it easier to present multiple plays to voting fans. The bundles are entered into the system 5602 at the direction of the coach orchestrating the game plan and typically calling the plays. A coach may assign a bundle number such as “R12” 5603 so that it is easier to call plays during a live game. [0062] FIG. 57 is a screenshot illustrating an installs section within a coaching management system playbook, according to some embodiments of the present disclosure. In the installs section, plays can be organized into groups of installs. In some embodiments, installs include plays that teams will learn in an upcoming period of time 5701 . Installs can be sorted by date 5702 and new installs can be added 5703 . [0063] FIG. 58 is a screenshot illustrating a player roster section in a coaching management system, according to some embodiments of the present disclosure. In the roster section, players on the roster can be stored 5800 , sorted and searched by various attributes 5801 . For example, a member of the coaching staff could sort/filter the players by offense, defense or special teams. Players can be assigned to groups 5802 , which indicate the position they play. They can also be assigned to packages 5803 , which indicate the number of running backs, tight ends, receivers and other personnel on the field, sometimes called the personnel grouping. Players can be viewed by groups 5900 , as shown in the exemplary screenshot of FIG. 59 , and by packages 6000 , as shown in exemplary screenshot of FIG. 60 . [0064] FIG. 61 is a screenshot illustrating a personnel view in a coaching management system, according to some embodiments of the present disclosure. Personnel view includes access to detailed personnel information, such as participation in formations and play statistics 6100 . [0065] FIG. 62 is a screenshot illustrating a game plan section in a coaching management system, according to some embodiments of the present disclosure. In the game plan section, game plans for an upcoming weekend can be created 6200 . Plays can also be selected for a game sheet 6201 , pages can be added to a game board 6202 , plays can be dragged in or out of a game plan 6203 , columns of plays can be cleared 6204 , and game plans can be saved 6205 . A game plan 6200 is embodied within a game board. A game board is made up of one or more game sheets. A game sheet is made up of multiple scripts 6300 , described below, and plays organized by situation. [0066] FIG. 63 is a screenshot illustrating script creation in a coaching management system, according to some embodiments of the present disclosure. In some embodiments, a script includes a series of plays run in sequence during specific scenarios: start of game, start of second half, goal line within the five yard line, etc. Plays can be added to a script from other scripts and playlists 6302 . Scripts can be created 6300 and assigned to a practice day 6300 . Scripts can also be assigned to be practiced for specific game and opponents 6400 , as shown in the exemplary screenshot of FIG. 64 . [0067] FIG. 65 is a screenshot illustrating a game plan play sheet section in a coaching management system, according to some embodiments of the present disclosure. A play sheet 6500 can be generated that allows quick selection of bundles and plays during a game. For example, a member of the coaching staff can see all of the bundles (sets of plays) for the situation 3 rd and long. This allows the coaching staff to quickly choose the plays to push out to fans based on the situation on the field. [0068] FIG. 66 is a screenshot illustrating a calendar section in a coaching management system, according to some embodiments of the present disclosure. A schedule can be created to install a game plan for a specific game 6600 . Game plans can be organized by category 6601 , assigned to time slots in a calendar 6602 , and organized for viewing by day or week 6603 . A schedule can also include a scroll feature to view earlier and later events 6604 . Events for the day can also appear in list format to identify points of emphasis for the day 6605 . Points of emphasis could mean players on the injury report who won't be reporting to practice, for example. Events can also be viewed by week, as shown in the exemplary screenshot of FIG. 67 . A team schedule can be viewed by week 6701 and events can be organized by time slot and emphasis 6702 . A team schedule can also be viewed by day 6800 , as shown in the exemplary screenshot of FIG. 68 . [0069] FIG. 69 is a screenshot illustrating scouting reports in a coaching management system, according to some embodiments of the present disclosure. Scouting reports can be viewed and sorted by date 6900 . Scouting reports can also be created 6901 . [0070] FIG. 70 is a screenshot illustrating analytics in a coaching management system, according to some embodiments of the present disclosure. A variety of analytics reports can be delivered by team, game, opponent, offense, and defense 7000 . Referees/Admin [0071] As shown in the exemplary screenshot of FIG. 71 , the administrator (admin) can manage a game by accessing the system through a unique URL and login 7101 . The admin can enter down, distance, score, quarter, time (and save changes) during a game 7102 . The admin can start the next set of plays once the referee (on the field) has placed the ball 7103 . At this point, the coaches will receive a notification on their app that they have a set amount of time (e.g., 7 seconds) to input the next set of plays. The admin can also indicate a change in possession as needed, at which time a push notification will be sent out to all users that offense and defense has switched. [0072] FIG. 72 shows a screenshot of a referee application, according to some embodiments of the present disclosure. A referee application indicates a status of the system. A status of the system is described in more detail below. Briefly, a status of the system can include ready for next play, coaches selecting plays, etc. 7200 . A referee application can include a link to initiate a play 7201 , to release a winning play (e.g., results of a play) to the fans 7202 , and to switch possession of the ball to indicate which team is on offense and defense 7203 . There can also include an input to select coach selection time and fan voting time. Coach selection time and fan voting time can define the length of states during a poll, as described in more detail below. Game Day/Non-Game Day Production Personnel [0073] Production personnel can access the system as shown in the exemplary screenshot of FIG. 73 . Production personnel can view participation statistics in real time of concurrent users on the system 7300 , send notifications if they are not participating 7301 , troubleshoot for technical issues 7302 , and alert Marketing/Customer service to flag for retention and participating strategies like rewards, etc. 7303 . Team Product Marketing/Customer Service [0074] As shown in the exemplary screenshot of FIG. 74 , the system allows product marketing/customers service to view participation statistics in real time as well as analyzing data during non-games 7401 . They can use data to custom tailor “MyStat” 7402 and MyAchievements” to various fans. They can also tap the fan analytic database to reach out to inactive fans and try to re-engage them and other marketing/service details 7403 . Game Engine: Finite State Machine [0075] FIG. 75 illustrates an exemplary finite state machine, according to some embodiments of the present disclosure. The Game Engine is a system for organizing and running an official football game. This includes orchestrating exchanges between the fans, coaches, and referees via a central software solution. [0076] The system is modeled as a finite state machine. This means the system is in exactly one state at any given time. As different actions occur (referee pushing a button, timer completed, etc.) the system moves onto other states. These states define what is possible and occurring at any given moment. The finite machine can be executed by a computing device. (1) Pregame 7501 [0077] When a new game is created and scheduled, its first state is the “pregame” state. The system has been configured with two teams, but the game hasn't actually started yet. In this state users will be able to interact with the game in different ways from when the game is running. This might include interactions/planning with their team coach. [0078] The only action from here that will change the state of the game is having the appropriate official input the command to start the game (via the Admin Application). This will transition the game to the state “coach creating polls”. [0079] All states except “pregame” and “game over” are considered to mean the game is currently “active”. (2) Coach Creating Polls 7502 [0080] This state means the coaches are currently selecting plays for inclusion in polls that will be sent out to and voted on by fans. Coaches may also submit a “coach override” during this time. In this state, the system accepts play choice options for a poll from the Coach Application. A timer is started which can automatically transition to the “notifying fans of polls” state. The timer can range between 1 second and 60 seconds. In some embodiments, the timer is set for seven seconds. (3) Notifying Fans of Polls 7503 [0081] This state means the system is currently working to send both polls (one for each team) to their fans. In this state, coaches are no longer able to submit play choice options for a poll. A timer is started that will automatically transition to the “fan voting” state. The timer can range between 1 second and 60 seconds. In some embodiments, the timer is set for two seconds. The system verifies that each coach was able to create a poll. If a coach didn't create their poll, the system can create a poll for them and populate it with three random play options. Once both polls are ready they are transmitted to all fans. (4) Fan Voting 7504 [0082] This state means the system is accepting votes from all fans. In this state, the poll sent to the fan in the previous state is made visible now. Vote submissions are now accepted by the system. A timer is started which automatically transitions the game to the “notify everyone of results” state. The timer can range between 1 second and 60 seconds. In some embodiments, the timer is set for ten seconds. (5) Notifying Users of Results 7505 [0083] This state means the system is sending out vote results to all fans and coaches. In this state, votes are no longer accepted by the system. Poll voting results are tabulated and a winning play or a tie is determined for each poll. A summary of each poll results are broadcast to all fans and coaches. A record of the vote summaries is stored for future use. A timer is started which automatically transitions the game to the “play in action” state. The timer can range between 1 second and 60 seconds. In some embodiments, the timer is set for two seconds. (6) Play in Action 7506 [0084] This state means that the winning plays are now being executed on the field by the actual football players. The system is waiting for input via the Admin Application about the final result of the play. Depending on the results, the game can transition into two different states: 1. If the system determines the game is over then the game transitions into the state “game over”. 2. If the game is not technically over, then the system waits for a command from an official to start the next entire polling process. This is done by transitioning the game into the “coach creating polls” state again. (7) Game Over 7507 [0087] In this state the game is now over and is no longer capable of going back to any of the other states. [0088] In some embodiments, the total execution time for the first four states is under 100 seconds. In some embodiments, the total execution time is in between 30 and 60 seconds. [0089] The processes of the live-game system described above may be implemented in software, hardware, firmware, or any combination thereof. The processes are preferably implemented in one or more computer programs executing on a programmable computer (which can be part of the computer server system) including a processor, a storage medium readable by the processor (including, e.g., volatile and non-volatile memory and/or storage elements), and input and output devices. Each computer program can be a set of instructions (program code) in a code module resident in the random access memory of the computer. Until required by the computer, the set of instructions may be stored in another computer memory (e.g., in a hard disk drive, or in a removable memory such as an optical disk, external hard drive, memory card, or flash drive) or stored on another computer system and downloaded via the Internet or other network. [0090] Having thus described several illustrative embodiments, it is to be appreciated that various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to form a part of this disclosure, and are intended to be within the spirit and scope of this disclosure. While some examples presented herein involve specific combinations of functions or structural elements, it should be understood that those functions and elements may be combined in other ways according to the present disclosure to accomplish the same or different objectives. In particular, acts, elements, and features discussed in connection with one embodiment are not intended to be excluded from similar or other roles in other embodiments. [0091] Additionally, elements and components described herein may be further divided into additional components or joined together to form fewer components for performing the same functions. For example, the computer server system may comprise one or more physical machines, or virtual machines running on one or more physical machines. In addition, the computer server system may comprise a cluster of computers or numerous distributed computers that are connected by the Internet or another network. [0092] Accordingly, the foregoing description and attached drawings are by way of example only, and are not intended to be limiting. [0093] Those of skill in the art would appreciate that the various illustrations in the specification and drawings described herein can be implemented as electronic hardware, computer software, or combinations of both. To illustrate this interchangeability of hardware and software, various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware, software, or a combination depends upon the particular application and design constraints imposed on the overall system. Skilled artisans can implement the described functionality in varying ways for each particular application. Various components and blocks can be arranged differently (for example, arranged in a different order, or partitioned in a different way) all without departing from the scope of the subject technology. [0094] Furthermore, an implementation of the communication protocol can be realized in a centralized fashion in one computer system, or in a distributed fashion where different elements are spread across several interconnected computer systems. Any kind of computer system, or other apparatus adapted for carrying out the methods described herein, is suited to perform the functions described herein. [0095] A typical combination of hardware and software could be a general purpose computer system with a computer program that, when being loaded and executed, controls the computer system such that it carries out the methods described herein. The methods for the communications protocol can also be embedded in a computer program product, which comprises all the features enabling the implementation of the methods described herein, and which, when loaded in a computer system is able to carry out these methods. [0096] Computer program or application in the present context means any expression, in any language, code or notation, of a set of instructions intended to cause a system having an information processing capability to perform a particular function either directly or after either or both of the following: a) conversion to another language, code or notation; b) reproduction in a different material form. Significantly, this communication protocol can be embodied in other specific forms without departing from the spirit or essential attributes thereof, and accordingly, reference should be had to the following claims, rather than to the foregoing specification, as indicating the scope of the invention. [0097] The communications protocol has been described in detail with specific reference to these illustrated embodiments. It will be apparent, however, that various modifications and changes can be made within the spirit and scope of the disclosure as described in the foregoing specification, and such modifications and changes are to be considered equivalents and part of this disclosure.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a removable hose and tool caddy 2. Background Information In floor cleaning units, it is advantageous to have a floor cleaning mode or an above-the-floor cleaning mode. The above-the-floor-cleaning mode typically requires an accessory hose and tools, such as a crevice tool and upholstery tool. Further, a bare floor cleaning tool is often installed on the unit to clean bare floors in the floor cleaning mode. For convenience it is usually desirable to store these tools on the unit. However, it may further be desirable in other cases to remove the hose and tool from the unit to reduce the weight of the unit. Hence it is an object of the present invention to provide a removable hose and tool caddy that may be easily mounted to the floor cleaning unit for convenient access. It is another object of the present invention to provide a removable hose and tool caddy that may be removed from the floor cleaning unit and conveniently stored. SUMMARY OF THE INVENTION The foregoing and other objects of the present invention will be readily apparent from the following description and the attached drawings. In one embodiment of the present invention, a floor cleaning unit having a housing and a removable caddy which may be mounted on and removed from the housing for storing accessories. The caddy includes a body which removably mounts to the housing. A connector assembly is included on the body for removably mounting the body on the housing. The connector assembly includes a slot for receiving a hook member attached to the housing. An accessory retainer is formed on the body for storing the floor cleaning unit accessories, whereby the caddy and the floor cleaning unit accessories stored thereon may be slidably removed from the floor cleaning unit by merely applying a force to the body. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described, by way of example, with reference to the attached drawings, of which: FIG. 1 is a perspective view of a carpet extractor embodying the present invention; FIG. 2 is an exploded view of a carpet extractor embodying the present invention illustrating the principal elements thereof; FIG. 3 is an exploded view of the base assembly illustrating the principal elements thereof; FIG. 4 is a bottom view of the extractor with the suction nozzle, wheels, handle assembly, and the brush assembly removed for illustrative purposes; FIG. 5 is a top plan view of the brush drive turbine mounted to the distributor; FIG. 6 is an exploded view of the combined suction nozzle, hood, and front body illustrating the principal elements thereof; FIG. 7 is a partial, front and top perspective view of the front portion of the suction nozzle of the carpet extractor of the present invention; FIG. 8 is a bottom view of the front plate of the suction nozzle assembly of the carpet extractor of the present invention; FIG. 9 is side elevational view of the accessory hose of the carpet extractor of the present invention; FIG. 10 is an elevational view taken along line 10 — 10 of FIG. 9 ; FIG. 11A is a partial view of FIG. 8 and with the accessory hose of FIG. 9 inserted in the hose opening; FIG. 11B is view similar to FIG. 11A but showing the accessory hose in a position to block suction to the suction nozzle; FIG. 12 is a top view of the recovery tank with the lid assembly removed for illustrative purposes; FIG. 13 is a perspective view of the baffle assembly for the recovery tank; FIG. 14 is a bottom and front perspective view of the lid assembly for the recovery tank of FIG. 12 ; FIG. 15A is a partial front perspective view of the recovery tank and related elements locked upon the base assembly of the carpet extractor of the present invention; FIG. 15B is a view similar to FIG. 15A but with the latch in a position that unlocks the recovery tank; FIG. 16 is a top view of the lid assembly for the recovery tank of FIG. 12 ; FIG. 17 is a perspective view of the handle of the recovery tank; FIG. 18A is a sectional view taken along line 18 A— 18 A; FIG. 18B is a view similar to FIG. 18A but with the handle of the recovery tank in a carry position; FIG. 18C is a view similar to FIG. 18A but with the handle of the recovery tank in a rearward discharge position; FIG. 19A is a partial side sectional view taken vertically through the carpet extractor of FIG. 1 ; FIG. 19B is a view similar to FIG. 19A but with the handle assembly pivoted down; FIG. 20 is a partial side sectional view of the carpet extractor without the accessory hose and other tools; FIG. 21A is a view similar to FIG. 21B but with the nub of the slot of the tool caddy disengaged from the hook of the upper handle portion of the carpet extractor; FIG. 21B is an enlarged sectional view of the portion of the carpet extractor as indicated in FIG. 20 ; FIG. 22 is a front and right perspective view of the accessory tool storage caddy; FIG. 23 is a rear and left perspective view of the accessory tool storage caddy; FIG. 24 is a partial rear elevational view of the carpet extractor with the accessory tool caddy mounted thereon and including the related tools on the caddy; FIG. 25 is a top and rear perspective view of the carrying handle for the supply tank assembly; FIG. 26A is a view similar to FIG. 26B but with the carrying handle unlatched from the edge of the hood of the upper handle portion of the handle assembly of the carpet extractor; FIG. 26B is an enlarged sectional view of the portion of the carpet extractor as indicated in FIG. 20 ; FIG. 27 is an exploded view of the upper portion of the fluid distribution system of the FIG. 16 ; FIG. 27A is an enlarge view of the section of the support shelf circled in FIG. 27 ; FIG. 28 is a partial sectional view taken along line 28 — 28 of FIG. 1 ; FIG. 29 is a vertical sectional view of the cap and valve provided therein for either the clean water supply tank or detergent tank shown in FIG. 27 ; FIG. 30 is a schematic view of the fluid distribution system of the embodiment shown in FIG. 1 ; FIG. 31 is a vertical front section of the pressure-actuated shut off valve shown in FIG. 30 ; FIG. 32 is a fragmentary rear perspective view of an upper portion of the handle of FIG. 1 with portions cut away to show elements of the trigger switch and actuating rods for the cleaning mode switch assembly; FIG. 33 is a fragmentary front rear perspective view of an upper portion of the handle of FIG. 1 with portions cut away to show the cleaning mode switch assembly and related parts; FIG. 34 is a schematic diagram showing the electrical circuit for the fluid distribution system used in the embodiment shown in FIG. 1 ; FIG. 34A is a schematic diagram showing another electrical circuit for the fluid distribution system used in the embodiment of FIG. 1 that automatically cleans the carpet or floor using one cleaning mode on the forward stroke of a cleaning cycle and another cleaning mode for the reverse stroke of the cleaning cycle; FIG. 35 is an exploded view of the wheel rotation activating assembly and left rear wheel of the embodiment shown in FIG. 1 , which uses the electrical circuit of FIG. 34A ; FIG. 36A is a partial left side view of the base of the carpet extractor of FIG. 1 showing the wheel rotation activating assembly of FIG. 35 operating to wash the carpet or floor during the forward stroke; FIG. 36B is as a view similar to FIG. 36A but with the wheel rotation activating assembly being operated to rinse the carpet or floor during the reverse stroke; FIG. 37 is a side elevational view of another actuator lever and related parts used on the wheel rotation activating assembly of FIG. 35 ; FIG. 38 is a sectional view taken along line 38 — 38 of FIG. 37 ; FIG. 39 is an exploded view of another version of a wheel rotation activating assembly used in the embodiment shown in FIG. 1 ; FIG. 40A is a partial left side view of the base of the carpet extractor of FIG. 1 showing the wheel rotation activating assembly of FIG. 39 operating to wash the carpet or floor during the forward stroke; FIG. 40B is a view similar to FIG. 36A but with the wheel rotation activating assembly being operated to rinse the carpet or floor during the reverse stroke; FIG. 41 is a vertical side sectional view through the center of the metering plate shown in FIG. 27 ; FIG. 42 is an exploded view of another version of a wheel rotation activating assembly and related elements used on the right rear wheel in the embodiment shown in FIG. 1 ; FIG. 43A is a partial left side view of FIG. 42 showing the wheel rotation activating assembly operating to wash the carpet or floor during the forward strike; FIG. 43B is a view similar to FIG. 43A but with the wheel rotation activating assembly being operated to rinse the carpet or floor during the reverse stroke; and FIG. 44 is a partial cross-sectional view of the hose clip assembly secured to the accessory hose, hose end, and solution tube. DETAILED DESCRIPTION OF THE INVENTION Referring to the drawings, FIG. 1 depicts a perspective view of an upright carpet extractor 60 according to one embodiment of the present invention. The upright carpet extractor 60 comprises an upright handle assembly 62 pivotally connected to the rear portion of the floor-engaging portion or base assembly 64 that moves and cleans along a surface 74 such as a carpet. The base assembly 64 includes a brush assembly 70 ( FIG. 3 ) having a plurality of rotating scrub brushes 72 ( FIG. 30 ) for scrubbing the surface. A supply tank assembly 76 is removably mounted to the handle portion 62 of the extractor 60 and includes a combination carrying handle and securement latch 78 pivotally connected thereto. A combined air/water separator and recovery tank 80 removably sits atop base assembly 64 and is surrounded by a hood portion 82 . As depicted in FIG. 2 , the base assembly 64 includes a frame assembly 83 which comprises a generally unitary molded rear body 84 having two laterally displaced wheels 66 L, 66 R rotatably attached to the rear of the rear body 84 via axles 67 . Referring to FIG. 3 , integrally molded into the bottom of the rear body 84 is a circular stepped basin 86 receiving therein the motor/fan assembly 90 . A suitable motor/fan assembly is shown in U.S. Pat. No. 5,500,977, the disclosure of which is incorporated by reference. An air driven turbine 98 providing motive power for the brush assembly 70 is mounted on the front portion of the rear body 84 . The brush assembly 70 is contained in a brush cavity 73 formed in the underside of the front body 92 . A suitable brush assembly 70 is taught in U.S. Pat. No. 5,867,857, the disclosure which is incorporated herein by reference. Brush assembly 70 is operated by a suitable gear train (or other known means), not shown, contained in transmission housing 100 . A suitable air turbine driven gear train is taught in U.S. Pat. No. 5,443,362, the disclosure of which is incorporated by reference. Referring now to FIG. 4 , the frame assembly 83 also comprises a front body 92 , which is secured to rear body 84 . In particular, lateral T-shaped tabs 94 extending from the rear of the front body 92 slidably engage complementary journals 96 of the rear body 84 . Integrally molded into the underside of rear body 84 of frame assembly 83 (see FIG. 5 ) is a vacuum manifold 102 having extensions for providing a vacuum source for the turbine 98 . The motor fan assembly 90 generally provides suction to manifold 102 . Atmospheric air, driving a brush turbine rotor enters by way of turbine inlet 110 , passing through a screen (not shown) to filter out the dirt and then passing through the rotor. Positioned within inlet 110 is a throttle valve door 114 ( FIG. 5 ) for energizing or de-energizing brush turbine rotor. Such a suitable brush turbine 98 is disclosed in U.S. Pat. No. 5,860,188 which is hereby incorporated by reference. Referring now to FIG. 5 , a manual override mechanism 112 is provided whereby the operator, operating in the floor-cleaning mode, may selectively close throttle valve 114 thereby de-energizing brush drive turbine 98 . Alternatively, the operator may select an intermediate position whereby throttle valve 114 is partially closed thereby reducing the air flow through throttle valve 114 causing brush drive turbine 98 to rotate at a slower speed resulting in slower rotating brushes. Override mechanism 112 comprises a table 113 integrally molded to the body of brush drive turbine 98 and extending rearwardly having slide 116 slidingly attached thereto. Extending upwardly from slide 116 is lever arm 118 having a conveniently shaped finger cap 120 ( FIG. 3 ) atop thereof. Lever arm 118 extends upward through a suitable opening (not shown) in the hood 82 whereby cap 120 is received within recess 121 in hood 82 as seen in FIG. 3 . Referring to FIG. 5 , movement of the cap 120 ( FIG. 3 ) in turn moves the slide 116 to rotating a bell crank 117 , which in turn rotates the shaft of the valve 114 , attached thereto. In particular, projecting upward from slide 116 is an arcuate rib 119 . As slide 116 is moved rearward by the operator, the rib 119 engages the bell crank 117 rotating the bell crank 117 and throttle valve 114 counterclockwise thereby closing throttle valve 114 and de-energizing brush drive turbine 98 . Upon return of the slide 116 to its original position (as illustrated in FIG. 5 ), a spring 123 , secured between the bell crank 117 and the slide 116 , causes the bell crank 117 to rotate clockwise, thereby rotating throttle valve 114 to the full open position. Generally as the slide 116 moves from one position to the other, a cantilevered tab releasingly engages concavities in the surface of the table, which corresponds to the open and close position of valve 114 . A similar mechanism is disclosed in U.S. Pat. No. 5,860,188, the disclosure of which is incorporated by reference. Further, when the handle assembly 62 is pivoted in the upright storage position, an actuating rod 122 , connected to the handle, links with the lever arm 118 via linking member 125 to turn the brushes off as disclosed by U.S. Pat. No. 5,983,442, the disclosure which is hereby incorporated by reference. Turning to FIGS. 3 and 6 , a floor suction nozzle 124 assembly is removably mounted to the hood portion 82 of the base assembly 64 ( FIG. 3 ). In particular, the floor suction nozzle assembly 124 includes a front plate 126 secured to a rear plate 128 that in combination define dual side ducts 130 , 132 separated by a tear drop shaped opening 134 . The opening 134 extends down from an accessory hose opening 136 ( FIG. 3 ), formed in the front portion 126 , to a predetermined distance above the suction inlet 138 of the suction nozzle 124 . The front and rear plates or portions 126 , 128 are secured to one another by ultrasonic welding and screw fasteners, however, other types of ways to secure them such as for example, by adhesive, can be used. The distance above the suction inlet 138 for the opening 134 is about one fourth of an inch, which provides a flow path for liquid and dirt pick up in the center of the suction inlet 138 of the nozzle 124 . As best seen in FIG. 6 , the opposite side walls 140 , 142 surrounding the tear drop shaped opening 134 converge downwardly into s-shaped curves 144 , 146 that terminate into a lower curved front end 148 . This shape helps smooth the airflow thereby reducing any back flow, eddies, or recirculation. The side ducts 130 , 132 are symmetrical which produces a more uniform distribution of suction across the suction inlet 138 . In particular, a computer simulation shows the velocity variation across the suction inlet 138 to improve from 75 percent (from the left side to the center) for the prior art one duct nozzle design to about 16 percent for this dual side duct nozzle. The side ducts 130 , 132 converge upstream into a recessed throat portion 149 , which terminates into an upwardly extending rear duct 150 . As shown in FIG. 7 , a seal 151 is disposed around the outlet 154 of the rear duct 150 . As illustrated in FIGS. 3 , 15 A and 15 B, the rear duct 150 is positioned in a complementary recess portion 152 formed in the front lower portion of the recovery tank 80 . The outlet 154 of the duct 150 aligns and fluidly connects with the inlet 153 ( FIGS. 15A and 15B ) of a front vertical duct 156 ( FIG. 3 ) of the recovery tank 80 . Referring back to FIG. 6 , the suction nozzle 124 includes two projections 160 , 158 extending rearwardly from the rear side of the rear portion 128 . The projections 160 , 158 extend into apertures 163 , 165 formed in the hood 82 and slidably engage complimentary unshaped holders 162 , 164 integrally formed on the front body 92 . To remove the suction nozzle 124 , the recovery tank 80 ( FIG. 2 ) must first be removed from the rear body of the 84 of the frame 83 . Then, the nozzle is slid or pulled forward disengaging the projections from the holders 162 , 164 . Turning to FIG. 7 , as previously stated, the accessory hose opening 136 is formed in a recess 167 of the front portion 126 of the suction nozzle 124 . An elastomeric circular seal 166 is attached upon the top of the edge 204 of the opening 136 . As illustrated in FIG. 3 , a door 168 is pivotally connected to the front portion 126 and releasbly fits into the complimentary recess 167 to cover the opening 136 when the carpet extractor 60 is used to clean the floor. In more detail, integrally formed lateral pins 170 (only one shown in FIG. 3 ) on opposite sides of the door 168 are received in respective journals 174 L, 174 R ( FIG. 8 ) to form the pivotal connection. To releasably lock the door 168 , two lateral tabs 178 (only one shown) extending outwardly from opposite sides of the door 168 deflect and engage lateral notches 184 L, 184 R ( FIG. 8 ) formed in the underside of the side wall 182 ( FIG. 8 ) of the recess 167 , when the door 168 closes with sufficient force to overcome the elasticity of the tabs 178 . To unlock the door 168 , the front of the door 168 is pulled with sufficient force to deflect the tabs 178 and disengage them from the notches 184 . An accessory hose 188 ( FIG. 9 ) cooperates with the opening 136 so that the carpet extractor 60 can be used, for example, to clean upholstery and/or stairs. In particular, as shown in FIGS. 9 and 10 , the hose end 190 includes a flange portion 192 and a pair of projections 194 , 196 ( FIG. 10 ) located on opposite sides of the hose end 190 for alignment and insertion into respective complementary slots 198 , 200 ( FIG. 7 ) formed at the edge 204 ( FIG. 157 ) of the hose opening 136 ( FIG. 7 ). The projection 196 and its respective slot 200 is of a larger size than the projection 194 and its respective slot 198 to ensure that the hose end is inserted in the proper position to block the suction to the suction nozzle 124 which will be explained as follows. Referring to FIGS. 11A and 11B , the hose end 190 is inserted into the hose opening 136 until the projections 194 , 196 are below the edge 204 as seen in FIG. 11A and then rotated clockwise (when viewed from the top) until the projection 196 abuts against a stop member 202 , extending downward from the underside of the edge 204 of the opening 136 , as seen in FIG. 11B . In this position, a front wall 206 extending down from the hose end 190 contacts the recessed top surface 208 ( FIG. 3 ) of the rear portion of the floor suction nozzle 124 at the throat portion 149 . The front wall 206 extends across the throat portion 149 thereby blocking vacuumized air from the suction inlet 138 and side ducts 130 , 132 of the suction nozzle 124 and thus preventing the floor suction nozzle 124 from picking up liquid and dirt. However, in this mode, working air including entrained liquid is drawn through the hose 188 by a suitable upholstery hand tool 446 ( FIG. 24 ) traveling through the throat portion 149 and upwardly extending duct 156 and into the recovery tank 80 . Also as shown in FIGS. 11A and 11B , during the rotation of the hose end 190 , the projections 194 , 196 cam against respective ramp portions 212 , 214 ( FIG. 11A ) formed on the underside of the edge 204 of the opening 136 , riding over the ramp portions 212 , 214 , which action is allowed by sufficient force to overcome the elastic force of the elastomeric seal 166 ( FIG. 7 ). The hose end 190 is held in place by the ramp portions 212 , 214 until the hose end 190 is rotated back with sufficient force again to compress the seal 166 thereby allowing the projections 194 , 196 to ride over the ramp portions 212 , 214 . Further, a stop portion 201 located adjacent the left edge of the slot 200 will abut against the projection 196 preventing the hose end 190 from inadvertently rotating counter clockwise after initial insertion of the hose end 190 into the opening 136 . As depicted in FIG. 30 , the accessory hose 188 ( FIG. 9 ) includes a solution tube 216 , which fluidly connects to a discharge nipple 218 of control valve 877 . The discharge nipple 218 is positioned in an opening formed in the left side of the base assembly 64 as seen in FIG. 1 . The control valve 877 allows mixed detergent and clean water to flow through the solution tube 216 and dispense by typical spray means 220 ( FIG. 9 ). A typical on-off trigger operated valve 222 ( FIG. 9 ) is provided to control the amount of solution dispensed. A quick disconnect coupling 224 ( FIG. 9 ) removably attaches to the discharge nipple 218 similar to that disclosed in U.S. Pat. No. 5,500,977, the disclosure of which is incorporated by reference. As seen in FIG. 9 , a pair of hose clips 195 is clipped on the hose 188 at the corrugated portion 541 for releasably securing the solution tube 216 and/or one of the hose ends 190 , 193 to the hose 188 . In particular, as depicted in FIG. 44 , the clip 195 has an inner C-shaped portion 518 that receives the corrugated portion 541 of the hose 188 and a pair of outer c-shaped clips 526 , 528 integrally formed on respective opposite legs 520 , 522 of the clip 195 . The outer clips 526 , 528 are oriented such that the middle or bight portion 524 of each of the outer clips 526 , 528 are integrally formed on the opposite legs 520 , 522 . Specifically, the middle portions 524 are oriented at a location along the legs 520 , 522 such that a line connecting the two middle portions 524 of the clips 526 , 528 is perpendicular to a line bisecting the inner clip 518 at its middle portion 530 . The outer clip 528 receives the solution tube 216 . The outer clip 526 receives a projection 536 formed at the hose end 193 connected to the accessory tool. A similar projection 536 is also formed at the hose end 190 for connection to the opening 136 . Each projection 536 has a three integrally molded curved ribs 542 (see also FIG. 9 ) extending around the longitudinal axis of the projection 536 that cooperatively snap fit into the outer clip 526 Triangularly shaped reinforcement plates 540 are integrally molded to the ends of the projection 536 and hose end 193 or 190 . As should be apparent due to the fact that the clips are of similar shape and size, the solution hose 216 can be received by the outer clip 526 and the projection 536 can be received by the outer clip 528 . Further, the hose clip 195 can be used to secure the hose end 190 or 193 and solution tube 216 with only the outer clips 526 , 528 , without the hose 188 being attached to the inner clip 518 , or alternatively, only the inner clip 518 and one of the outer clips 526 , 528 can used to secure the hose 188 and either the solution tube or hose end 193 or 190 . All of the clips have integrally formed rounded nub portions 532 at their free ends for addition securement of their respective objects. Also, the inner clip 518 has a pair of nubs 545 along its middle portion for addition reinforcement. The inner clip 518 can slide along the hose 188 and the outer clips 526 , 528 can slide along the solution tube 216 at desired positions. As depicted in FIG. 3 , the recovery tank 80 is configured to include a raised portion 260 defining a generally concave bottom whereby tank 80 sets down over and surrounds a portion of the motor cover 230 of base frame assembly 64 . It is preferred that recovery tank 80 set atop and surround a portion of the motor fan assembly 90 thereby providing sound insulating properties and assisting in noise reduction of the extractor. Referring to FIG. 12 , the recovery tank has a front arcuate wall 232 , opposite sidewalls 234 L, 234 R and rear wall 238 integrally formed around the bottom 240 . The vertical rectangular duct 156 , formed with the inner surface of the front wall 232 , includes a rear wall 242 and opposite sidewalls 244 L and 244 R. Positioned inside tank 80 is a T-shaped baffle assembly 246 comprising two vertical upstanding baffles 248 and 250 welded to a bottom base portion 252 . As depicted in FIG. 13 , the baffle 250 has an opening 254 formed near the intersection of the two baffles 248 , 250 . The opening 254 is located to the left of the intersection underlying the inlet chamber 304 ( FIG. 14 ). The bottom base portion 252 includes a semicircular cap portion 258 that fits over the front arcuate part 259 of the raised portion 260 of the bottom wall 240 of the recovery tank 80 as seen in FIG. 12 . The baffle 250 is slightly curved and has a cut out portion 262 ( FIG. 13 ) formed on its lower edge to conform to fit around the width of the cap portion 258 . A pair of retaining ribs 264 , 266 is integrally formed on opposite sides of the front part 259 of the raised portion 260 . The upper end of each of the ribs 264 , 266 is spaced from the raised portion 260 thereby defining a notch for receiving the lower peripheral wall 272 of the cap portion 258 . The rear portion 280 of the base 252 includes an integrally formed u-shaped clip 274 that grasps around the width of the rear part 278 of the raised portion 260 . Integrally formed on the upper surface of the clip 274 are two pairs of ribs 282 , 284 , each pair being located on opposite sides of the baffle 248 . The ribs 282 , 284 slidably engage respective pairs of locking tabs 286 , 288 , which extend over the ribs. The baffle assembly 246 is removably mounted upon the raised portion 260 by sliding the ribs 282 , 284 under the tabs 286 , 288 and then inserting the peripheral wall 272 of the cap portion 258 between the retaining ribs 264 , 266 and front portion 259 such that the baffle is positioned just behind the retaining ribs 264 , 266 in abutment with them. In this position, the retaining ribs 264 , 266 act as stops to prevent the ribs 282 , 284 on the clip 274 from slidably disengaging from the locking tabs 286 , 288 and inadvertently disconnecting the baffle assembly 246 from the recovery tank 80 . To remove the baffle assembly 246 , a user simply pulls the baffle assembly 246 upwardly with sufficient force to overcome the frictional force between the retaining ribs 264 , 266 and baffle 250 and slide the ribs 282 , 284 out of the locking tabs 286 , 288 . The baffles 248 , 250 act to limit the degree of fluid sloshing during the forward and reverse push-pull operation of the extractor in the floor cleaning mode and assists in separation of liquid from the working air as described further below. In addition to their function as anti-slosh baffles, baffles 248 and 250 also serve to prevent the establishment of a “short circuited” working airflow from the exit opening 308 ( FIG. 14 ) of inlet chamber 304 directly to inlet opening 310 of exit chamber 306 . Baffles 248 and 250 act to disburse the incoming working air over that portion of the recovery tank's volume upstream of baffles 248 and 250 by forcing the working air to pass through openings 254 , 291 and 293 . Thus, the velocity of the air as it passes through the recovery tank 80 is slowed to a minimum value and the time that the working air spends within tank 80 is at a maximum thereby providing for more complete liquid precipitation. It is preferred that baffles 248 and 250 are free standing with the opening 254 there between and openings 291 and 293 between the tank side walls 234 L, 234 R and baffle 250 to permit the free flow of recovered fluid there past. As shown in FIG. 2 , the recovery tank 80 is releasably affixed to motor cover 230 by two rotatable latches 294 L and 294 R ( FIG. 2 ) having curved tangs 295 L and 295 R. As depicted in FIGS. 15A and 15B , the latches 294 (the left one shown in these figures) are slidingly received within slots 296 , in the left and right side walls 234 of the tank 80 . FIG. 15A illustrates the latch 294 L received in the slot 296 to affix the tank 80 to the motor cover 230 and FIG. 15B shows the latch 294 L disengaged from the slot 296 to unlatch the tank 80 from the motor cover 230 . Referring to FIG. 14 , the recovery tank lid assembly 301 incorporates therein air/fluid separator comprising a hollowed lid 298 and bottom plate 300 sealingly welded together forming a plenum therebetween. The plenum is divided into two separate and distinct chambers, an inlet chamber 304 and exit chamber 306 , by separator wall 309 integrally molded into lid 298 and extending between the lid 298 and bottom plate 300 . Inlet chamber 304 fluidly communicates with the front duct 156 ( FIG. 3 ) through inlet opening 303 in the bottom plate 300 . An inlet chamber exit passageway 308 in bottom plate 300 provides fluid communication between tank 80 and inlet chamber 304 . Similarly, exit chamber 306 includes inlet opening 310 , in bottom plate 300 providing fluid communication between tank 80 and exit chamber 306 . An integrally formed arcuate lip or wall 312 extends down from the bottom surface of the bottom plate 300 and surrounds the inner semicircular edge of the passageway 308 . The wall 312 prevents drops of liquid on the upper surface of the bottom plate from traveling through the passageway 308 and across the lower bottom surface of the bottom plate 306 to the entrance passageway 310 of the exit chamber 306 , where the drops can be drawn into the motor fan assembly 90 ( FIG. 3 ). Instead, any drops passing through the passageway 308 will drip off the lower edge of the wall 312 and into the tank 80 ( FIG. 12 ). As seen in FIG. 3 , it is preferable to provide a float 314 within a suitable float cage 316 to choke the flow of working air through passage 310 when the reclaimed fluid within recovery tank 80 reaches a desired level. A raised portion or nub 318 on the lid 298 is aligned over the float 314 to enhance the viewing of the float 314 when raised to indicate that the recovery tank 80 is full. Exit chamber 306 ( FIG. 14 ) further includes discharge opening 320 for fluid communication with an integrally molded stand pipe 322 of tank 80 when lid assembly 301 is attached to the open top of tank 80 . Referring back to FIG. 14 , integrally molded into lid 298 so as to be positioned about the periphery of exit opening 308 in bottom plate 300 are two vortex impeding arcuate baffles 324 and 326 . The rear baffle 324 is attached to the bottom surface of the top wall 328 of the lid 298 and extends almost across the exit opening 308 such that it is spaced from the outer edge of the opening 308 near the side wall 330 . The rear baffle 324 is also positioned a small distance in front of the center of the exit opening 308 . Front baffle 326 attached to the bottom surface of the top wall 328 of the lid 298 and extends from the side wall 330 to the edge of opening 308 . A second flat rear baffle 327 , attached to the side wall 330 and bottom surface of top wall 328 , is oriented perpendicular with the side wall 330 and extends a partial distance across the exit opening 308 . As viewed from the front of the opening, the front baffle 326 is oriented convexly and the rear baffle 324 is oriented concavely. The baffles 324 , 326 are generally oriented perpendicularly with respect to each to other. An s-shaped rib 331 , integrally formed on the bottom surface of the top wall 328 , extends partially down a distance therefrom and is further attached between the separator wall 309 and side wall 330 . The distance is about half of that between the bottom plate 300 and top wall 328 of the lid 301 . The air and soiled liquid is extracted from the carpet and drawn through the suction nozzle 124 and side suction ducts 130 , 132 to the inlet 303 by the motor/fan assembly 90 ( FIG. 3 ). Then, as indicated by the arrows shown in FIG. 16 through the translucent lid 298 , the stream of air and water coming from the inlet 303 impinges on the front baffle 326 where a portion of it is then deflected to the center of the rear baffle 324 directing it to the front baffle 326 where a portion of it is then deflected to the center of the rear baffle 324 . The air and liquid stream circulates around the front portion of the opening 308 , due to concave nature of the baffle 324 , and thus allows more separation of air from the water. In particular, the deflection of the air from the baffles 324 , 326 and the re-circulation of the stream facilitates separation of the liquid from the air, due to the slowing of the stream, thereby allowing more time for the air to separate from the liquid. Further, when the stream of air is forced to turn, the relatively lighter air is able to negotiate the turn, where as the heavier liquid does not, thereby causing further separation. The rib 331 is located and oriented to deflect the air downward to slow it down and also direct a portion of the stream into the rear corners of the inlet chamber 304 . There, the stream stalls allowing further separation, where it is also deflected by baffle 327 . Also, the position of the baffle 324 near the center of the exit opening 308 causes the air and liquid stream to flow into a smaller portion of the opening 308 thereby minimizing splashing as the liquid collects on the bottom 240 of the tank 80 . This reduces the possibility of liquid entering the motor area. With reference to FIGS. 3 and 14 , the liquid enters the inlet chamber exit passageway 308 and travels down into the bottom of the tank 80 . The separated air travels through the float cage 316 and into the stand pipe 322 exiting out the bottom of the rear body 84 of the frame assembly 83 as seen in FIG. 3 . As seen in FIG. 4 , the working air exits along a pair of vents 335 formed on the bottom plate 333 of the extractor 60 . The vents 335 are oriented such that a line extending between them is parallel to the front body 92 . In effect, the exiting working air provides heat to the cleaning path of the carpet created by the extractor 60 . A unshaped carrying handle 332 is pivotally connected to the upper portion of the recovery tank 80 as seen in FIG. 2 . In particular, as depicted in FIG. 17 , the carrying handle 332 includes a transverse curved portion 334 and a pair of circular end portions 336 L, 336 R, each integrally formed on respective opposite free ends of the curved portion 334 . Each of the end portions 336 has an inwardly extending curved wall 340 that extends circumferentially around the outer edge of the end portion 336 . The carry handle 332 is pivotally attached to the tank 80 ( FIG. 12 ) by mounting C-shaped sleeves 342 , that extend inward from inner surfaces of the ends 336 of the leg portions 344 L, 344 R of the handle, over respective pivot posts 346 L, 346 R ( FIG. 12 ) that extend out from opposing sides of the recovery tank 80 . The carry handle 332 is pivotable into a forward, generally horizontal latched position ( FIG. 18A ), a generally upright carry position ( FIG. 18B ), and a rearward tank discharge position ( FIG. 18C ). With reference to FIGS. 18A , 18 B, and 18 C, the carrying handle 332 locks the recovery tank lid 301 to sealingly close the top of the recovery tank 80 . Lid retaining members 348 L, 348 R (only the left one is illustrated in these figures, but the right one is similar) are preferably located on opposing outer edges of the lid 301 to engage respective lid latching members 350 on inner surfaces of the ends 336 of the carry handle 332 to securely latch the lid 301 onto the recovery tank 80 . The lid latching members 350 are preferably sized and arranged on the carry handle 332 such that the lid latching members 350 engage the lid retaining members 348 and latch the lid 301 on the recovery tank 80 when the handle 332 is in the latched position ( FIG. 18A ) and when the handle 332 is in the carry position ( FIG. 18B ), but not when the handle 332 is in the discharge position ( FIG. 18C ). A typical boss 354 and recess 356 detent arrangement is provided on the lid latching members 350 and the lid retaining members 348 , respectively, to releasably retain the carrying handle 332 in the latched position. Such a latching arrangement and carrying handle design is similar to that of U.S. Pat. No. 5,901,408, the disclosure of which is hereby incorporated by reference. Referring to FIG. 2 , the handle assembly 62 basically comprises an upper handle portion 358 and lower body portion 360 . The lower body portion 360 has a pair of trunnions 362 L, 362 R that are received in complementary journals 364 L, 364 R formed in the rear body 84 of the frame assembly 83 of the base 64 . Trunnion brackets 366 L, 366 R are mounted over the trunnions to cover them, thereby pivotally securing the handle assembly 62 to the base 64 . A handle release pedal 368 is pivotally connected to the rear center portion of the rear body 84 between the journals 364 . The pedal 368 includes a rear foot engaging portion 370 for depression by a foot or other object. The pedal 368 further includes an elongated pivot rod 371 which extends longitudinally and is integrally formed with the foot engaging portion 370 . Ears 372 L, 372 R, integrally formed with the body and extending rearwardly, are provided on opposite sides of the foot engaging portion 370 . A hook shaped spring arm 374 , integrally formed with the foot engaging portion 370 , extends forwardly and bears against the rear body 84 of the frame 83 . As depicted in FIG. 19A , the arcuate end 376 of the arm 374 bears against the rear body 84 and urges the ears 372 (only the right one of which is shown) upwardly such that they are positioned and aligned behind respective rear stops 378 (only one of which is shown), integrally formed on the outer surface of the lower body portion 360 of the handle assembly 62 . Thus, the ears 372 will engage the stops 378 , thereby preventing the handle assembly 62 from pivoting down. However, when the pedal 368 is depressed as seen in FIG. 19B , the elastic spring arm 374 bends to allow the ears 372 to pivoted down and away from the stops 378 and thus, the handle assembly 62 is permitted to pivot down. As seen in FIGS. 20 , 21 A and 21 B, the upper handle portion 358 has an integrally formed hook 380 extending upwardly. As best seen in FIGS. 21A and 21B , just below the nose 382 of the hook 380 is a notch 384 . As seen in FIG. 2 , a wire cover 386 (a portion of which is shown in FIG. 2 ) is mounted within the lower body portion 360 and includes an integrally formed rear flange portion 390 having a pair of tubular receptacles 392 L, 392 R formed on opposite ends thereof. As depicted and seen in FIG. 20 , an accessory tool storage caddy 388 is removably mounted to the rear of the handle assembly 62 . In particular, as shown in FIG. 22 , the caddy 388 comprises a body 394 having a pair of posts 396 L, 396 R extending down from the bottom of the body 394 . The rear side of the caddy 388 , depicted in FIG. 23 , includes an inverted u-shaped support wall 398 extending rearwardly upon which the accessory hose 188 ( FIG. 24 ) is wound around. Integrally formed stiffening ribs 406 positioned between the body 394 and inner surface of the support wall 398 provide additional support to the support wall 398 . The hose 188 releasably snap fits into clips 400 , 402 , and 404 formed on the body 394 . In particular, the pair of side clips 400 , 402 located on opposite sides of the body 394 extend rearwardly from the body 394 over the support wall 398 . The top clip 404 extends rearwardly from the body 394 over the bight portion 408 of the support wall 398 . The clips 400 , 402 , and 404 include nubs 410 that further secure the hose 188 to the body 394 and support wall 398 . As shown in FIG. 24 , the hose 188 also is received by the upper hook 409 of a dual cord and hose hook assembly 411 with the lower hook 413 for receiving the cord (not shown). The hook assembly 411 is snap connected to the lower part of the lower body 360 of the handle assembly 62 . Integrally formed to the body 394 are aligned upper and lower enclosed u-shaped holders 412 , 414 extending outwardly from the rear side of the body 394 for receiving an accessory tool such as a bare floor cleaning tool 444 . The lower holder 414 has a bottom wall 416 ( FIG. 23 ) to support the bare floor cleaning tool 444 . Referring back to FIG. 23 , in the center of the caddy 388 is formed a tongue member 418 that extends upwardly and outwardly at a slight angle. An upstanding fin portion 420 is integrally formed with the tongue member at the center of its rear surface and extends perpendicular to the tongue member 418 . The fin portion 420 is also integrally formed with the body 394 to provide reinforcement to the tongue member 418 . The tongue member 418 and fin portion 420 receive the hose end of an upholstery hand tool 446 for storage as seen in FIG. 24 . Near the left of the tongue member 418 is a pocket holder 422 that has opposing end members 432 , 434 that define a channel 436 for slidingly receiving the tapered working end 438 of a crevice tool 440 as seen in FIG. 24 . The end member 434 is convexly curved, when viewed from the rear, to guide the working end 438 of the crevice tool into the channel 436 . A looped piece 442 laterally extends over the crevice tool, which in combination with a front plate 443 ( FIG. 22 ) extending across the front of the working end 438 , provides for additional securement. As best shown in FIG. 22 , integrally formed with the top clip 404 and extending forward and down from the front side of the top clip 404 is a pair of hooks 424 L, 424 R for hooking the caddy 388 around a coat hangar or the like for storage. A vertical slot 426 is formed in the middle of the body 394 . Just above the top edge of the slot on the rear side is a projection or nub 428 formed on the body as best seen in FIG. 24 . The caddy 388 is mounted to the rear of the handle assembly 62 by inserting the hook 380 into the slot 426 as shown in FIG. 21A , until the nub 428 seats securely into the notch 384 under the nose 382 of the hook 380 as seen in FIG. 21B , and slidably inserting the posts 396 into their respective tubular receptacles 392 as seen in FIGS. 20 and 24 . As shown in FIG. 22 , spacers 430 are integrally formed on the front surface of the body 394 on opposite sides of the slot 426 to provide additional stability to the caddy when mounted to the handle assembly 62 . Alternately, the vertical slot 426 could be located on the handle assembly 62 and the hook 380 could be located on the body 394 . Likewise, spacers 430 could be provided on the handle assembly 62 to provide the additional stability when caddy 388 is mounted on handle assembly 62 . To remove the caddy, a user grasps the caddy 388 and pulls upward, which cause the nub 428 to cam against the nose 382 so that the nub 428 unseats from the notch 384 of the hook 380 , and slides the posts 396 out of the tubular receptacles 392 . The supply tank assembly 76 comprises a clean water supply tank 620 and a detergent supply tank 622 adhesively mounted to the clean water supply tank 620 as depicted in FIG. 1 . The supply tank assembly 76 includes the combination carrying handle and tank securement latch 78 providing a convenient means for carrying the tank and/or securing the tank to the extractor handle assembly 62 . As seen in FIG. 25 , tank handle 78 comprises a generally unshaped plastic handle bar 447 having circular camming ends 448 and 450 integrally attached at each leg thereof 452 , 454 . The two camming ends 448 and 450 are generally parallel with respect to each other and each has an integrally formed pivot pin 456 extending inwardly into respective lateral recesses 460 , 462 ( FIG. 27 ) formed in the water tank for rotatable attachment of the carry handle 78 to the tank assembly 76 . Each pin 456 includes a lateral webbed offset 464 which cams upon the surface 480 ( FIG. 2 ) of the water tank 620 as the handle 78 rotates counter clockwise about the pins 456 . Further, as the handle 78 rotates counterclockwise, integrally molded cantilever springs 466 (one associated with each end portion) acting upon the surface of the water tank bends, thereby storing energy therein biasing the carrying handle 78 clockwise. When tank assembly 76 is placed upon support shelf 743 of handle assembly 62 and rotated clockwise (as viewed in FIG. 26A ) into the installed position, camming ribs 468 (provided upon each arm 434 and 436 ) engage and cam upon the edge 472 of hood 470 of the upper handle 358 forcing handle 78 downward until the notch or rear end 474 of the rib 468 , on handle bar 447 , entraps the edge 470 therein thereby securing tank 40 in place as depicted in FIG. 26B . As seen in FIG. 2 , the edge 472 jogs or dips thereby defining grooves 476 which receive the ribs 468 to guide the carrying handle 78 during installation. To release tank assembly 76 the operator grasps handle bar 447 pulling it downward against the retarding force of cantilever springs 466 , thereby releasing the notch or rear end 474 from locking engagement with edge 472 of hood 470 and removes the tank assembly 76 from the support shelf 743 of extractor handle assembly 62 . Lateral offsets 478 ( FIG. 25 ) on each of the legs 452 , 454 of the handle 78 provide rotational stops which engage the tank surface 480 thereby preventing over travel of handle 78 and inadvertent removal of the handle from pins 456 . As depicted in FIG. 27 , the supply tank assembly 76 is positioned upon a bottom base 624 , which with the tank assembly 76 is removably mounted to the support shelf 743 , which is secured to the lower body 360 ( FIG. 2 ) of handle portion 62 ( FIG. 2 ), and fluidly connected to a unshaped reservoir 721 underneath the support shelf 743 via respective solution release valves 746 . The reservoir 721 is vibrationally welded to the underside of the support shelf 743 . Each of the supply tanks 620 , 622 includes a solution release valve 746 . The solution release valve 746 is normally in the closed position. However, as the tank assembly 76 is placed upon the reservoir 721 , the solution release valve 746 in each of the supply tanks 620 , 622 opens permitting clean water from the clean water supply tank 620 and detergent from the detergent supply tank 622 to flow into the reservoir 721 . Upon removal of the tank assembly 76 from the reservoir 721 , the solution release valve 746 closes prohibiting liquid from flowing out of the supply tanks 620 , 622 . As seen in FIG. 28 , the solution release valve 746 is incorporated into bottom plate 712 of the detergent tank 622 . The other solution release valve 746 is incorporated into the bottom plate 712 of the clean water tank 620 , which is of similar construction. Thus, only the one for the detergent tank 620 will be described in more detail. The solution release valve 746 comprises a valve body 742 having an elongate plunger 744 extending coaxially upward therethrough. The plunger 744 having an outside diameter less than the inside diameter of the valve body 742 is provided with at least four flutes 745 ( FIG. 27 ) to maintain alignment of the plunger 744 within the valve body 742 as the plunger 744 axially translates therein and permits the passage of fluid therethrough when the plunger 744 is in the open position. The valve body 742 having a vertically extending bore 756 ( FIG. 27 ) slidingly receives therein the upper shank portion of the plunger 744 . An elastomeric circumferential seal 748 circumscribes plunger 744 for sealingly engaging valve body 742 . The seal 748 is urged against the valve body 742 by action of the compression spring 752 , circumscribing plunger 744 . The spring 752 is positioned between the body 742 and the seal 748 . The solution release valve 746 is normally in the closed position. However, with reference to FIG. 27 , as the supply tank assembly 76 is placed upon the support shelf 743 of the handle 612 , the pin 738 of the reservoir 721 aligns with plunger 744 , thereby forcing plunger 744 upward to separate the seal 748 from the valve body 742 , compressing spring 752 , and opening the valve body 742 permitting detergent from the detergent supply tank 622 to flow through bore 756 of the valve body 742 into the reservoir 721 . Upon removal of supply tank assembly 76 from the support shelf 743 , the energy stored within compression spring 752 urges the seal 748 down against the valve body 742 to close the valve 746 . As depicted in FIG. 28 , an elastomeric tank seal 500 has an annular groove 501 that receives the edge 503 of the outlet opening of the bottom plate 712 to secure it to the edge 503 . Upper and lower annular ribs 505 , 507 formed on the outer surface of the valve body 742 secure the elastomeric seal 500 to the valve body 742 . In particular, the lower rib 507 engages the underside of a lip 509 on the seal and the upper rib extends over and engages the top edge 511 of the outlet opening. Turning to FIG. 27 , the support shelf 743 includes two circular openings 760 , 762 align with their respective solution release valves 746 associated with the corresponding clean water and detergent tanks 620 , 622 . The pin 738 associated with the solution release valve 746 of the clean water tank 620 is integrally formed on the reservoir 721 and extends through the opening 760 . The pin 738 associated with the solution release valve 746 of the detergent tank 622 is integrally formed on a metering plate 764 , which covers the opening 762 . As seen in FIG. 41 , the metering plate 764 is generally circular in shape and includes a channel 766 circumferentially extending around the pin 738 . The bottom of the channel 766 has an orifice 768 which meters the detergent solution at a value for the desired mix with the clean water. A toroid or donut shaped filter 770 ( FIG. 27 ) is inserted into the channel for filtering out particles of the detergent. The metering plate 764 has an outer groove 772 extending around the wall 773 surrounding the channel 766 that receives a seal 771 . A pair of L-shaped grooves 777 , 779 are also formed on opposite sides of the wall 773 . Referring to FIG. 27A , a pair of lateral projections 781 extending from the inner wall 789 ( FIG. 27A ) of the opening 762 ( FIG. 27A ) in the support shelf 743 each slidably engage a respective groove 777 or 779 ( FIG. 41 ) to secure the metering plate 764 ( FIG. 41 ) to the support shelf 743 within the opening 762 , as the metering plate 764 is inserted into the opening 762 and turned. Also, as the metering plate 764 is turned, a pair of protrusions 785 ( FIG. 41 ) extending down from the upper portion of the metering plate 764 ride up respective ramps 791 , 793 formed in respective recesses 795 , 797 and seat down behind the ramps to additionally secure the metering plate 764 to the support shelf 743 within the opening 762 . As also depicted in FIG. 27 , each of the tanks 620 , 622 has a cap 720 covering a top opening for filling the corresponding clean water tank 620 or detergent tank 622 with liquid. As best seen in FIG. 29 , the top of cap 720 comprises a multiplicity of air breathing orifices 724 . An elastomeric umbrella valve 726 is mounted to the underside of the top of the cap 720 under the orifices 724 . As the ambient pressure within the associated tank 620 or 622 drops, by discharge of cleaning solution from therein, atmospheric pressure acting upon the top side of umbrella valve 726 causes the peripheral edge 728 to unseat from the surface 732 of cap 720 thereby permitting the flow of atmospheric air into the associated tank 620 or 622 until the ambient pressure therein equals atmospheric. Once the pressure on both sides of the umbrella valve 726 equalize due to the shut off valves 800 , 820 ( FIG. 30 ) closing, the energy stored by deflection of the umbrella valve causes the peripheral edge 728 to reseat itself against surface 732 thereby preventing leakage of cleaning solution through the outlet of the associated tank 620 or 622 . In effect, this prevents cross flow between the two tanks 620 , 622 , when the extractor unit 60 is turned off, thereby prohibiting mixing of the solutions in the tanks 620 , 622 . Referring to back to FIG. 27 , cap 720 and flat circular seal 718 sealingly close fill opening 716 . Liquid pressure against umbrella valve 726 further urges peripheral edge 728 against surface 732 thereby providing a leak free container. Such a valve is disclosed in co-owned U.S. Pat. No. 5,500,977, the disclosure of which is hereby incorporated by reference. The reservoir 721 has a pair of dividing plates 733 which separates into a first compartment 780 fluidly connected to the clean water tank 620 and a second compartment 782 fluidly connected to the detergent tank 622 . The first compartment 780 includes inner and outer outlet ports 786 , 788 . The second compartment 782 includes an outlet port 784 . FIG. 30 illustrates the overall solution distribution system, which will be described below. The inner outlet port 786 ( FIG. 27 ) of the first compartment 780 ( FIG. 27 ) is fluidly connected to a mixing Tee 796 via a flexible hose 790 and the outer outlet port 788 ( FIG. 27 ) is fluidly connected to a distributor 792 via a flexible hose 794 . The outlet port 784 ( FIG. 27 ) of the second compartment 782 ( FIG. 27 ) is fluidly connected to the mixing Tee 796 via a suitable flexible hose 798 . The shut off valve 800 is connected between the outer outlet port 788 of the first compartment 780 and the inlet 105 R ( FIG. 5 ) of the distributor 792 for turning on and off the flow of clean water used for rinsing. This shut off valve 800 is in the form of a solenoid valve, however, other types of valves also could be used. A pressure actuated shut off valve 804 is connected between the inner outlet port 786 of the first compartment 780 and the mixing Tee 796 for turning off and on the flow of water. This shut off valve 804 is opened and closed by outside pressure via a conduit 806 connected between it and the outlet 807 of a pump 808 through a Tee 817 . In particular, as shown in FIG. 31 , the pressure actuated shutoff valve 804 comprises a valve body 810 having a first port 812 fluidly connected to the clean water tank 620 and a second port 814 fluidly connected to the mixing Tee 796 via a flexible hose 815 . A flexible rubber diaphragm 816 extends generally horizontally across the center of the valve body 810 . The diaphragm 816 includes a valve seal 818 integrally formed on the diaphragm 816 at its center. The valve 804 includes a pressure port 822 fluidly connected to the outlet 807 ( FIG. 30 ) of the pump 808 . In operation, when the pressure at the pressure port 822 is below a predetermined value such as between 7 to 10 psi, the valve seal 818 is spaced from the pressure port 822 to allow water to flow in both directions. Such a pressure value at the pressure port 822 occurs when the main shut off valve 820 is opened. The pump 808 also pressurizes the water mixed with detergent to draw it to the distributor 792 . In this example, water flows to the inlet 105 L ( FIG. 5 ) of distributor 792 due to gravity and the pressure produced by the pump 808 . However, in this open position, the pressure actuated shut off valve 804 could allow detergent to flow in the opposite direction, if for example, the pump 808 were placed between the valve 804 and the clean water tank 620 to draw the detergent to the clean water tank 620 by pressure. When the pressure exerted on the diaphragm 816 exceeds a second predetermined value such as between 20 to 30 psi, it flexes the diaphragm 816 towards the first port 812 , urging the valve seal 818 against the first port 812 , thereby sealing the first port 812 to close the valve 804 . Thus, with the valve 804 closed, clean water or detergent is prevented from flowing through it. When the pressure lowers below the predetermined value, the diaphragm 816 flexes back to unseal the valve seal 818 from the first port 812 thereby opening the valve 804 . Optionally, a spring 821 , inserted around the portion of the first port 812 extending into the valve body 810 , can be positioned between the inner upper wall 811 of the valve body 810 and diaphragm 816 to urge the valve seal 818 to unseal quicker. Referring back to FIG. 30 , the outlet of the mixing Tee 796 is fluidly connected via flexible hose 823 to the inlet of the pump 808 , which provides pressure to draw the cleaning solution to the distributor 792 via the inlet 105 L ( FIG. 5 ). A relief valve 809 is fluidly connected across the pump 808 to limit the pressure at the outlet 807 of the pump 808 to a predetermine value. The outlet 807 of the pump 808 is fluidly connected to the main shut off valve 820 via flexible hoses 825 , 874 and 876 . This shut off valve 820 is in the form of a solenoid valve, however, other electrical actuated valves could be also used. Referring to FIGS. 32 and 33 , a trigger switch 821 is used to dispense either mixed detergent and clean water or only clean water. The trigger switch 821 includes a trigger 822 pivotally connected to the upper handle portion 358 approximately near a closed looped hand grip 824 ( FIG. 1 ) of the upper handle portion 358 at a pivot 834 . Integrally molded onto the trigger 822 are two cantilever springs 826 , 828 ( FIG. 33 ), one on each lateral side thereof. The cantilever springs 826 , 828 urge the trigger 822 outwardly or downwardly which places one of the selected shut off valves 800 , 820 ( FIG. 30 ) in the closed position. In particular as depicted in FIG. 32 , an arm 830 having a curved end portion 832 extends downwardly from the pivot 834 of the trigger 822 terminating adjacent a microswitch 836 of the trigger switch 821 . A lever arm 838 is connected to the microswitch 836 and extends over a spring-loaded push button 844 on the microswitch 836 . When the upper portion of the trigger 822 is positioned downwardly, the curved end portion 832 is spaced from the lever arm 838 . In this position with reference to FIG. 34 , the microswitch 836 opens the circuit between one of the solenoid shut off valves 800 , 820 and the main power source 842 , thereby denergizing the selected valve 800 or 820 and closing it. When the upper portion of the trigger 822 is squeezed or depressed, the curved end portion 832 cams against the lever arm 838 such that the lever arm 838 depresses the push button 844 on the microswitch 836 . Upon depression of the push button 844 , the microswitch 836 closes the circuit as depicted in FIG. 34 between one of the solenoid shut off valves 800 , 820 and the main power switch assembly 846 ( FIG. 34 ). If the main power switch assembly 846 is switched on to connect the power source 842 to the selected solenoid shut off valve 800 or 820 and the trigger 822 is squeezed or depressed, the selected solenoid shut off valve energizes and opens. A cleaning mode switch assembly 848 is connected between the microswitch 836 and the water and main solenoid shut off valves 800 , 820 to select the mode of cleaning. As shown in FIG. 33 , the cleaning mode switch assembly 848 and main power switch assembly 846 include respective rocker arms 850 , 852 positioned adjacent each other and mounted in a module 854 which is mounted in the upper handle portion 358 . The rocker arms 850 , 852 are actuated by corresponding slide switches 856 , 858 which are received in a recess 860 ( FIG. 1 ) just below the hand grip 824 . The slide switches 856 , 858 snap connect into corresponding slots 862 , 864 formed on the upper portions of respective actuating rods 866 , 868 . Cam portions 870 are formed on lower portions of the actuating rods 866 , 868 for engaging their corresponding rocker arms 850 , 852 . When one of the slide switches 856 , 858 is slid downwardly, the cam portion 870 depresses the lower portion 871 of the rocker arm 850 or 852 to switch it in one position. This action also raises the upper portion 872 of the rocker arm 850 or 852 . Then, when the slide switch 856 or 858 is then slid upwardly back, the cam portion 870 depresses the upper portion of the rocker arm 850 or 852 to switch it in another position and thereby raise the lower portion 971 of the rocker arm 850 or 852 . In other words viewed from FIG. 33 , the cleaning mode switch assembly 848 can be located on right portion of the recess 860 instead of the left portion and the main power switch assembly 846 can be located on the left portion of the recess 860 instead of the right portion. In operation, a user slides the slide switch 856 of the main power switch assembly 846 down to electrically connect the power source 842 to the microswitch 836 , suction motor 90 , and pump 808 , turning them on. Referring to FIG. 30 , the pump 808 conducts the pressurized cleaning solution through the flexible hose 874 to a control valve 877 which selectively allows the liquid to flow to either the inlet 105 L ( FIG. 5 ) of the cleaning distributor 792 via supply tube 876 or the hand-held cleaning attachment 188 ( FIG. 9 ) via a solution tube 216 . The cleaning liquid distributor 792 evenly distributes the cleaning liquid to each of the rotary scrub brushes 72 . The scrub brushes 72 then spread the cleaning liquid onto the carpet (or bare floor), scrub the cleaning liquid into the carpet and dislodge embedded soil. Such a distributor 792 and scrub brushes 72 are substantially disclosed in commonly owned U.S. Pat. No. 5,867,857, the disclosure of which is hereby incorporated herein as of reference. Referring to FIG. 1 , as is commonly known, the carpet extractor 60 distributes cleaning solution to the carpeted surface and substantially simultaneously extracts it along with the dirt on the carpet in a continuous operation. In particular, soiled cleaning liquid is extracted from the carpet by the suction nozzle 124 , which communicates with the recovery tank 80 . A vacuum is created in the recovery tank 80 by the motor fan assembly 90 ( FIG. 3 ) that draws air from the recovery tank 80 and exhausts the air to the carpeted surface as previously described. If the wash cleaning mode is desired, the user slides the slide switch 858 of the cleaning mode switch assembly 848 upwardly to the upper end of the recess 860 to electrically connect the microswitch 836 ( FIG. 34 ) to the main solenoid shut off valve 820 ( FIG. 34 ). With reference to FIG. 30 , the control valve 877 is positioned to direct the cleaning solution to the distributor 792 . Then, the user squeezes the trigger 822 ( FIG. 1 ), which opens the main solenoid, shut off valve 820 to allow the cleaning solution composed of detergent mixed with clean water to flow to the distributor 792 and brushes 72 , where it is distributed and scrubbed on the carpet. If rinsing is desired, the user slides the slide switch 858 of the cleaning mode switch assembly 848 downwardly to the lower end of the recess 860 to electrically connect the microswitch 836 to the water solenoid shut off valve 800 . Then, the user squeezes the trigger 822 , which opens the water solenoid shut off valve 800 to allow clean water from the clean water tank 620 to flow to the distributor 792 and brushes 72 , where it is distributed and scrubbed into the carpet. FIG. 34A depicts an electrical schematic diagram of the distribution system of the carpet extractor 60 that automatically cleans the carpet or floor using one cleaning mode on the forward stroke of a cleaning cycle and another cleaning mode for the reverse stroke of the cleaning cycle. Components from the circuit shown in FIG. 34 , which are identical in structure and have identical functions will be identified by the same reference numbers for this circuit. In this circuit, a second microswitch 886 is connected between the water and main solenoid shut off valves 800 , 820 . As depicted in FIG. 35 , the microswitch 886 is part of a wheel rotation activating assembly 888 associated with the right rear wheel 66 R on the right side of the foot portion base assembly 64 ( FIG. 2 ). A lever arm 890 is connected to the microswitch 886 and extends over a spring-loaded push button 892 ( FIGS. 36A and 36B ) on the microswitch 886 . A microswitch cover 887 covers the microswitch 886 and this assembly is mounted to the rear body 84 ( FIGS. 26A and 26B ). The wheel rotation activating assembly 888 further includes a magnet 896 secured to an actuation lever 898 positioned spacedly adjacent a steel wheel disc 894 mounted to the rear extractor wheel 66 R by screws 895 . As depicted in FIGS. 36A and 36B , rollers 900 , having axles 901 ( FIG. 35 ) extending therethrough, are rotatably mounted to the actuation lever 898 . The rollers 900 ride on the wheel disc 894 to ensure clearance between the magnet 896 and wheel disc 896 . The axle 67 of the rear extractor wheel 66 R slidably extends through the actuation lever 898 such that the actuation lever 898 is allowed to pivot or rotate around it. The actuation lever 898 is further positioned in a recess of the rear body 84 adjacent the microswitch 886 . The magnets 896 follow the direction of rotation of the wheel 66 R due to the magnetic attraction between them, thereby causing the actuation lever 898 to rotate. Alternatively, FIGS. 37 and 38 depict another actuation lever 912 with accompanying magnet 914 and rollers 916 . These rollers 900 include rubber tires 918 secured around them and axles 920 extending through the center. The rollers 916 with the tires 918 are rotatably positioned in recesses 924 formed in the side of the actuator lever 912 opposing the wheel disc 894 . The axles 920 are snap connected into u-shaped holders 922 formed in the side of the actuator lever 912 opposing the wheel disc 894 . In particular with reference to FIG. 38 , the axles 920 are slidably inserted between elastic legs 926 , 928 of the holder 922 , engaging a pair of opposing ledges or barbs 930 formed on the legs 926 , 928 which cause the legs 926 , 928 to deflect outwardly to allow the holder to pass through. After the holder is inserted beyond the barbs 930 , the legs retract back so that the barbs 930 secure the axles within the holder. The magnet 914 is seated into an opening 929 of the actuation lever 898 and held securely in place by elastic catches 932 , 934 engaging it against a rib 931 extending across the center of the opening 929 . When the carpet extractor unit 60 ( FIG. 1 ) goes forward as indicated by the rotation of the rear wheel 66 R in FIG. 36A , the actuation lever 898 and lever arm 890 are disengaged from the push button 892 of the microswitch 886 . In this position, the microswitch 886 electrically connects the power source 842 to the main solenoid shut off valve 820 , depicted in FIG. 34A . Thus, when the trigger 822 is squeezed, the main solenoid shut off valve 820 energizes and opens, thereby allowing water mixed with detergent to be supplied to the distributor 792 or hand-held cleaning attachment. When the extractor unit 60 moves rearward as indicated by the rotation of the rear wheel 66 R in FIG. 36B , the actuation lever 898 engages the lever arm 890 , which depresses the push button 892 . This causes the microswitch 886 to electrically connect the power source 842 to the water solenoid shut off valve 800 as shown in FIG. 34A , thereby energizing it to open. Also, in this position, the microswitch 886 disconnects the power source 842 to main solenoid shut off valve 820 , thereby deenergizing it. Thus, clean water is automatically distributed on the floor surface. Another wheel rotation activating assembly 889 is shown in FIGS. 39 , 40 A, and 40 B. It comprises a paddle wheel 906 that rotates an actuation lever 908 to activate the microswitch 886 . The paddle wheel 906 and actuation lever 908 are rotatably mounted in a housing 907 and the microswitch is fixedly secured to the housing 907 as best seen in FIGS. 40A and 40B . This assembly is mounted to the rear body 84 ( FIG. 3 ) of the extractor unit 60 . The paddle wheel 906 has grooves 911 ( FIG. 39 ) which frictionally engage ribs 909 ( FIG. 35 ) on the right rear extractor wheel 66 R ( FIG. 35 ), securing it thereto. As shown in FIG. 40A , when the extractor unit 60 ( FIG. 1 ) moves forward, the paddle wheel 906 rotates in the direction of the arrow such that the elastic paddles 910 on the paddle wheel 906 strike the actuation lever 908 causing it to rotate away from the lever arm 890 , disengaging it from the push button 892 of the microswitch 886 . As depicted in FIG. 40B , when the extractor unit 60 is moves rearward, the paddle wheel 906 rotates in the direction of the arrow such that the paddles 910 on the paddle wheel 906 strike the actuation lever 908 causing it to rotate and engage the lever arm 890 which depresses the push button 892 on the microswitch 886 . Still another wheel rotation activating assembly 941 is shown in FIGS. 42 , 43 A and 43 B. The wheel rotation activating assembly 941 comprises an actuator lever 940 , wave washer 942 , and microswitch 946 . In this assembly, the microswitch 946 is designed to electrically connect the power source 842 to the main solenoid shut off valve 820 ( FIG. 34A ) for washing, when its push button 948 is depressed, and to electrically connect the power source 842 to the water solenoid shut off valve 800 , when the push button 948 is not depressed. The axle 67 extends through the wave washer 942 and actuator lever 940 . The actuator lever 940 rotates with the left rear wheel 66 L due to friction generated by the wave washer 942 . When the extractor unit 60 moves forward as shown in FIG. 43A by the arrow indicating the direction of the wheel rotation, the actuator lever 940 rotates to engage the lever arm 950 and depress the push button 948 on the microswitch 946 . When the extractor unit 60 ( FIG. 1 ) moves rearward as shown in FIG. 43B by the arrow indicating the direction of the wheel rotation, the actuator lever 940 moves away from the microswitch 946 disengaging the lever arm 950 from the push button 948 and traveling until it strikes a stop 952 attached on the rear body 84 ( FIG. 42 ). Upon engaging either the stop 952 or microswitch 946 , the actuator lever 940 slips against the wheel hub, allowing the left rear wheel 66 L to rotate and therefore allowing the unit to continue moving in the forward or rearward direction. If rinsing is desirable on both the forward and reverse strokes the user slides the slide switch 858 of the cleaning mode switch assembly 848 downwardly to the lower end of the recess 860 to electrically connect the microswitch 886 to the water solenoid shut off valve 800 . Then, the user squeezes the trigger 822 , which opens the water solenoid shut off valve 800 to allow clean water from the clean water tank 620 to flow to the distributor 792 and brushes 72 , where it is distributed and scrubbed into the carpet. Alternatively, if washing is desired on both the forward and reverse strokes, a three position cleaning mode switch assembly could be used instead of the two position cleaning mode switch assembly with the third position being directly connected to the main solenoid shut off valve 820 bypassing the second microswitch 886 of the wheel rotating activating assembly 888 . By incorporating a rinse application as shown in the embodiments, a higher concentration of detergent in the cleaning fluid, generally two or more times as much as the clean water, can be used to wash the carpet during the first forward stroke, since the rinse application will rinse or remove the detergent residue not extracted. In particular, the carpet extractor will distribute the cleaning solution having the high detergent concentration on the forward stroke as it substantially and simultaneously extracts it along with the dirt on the carpet in a continuous operation. Then, the carpet extractor will distribute the cleaning solution having the clean water on the reverse stroke to rinse the detergent residue not extracted as the carpet extractor substantially and simultaneously extracts it along with the dirt on the carpet in a continuous operation. Thus, cleaning performance is improved. The present invention has been described by way of example using the illustrated embodiments. Upon reviewing the detailed description and the appended drawings, various modifications and variations of the embodiments will become apparent to one of ordinary skill in the art. All such obvious modifications and variations are intended to be included in the scope of the present invention and of the claims appended hereto. For example, clean water could be applied on the forward stroke and detergent solution on the reverse stroke. Also, a certain liquid might be added to the clean water or be used alone to improve the rinsing operation. In view of the above, it is intended that the present invention not be limited by the preceding disclosure of the embodiments, but rather be limited only by the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of prior U.S. patent application Ser. No. 10/026,728, filed Dec. 21, 2001, now U.S. Pat. No. 6.956,484, which is hereby incorporated by reference in its entirety as if fully set forth herein. FIELD OF THE INVENTION The present invention relates generally to ignition interlock devices, such as are used in vehicles of drivers with DUI convictions (who, e.g., are endowed with special driving privileges and are in that connection under supervision by a probation officer or the state as a condition of such privileges). BACKGROUND OF THE INVENTION Essentially, an ignition interlock is a device that includes a breathalyzer which prohibits a vehicle from starting if the breathalyzer returns a reading of “under the influence” (i.e., corresponding to a statutory level of impairment or even a lower level of impairment prescribed by the manufacturer). Several courts throughout the U.S. are now requiring that interlock devices be placed in vehicles operated by individuals convicted of DUI offenses. The “LIFESAFER”™ ignition interlock system of the LifeSafer Interlock company (Cincinnati, Ohio) is a well-known conventional example. In it, a buzz tone is emitted during a breathalyzer test to indicate when a deep breath sample containing alveolar air has been provided and, thus, is sufficient to be analyzed. It has been found that a major drawback of conventional interlock devices is that they might not be effective in deterring DUI offenses if an individual other than the defendant (i.e., the person who has been assigned the interlock device) actually operates the interlock. For instance, a defendant who is once again “under the influence” still might be able to operate the vehicle by asking his/her friend or spouse to supply a “clean” breath sample that will unlock the ignition. A general solution that has been sought to eradicate this “loophole” has been to require an original “breath pattern” from the defendant against which subsequent attempts to unlock the ignition are compared; this helps thwart the occurrence of non-genuine breath samples. Examples of such an arrangement is disclosed in U.S. Pat. Nos. 4,738,333, 4,912,458 and 4,901,058. However, this solution has been found to present numerous difficulties and drawbacks. For instance, accuracy in comparing “breath patterns” can be highly elusive. U.S. Pat. No. 6,229,908 discloses an ignition interlock system in which an individual's fingerprint may be used to verify his/her identity and blood-alcohol content is determined using spectroscopic analysis of the finger from which the fingerprint is obtained. Aside from cost considerations, a major drawback to such a device is that for purposes of motor vehicle operation, state statutes specify the manner in which blood-alcohol content is to be determined and spectroscopic analysis is generally not so specified. Rather, the use of a breathalyzer is typically called for. It would not be sufficient to use fingerprint authentication for interlock devices, because as discussed above, the defendant may provide the authentication while someone else supplies a “clean” breath. A need has therefore been recognized in connection with providing an effective, foolproof ignition interlock device that precludes loopholes of the type described above. SUMMARY OF THE INVENTION In accordance with at least one presently preferred embodiment of the present invention, it is contemplated that a system be provided that obtains a photographic image of an individual attempting to disengage an ignition interlock device. Preferably, the photographic image is obtained simultaneously with a breath being blown into the breathalyzer device. Response of the breathalyzer device may preferably be recorded by time and date along with the obtained image. On a periodic basis, photographed images can then be reviewed during routine maintenance, in order to adequately ascertain whether the operator of the vehicle (or other machinery) in each instance indeed corresponded to the individual for whom the interlock device was intended. In summary, the present invention provides, in one aspect, an apparatus for identifying one or more individuals impaired by a controlled substance, the apparatus comprising: a detection device being adapted to ascertain the degree to which an individual is affected by a controlled substance; and a photographic unit; the photographic unit being operable, responsive to the detection device, to facilitate photographic identification of an individual tested by the detection device who is affected by a controlled substance beyond a predetermined threshold level. In another aspect, the present invention provides a method of identifying one or more individuals impaired by a controlled substance, the method comprising the steps of: providing a photographic unit; ascertaining the degree to which an individual is affected by a controlled substance; and operating the photographic unit, responsive to the ascertaining step, to facilitate photographic identification of an individual who is affected by a controlled substance beyond a predetermined threshold level. For a better understanding of the present invention, together with other and further features and advantages thereof, reference is made to the following description, taken in conjunction with the accompanying drawings, and the scope of the invention will be pointed out in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 schematically illustrates an ignition interlock device with photo identification. FIG. 2 schematically illustrates a timeclock apparatus with photo identification. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 schematically illustrates a motor vehicle 100 or other machinery in which an ignition interlock device, in accordance with at least one embodiment of the present invention, may be employed. An ignition 102 of the vehicle 100 (or other machinery) may be engageable via interlock device 104 . Interlock device 104 preferably includes a breathalyzer 106 . A photographic unit 108 , on the other hand, preferably includes a photographic apparatus 110 and image storage arrangement 112 . Preferably, an individual (who is likely a defendant required to use an ignition interlock device), when wishing to start the ignition 102 , will take a test with breathalyzer 106 in conventional manner (e.g. via emitting a sufficient blow of his/her breath into the equipment). If the test determines a state of “under the influence” then, per usual, the interlock device 104 will engage to prevent activation of ignition 102 and, thus, operation of the vehicle 100 or other machinery. Preferably, breathalyzer 106 will also include an arrangement 107 (as conventionally known) for determining whether a breath sample provided by the operator is suitable for testing in the first place. As discussed below, this arrangement 107 will preferably serve to provide an activation prompt to photographic unit 108 . Thus, in accordance with a preferred embodiment of the present invention, the activation of photographic unit 108 will immediately prompt photographic apparatus 110 to take a picture of the individual who is in the process of taking a breathalyzer test. Thus, the photographic apparatus 110 will preferably be mounted in such a manner as to obtain a good view of an individual in the position at which the breathalyzer test is being taken (e.g. it could be mounted inside an automobile and aimed towards the driver's seat). The image storage arrangement 112 , preferably integral with the photographic apparatus 110 , will preferably be suitable for storing the obtained photographic image until such a time that it and other stored images are reviewed to determine whether the image of the photographed individual corresponds to the individual for whom the ignition interlock device is intended. In other words, for example, photographed images (preferably those corresponding to a “failure” condition, or an impaired state of one or more individuals) can be reviewed on a periodic basis during routine maintenance, in order to adequately ascertain whether the operator of the vehicle (or other machinery) in each instance indeed corresponded to the individual for whom the interlock device was intended. Conceivably, when a “failure” state is indicated for a particular incident, a court may be notified. It should well be appreciated that by having an image of an individual who was being tested at the time of a “failure”, a court would have the ability to confidently enforce violations of probation orders (e.g., by preventing a defendant from asserting that someone else was being tested at that point in time). As discussed above, interlock device 104 will preferably provide a prompt in order for photographic unit 108 to be activated. Although such a prompt may take any of a large number of conceivable forms, it is presently contemplated in accordance with an embodiment of the present invention that the prompt be an audible prompt (wherein the photographic unit 108 would include an appropriate audio receptor, not shown, that is suitable for detecting the audible prompt and thence activating the photographic apparatus 110 ). In a further refinement, such an audible prompt could be similar to the buzz tone associated with the aforementioned “LIFESAFER”™ interlock device, whereby the buzz tone would serve to activate the photographic unit 108 . In accordance with a preferred embodiment of the present invention, the photographic apparatus 110 and image storage arrangement 112 are integrated into a single, cohesive unit (e.g. in a common housing). The “SILENT WITNESS”™ camera manufactured by Silent Witness Enterprises Ltd., Surrey, British Columbia, Canada, represents a highly favorable arrangement that could function as just described, that is, which includes both a camera and an image storage arrangement. Although in a presently preferred embodiment of the present invention it is contemplated that an ignition interlock device be employed in an automobile or other motor vehicle, it is conceivable to employ the interlock device in other settings. For instance, the machinery 100 illustrated in FIG. 1 could be in the form of machinery at a factory or plant (e.g. a printing press, lathe machinery, etc.) that would only be operable upon a worker taking a breathalyzer test and being positively identified via a photographic apparatus, in a manner similar to that discussed heretofore. Several advantages are apparent in connection with an ignition interlock device in accordance with at least one embodiment of the present invention. Employers may find such a device highly desirable as it may accord protection from liability in situations where there might otherwise be an accident as a result of a worker who is intoxicated (or otherwise affected by a controlled substance beyond a predetermined threshold level) on the job. Settings where this may be useful could include, for example, public transportation companies (where, for instance, bus or trolley drivers would undergo the breathalyzer test prior to operating a vehicle), trucking companies, and even in manufacturing environments, as described above, in which heavy or complex machinery is operated and in which significant dangers are presented if an operator is otherwise intoxicated (or otherwise affected by a controlled substance beyond a predetermined threshold level). Another potential employment setting would be a timeclock apparatus. In this scenario, photographic images would be obtained of employees, “punching in” to a timeclock, who are impaired by a controlled substance. Any employee so impaired would thus be deterred from having another individual punch the timeclock in his/her place. Such an embodiment would appear to be appropriate in instances, e.g., in which an employer may wish to bar an employee, who is impaired by a given controlled substance beyond a given threshold level, from working that day (or after lunch, when an employee may have had access to alcohol), regardless of whether or not the employee is to operate machinery. FIG. 2 schematically illustrates a timeclock apparatus 200 in which an interlock device, in accordance with at least one embodiment of the present invention, may be employed. A timeclock apparatus 200 with time card slot 202 may be engageable via interlock device 204 . Interlock device 204 preferably includes a breathalyzer 206 . A photographic unit 208 , on the other hand, preferably includes a photographic apparatus 210 and image storage arrangement 212 . It is believed that the inclusion of a photographic apparatus in an ignition interlock device in a motor vehicle or other machinery will provide an additional deterrence factor that may help reduce the likelihood of drunk driving (or impaired machine operation) even further. Particularly, the mere presence of the photographic apparatus, through profound psychological effect, may well provide a significant impetus for an individual to avoid even contemplating any type of loophole for circumventing the interlock. Although the use of photographic apparatus and image identification has been utilized in “home arrest” settings, it is believed that the presently contemplated use of photographic apparatus and positive identification in connection with the operation of motor vehicles or other machinery has never been contemplated. In a “home arrest” setting, an individual who is confined to the home for part or all of the day and who wears a tracking device, such as an ankle bracelet, to deter unwarranted flight, may be required to “check in” at a breathalyzer device in the home at predetermined times, or even at random times, throughout the day in order to impart a standard of behavior modification. Among many other possibilities, a visual image of the individual may then be transmitted over a communications link to present a visual image of the prisoner, e.g., at a police station or monitoring service. However, the “home arrest” arrangement just described does not serve to prevent or allow the operation of machinery. (An example of such a “home arrest” arrangement may be found in U.S. Pat. No. 4,843,377.) Though the disclosure heretofore has largely focused on contexts in which alcohol consumption is consumed, it should be understood that the embodiments of the present invention are applicable to other types of controlled substances as well, such as, for example, a narcotic drug (e.g., cocaine, heroin or marijuana). In such cases, appropriate detection equipment would be interfaced with an interlock in a vehicle or other machinery and could preferably operate in substantially similar manner as the inventive equipment described heretofore in connection with alcohol. Though the disclosure heretofore has largely contemplated the use of photographic apparatus to record “still” shots of an individual, such as a digital camera that takes “snapshots”, it should be understood that essentially any type of photographic equipment, configured for producing essentially any type of still or moving record of an individual, could be used, such as a VHS camera or camcorder. If not otherwise stated herein, it is to be assumed that all patents, patent applications, patent publications and other publications (including web-based publications) mentioned and cited herein are hereby fully incorporated by reference herein as if set forth in their entirety herein. Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/428,653, filed Dec. 30, 2010; U.S. Provisional Application No. 61/493,447, filed Jun. 4, 2011; U.S. Provisional Application No. 61/550,889, filed Oct. 24, 2011; and U.S. Provisional Application No. 61/556,142, filed Nov. 4, 2011, the entire contents of which are hereby incorporated by reference and should be considered a part of this specification. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] In general, the disclosure relates to methods and apparatuses for filtering blood. The filtration systems can be catheter-based for insertion into a patient's vascular system. [0004] 2. Description of the Related Art [0005] Thromboembolic disorders, such as stroke, pulmonary embolism, peripheral thrombosis, atherosclerosis, and the like, affect many people. These disorders are a major cause of morbidity and mortality in the United States and throughout the world. Thromboembolic events are characterized by an occlusion of a blood vessel. The occlusion can be caused by a clot which is viscoelastic (jelly-like) and is comprised of platelets, fibrinogen, and other clotting proteins. [0006] Percutaneous aortic valve replacement has been in development for some time now and stroke rates related to this procedure are between four and twenty percent. During catheter delivery and valve implantation plaque or other material may be dislodged from the vasculature and may travel through the carotid circulation and into the brain. When an artery is occluded by a clot or other embolic material, tissue ischemia (lack of oxygen and nutrients) develops. The ischemia will progress to tissue infarction (cell death) if the occlusion persists. Infarction does not develop or is greatly limited if the flow of blood is reestablished rapidly. Failure to reestablish blood-flow can lead to the loss of limb, angina pectoris, myocardial infarction, stroke, or even death. [0007] Occlusion of the venous circulation by thrombi leads to blood stasis which can cause numerous problems. The majority of pulmonary embolisms are caused by emboli that originate in the peripheral venous system. Reestablishing blood flow and removal of the thrombus is highly desirable. [0008] Techniques exist to reestablish blood flow in an occluded vessel. One common surgical technique, an embolectomy, involves incising a blood vessel and introducing a balloon-tipped device (such as a Fogarty catheter) to the location of the occlusion. The balloon is then inflated at a point beyond the clot and used to translate the obstructing material back to the point of incision. The obstructing material is then removed by the surgeon. While such surgical techniques have been useful, exposing a patient to surgery may be traumatic and is best avoided when possible. Additionally, the use of a Fogarty catheter may be problematic due to the possible risk of damaging the interior lining of the vessel as the catheter is being withdrawn. [0009] A common percutaneous technique is referred to as balloon angioplasty where a balloon-tipped catheter is introduced into a blood vessel, typically through an introducing catheter. The balloon-tipped catheter is then advanced to the point of the occlusion and inflated in order to dilate the stenosis. Balloon angioplasty is appropriate for treating vessel stenosis but is generally not effective for treating acute thromboembolisms. [0010] Another percutaneous technique is to place a microcatheter near the clot and infuse Streptokinase, Urokinase, or other thrombolytic agents to dissolve the clot. Unfortunately, thrombolysis typically takes hours or days to be successful. Additionally, thrombolytic agents can cause hemorrhage and in many patients the agents cannot be used at all. [0011] Another problematic area is the removal of foreign bodies. Foreign bodies introduced into the circulation can be fragments of catheters, pace-maker electrodes, guide wires, and erroneously placed embolic material such as thrombogenic coils. Retrieval devices exist for the removal of foreign bodies, some of which form a loop that can ensnare the foreign material by decreasing the size of the diameter of the loop around the foreign body. The use of such removal devices can be difficult and sometimes unsuccessful. [0012] Moreover, systems heretofore disclosed in the art are generally limited by size compatibility and the increase in vessel size as the emboli is drawn out from the distal vascular occlusion location to a more proximal location near the heart. If the embolectomy device is too large for the vessel it will not deploy correctly to capture the clot or foreign body, and if too small in diameter it cannot capture clots or foreign bodies across the entire cross section of the blood vessel. Additionally, if the embolectomy device is too small in retaining volume then as the device is retracted the excess material being removed can spill out and be carried by flow back to occlude another vessel downstream. [0013] Various thrombectomy and foreign matter removal devices have been disclosed in the art. Such devices, however, have been found to have structures which are either highly complex or lacking in sufficient retaining structure. Disadvantages associated with the devices having highly complex structure include difficulty in manufacturability as well as difficulty in use in conjunction with microcatheters. Recent developments in the removal device art features umbrella filter devices having self folding capabilities. Typically, these filters fold into a pleated condition, where the pleats extend radially and can obstruct retraction of the device into the microcatheter sheathing. [0014] Extraction systems are needed that can be easily and controllably deployed into and retracted from the circulatory system for the effective removal of clots and foreign bodies. There is also a need for systems that can be used as temporary arterial or venous filters to capture and remove thromboemboli generated during endovascular procedures. The systems should also be able to be properly positioned in the desired location. Additionally, due to difficult-to-access anatomy such as the cerebral vasculature and the neurovasculature, the systems should have a small collapsed profile. [0015] The risk of dislodging foreign bodies is also prevalent in certain surgical procedures. It is therefore further desirable that such emboli capture and removal apparatuses are similarly useful with surgical procedures such as, without limitation, cardiac valve replacement, cardiac bypass grafting, cardiac reduction, or aortic replacement. SUMMARY OF THE INVENTION [0016] One aspect of the disclosure is a catheter-based endovascular system and method of use for filtering blood that captures and removes particles caused as a result of a surgical or endovascular procedures. The method and system include a first filter placed in a first vessel within the patient's vascular system and a second filter placed in a second vessel within the patient's vascular system. In this manner, the level of particulate protection is thereby increased. [0017] One aspect of the disclosure is an endovascular filtration system and method of filtering blood that protects the cerebral vasculature from embolisms instigated or foreign bodies dislodged during a surgical procedure. In this aspect, the catheter-based filtration system is disposed at a location in the patient's arterial system between the site of the surgical procedure and the cerebral vasculature. The catheter-based filtration system is inserted and deployed at the site to capture embolisms and other foreign bodies and prevent their travel to the patient's cerebral vasculature so as to avoid or minimize thromboembolic disorders such as a stroke. [0018] One aspect of the disclosure is an endovascular filtration system and method of filtering blood that provides embolic protection to the cerebral vasculature during a cardiac or cardiothoracic surgical procedure. According to this aspect, the filtration system is a catheter-based system provided with at least a first filter and a second filter. The first filter is positioned within the brachiocephalic artery, between the aorta and the right common carotid artery, with the second filter being positioned within the left common carotid artery. [0019] One aspect of the disclosure is a catheter-based endovascular filtration system including a first filter and a second filter, wherein the system is inserted into the patient's right brachial or right radial artery. The system is then advanced through the patient's right subclavian artery and into the brachiocephalic artery. Alternately, the system may be inserted directly into the right subclavian artery. At a position within the brachiocephalic trunk between the aorta and the right common carotid artery, the catheter-based system is manipulated to deploy the first filter. The second filter is then advanced through or adjacent to the deployed first filter into the aorta and then into the left common carotid artery. Once in position within the left common carotid artery the catheter-based system is further actuated to deploy the second filter. After the surgical procedure is completed, the second filter and the first filter are, respectively, collapsed and withdrawn from the arteries and the catheter-based filtration system is removed from the patient's vasculature. In an alternate embodiment, either or both the first and second filters may be detached from the filtration system and left inside the patient for a therapeutic period of time. [0020] One aspect of the disclosure is a catheter-based filtration system comprising a handle, a first sheath, a first filter, a second sheath and a second filter. The first and second sheaths are independently actuatable. The handle can be a single or multiple section handle. The first sheath is translatable relative to the first filter to enact deployment of the first filter in a first vessel. The second sheath is articulatable from a first configuration to one or more other configurations. The extent of articulation applied to the second sheath is determined by the anatomy of a second vessel to which access is to be gained. The second filter is advanced through the articulated second sheath and into the vessel accessed by the second sheath and, thereafter, deployed in the second vessel. Actuation of the first sheath relative to the first filter and articulation of the second filter is provided via the handle. In some embodiments, the handle includes a locking mechanism configured to lock the first sheath relative to the second sheath. In certain embodiments, the handle also includes a distal flush port. [0021] In some aspects of the disclosure, the second filter is carried on a guiding member having a guidewire lumen extending therethrough. In certain aspects, the guiding member is a catheter shaft. A guiding member having a guidewire lumen allows the user to precisely deliver the second filter by advancing the filter system over the guidewire. The guiding member can be configured to have increased column strength to aid advancement of the second filter. In some aspects, the guiding member includes a flexible portion to better position the second filter within the vessel. [0022] In some aspects the first sheath is a proximal sheath, the first filter is a proximal filter, the second sheath is a distal sheath, and the second filter is a distal filter. The proximal sheath is provided with a proximal hub housed within and in sliding engagement with the handle. Movement of the proximal hub causes translation of the proximal sheath relative to the proximal filter. The distal sheath includes a distal shaft section and a distal articulatable sheath section. A wire is provided from the handle to the distal articulatable sheath section. Manipulation of the handle places tension on the wire causing the distal articulatable sheath section to articulate from a first configuration to one or more other configurations. The articulatable distal sheath is capable of rotation, translation, and deflection (both in a single plane and both partially in a first plane and partially in a second, different plane). In some embodiments, the handle includes a locking mechanism to prevent the articulatable distal sheath from deviating from a desired configuration. In certain embodiments, the locking mechanism may lock automatically when the operator actuates a control or releases the handle. [0023] In some aspects the proximal filter and the distal filter are both self-expanding. The proximal filter and the distal filter both may comprise an oblique truncated cone shape. Movement of the proximal sheath relative to the proximal filter causes the proximal filter to expand and deploy against the inside wall of a first vessel. The distal filter is then advanced through or adjacent to the distal shaft and distal articulatable sheath into expanding engagement against the inner wall of a second vessel. In some embodiments, a tethering member extends from the proximal sheath to the proximal filter to help draw the proximal filter opening toward the first vessel wall. [0024] Another aspect of the disclosure is a single filter embolic protection device comprising a single filter device comprising a sheath, a filter shaft, and a filter assembly. In some aspects, the filter assembly is designed to accommodate a catheter-based device passing between the filter and the vessel wall. In certain embodiments, the filter assembly may include a channel, a gap, or an inflatable annulus. The filter assembly may also include one or more filter lobes. In another embodiment, the filter assembly may resemble an umbrella having a plurality of tines and a filter element connecting each tine. The filter assembly may alternatively include a plurality of overlapping filter portions, wherein a catheter may pass between a first filter portion and a second filter portion of the filter assembly. BRIEF DESCRIPTION OF THE DRAWINGS [0025] FIG. 1 illustrates an exemplary prior art catheter being advanced through a portion of a subject's vasculature. [0026] FIGS. 1A-1D illustrate an exemplary dual filter system. [0027] FIGS. 1E and 1F illustrate exemplary proximal filters. [0028] FIGS. 2A-2D illustrate an exemplary method of delivering and deploying a dual filter system [0029] FIGS. 3-5 illustrate a portion of an exemplary delivery procedure for positioning a blood filter. [0030] FIGS. 6A and 6B illustrate an exemplary embodiment of an articulating distal sheath. [0031] FIGS. 7A-7C illustrate a portion of an exemplary filter system. [0032] FIGS. 8A-8C illustrate an exemplary pull wire. [0033] FIGS. 9A-9C show an exemplary embodiment of a distal sheath with slots formed therein. [0034] FIGS. 9D-9E show an exemplary embodiment of a distal sheath capable of deflecting in multiple directions. [0035] FIGS. 9F and 9G illustrate exemplary guidewire lumen locations in the distal sheath. [0036] FIGS. 10A and 10B illustrate a portion of exemplary distal sheath adapted to be multi-directional. [0037] FIGS. 11A-11E illustrate merely exemplary anatomical variations that can exist. [0038] FIGS. 12A and 12B illustrate an exemplary curvature of a distal sheath to help position the distal filter properly in the left common carotid artery. [0039] FIGS. 13A and 13B illustrate alternative distal sheath and distal shaft portions of an exemplary filter system. [0040] FIG. 14 illustrates a portion of an exemplary system including a distal shaft and a distal sheath. [0041] FIGS. 15A-15D illustrate alternative embodiments of the coupling of the distal shaft and distal sheath. [0042] FIG. 16 illustrates an exemplary embodiment of a filter system in which the distal sheath is biased to a curved configuration. [0043] FIG. 17 illustrates a portion of an alternative filter system. [0044] FIGS. 18A and 18B illustrate an exemplary proximal filter. [0045] FIGS. 19A-19C , 20 A- 20 B, 21 , 22 A-B illustrate exemplary proximal filters. [0046] FIGS. 23A-23F illustrate exemplary distal filters. [0047] FIGS. 24A-24C illustrate exemplary embodiments in which the system includes at least one distal filter positioning, or stabilizing, anchor. [0048] FIGS. 25A-25D illustrate an exemplary embodiment of coupling a distal filter to a docking wire inside of the subject. [0049] FIGS. 26A-26G illustrate an exemplary method of preparing an exemplary distal filter assembly for use. [0050] FIGS. 27A and 27B illustrate an exemplary embodiment in which a guiding member, secured to a distal filter before introduction into the subject is loaded into an articulatable distal sheath. [0051] FIGS. 28A-28E illustrate an exemplary distal filter assembly in collapsed and expanded configurations. [0052] FIGS. 29A-29E illustrate a portion of an exemplary filter system with a lower delivery and insertion profile. [0053] FIGS. 30A and 30B illustrate a portion of an exemplary filter system. [0054] FIGS. 31A-31C illustrate an exemplary over-the-wire routing system that includes a separate distal port for a dedicated guidewire. [0055] FIGS. 32A-32E illustrate an exemplary routing system which includes a rapid-exchange guidewire delivery. [0056] FIGS. 33A-D illustrates a filter system which includes a tubular core member. [0057] FIGS. 34A-C illustrate a filter system with a flexible coupler. [0058] FIGS. 35A-E illustrate alternate designs for a flexible coupler. [0059] FIGS. 36A-C illustrate a method of using a tethering member. [0060] FIGS. 36D-E illustrate attachment points for a tethering member. [0061] FIGS. 37A-D illustrate multiple embodiments for a tethering member. [0062] FIGS. 38A-D illustrate multiple embodiments for an aortic filter designed to form a seal around a catheter. [0063] FIGS. 39A-C illustrate an aortic filter system having multiple aortic filters. [0064] FIGS. 40A-B exemplify multiple embodiments for an aortic filter. [0065] FIGS. 41A-B illustrate an aortic filter having an inflatable annulus. [0066] FIG. 42 illustrates a distal portion of an exemplary filter system. [0067] FIGS. 43-46 illustrate exemplary control handles of the blood filter systems. [0068] FIGS. 47A-H illustrate cross-sectional portions of an exemplary control handle. [0069] FIG. 48 depicts an alternative control handle with a rotary tip deflection control. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0070] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process can be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations can be described as multiple discrete operations in turn, in a manner that can be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures described herein can be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments can be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as can also be taught or suggested herein. [0071] The disclosure relates generally to intravascular blood filters used to capture foreign particles. In some embodiments the blood filter is a dual-filter system to trap foreign bodies to prevent them from traveling into the subject's right and left common carotid arteries, while in other embodiments, the blood filter is a single filter system. The filter systems described herein can, however, be used to trap particles in other blood vessels within a subject, and they can also be used outside of the vasculature. The systems described herein are generally adapted to be delivered percutaneously to a target location within a subject, but they can be delivered in any suitable way, and need not be limited to minimally-invasive procedures. [0072] Filter systems in accordance with the present invention can be utilized to reduce the occurrence of emboli entering the cerebral circulation as a consequence of any of a variety of intravascular interventions, including, but not limited to, transcatheter aortic-valve implantation (TAVI), surgical valve repair or replacement, atrial fibrillation ablation, cardiac bypass surgery, or transthoracic graft placement around the aortic arch. For example, the present filter or filters may be placed as described elsewhere herein prior to a minimally invasive or open surgical repair or replacement of a heart valve, such as the mitral or aortic valve. The filter system may alternatively be placed prior to cardiac ablation such as ablation of the pulmonary vein to treat atrial fibrillation. Ablation may be accomplished using any of a variety of energy modalities, such as RF energy, cryo, microwave or ultrasound, delivered via a catheter having a distal end positioned within the heart. The present filter systems may alternatively be placed prior to cardiac bypass surgery, or prior to transthoracic graft placement around the aortic arch, or any of a variety of other surgeries or interventions that are accompanied by a risk of cerebral embolization. [0073] In one application, the filter systems described herein are used to protect the cerebral vasculature against embolisms and other foreign bodies entering the bloodstream during a cardiac valve replacement or repair procedure. To protect both the right common carotid artery and the left common carotid artery during such procedures, the system described herein enters the aorta from the brachiocephalic artery. Once in the aortic space, there is a need to immediately navigate a 180 degree turn into the left common carotid artery. In gaining entry into the aorta from the brachiocephalic artery, use of prior art catheter devices 1 will tend to hug the outer edge of the vessel 2 , as shown in FIG. 1 . To then gain access to the left common carotid artery 3 with such prior art devices can be a difficult maneuver due to the close proximity of the two vessels which may parallel one another, often within 1 cm of separation, as shown in, for example, FIGS. 1-5 . This sharp turn requires a very small radius and may tend to kink the catheter reducing or eliminating a through lumen to advance accessories such as guidewires, filters, stents, and other interventional tools. The catheter-based filter systems described herein can traverse this rather abrupt essentially 180 degree turn to thereby deploy filters to protect both the right and left common carotid arteries. [0074] FIGS. 1A-1C illustrate an exemplary filter system having control handle portion 5 and filter system 10 . In some embodiments, control handle portion 5 may include a distal flush port 4 . Filter system 10 includes proximal sheath 12 , proximal shaft 14 coupled to expandable proximal filter 16 , distal shaft 18 coupled to distal articulatable sheath 20 , distal filter 22 , and guiding member 24 . FIG. 1B illustrates proximal filter 16 and distal filter 22 in expanded configurations. FIG. 1C illustrates the system in a delivery configuration, in which proximal filter 16 (not seen in FIG. 1C ) is in a collapsed configuration constrained within proximal sheath 12 , while distal filter 22 is in a collapsed configuration constrained within distal articulatable sheath 20 . [0075] FIG. 1D is a sectional view of partial system 10 from FIG. 1C . Proximal shaft 14 is co-axial with proximal sheath 12 , and proximal region 26 of proximal filter 16 is secured to proximal shaft 14 . In its collapsed configuration, proximal filter 16 is disposed within proximal sheath 12 and is disposed distally relative to proximal shaft 14 . Proximal sheath 12 is axially (distally and proximally) movable relative to proximal shaft 14 and proximal filter 16 . System 10 also includes distal sheath 20 secured to a distal region of distal shaft 18 . Distal shaft 18 is co-axial with proximal shaft 14 and proximal sheath 12 . Distal sheath 20 and distal shaft 18 , secured to one another, are axially movable relative to proximal sheath 12 , proximal shaft 14 and proximal filter 16 . System 10 also includes distal filter 22 carried by guiding member 24 . In FIG. 1D distal filter 22 is in a collapsed configuration within distal sheath 22 . Guiding member 24 is coaxial with distal sheath 20 and distal shaft 18 as well as proximal sheath 12 and proximal shaft 14 . Guiding member 24 is axially movable relative to distal sheath 20 and distal shaft 18 as well as proximal sheath 12 and proximal shaft 14 . Proximal sheath 12 , distal sheath 20 , and guiding member 24 are each adapted to be independently moved axially relative to one other. That is, proximal sheath 12 , distal sheath 20 , and guiding member 24 are adapted for independent axial translation relative to each of the other two components. [0076] In the embodiments in FIGS. 1A-1F , proximal filter 16 includes support element or frame 15 and filter element 17 , while distal filter 22 includes support element 21 and filter element 23 . The support elements generally provide expansion support to the filter elements in their respective expanded configurations, while the filter elements are adapted to filter fluid, such as blood, and trap particles flowing therethrough. The expansion supports are adapted to engage the wall of the lumen in which they are expanded. The filter elements have pores therein that are sized to allow the blood to flow therethrough, but are small enough to prevent unwanted foreign particles from passing therethrough. The foreign particles are therefore trapped by and within the filter elements. [0077] In one embodiment, filter element 17 is formed of a polyurethane film mounted to frame 15 , as shown in FIGS. 1E and 1F . Film element 17 can measure about 0.0001 inches to about 0.1 inches in thickness. In some embodiments, the film thickness measures between 0.005 and 0.05, or between 0.015 and 0.025. In some situations, it may be desirable to have a filter with a thickness less than 0.0001 or greater than 0.1 inches. Other polymers may also be used to form the filter element, in the form of a perforated sheet or woven or braided membranes. Thin membranes or woven filament filter elements may alternatively comprise metal or metal alloys, such as nitinol, stainless steel, etc. [0078] Filter element 17 has through holes 27 to allow fluid to pass and will resist the passage of the embolic material within the fluid. These holes can be circular, square, triangular or other geometric shapes. In the embodiment as shown in FIG. 1E , an equilateral triangular shape would restrict a part larger than an inscribed circle but have an area for fluid flow nearly twice as large making the shape more efficient in filtration verses fluid volume. It is understood that similar shapes such as squares and slots would provide a similar geometric advantage. In certain embodiments, the filter holes are laser drilled into the filter membrane, but other methods can be used to achieve a similar result. In some embodiments filter holes 27 are between about 1 micron and 1000 microns (1 mm). In certain embodiments, the hole size is between 1 micron and 500 microns. In other embodiments, the hole size is between 50 microns and 150 microns. However, the hole size can be larger, depending on the location of the filter within the subject and the type of particulate sought to be trapped in the filter. [0079] In several embodiments, frame element 15 can be constructed of a shape memory material such as Nitinol, or other materials such as stainless steel or cobalt super alloy (MP35N for example) that have suitable material properties. Frame element 15 could take the form of a round wire or could also be of a rectangular or elliptical shape to preserve a smaller delivery profile. In one such embodiment, frame element 15 comprises Nitinol wire where the hoop is created from a straight piece of wire and shape set into a frame where two straight legs run longitudinally along the delivery system and create a circular distal portion onto which the filter film will be mounted. The circular or loop portion may include a radiopaque marker such as a small coil of gold, platinum iridium, or other radiopaque marker for visualization under fluoroscopy. In other embodiments, the frame element may not comprise a hoop, but include a spinal element disposed across a longitudinal length of the filter element. In still other embodiments, the filter element may not include a frame element. [0080] The shape of the filter opening or frame elements 15 , 17 may take a circular shape when viewed axially or other shape that apposes the vessel wall. In some embodiments, such as those illustrated in FIGS. 1E , 1 F and 25 D, the shape of frame element 15 and filter element 17 are of an oblique truncated cone having a non-uniform or unequal length around and along the length of the conical filter 16 . In such a configuration, much like a windsock, the filter 16 would have a larger opening (upstream) diameter and a reduced ending (downstream) diameter. The unconstrained, fully expanded filter diameter can measure between 3 mm and 30 mm, but in some embodiments, the diameter may be less than 3 mm or greater than 30 mm. In some embodiments, the diameter may range between 10-25 mm or between 15-20 mm. The length of the filter may range between 10 mm and 50 mm, but the length of the filter may be less than 10 mm or greater than 50 mm. In some embodiments, the length may range between 10 mm and 30 mm or between 30 mm and 50 mm. In one embodiment, the diameter of the filter opening could measure about 15-20 mm in diameter and have a length of about 30-50 mm. A selection of different filter sizes would allow treatment of a selection of patients having different vessel sizes. [0081] In some embodiments the material of the filter element is a smooth and/or textured surface that is folded or contracted into a small delivery catheter by means of tension or compression into a lumen. A reinforcement fabric 29 , as shown in FIG. 1F , may be added to or embedded in the filter to accommodate stresses placed on the filter material by means of the tension or compression applied. This will also reduce the stretching that may occur during delivery and retraction of filter element 17 . This reinforcement material 29 could be a polymer or metallic weave to add additional localized strength. This material could be imbedded into the polyurethane film to reduce its thickness. In one particular embodiment, this imbedded material could be a polyester weave mounted to a portion of the filter near the longitudinal frame elements where the tensile forces act upon the frame and filter material to expose and retract the filter from its delivery system. In some embodiments, the film measures between 0.0005 and 0.05, between 0.0025 and 0.025, or between 0.0015 and 0.0025 inches thick. In certain embodiments, the thickness is between 0.015 and 0.025 inches. In some situations, it may be desirable to have a filter with a thickness less than 0.0001 or greater than 0.1 inches. In some embodiments, the reinforcement fabric has a pore size between about 1 micron and about 1000 microns. In certain embodiments, the pore size is between about 50 microns and about 150 microns. While such an embodiment of the filter elements has been described for convenience with reference to proximal filter element 17 , it is understood that distal filter element 23 could similarly take such form or forms. [0082] As shown in FIG. 1B , proximal filter 16 has a generally distally-facing opening 13 , and distal filter 22 has a generally proximally-facing opening 19 . The filters can be thought of as facing opposite directions. As described in more detail below, the distal sheath is adapted to be steered, or bent, relative to the proximal sheath and the proximal filter. As the distal sheath is steered, the relative directions in which the openings face will be adjusted. Regardless of the degree to which the distal sheath is steered, the filters are still considered to having openings facing opposite directions. For example, the distal sheath could be steered to have a 180 degree bend, in which case the filters would have openings facing in substantially the same direction. The directions of the filter openings are therefore described if the system were to assume a substantially straightened configuration, an example of which is shown in FIG. 1B . Proximal filter element 17 tapers down in the proximal direction from support element 15 , while distal filter element 23 tapers down in the distal direction from support element 21 . A fluid, such as blood, flows through the opening and passes through the pores in the filter elements, while the filter elements are adapted to trap foreign particles therein and prevent their passage to a location downstream to the filters. [0083] In several embodiments, the filters are secured to separate system components. In the embodiment in FIGS. 1A-1D , for example, proximal filter 16 is secured to proximal shaft 14 , while distal filter 22 is secured to guiding member 24 . In FIGS. 1A-1D , the filters are secured to independently-actuatable components. This allows the filters to be independently positioned and controlled. Additionally, the filters are collapsed within two different tubular members in their collapsed configurations. In the embodiment in FIGS. 1A-1D , for example, proximal filter 16 is collapsed within proximal sheath 12 , while distal filter 22 is collapsed within distal sheath 20 . In the system's delivery configuration, the filters are axially-spaced from one another; however, in an alternative embodiment, the filters may be positioned such that a first filter is located within a second filter. For example, in FIG. 1D , distal filter 22 is distally-spaced relative to proximal filter 16 . [0084] In some embodiments the distal sheath and the proximal sheath have substantially the same outer diameter (see, e.g., FIGS. 1C and 1D ). When the filters are collapsed within the sheaths, the sheath portion of the system therefore has a substantially constant outer diameter, which can ease the delivery of the system through the patient's body and increase the safety of the delivery. In FIG. 1D , distal and proximal sheaths 20 and 12 have substantially the same outer diameter, both of which have larger outer diameters than the proximal shaft 14 . Proximal shaft 14 has a larger outer diameter than distal shaft 18 , wherein distal shaft 18 is disposed within proximal shaft 14 . Guiding member 24 has a smaller diameter than distal shaft 18 . In some embodiments the proximal and distal sheaths have an outer diameter between 3 French (F) and 14 F. In certain embodiments, the outer diameter is between 4 F and 8 F. In still other embodiments, the outer diameter is between 4 F and 6 F. In some embodiments the sheaths have different outer diameters. For example, the proximal sheath can have a size of 6 F, while the distal sheath has a size of 5 F. In an alternate embodiment the proximal sheath is 5 F and the distal sheath is 4 F. A distal sheath with a smaller outer diameter than the proximal sheath reduces the delivery profile of the system and can ease delivery. In some methods of use, the filter system is advanced into the subject through an incision made in the subject's right radial artery. In a variety of medical procedures a medical instrument is advanced through a subject's femoral artery, which is larger than the right radial artery. A delivery catheter used in femoral artery access procedures has a larger outer diameter than would be allowed in a filter system advanced through a radial artery. Additionally, in some uses the filter system is advanced from the right radial artery into the aorta via the brachiocephalic trunk. The radial artery has the smallest diameter of the vessels through which the system is advanced. The radial artery therefore limits the size of the system that can be advanced into the subject when the radial artery is the access point. The outer diameters of the systems described herein, when advanced into the subject via a radial artery, are therefore smaller than the outer diameters of the guiding catheters (or sheaths) typically used when access is gained via a femoral artery. [0085] FIG. 6A illustrates a portion of a filter delivery system in a delivery configuration. The system's delivery configuration generally refers to the configuration when both filters are in collapsed configurations within the system. FIG. 6B illustrates that the distal articulating sheath is independently movable with 3 degrees of freedom relative to the proximal sheath and proximal filter. In FIG. 6A , proximal sheath 60 and distal sheath 62 are coupled together at coupling 61 . Coupling 61 can be a variety of mechanisms to couple proximal sheath 60 to distal sheath 62 . For example, coupling 61 can be an interference fit, a friction fit, a spline fitting, end to end butt fit or any other type of suitable coupling between the two sheaths. When coupled together, as shown in FIG. 6A , the components shown in FIG. 6B move as a unit. For example, proximal sheath 60 , proximal shaft 64 , proximal filter 66 , distal shaft 68 , and the distal filter (not shown but within distal sheath 62 ) will rotate and translate axially (in the proximal or distal direction) as a unit. When proximal sheath 60 is retracted to allow proximal filter 66 to expand, as shown in FIG. 6B , distal sheath 62 can be independently rotated (“R”), steered (“S”), or translated axially (“T”) (either in the proximal “P” direction or distal “D” direction). The distal sheath therefore has 3 independent degrees of freedom: axial translation, rotation, and steering. The adaptation to have 3 independent degrees of freedom is advantageous when positioning the distal sheath in a target location, details of which are described below. [0086] FIGS. 2A-2D illustrate a merely exemplary embodiment of a method of using any of the filter systems described herein. System 10 from FIGS. 1A-1D is shown in the embodiment in FIGS. 2A-2D . System 10 is advanced into the subject's right radial artery through an incision in the right arm. The system is advanced through the right subclavian artery and into the brachiocephalic trunk 11 , and a portion of the system is positioned within aorta 9 as can be seen in FIG. 2A (although that which is shown in FIG. 2A is not intended to be limiting). [0087] Proximal sheath 12 is retracted proximally to allow proximal filter support element 15 to expand to an expanded configuration against the wall of the brachiocephalic trunk 11 , as is shown in FIG. 2B . Proximal filter element 17 is secured either directly or indirectly to support element 15 , and is therefore reconfigured to the configuration shown in FIG. 2B . The position of distal sheath 20 can be substantially maintained while proximal sheath 12 is retracted proximally. Once expanded, the proximal filter filters blood traveling through the brachiocephalic artery 11 , and therefore filters blood traveling into the right common carotid artery 7 . The expanded proximal filter is therefore in position to prevent foreign particles from traveling into the right common carotid artery 7 and into the cerebral vasculature. [0088] Distal sheath 20 is then steered, or bent, and distal end 26 of distal sheath 20 is advanced into the left common carotid artery 13 , as shown in FIG. 2C . Guiding member 24 is thereafter advanced distally relative to distal sheath 20 , allowing the distal support element to expand from a collapsed configuration to a deployed configuration against the wall of the left common carotid artery 13 as shown in FIG. 2D . The distal filter element is also reconfigured into the configuration shown in FIG. 2D . Once expanded, the distal filter filters blood traveling through the left common carotid artery 13 . The distal filter is therefore in position to trap foreign particles and prevent them from traveling into the cerebral vasculature. [0089] In several embodiments, the proximal and distal filter elements or frame elements comprise elastic or shape memory material causing the filters to expand as they exit their respective sheaths. In other embodiments, mechanical or hydraulic mechanisms may be used to expand each filter element. Once the filters are in place and expanded, an optional medical procedure can then take place, such as a valvuloplasty and/or replacement heart valve procedure. Any plaque or thrombus dislodged during the heart valve procedure that enters into the brachiocephalic trunk or the left common carotid artery will be trapped in the filters. [0090] The filter system can thereafter be removed from the subject (or at any point in the procedure). In an exemplary embodiment, distal filter 22 is first retrieved back within distal sheath 20 to the collapsed configuration. To do this, guiding member 24 is retracted proximally relative to distal sheath 20 . This relative axial movement causes distal sheath 20 to engage strut 28 and begin to move strut 28 towards guiding member 24 . Support element 21 , which is coupled to strut 28 , begins to collapse upon the collapse of strut 28 . Filter element 23 therefore begins to collapse as well. Continued relative axial movement between guiding member 24 and distal sheath 20 continues to collapse strut 28 , support element 21 , and filter element 23 until distal filter 22 is retrieved and re-collapsed back within distal sheath 20 (as shown in FIG. 2C ). Any foreign particles trapped within distal filter element 23 are contained therein as the distal filter is re-sheathed. Distal sheath 20 is then steered into the configuration shown in FIG. 2B , and proximal sheath is then advanced distally relative to proximal filter 16 . This causes proximal filter 16 to collapse around distal shaft 18 , trapping any particles within the collapsed proximal filter. Proximal sheath 12 continues to be moved distally towards distal sheath 20 until in the position shown in FIG. 2A . The entire system 10 can then be removed from the subject. [0091] In any of the embodiments mentioned herein, the filter or filters may alternatively be detached from the delivery catheter, and the delivery catheter removed leaving the filter behind. The filter or filters can be left in place permanently, or retrieved by snaring it with a retrieval catheter following a post procedure treatment period of time. Alternatively, the filters may remain attached to the catheter, and the catheter may be left in place post procedure for the treatment period of time. That treatment period may be at least one day, one week, three weeks, five weeks or more, depending upon the clinical circumstances. Patients with an indwelling filter or filters may be administered any of a variety of thrombolytic or anticoagulant therapies, including tissue plasminogen activator, streptokinase, coumadin, heparin and others known in the art. [0092] An exemplary advantage of the systems described herein is that the delivery and retrieval system are integrated into the same catheter that stays in place during the procedure. Unloading and loading of different catheters, sheaths, or other components is therefore unnecessary. Having a system that performs both delivery and retrieval functions also reduces procedural complexity, time, and fluoroscopy exposure time. In addition, only a minimal portion of the catheter is in the aortic arch, thus greatly reducing the change of interference with other catheters. [0093] FIGS. 7A-7B illustrate a perspective view and sectional view, respectively, of a portion of an exemplary filter system. The system includes distal shaft 30 and distal articulatable sheath 34 , coupled via coupler 32 . FIG. 7B shows the sectional view of plane A. Distal sheath 34 includes steering element 38 extending down the length of the sheath and within the sheath, which is shown as a pull wire. The pull wire can be, for example without limitation, stainless steel, tungsten, alloys of cobalt such as MP35N®, or any type of cable, either comprised of a single strand or two or more strands. Distal sheath 34 also includes spine element 36 , which is shown extending down the length of the sheath on substantially the opposite side of the sheath from steering element 38 . Spine element 36 can be, for example without limitation, a ribbon or round wire. Spine element 36 can be made from, for example, stainless steel or Nitinol. Spine element 36 resists axial expansion or compression of articulatable sheath 34 upon the application of an actuating axial pull or push force applied to steering element 38 , allowing sheath 34 to be deflected toward configuration 40 , as shown in phantom in FIG. 7A . FIG. 7C shows an alternative embodiment in which distal sheath 33 has a non-circular cross section. Also shown are spine element 35 and steering element 37 . [0094] FIGS. 8A-8C illustrate views of exemplary pull wire 42 that can be incorporated into any distal sheaths described herein. Plane B in FIG. 8B shows a substantially circular cross-sectional shape of pull wire 42 in a proximal portion 44 of the pull wire, while plane C in FIG. 8C shows a flattened cross-sectional shape of distal portion 46 . Distal portion 46 has a greater width than height. The flattened cross-sectional shape of distal portion 46 provides for an improved profile, flexibility, and resistance to plastic deformation, which provides for improved straightening. [0095] FIGS. 9A-C show an alternative embodiment of distal sheath 48 that includes slots 50 formed therein. The slots can be formed by, for example, grinding, laser cutting or other suitable material removal from distal sheath 48 . Alternatively, the slots can be the openings between spaced apart coils or filars of a spring. The characteristics of the slots can be varied to control the properties of the distal sheath. For example, the pitch, width, depth, etc., of the slots can be modified to control the flexibility, compressibility, torsional responsiveness, etc., of distal sheath 48 . More specifically, the distal sheath 48 can be formed from a length of stainless steel hypotubing. Transverse slots 50 are preferably formed on one side of the hypotubing, leaving an opposing spine which provides column strength to avoid axial compression or expansion upon application of an axial force to the pull wire and also limits deflection to a desired single plane or predetermined planes. [0096] FIG. 9B shows a further embodiment of the distal sheath in greater detail. In this embodiment distal sheath 48 includes a first proximal articulatable hypotube section 49 . Articulatable hypotube section 49 is fixed to distal shaft 30 (not shown in FIG. 9A ). A second distal articulatable section 51 is secured to first proximal section 49 . Pull wire 38 extends from the handle through distal shaft section 49 and is affixed to a distal portion of distal shaft portion 51 . This embodiment allows for initial curvature of distal sheath proximal section 49 in a first direction such as away from the outer vessel wall in response to proximal retraction of the pull wire 38 . Distal sheath distal section 51 is then articulated to a second curvature in a second, opposite direction. This second curvature of distal shaft section 51 is adjustable based upon tension or compression loading of the sheath section by pull wire 38 . Alternatively, a first pull wire can be attached at a distal portion of section 49 and a second pull wire can be attached at a distal portion of section 51 to allow independent deflection of the two deflection sections. [0097] As shown in FIG. 9B , pull wire 38 in a single pull wire embodiment crosses to an opposite side of the inner lumen defined by sections 49 and 51 from the slots 50 as it transitions from the first distal sheath proximal section 49 to second distal sheath distal section 51 . As best shown in FIG. 9C , distal sheath proximal section 49 would articulate first to initialize a first curve, concave in a first direction as the slots 50 compress in response to proximal retraction of the pull wire 38 . As the tension on pull wire 38 is increased and the slots bottom out, distal sheath distal section 51 begins to form a second curve concave in a second direction opposite to the direction of the first curve, due to pull wire 38 crossing the inner diameter of the lumen through distal sheath sections 49 and 51 . As can be seen in FIG. 9C , as it nears and comes to the maximum extent of its articulation, distal sheath distal section 51 can take the form of a shepherd's staff or crook. [0098] Distal sheath proximal section 49 could take the form of a tubular slotted element or a pre-shaped curve that utilizes a memory material such as Nitinol or any other material exhibiting suitable properties. In some embodiments outer diameter of distal sheath proximal section 49 is between 0.02 inches and 0.2 inches. In certain embodiments, the outer diameter is between 0.05 inches and 0.1 inches, or between 0.06 inches and 0.075 inches. In some embodiments, the inner diameter of distal sheath proximal section 49 is between 0.02 inches and 0.2 inches. In certain embodiments, the inner diameter is between 0.03 inches and 0.08 inches or between 0.05 inches and 0.07 inches. In several embodiments, the length of distal sheath proximal section 49 may measures between 0.1 inches and 2.5 inches. In some embodiments, the length of distal sheath proximal section 49 may measure between about 0.50 inches and 1 inch or between 0.6 inches and 0.8 inches. In certain embodiments, the length of distal sheath proximal section 49 may be longer than 2.5 inches. It is understood that these sizes and proportions will vary depending on the specific application and those listed herein are not intended to be limiting. Transverse slots 50 can measure from about 0.002 inches to about 0.020 inches in width (measured in the axial direction) depending on the specific application and the degree of curvature desired. In some embodiments the slots can measure less than 0.002 inches or greater than 0.02 inches. In certain embodiments, the slots 50 can measure about 0.002 inches to 0.01 inches or between 0.006 and 0.01 inches. [0099] The curvature of proximal section 49 may be varied from about 0 degrees to 90 degrees or more depending on the width and number of the slots 50 . In several embodiments, the maximum degree of deflection ranges from about 15 degrees to about 75 degrees, from about 45 degrees to about 60 degrees. Commencement of deflection of distal section 51 can occur prior to, simultaneously with or following commencement of deflection of proximal section 49 based upon the relative stiffness of the sections or configuration of the pull wire as will be apparent to those of skill in the art. [0100] The distal sheath is configured such that the maximum net curvature between the primary axis of the catheter prior to any deflection and the distal tip axis is between about 90 and about 220 degrees. In other embodiments, the maximum deflection is between about 120 degrees and about 200 degrees, or between about 150 degrees and about 180 degrees. When the distal sheath is in its curved configuration, with a net deflection from the primary axis of at least about 150 degrees, the lateral distance between the primary axis and the distal tip ranges from about 5 mm to about 15 mm. [0101] The position of at least a second group of slots 50 may also be rotationally displaced about the axis of the tube with respect to a first group of slots to allow a first portion of the distal sheath to bend in a first plane and a second portion of the distal sheath to bend out-of-plane to access more complex anatomy as shown in FIGS. 9D and 9E . The second set of slots 50 may be displaced circumferentially from the first set of slots by about 5 degrees to about 90 degrees. In certain embodiments, the slots are displaced from about 15 to 60 degrees or from about 20 to about 40 degrees. The curvature of the out of plane curve may vary from about 20 degrees to about 75 degrees, but in some embodiments, the out of plane curvature may be less than 20 degrees or greater than 75 degrees. In several embodiments, the curvature of the out of plane curve is from about 20 degrees to 40 degrees, from about 30 degrees to about 50 degrees, from about 40 degrees to about 60 degrees, or from about 50 degrees to 75 degrees. Alternatively, this out-of-plane bend could be achieved by prebending the tube after laser cutting the slots to create a bias or by any other method which would create a bias. The shape could also be multi-plane or bidirectional where the tube would bend in multiple directions within the same section of laser cut tube. [0102] In several embodiments, distal sheath distal section 51 is a selectable curve based upon the anatomy and vessel location relative to one another. This section 51 could also be a portion of the laser cut element or a separate construction where a flat ribbon braid could be utilized. It may also include a stiffening element or bias ribbon to resist permanent deformation. In one embodiment it would have a multitude of flat ribbons staggered in length to create a constant radius of curvature under increased loading. [0103] In some embodiments, distal sheath 34 incorporates a guidewire lumen 58 through which a guidewire may pass as shown in FIG. 9F . Alternatively, in FIG. 9G , the guidewire lumen is coaxial with guiding member lumen 59 . Removing the guidewire lumen from the wall of distal sheath 34 has the added benefit of increasing the distal sheath luminal cross sectional area, reducing deployment and retrieval forces, and increasing the capacity for debris within the distal sheath. [0104] FIGS. 10A and 10B illustrate a portion of exemplary distal sheath 52 that is adapted to be multi-directional, and is specifically shown to be bi-directional. Distal sheath 52 is adapted to be steered towards the configurations 53 and 54 shown in phantom in FIG. 10A . FIG. 10B is a sectional view in plane D, showing spinal element 55 and first and second steering elements 56 disposed on either side of spinal element 55 . Steering elements 56 can be similar to steering element 38 shown in FIG. 7B . The steering elements can be disposed around the periphery of distal sheath at almost any location. [0105] Incorporating steerable functionality into tubular devices is known in the area of medical devices. Any such features can be incorporated into the systems herein, and specifically into the articulatable distal sheaths. [0106] In some embodiments the distal sheath includes radiopaque markers to visualize the distal sheath under fluoroscopy. In some embodiments the distal sheath has radiopaque markers at proximal and distal ends of the sheath to be able to visualize the ends of the sheath. [0107] An exemplary advantage of the filter systems described herein is the ability to safely and effectively position the distal sheath. In some uses, the proximal filter is deployed in a first bodily lumen, and the distal filter is deployed in a second bodily lumen different than the first. For example, as shown in FIG. 2D , the proximal filter is deployed in the brachiocephalic trunk and the distal filter is deployed in a left common carotid artery. While both vessels extend from the aortic arch, the position of the vessel openings along the aortic arch varies from patient-to-patient. That is, the distance between the vessel openings can vary from patient to patient. Additionally, the angle at which the vessels are disposed relative to the aorta can vary from patient to patient. Additionally, the vessels do not necessarily lie within a common plane, although in many anatomical illustrations the vessels are typically shown this way. For example, FIGS. 11A-11C illustrate merely exemplary anatomical variations that can exist. FIG. 11A is a top view (i.e., in the superior-to-inferior direction) of aorta 70 , showing relative positions of brachiocephalic trunk opening 72 , left common carotid artery opening 74 , and left subclavian opening 76 . FIG. 11B is a side sectional view of aortic 78 illustrating the relative angles at which brachiocephalic trunk 80 , left common carotid artery 82 , and left subclavian artery 84 can extend from aorta 78 . FIG. 11C is a side sectional view of aorta 86 , showing vessel 88 extending from aorta 86 at an angle. Any or all of the vessels extending from aorta 86 could be oriented in this manner relative to the aorta. FIGS. 11D and 11E illustrate that the angle of the turn required upon exiting the brachiocephalic trunk 92 / 100 and entering the left common carotid artery 94 / 102 can vary from patient to patient. Due to the patient-to-patient variability between the position of the vessels and their relative orientations, a greater amount of control of the distal sheath increases the likelihood that the distal filter will be positioned safely and effectively. For example, a sheath that only has the ability to independently perform one or two of rotation, steering, and axial translation may not be adequately adapted to properly and safely position the distal filter in the left common carotid artery. All three degrees of independent motion as provided to the distal sheaths described herein provide important clinical advantages. Typically, but without intending to be limiting, a subject's brachiocephalic trunk and left carotid artery are spaced relatively close together and are either substantially parallel or tightly acute (see, e.g., FIG. 11E ). [0108] FIGS. 12A and 12B illustrates an exemplary curvature of a distal sheath to help position the distal filter properly in the left common carotid artery. In FIGS. 12A and 12B , only a portion of the system is shown for clarity, but it can be assumed that a proximal filter is included, and in this example has been expanded in brachiocephalic trunk 111 . Distal shaft 110 is coupled to steerable distal sheath 112 . Distal sheath 112 is steered into the configuration shown in FIG. 12B . The bend created in distal sheath 112 , and therefore the relative orientations of distal sheath 112 and left common carotid artery 113 , allow for the distal filter to be advanced from distal sheath 112 into a proper position in left common carotid 113 . In contrast, the configuration of distal sheath 114 shown in phantom in FIG. 12A illustrates how a certain bend created in the distal sheath can orient the distal sheath in such a way that the distal filter will be advanced directly into the wall of the left common carotid (depending on the subject's anatomy), which can injure the wall and prevent the distal filter from being properly deployed. Depending on the angulation, approach angle, spacing of the openings, etc., a general U-shaped curve (shown in phantom in FIG. 12A ) may not be optimal for steering and accessing the left common carotid artery from the brachiocephalic trunk. [0109] In some embodiments the distal sheath is adapted to have a preset curved configuration. The preset configuration can have, for example, a preset radius of curvature (or preset radii of curvature at different points along the distal sheath). When the distal sheath is articulated to be steered to the preset configuration, continued articulation of the steering element can change the configuration of the distal sheath until is assumes the preset configuration. For example, the distal sheath can comprise a slotted tube with a spine extending along the length of the distal sheath. Upon actuation of the steering component, the distal sheath will bend until the portions of the distal sheath that define the slots engage, thus limiting the degree of the bend of the distal sheath. The curve can be preset into a configuration that increases the likelihood that the distal filter will, when advanced from the distal sheath, be properly positioned within the left common carotid artery. [0110] FIGS. 13A and 13B illustrate alternative distal sheath and distal shaft portions of an exemplary filter system. FIGS. 13A and 13B only show distal shaft 120 and distal sheath 122 for clarity, but the system may also includes a proximal filter (not shown but has been deployed in brachiocephalic trunk). The distal shaft/distal sheath combination has a general S-bend configuration, with distal shaft 120 including a first bend 124 in a first direction, and distal sheath 122 configured to assume bend 126 in a second direction, wherein the first and second bends form the general S-bend configuration. FIG. 13B shows distal sheath 122 pulled back in the proximal direction relative to the proximal filter to seat the curved distal sheath against the bend. This both helps secure the distal sheath in place as well as reduces the cross sectional volume of the filter system that is disposed with the aorta. The distal shaft and distal sheath combination shown in FIGS. 13A and 13B can be incorporated into any of the filter systems described herein. [0111] Exemplary embodiments of the delivery and deployment of a multi-filter embolic protection apparatus will now be described with reference to FIGS. 2A-2D , 13 A, 13 B, 14 , 1 , 3 , 4 and 5 . More particularly, the delivery and deployment will be described with reference to placement of the filter system in the brachiocephalic and left common carotid arteries. The preferred access for the delivery of the multi-filter system 10 is from the right radial or right brachial artery, however other access locations such as the right subclavian artery are possible. The system is then advanced through the right subclavian artery to a position within the brachiocephalic artery 11 . At this point, proximal filter 16 may be deployed within into expanding engagement with the inner lining of brachiocephalic artery 11 . Alternatively, access to the left common carotid could be gained prior to deployment of proximal filter 16 . Deployment of proximal filter 16 protects both the brachiocephalic artery 11 and the right common carotid artery 7 against emboli and other foreign bodies in the bloodstream. [0112] Entry into the aortic space, as illustrated in FIG. 3 , is then accomplished by further advancement of the system from the brachiocephalic trunk. During this step, the filter system will tend to hug the outer portion of the brachiocephalic trunk as shown in FIG. 4 . Initial tensioning of pull wire 38 causes distal sheath 48 to move the catheter-based filter system off the wall of the brachiocephalic artery just before the ostium or entrance into the aorta, as shown in FIG. 4 . As the catheter path will hug the outer wall of the brachial cephalic artery, a curve directed away from this outer wall will allow additional space for the distal portion of the distal sheath to curve into the left common carotid artery, as shown in FIG. 5 . [0113] The width of slots 50 will determine the amount of bending allowed by the tube when tension is applied via pull wire 38 . For example, a narrow width slot would allow for limited bending where a wider slot would allow for additional bending due to the gap or space removed from the tube. As the bending is limited by the slot width, a fixed shape or curve may be obtained when all slots are compressed and touching one another. Additional features such as chevrons may be cut into the tube to increase the strength of the tube when compressed. Other means of forming slots could be obtained with conventional techniques such as chemical etching, welding of individual elements, mechanical forming, metal injection molding or other conventional methods. [0114] Once in the aortic space, the distal sheath is further tensioned to adjust the curvature of the distal shaft distal section 51 , as shown in FIG. 9B . The amount of deflection is determined by the operator of the system based on the particular patient anatomy. [0115] Other techniques to bias a catheter could be external force applications to the catheter and the vessel wall such as a protruding ribbon or wire from the catheter wall to force the catheter shaft to a preferred position within the vessel. Flaring a radial element from the catheter central axis could also position the catheter shaft to one side of the vessel wall. Yet another means would be to have a pull wire external to the catheter shaft exiting at one portion and reattaching at a more distal portion where a tension in the wire would bend or curve the catheter at a variable rate in relation to the tension applied. [0116] This multi-direction and variable curvature of the distal sheath allows the operator to easily direct the filter system, or more particularly, the distal sheath section thereof, into a select vessel such as the left common carotid artery or the left innominate artery. Furthermore, the filter system allows the operator to access the left common carotid artery without the need to separately place a guidewire in the left common carotid artery. The clinical variations of these vessels are an important reason for the operator to have a system that can access differing locations and angulations between the vessels. The filter systems described herein will provide the physician complete control when attempting to access these vessels. [0117] Once the distal sheath is oriented in the left common carotid, the handle can be manipulated by pulling it and the filter system into the bifurcation leaving the aortic vessel clear of obstruction for additional catheterizations, an example of which is shown in FIG. 12B . At this time, distal filter 22 can be advanced through proximal shaft 14 and distal shaft 18 into expanding engagement with left common carotid artery 13 . [0118] FIG. 14 illustrates a portion of an exemplary system including distal shaft 130 and distal sheath 132 . Distal sheath is adapted to be able to be steered into what can be generally considered an S-bend configuration, a shepherd's staff configuration, or a crook configuration, comprised of first bend 131 and second bend 133 in opposite directions. Also shown is rotational orb 134 , defined by the outer surface of the distal sheath as distal shaft 130 is rotated at least 360 degrees in the direction of the arrows shown in FIG. 14 . If a typical aorta is generally in the range from about 24 mm to about 30 mm in diameter, the radius of curvature and the first bend in the S-bend can be specified to create a rotational orb that can reside within the aorta (as shown in FIG. 14 ), resulting in minimal interference with the vessel wall and at the same time potentially optimize access into the left common carotid artery. In other distal sheath and/or distal shaft designs, such as the one shown in FIG. 12A , the rotational orb created by the rotation of distal shaft 110 is significantly larger, increasing the risk of interference with the vessel wall and potentially decreasing the access into the left common carotid artery. In some embodiments, the diameter of the rotation orb for a distal sheath is less than about 25 mm. [0119] Referring back to FIG. 12A , distal sheath 112 , in some embodiments, includes a non-steerable distal section 121 , an intermediate steerable section 119 , and a proximal non-steerable section 117 . When the distal sheath is actuated to be steered, only steerable portion 119 bends into a different configuration. That is, the non-steerable portions retain substantially straight configurations. The distal non-steerable portion remains straight, which can allow the distal filter to be advanced into a proper position in the left common carotid artery. [0120] While FIG. 12A shows distal sheath 112 in a bent configuration, the distal sheath is also positioned within the lumen of the aorta. In this position, the distal sheath can interfere with any other medical device or instrument that is being advanced through the aorta. For example, in aortic valve replacement procedures, delivery device 116 , with a replacement aortic valve disposed therein, is delivered through the aorta as shown in FIG. 12B . If components of the filter system are disposed within the aorta during this time, delivery device 116 and the filter system can hit each other, potentially damaging either or both systems. The delivery device 116 can also dislodge one or both filters if they are in the expanded configurations. The filter system can additionally prevent the delivery device 116 from being advanced through the aorta. To reduce the risk of contact between delivery device 116 and distal sheath 112 , distal sheath 112 (and distal shaft 110 ) is translated in the proximal direction relative to the proximal filter (which in this embodiment has already been expanded but is not shown), as is shown in FIG. 12B . Distal sheath 112 is pulled back until the inner curvature of distal sheath 112 is seated snugly with the vasculature 115 disposed between the brachiocephalic trunk 111 and the left common carotid artery 113 . This additional seating step helps secure the distal sheath in place within the subject, as well as minimize the amount of the filter system present in the aortic arch. This additional seating step can be incorporated into any of the methods described herein, and is an exemplary advantage of having a distal sheath that has three degrees of independent motion relative to the proximal filter. The combination of independent rotation, steering, and axial translation can be clinically significant to ensure the distal filter is properly positioned in the lumen, as well as making sure the filter system does not interfere with any other medical devices being delivered to the general area inside the subject. [0121] An additional advantage of the filter systems herein is that the distal sheath, when in the position shown in FIG. 12B , will act as a protection element against any other medical instruments being delivered through the aorta (e.g., delivery device 116 ). Even if delivery device 116 were advanced such that it did engage distal sheath 112 , distal sheath 112 is seated securely against tissue 115 , thus preventing distal sheath 112 from being dislodged. Additionally, distal sheath 112 is stronger than, for example, a wire positioned within the aorta, which can easily be dislodged when hit by delivery device 116 . [0122] FIGS. 15A-15D illustrate alternative embodiments of the coupling of the distal shaft and distal sheath. In FIG. 15A distal shaft 140 is secured to distal sheath 142 by coupler 144 . Shaft 140 has a low profile to allow for the collapse of the proximal filter (see FIG. 1C ). Shaft 140 also has column strength to allow for axial translation, has sufficient torque transmission properties, and is flexible. The shaft can have a support structure therein, such as braided stainless steel. For example, the shaft can comprise polyimide, Polyether ether ketone (PEEK), Nylon, Pebax, etc. FIG. 15B illustrates an alternative embodiment showing tubular element 146 , distal shaft 148 , and distal sheath 150 . Tubular element 146 can be a hypotube made from stainless steel, Nitinol, etc. FIG. 15C illustrates an exemplary embodiment that includes distal shaft 152 , traction member 154 , and distal sheath 156 . Traction member 154 is coupled to shaft 152 and shaft 152 is disposed therein. Traction member 154 couples to shaft 152 for torquebility, deliverability, and deployment. Traction member 154 can be, for example without limitation, a soft silicone material, polyurethane, polyimide, or other material having suitable properties. FIG. 15D shows an alternative embodiment in which the system includes bushing 162 disposed over distal shaft 158 , wherein distal shaft 158 is adapted to rotate within bushing 162 . The system also includes stop 160 secured to distal shaft 158 to substantially maintain the axial position of bushing 162 . When the system includes bushing 162 , distal sheath 164 can be rotated relative to the proximal sheath and the proximal filter when the distal sheath and proximal sheath are in the delivery configuration (see FIG. 1B ). [0123] FIG. 16 illustrates an exemplary embodiment of filter system 170 in which distal sheath 172 is biased to a curved configuration 174 . The biased curved configuration is adapted to facilitate placement, delivery, and securing at least the distal filter. As shown, the distal sheath is biased to a configuration that positions the distal end of the distal sheath towards the left common carotid artery. [0124] FIG. 17 illustrates a portion of an exemplary filter system and its method of use. FIG. 17 shows a system and portion of deployment similar to that shown in FIG. 2D , but distal sheath 182 has been retracted proximally relative to guiding member 190 and distal filter 186 . Distal sheath 182 has been retracted substantially from the aortic arch and is substantially disposed with the brachiocephalic trunk. Guiding member 190 can have preset curve 188 adapted to closely mimic the anatomical curve between the brachiocephalic trunk and the left common carotid artery, thus minimizing the amount of the system that is disposed within the aorta. As shown, distal sheath 182 has been retracted proximally relative to proximal filter 180 . [0125] FIG. 18A is a perspective view of a portion of an exemplary embodiment of a filter system, while FIG. 18B is a close-up view of a portion of the system shown in FIG. 18A . The distal sheath and the distal filter are not shown in FIGS. 18A and 18B for clarity. The system includes proximal filter 200 coupled to proximal shaft 202 , and push rod 206 coupled to proximal shaft 202 . A portion of proximal sheath 204 is shown in FIG. 18A in a retracted position, allowing proximal filter 200 to expand to an expanded configuration. Only a portion of proximal sheath 204 is shown, but it generally extends proximally similar to push rod 206 . The proximal end of proximal shaft 202 is beveled and defines an aspiration lumen 216 , which is adapted to receive an aspirator (not shown) to apply a vacuum to aspirate debris captured within distally facing proximal filter 200 . Push rod 206 extends proximally within proximal sheath 204 and is coupled to an actuation system outside of the subject, examples of which are described below. Push rod 206 takes up less space inside proximal sheath 204 than proximal shaft 202 , providing a lower profile. [0126] The system also includes proximal seal 214 disposed on the outer surface of proximal shaft 202 and adapted to engage the inner surface of the proximal sheath. Proximal seal 214 prevents bodily fluids, such as blood, from entering the space between proximal sheath 204 and proximal shaft 202 , thus preventing bodily fluids from passing proximally into the filter system. The proximal seal can be, for example without limitation, a molded polymer. The proximal seal can also be machined as part of the proximal shaft, such that they are not considered two separate components. [0127] In some specific embodiments the push rod is between 0.001 inches and 0.05 inches in diameter. In some embodiments, the diameter is between 0.01 inches and 0.025 inches in diameter. The pushrod can be constructed from any number of polymeric or metal materials, such as stainless steel. The proximal shaft can be, for example without limitation, an extruded or molded plastic, a hypotube (e.g., stainless steel), machined plastic, metal, etc. [0128] Proximal filter 200 includes filter material 208 , which comprises pores adapted to allow blood to pass therethrough, while debris does not pass through the pores and is captured within the filter material. Proximal filter 200 also includes strut 210 that extends from proximal shaft 202 to expansion support 212 . Expansion support 212 has a generally annular shape but that is not intended to be limiting. Proximal filter 200 also has a leading portion 220 and a trailing portion 222 . Leading portion 220 generally extends further distally than trailing portion 222 to give filter 200 a generally canted configuration relative to the proximal shaft. The canted design provides for decreased radial stiffness and a better collapsed profile. Strut 210 and expansion support 212 generally provide support for filter 200 when in the expanded configuration, as shown in FIG. 18A . [0129] FIGS. 19A-19C illustrate exemplary embodiments of proximal filters and proximal shafts that can be incorporated into any of the systems herein. In FIG. 19A , filter 230 has flared end 232 for improved filter-wall opposition. FIG. 19B shows proximal shaft 244 substantially co-axial with vessel 246 in which filter 240 is expanded. Vessel 246 and shaft 244 have common axis 242 . FIG. 19C illustrates longitudinal axis 254 of shaft 256 not co-axial with axis 252 of lumen 258 in which filter 250 is expanded. [0130] FIGS. 20A and 20B illustrate an exemplary embodiment including proximal filter 260 coupled to proximal shaft 262 . Filter 260 includes filter material 264 , including slack material region 268 adapted to allow the filter to collapse easier. Filter 260 is also shown with at least one strut 270 secured to shaft 262 , and expansion support 266 . As shown in the highlighted view in FIG. 20B , filter 260 includes seal 274 , radiopaque coil 276 (e.g., platinum), support wire 278 (e.g., Nitinol wire), and filter material 264 . Any of the features in this embodiment can be included in any of the filter systems described herein. [0131] FIG. 21 illustrates an exemplary embodiment of a proximal filter. Proximal filter 280 is coupled to proximal shaft 282 . Proximal filter 280 includes struts 286 extending from proximal shaft 282 to strut restraint 288 , which is adapted to slide axially over distal shaft 284 . Proximal filter 280 also includes filter material 290 , with pores therein, that extends from proximal shaft 282 to a location axially between proximal shaft 282 and strut restraint 288 . Debris can pass through struts 286 and become trapped within filter material 290 . When proximal filter 280 is collapsed within a proximal sheath (not shown), struts 286 elongate and move radially inward (towards distal shaft 284 ). Strut restraint 288 is adapted to move distally over distal shaft 284 to allow the struts to move radially inward and extend a greater length along distal shaft 284 . [0132] FIGS. 22A and 22B illustrate an exemplary embodiment of a proximal filter that can be incorporated into any filter system described herein. The system includes proximal filter 300 and proximal sheath 302 , shown in a retracted position in FIG. 22A . Proximal filter 300 includes valve elements 304 in an open configuration in FIG. 22A . When valve elements 304 are in the open configuration, foreign particles 306 can pass through opening 308 and through the valve and become trapped in proximal filter 300 , as is shown in FIG. 22A . To collapse proximal filter 300 , proximal sheath 302 is advanced distally relative to proximal filter 300 . As the filter begins to collapse, the valve elements are brought closer towards one another and into a closed configuration, as shown in FIG. 22B . The closed valve prevents extrusion of debris during the recapture process. [0133] The distal filters shown are merely exemplary and other filters may be incorporated into any of the systems herein. FIG. 23A illustrates a portion of an exemplary filter system. The system includes guiding member 340 (distal sheath not shown), strut 342 , expansion support 344 , and filter element 346 . Strut 342 is secured directly to guiding member 340 and strut 342 is secured either directly or indirectly to expansion support 344 . Filter material 346 is secured to expansion support 344 . Distal end 348 of filter material 346 is secured to guiding member 340 . [0134] FIG. 23B illustrates a portion of an exemplary filter system. The system includes guiding element 350 , strut support 352 secured to guiding element 350 , strut 354 , expansion support 356 , and filter material 358 . Strut support 352 can be secured to guiding element 350 in any suitable manner (e.g., bonding), and strut 354 can be secured to strut support 352 in any suitable manner. [0135] FIG. 23C illustrates a portion of an exemplary filter system. The system includes guiding element 360 , strut support 362 secured to guiding element 360 , strut 364 , expansion support 366 , and filter material 368 . Expansion support 366 is adapted to be disposed at an angle relative to the longitudinal axis of guiding member 360 when the distal filter is in the expanded configuration. Expansion support 366 includes trailing portion 362 and leading portion 361 . Strut 364 is secured to expansion support 366 at or near leading portion 361 . FIG. 23D illustrates an exemplary embodiment that includes guiding member 370 , strut support 372 , strut 374 , expansion support 376 , and filter material 378 . Expansion support 376 includes leading portion 373 , and trailing portion 371 , wherein strut 374 is secured to expansion element 376 at or near trailing portion 371 . Expansion support 376 is disposed at an angle relative to the longitudinal axis of guiding member 370 when the distal filter is in the expanded configuration. [0136] FIG. 23E illustrates an exemplary embodiment of a distal filter in an expanded configuration. Guiding member 380 is secured to strut support 382 , and the filter includes a plurality of struts 384 secured to strut support 382 and to expansion support 386 . Filter material 388 is secured to expansion support 386 . While four struts are shown, the distal filter may include any number of struts. [0137] FIG. 23F illustrates an exemplary embodiment of a distal filter in an expanded configuration. Proximal stop 392 and distal stop 394 are secured to guiding member 390 . The distal filter includes tubular member 396 that is axially slidable over guiding member 390 , but is restricted in both directions by stops 392 and 394 . Strut 398 is secured to slidable member 396 and to expansion support 393 . Filter material 395 is secured to slidable member 396 . If member 396 slides axially relative to guiding member 390 , filter material 395 moves as well. Member 396 is also adapted to rotate in the direction “R” relative to guiding member 390 . The distal filter is therefore adapted to independently move axially and rotationally, limited in axial translation by stops 392 and 394 . The distal filter is therefore adapted such that bumping of the guiding member or the distal sheath will not disrupt the distal filter opposition, positioning, or effectiveness. [0138] As shown in FIGS. 23A-23B , in some embodiments, the strut 342 , 354 has a straight configuration. A straight configuration may allow for a shorter attachment between the filter and the guiding member. In other embodiments, as shown in FIGS. 23C-23D , the strut 364 , 374 , takes a curved configuration. In still other embodiments, the strut has two or more curves. For example, the strut may take a sinusoidal configuration and transition from a first curve to the opposite curve to aid in transition to the filter frame. In some embodiments, the first curve may have a larger radius than the opposite curve. In still other embodiments, the first curve may have a smaller radius than the opposite curve. [0139] FIGS. 24A-24C illustrate exemplary embodiments in which the system includes at least one distal filter positioning, or stabilizing, anchor. The positioning anchor(s) can help position the distal anchor in a proper position and/or orientation within a bodily lumen. In FIG. 24A the system includes distal filter 400 and positioning anchor 402 . Anchor 402 includes expandable stent 404 and expandable supports 406 . Supports 406 and filter 400 are both secured to the guiding member. Anchor 402 can be any suitable type of expandable anchor, such as, for example without limitation, stent 404 . Anchor 402 can be self-expandable, expandable by an expansion mechanism, or a combination thereof. In FIG. 24A , stent 404 can alternatively be expanded by an expansion balloon. Anchor 402 is disposed proximal to filter 400 . FIG. 24B illustrates an embodiment in which the system includes first and second anchors 412 and 414 , one of which is proximal to filter 410 , while the other is distal to filter 410 . FIG. 24C illustrates an embodiment in which anchor 422 is distal relative to filter 420 . [0140] In some embodiments the distal filter is coupled, or secured, to a guiding member that has already been advanced to a location within the subject. The distal filter is therefore coupled to the guiding member after the distal filter has been advanced into the subject, rather than when the filter is outside of the subject. Once coupled together inside the subject, the guiding member can be moved (e.g., axially translated) to control the movement of the distal filter. In some embodiments the guiding member has a first locking element adapted to engage a second locking element on the distal filter assembly such that movement of the guiding member moves the distal filter in a first direction. In some embodiments the distal filter assembly has a third locking element that is adapted to engage the first locking element of the guiding member such that movement of the guiding member in a second direction causes the distal filter to move with the guiding member in the second direction. The guiding member can therefore be locked to the distal filter such that movement of the guiding member in a first and a second direction will move the distal filter in the first and second directions. [0141] By way of example, FIGS. 25A-25D illustrate an exemplary embodiment of coupling the distal filter to a docking wire inside of the subject, wherein the docking wire is subsequently used to control the movement of the distal filter relative to the distal sheath. In FIG. 25A , guide catheter 440 has been advanced through the subject until the distal end is in or near the brachiocephalic trunk 441 . A docking wire, comprising a wire 445 , locking element 442 , and tip 444 , has been advanced through guide catheter 440 , either alone, or optionally after guiding wire 446 has been advanced into position. Guiding wire 446 can be used to assist in advancing the docking wire through guide catheter 440 . As shown, the docking wire has been advanced from the distal end of guide catheter 440 . After the docking wire is advanced to the desired position, guide catheter 440 , and if guiding wire 446 is used, are removed from the subject, leaving the docking wire in place within the subject, as shown in FIG. 25B . Next, as shown in FIG. 25C , the filter system, including proximal sheath 448 with a proximal filter in a collapsed configuration therein (not shown), distal sheath 450 , with a distal filter assembly (not shown) partially disposed therein, is advanced over wire 445 until a locking portion of the distal filter (not shown but described in detail below) engages locking element 442 . The distal filter assembly will thereafter move (e.g., axially) with the docking wire. Proximal sheath 448 is retracted to allow proximal filter 454 to expand (see FIG. 25D ). Distal sheath 450 is then actuated (e.g., bent, rotated, and/or translated axially) until it is in the position shown in FIG. 25D . A straightened configuration of the distal sheath is shown in phantom in FIG. 25D , prior to bending, proximal movement, and/or bending. The docking wire is then advanced distally relative to distal sheath 450 , which advances distal filter 456 from distal sheath 450 , allowing distal filter 456 to expand inside the left common carotid artery, as shown in FIG. 25D . [0142] FIGS. 26A-26D illustrate an exemplary method of preparing an exemplary distal filter assembly for use. FIG. 26A illustrates a portion of the filter system including proximal sheath 470 , proximal filter 472 is an expanded configuration, distal shaft 474 , and articulatable distal sheath 476 . Distal filter assembly 478 includes an elongate member 480 defining a lumen therein. Elongate member 480 is coupled to distal tip 490 . Strut 484 is secured both to strut support 482 , which is secured to elongate member 480 , and expansion support 486 . Filter element 488 has pores therein and is secured to expansion support 486 and elongate member 480 . To load distal filter assembly 478 into distal sheath 476 , loading mandrel 492 is advanced through distal tip 490 and elongate member 480 and pushed against distal tip 490 until distal filter assembly 478 is disposed within distal sheath 476 , as shown in FIG. 26C . Distal tip 490 of the filter assembly remains substantially distal to distal sheath 476 , and is secured to the distal end of distal sheath 476 . Distal tip 490 and distal sheath 476 can be secured together by a frictional fit or other type of suitable fit that disengages as described below. Loading mandrel 492 is then removed from the distal filter and distal sheath assembly, as shown in FIG. 26D . [0143] FIG. 26E illustrates docking wire 500 including wire 502 , lock element 504 , and distal tip 506 . Docking wire 500 is first advanced to a desired position within the subject, such as is shown in FIG. 25B . The assembly from FIG. 26D is then advanced over docking wire, wherein distal tip 490 is first advanced over the docking wire. As shown in the highlighted view in FIG. 26F , distal tip 490 of the distal filter assembly includes first locking elements 510 , shown as barbs. As the filter/sheath assembly continues to be distally advanced relative to the docking wire, the docking wire locking element 504 pushes locks 510 outward in the direction of the arrows in FIG. 26F . After lock 504 passes locks 510 , locks 510 spring back inwards in the direction of the arrows shown in FIG. 26G . In this position, when docking wire 500 is advanced distally (shown in FIG. 26F ), lock element 504 engages with lock elements 510 , and the lock element 504 pushes the distal filter assembly in the distal direction. In this manner the distal filter can be distally advanced relative to the distal sheath to expand the distal filter. Additionally, when the docking wire is retracted proximally, locking element 504 engages the distal end 512 of elongate member 480 and pulls the distal filter in the proximal direction. This is done to retrieve and/or recollapse the distal filter back into the distal sheath after it has been expanded. [0144] FIGS. 27A and 27B illustrate an exemplary embodiment in which guiding member 540 , secured to distal filter 530 before introduction into the subject is loaded into articulatable distal sheath 524 . The system also includes proximal filter 520 , proximal sheath 522 , and distal shaft 526 . FIG. 27B shows the system in a delivery configuration in which both filters are collapsed. [0145] FIGS. 28A-28E illustrate an exemplary distal filter assembly in collapsed and expanded configurations. In FIG. 28A , distal filter assembly 550 includes a distal frame, which includes strut 554 and expansion support 555 . The distal frame is secured to floating anchor 558 , which is adapted to slide axially on elongate member 564 between distal stop 560 and proximal stop 562 , as illustrated by the arrows in FIG. 28A . The distal filter assembly also includes membrane 552 , which has pores therein and is secured at its distal end to elongate member 564 . The distal filter assembly is secured to a guiding member, which includes wire 566 and soft distal tip 568 . The guiding member can be, for example, similar to the docking wire shown in FIGS. 26A-26E above, and can be secured to the distal filter assembly as described in that embodiment. [0146] The floating anchor 558 allows filter membrane 552 to return to a neutral, or at-rest, state when expanded, as shown in FIG. 28A . In its neutral state, there is substantially no tension applied to the filter membrane. The neutral deployed state allows for optimal filter frame orientation and vessel apposition. In the neutral state shown in FIG. 28A , floating anchor 558 is roughly mid-way between distal stop 560 and proximal stop 562 , but this is not intended to be a limiting position when the distal filter is in a neutral state. [0147] FIG. 28B illustrates the distal filter being sheathed into distal sheath 572 . During the sheathing process, the distal filter is collapsed from an expanded configuration (see FIG. 28A ) towards a collapsed configuration (see FIG. 28C ). In FIG. 28B , distal sheath 572 is moving distally relative to the distal filter. The distal end of the distal sheath 572 engages with strut 554 as it is advanced distally, causing the distal end of strut 554 to moves towards elongate member 564 . Strut 554 can be thought of as collapsing towards elongate member 564 from the configuration shown in FIG. 28A . The force applied from distal sheath 572 to strut 554 collapses the strut, and at the same time causes floating anchor 558 to move distally on tubular member 564 towards distal stop 560 . In FIG. 28B , floating anchor 558 has been moved distally and is engaging distal stop 560 , preventing any further distal movement of floating anchor 558 . As strut 554 is collapsed by distal sheath 572 , strut 554 will force the attachment point between strut 554 and expansion support 555 towards tubular member 564 , beginning the collapse of expansion support 555 . Distal sheath 572 continues to be advanced distally relative to the distal filter (or the distal filter is pulled proximally relative to the distal sheath, or a combination of both) until the distal filter is collapsed within distal sheath 572 , as is shown in FIG. 28C . Filter membrane 552 is bunched to some degree when the filter is in the configuration shown in FIG. 28C . To deploy the distal filter from the sheath, guiding member 566 is advanced distally relative to the distal sheath (or the distal sheath is moved proximally relative to the filter). The distal portions of filter membrane 552 and expansion support 555 are deployed first, as is shown in FIG. 28D . Tension in the filter membrane prevents wadding and binding during the deployment. When strut 554 is deployed from the distal sheath, expansion support 555 and strut 554 are able to self-expand to an at-rest configuration, as shown in FIG. 28E . Floating anchor 558 is pulled in the distal direction from the position shown in FIG. 28D to the position shown in FIG. 28E due to the expansion of strut 554 . [0148] FIGS. 29A-29E illustrate a portion of an exemplary filter system with a lower delivery and insertion profile. In FIG. 29A , the system includes proximal sheath 604 with a larger outer diameter than distal sheath 602 . In some embodiments proximal sheath 604 has a 6 F outer diameter, while distal sheath 602 has a 5 F outer diameter. A guiding member including distal tip 606 is disposed within the distal sheath and the proximal sheath. [0149] FIG. 29B illustrates tear-away introducer 608 , with receiving opening 610 and distal end 612 . Introducer is first positioned within a subject with receiving opening 610 remaining outside the patient. As shown in FIG. 29C , the smaller diameter distal sheath is first advanced through the receiving opening of introducer 608 until the distal end of the distal sheath is disposed distal relative to the distal end of the introducer. The introducer is then split apart and removed from the subject, as shown in FIG. 29D . The filter system can then be advanced distally through the subject. The introducer can be a 5 F introducer, which reduces the insertion and delivery profile of the system. [0150] The embodiments in FIGS. 25A-25B above illustrated some exemplary systems and methods for routing filter systems to a desired location within a subject, and additional exemplary embodiments will now be described. FIGS. 30A and 30B illustrate an exemplary embodiment similar to that which is shown in FIGS. 27A and 27B . The filter system shows distal filter 650 and proximal filter 644 in expanded configurations. Proximal sheath 642 has been retracted to allow proximal filter 644 to expand. Distal filter, which is secured to guiding member 648 , are both advanced distally relative to distal articulating sheath 640 . The filter system does not have a dedicated guidewire that is part of the system, but distal sheath 640 is adapted to be rotated and steered to guide the system to a target location within the subject. [0151] FIGS. 31A-31C illustrate an exemplary over-the-wire routing system that includes a separate distal port for a dedicated guidewire. A portion of the system is shown in FIG. 31B , including distal articulating sheath 662 and proximal sheath 660 (the filters are collapsed therein). FIG. 31B is a highlighted view of a distal region of FIG. 31A , showing guidewire entry port 666 near the distal end 664 of distal sheath 662 . FIG. 31C is a sectional view through plane A of distal sheath 662 , showing guidewire lumen 672 , spine element 678 , distal filter lumen 674 , and steering element 676 (shown as a pull wire). Guidewire lumen 672 and distal filter lumen 674 are bi-axial along a portion of distal sheath, but in region 670 guidewire lumen 672 transitions from within the wall of distal sheath 662 to being co-axial with proximal sheath 660 . [0152] To deliver the system partially shown in FIGS. 31A-31C , a guidewire is first delivered to a target location within the subject. The guidewire can be any type of guidewire. With the guidewire in position, the proximal end of the guidewire is loaded into guidewire entry port 666 . The filter system is then tracked over the guidewire to a desired position within the subject. Once the system is in place, the guidewire is withdrawn from the subject, or it can be left in place. The proximal and distal filters can then be deployed as described in any of the embodiments herein. [0153] FIGS. 32A-32E illustrate an exemplary routing system which includes a rapid-exchange guidewire delivery. The system includes distal articulating sheath 680 with guidewire entry port 684 and guidewire exit port 686 . The system also includes proximal sheath 682 , a distal filter secured to a guiding member (collapsed within distal sheath 680 ), and a proximal filter (collapsed within proximal sheath 682 ). After guidewire 688 is advanced into position within the patient, the proximal end of guidewire 688 is advanced into guidewire entry port 684 . Distal sheath (along with the proximal sheath) is tracked over guidewire 688 until guidewire 688 exits distal sheath 680 at guidewire exit port 686 . Including a guidewire exit port near the entry port allows for only a portion of the guidewire to be within the sheath(s), eliminating the need to have a long segment of guidewire extending proximally from the subject's entry point. As soon as the guidewire exits the exit port, the proximal end of the guidewire and the proximal sheath can both be handled. [0154] FIG. 32B shows guidewire 688 extending through the guidewire lumen in the distal sheath and extending proximally from exit port 686 . Guidewire 688 extends adjacent proximal sheath 682 proximal to exit port 686 . In FIG. 32B , portion 690 of proximal sheath 682 has a diameter larger than portion 692 to accommodate the proximal filter therein. Portion 692 has a smaller diameter for easier passage of the proximal sheath and guidewire. FIG. 32C shows a sectional view through plane 32 C- 32 C of FIG. 32B , with guidewire 688 exterior and adjacent to proximal sheath 682 . Proximal filter 694 is in a collapsed configuration within proximal sheath 682 , and guiding member 696 is secured to a distal filter, both of which are disposed within distal shaft 698 . [0155] FIG. 32D shows relative cross-sections of exemplary introducer 700 , and distal sheath 680 through plane 32 D- 32 D. Distal sheath 680 includes guidewire lumen 702 and distal filter lumen 704 . In some embodiments, introducer 700 is 6 F, with an inner diameter of about 0.082 inches. In comparison, the distal sheath can have a guidewire lumen of about 0.014 inches and distal filter lumen diameter of about 0.077 inches. [0156] FIG. 32E shows a sectional view through plane 32 E- 32 E, and also illustrates the insertion through introducer 700 . Due to the smaller diameter of portion 692 of proximal sheath 682 , guidewire 688 and proximal sheath 682 more easily fit through introducer 700 than the distal sheath and portion of the proximal sheath distal to portion 692 . The size of the introducer may vary depending on the diameter of the filter system. The introducer may range in size from 4 F to 15 F. In certain embodiments, the size of the introducer is between 4 F and 8 F. Guidewire 688 may vary in diameter between 0.005 and 0.02 inches or between 0.01 and 0.015 inches. In some situations, it may be desirable to have a guidewire smaller than 0.005 inches or larger than 0.02 inches in diameter. The smaller diameter proximal portion 692 of proximal sheath 682 allows for optimal sheath and guidewire movement with the introducer sheath. In certain aspects, it may be desirable for the cross-section of proximal filter deployment member 697 to take a non-circular shape to reduce the profile of proximal sheath 682 . Guiding member 696 and distal sheath pull wire 676 are both disposed through distal shaft 698 . [0157] In certain embodiments, the guiding member is a core wire. Use of a core wire may be desirable to decrease the diameter of the filter system. A core wire is also flexible and able to access tortuous anatomies. The material and diameter of the guiding member may vary depending on the desired level of column strength or flexibility. In certain embodiments, the core wire may be tapered such that a distal section of the core wire has a smaller diameter than a proximal section of the core wire to increase flexibility at the distal section. [0158] In certain clinical scenarios, it may be desirable for the guiding member to take the form of a tubular core member having a guidewire lumen running therethrough. In several embodiments, the tubular core member is a catheter shaft. The presence of the guidewire lumen allows the user to deliver the filter system to the correct position by advancing the filter system over the guidewire. A tubular core member allows the user to select an appropriate guidewire for the procedure rather than restricting the user to the wire core shaft. A guiding member having a guidewire lumen can potentially reduce the delivery profile of the filter system by not requiring separate lumens for the guiding member and the guidewire. [0159] FIG. 33A illustrates filter system 700 having tubular core member 720 extending along an elongate axis of filter system 700 and slidably disposed through distal shaft 716 . The distal end of tubular core member 720 is positioned in a distal, atraumatic tip 740 of filter system 700 , while the proximal end of tubular core member 720 is positioned in the control handle. The proximal end of tubular core member 720 is connected to an actuation mechanism capable of advancing tubular core member 720 distally or retracting tubular core member 720 proximally with respect to distal shaft 716 . Distal filter assembly 726 may be mounted on a distal section of tubular core member 720 . Proximal filter 704 and distal filter 726 are illustrated as formed from a plurality of struts such as a woven wire or laser cut basket, however any of the polymeric membrane filters disclosed elsewhere herein may be used in filter system 700 . [0160] In certain embodiments, tubular core member 720 defines a guidewire lumen 745 . Tubular core member 720 may have a distal guidewire entry port at the distal end of tubular core member 720 and a proximal guidewire exit port at the proximal end of tubular core member 720 . In other embodiments, the proximal guidewire port may be positioned at any position along the length of the tubular core member. [0161] The length of tubular core member 720 may range from about 50 cm to about 300 cm. In some embodiments, the length may be less than 50 cm; while in other embodiments, the length may be greater than 300 cm. In several embodiments, the length of tubular core member 720 is between about 50 and about 150 cm, between about 75 and about 125 cm, or between about 100 cm and about 150 cm. The inner diameter of tubular core member 720 may range from about 0.01 to about 0.075 cm. In other embodiments, the inner diameter of tubular core member 720 is less than 0.01 cm; while in still other embodiments, the inner diameter is greater than 0.075 cm. The outer diameter of tubular core member 720 may range from about 0.025 to about 0.1 cm. In certain embodiments, the outer diameter of tubular core member 720 is less than 0.025 cm; while in other embodiments, the inner diameter is greater than 0.1 cm. [0162] In certain clinical scenarios, it may be desirable to increase the column strength of tubular core member 720 , thus improving support and pushability to aid advancement of distal filter assembly 726 out of distal sheath 718 . In certain scenarios, tubular core member 720 may be constructed from a material stiffer than the material from which distal shaft 716 is constructed. A stiffer tubular core member 720 can help improve the column strength of filter system 700 . The tubular core member 720 may be constructed from metallic materials such as stainless steel, Nitinol, cobalt chromium (MP35N), or other alloys used in medical devices. Alternatively, tubular core member 720 may be constructed from a polymer construction such as nylon, polyester, polypropylene, polyimide, or other polymers exhibiting similar properties. In some embodiments, tubular core member 720 may be constructed from a combination of metallic materials and polymeric materials. In some embodiments, the inner diameter of tubular core member 720 is either coated with or constructed of a lubricious polymer (e.g. HDPE, PTFE, FEP, etc.). In still other embodiments, tubular core member may include reinforcements. For example, a ribbon or other stiffening member may extend along a section of tubular core member 720 . Alternatively, tubular core member 720 may have a multi-lumen profile, a first lumen for a guidewire and a second lumen for a stiffening mandrel. Tubular core member 720 may also transition from a multi-lumen profile to a single lumen profile to increase flexibility along the single lumen section of the tubular core member. In still other embodiments, tubular core member 720 may include one or more longitudinal strands dispersed within the tubular core member shaft to improve tensile strength. In some embodiments, tubular core member 720 may have a braided or coiled shaft to increase column strength. In certain embodiments, the braid consists of both metallic and polymer materials. In other embodiments, the braid consists of only metal; while in still other embodiments, the braid consists of only polymer materials. [0163] In other clinical scenarios, it may be desirable to provide more flexibility in certain sections or along the entire length of tubular core member 720 . When filter system 700 is deployed in a curved lumen, a rigid tubular core member 720 or other guiding member may pull the leading portion 732 of distal filter 736 away from the vessel wall if the distal region of tubular core member 720 or other guiding member lacks sufficient flexibility to deflect relative to filter system 700 in a tortuous anatomy. [0164] In certain embodiments, tubular core member 720 may be constructed from a more flexible material. In other embodiments, a first portion of tubular core member 720 may be constructed from a flexible material, while a second portion of tubular core member 720 is constructed from a stiffer material. Alternatively, removal of portions of tubular core member 720 may provide greater flexibility along certain sections of tubular core member 720 . For example, a series of slots, cuts, or a spiral pattern may be cut into a section of tubular core member 720 to provide a flex zone having a greater flexibility than proximal and distal adjacent portions of tubular core member 720 . The pattern of cuts may vary along the tubular core member shaft to vary flexibility along tubular core member 720 . The flexible portion may alternatively comprise a coil, helix, or interrupted helix. In other embodiments, a first portion of the tubular core member may also have a thinner wall than a second portion of the tubular core member. In still other embodiments, tubular core member 720 may be tapered to increase stiffness along a first section of the tubular core member and increase flexibility along a second section of the tubular core member. [0165] In certain embodiments, a distal section of tubular core member 720 may be more flexible than a proximal section of the tubular core member 720 using any of the methods discussed above. The length of the flexible distal section may measure from about 5 cm to about 50 cm, from about 10 to about 40 cm, or from about 15 to about 25 cm. In other embodiments, the flexible distal section may be less than 5 cm or greater than 50 cm. [0166] Several embodiments may include a flexible coupler 722 to allow distal filter assembly 726 to deflect relative to the rest of filter system 700 . In several embodiments, tubular core member 720 includes a flexible coupler 722 positioned proximal to distal filter assembly 726 . In several embodiments, flexible coupler 722 defines a lumen through which a guidewire may pass. In some embodiments, flexible coupler 722 is spliced into a gap along tubular core member 720 . In some embodiments, tubular core member 720 may comprise a distal tubular core member and a proximal tubular core member. The distal end of the proximal tubular core member may be joined to the proximal end of flexible coupler 722 , while the proximal end of the distal tubular core member is joined to the distal end of flexible coupler 722 . In still other embodiments, tubular core member 720 and flexible coupler 722 are integrally formed such as by providing core member 720 with a plurality of transverse slots as is described elsewhere herein. [0167] In some clinical scenarios, it may be desirable for flexible coupler 722 to be more flexible than tubular core member 720 , while still demonstrating properties strong enough to resist deformation under tensile loads. Flexible coupler 722 may be constructed from materials, such as polymers, multiple polymers, Nitinol, stainless steel, etc. In certain embodiments, flexible coupler 722 may be created by piercing, slotting, grooving, scoring, cutting, laser cutting or otherwise removing material from a tubular body to increase flexibility. Alternatively, a flexible coupler 722 may be integrally formed with tubular core member 720 using any of the above mentioned patterns. In another embodiment, flexible coupler 722 is created by thinning a portion of tubular core member 720 to create a more flexible region. Flexible coupler 722 may also be deformed into a serrated or bellows shape without removing any material from the tubular body. Any of the other methods discussed above to increase the flexibility of tubular core member 720 may also be applied. [0168] In some embodiments, a flexible section 738 of tubular core member 722 may be configured to be more flexible than a proximal section of tubular core member 722 . In some aspects, flexible section 738 is positioned distal to flexible coupler 722 . The length of flexible section 738 may measure from about 5 mm to about 50 mm, from about 10 to about 30 mm, or from about 20 to about 40 mm. In other embodiments, the flexible distal section may be less than 5 mm or greater than 50 mm. [0169] FIGS. 33B-D illustrate cross sections at various positions along the dual filter system depicted in FIG. 33A . FIG. 33B illustrates a cross section of filter system 700 , proximal to proximal filter assembly 704 . Guidewire 721 is disposed through a lumen defined by tubular core member 720 , and tubular core member 720 is disposed through a lumen defined by distal shaft 716 . In certain embodiments, at least a portion of distal sheath 718 may be articulated via pull wire 737 . FIG. 33B shows that at least a portion of pull wire 737 may be disposed through distal shaft 716 , but external to tubular core member 720 . In some embodiments, at least a portion of pull wire 737 may pass through a lumen embedded in at least a portion of the distal shaft wall or distal sheath wall. In FIG. 33B , a portion of distal shaft 716 may be disposed through a lumen defined by proximal shaft 701 . Proximal filter frame 714 may extend through a lumen embedded in at least a portion of the proximal filter shaft wall 701 . Proximal filter shaft 701 is disposed through a lumen defined by proximal sheath 702 . [0170] FIG. 33C depicts a cross section distal to the cross section depicted in FIG. 33B through distal sheath 718 . Distal sheath is illustrated in a simplified form, but typically will include all of the deflection mechanisms of FIGS. 9A-9E , discussed above. FIG. 33C shows guidewire 721 disposed through a lumen defined by tubular core member 720 . At least a portion of tubular core member 720 is disposed through a lumen defined by distal sheath 718 . As depicted in 33 C, at least a portion of distal sheath 718 may be provided with a reinforcement such as an embedded coil or braid 719 to improve torqueing capabilities. In some embodiments, the entire length of distal sheath 718 may comprise a reinforcing element such as a braid. Pull wire 737 may extend through a lumen extending through at least a portion of the distal sheath 718 , and distal sheath spinal element 741 may extend through at least a portion of distal sheath 718 . In some embodiments, the outer diameter of distal sheath 718 is substantially similar to the outer diameter of proximal sheath 702 . In other embodiments, distal sheath 718 extends through a lumen defined by proximal sheath 702 . [0171] FIG. 33D depicts a cross section distal to the cross-section depicted in FIG. 33C . FIG. 33D shows guidewire 721 disposed through a lumen defined by tubular core member 720 . Tubular core member 720 is coaxial with flexible coupler 722 . In certain embodiments, the diameter of flexible coupler 722 may be larger than the diameter of tubular core member 720 . In other embodiments, flexible coupler 722 may have the same diameter as tubular core member 720 . In still other embodiments, the diameter of flexible coupler 722 may be smaller than the diameter of tubular core member 720 . In certain embodiments, the flexible coupler may not be a separate component. [0172] As shown in FIGS. 34A-C , a tubular core member 720 coupled with a flexible coupler 722 has the advantage of providing improved column strength along a substantial length of the filter system 700 , but providing the flexibility necessary for distal filter assembly 726 to position itself independent of the position of distal shaft 716 . Flexible coupler 722 allows distal filter frame element 728 to create a better seal against the vessel wall to help prevent embolic debris from flowing between distal filter 736 and the vessel wall. [0173] A filter system having a flexible coupler 722 is deployed similarly to the method described in FIGS. 2A-2D . In one embodiment, as distal sheath 718 is advanced into the left common carotid artery, tubular core member 720 is advanced distally relative to distal sheath 718 . FIG. 34B illustrates filter system 700 after tubular core member 720 is advanced into the left common carotid artery. Distal filter 736 expands and flexible coupler 722 deflects relative to filter system 700 such that distal filter frame element 728 is circumferentially apposed to the vessel wall. Strut 724 may be proximally retracted as desired to tilt the frame element 728 to improve the fit of the distal filter 736 within the vessel. [0174] In certain embodiments, the stiffness of tubular core member 720 may be further reduced during use by the operator by withdrawing the guidewire until the distal end of the guidewire is proximal to flexible coupler 722 such that the guidewire is no longer disposed within flexible coupler 722 , thus reducing stiffness. [0175] FIGS. 35A-B illustrate a tubular body 750 suitable for use as a flexible coupler 722 . A tubular body 750 having a proximal end 754 and a distal end 756 may be formed by wrapping a ribbon or wire around a mandrel or by laser cutting a tube with a spiral pattern to form a coil. The width of spaced regions 752 a,b between each adjacent coil loop 751 may be different in an unstressed orientation depending on the desired properties. In some embodiments, it may be desirable to provide greater flexibility, in which case, spaced region 752 b should be wider to allow for a greater range of movement. In certain clinical scenarios, it may be desirable to provide smaller spaced regions 752 a between each coil portion 751 to help prevent a first edge 753 a and a second edge 753 b of each coil portion 751 from dislodging plaque from the vessel wall or damaging the vessel wall. In an alternate embodiment, a flexible coupler 722 having wider spaced regions 752 a between each coil portion 751 may be covered by a thin sheath such as shrink wrap tubing to provide flexibility and protect the vessel wall from flexible coupler 722 . [0176] In FIG. 35C , a tubular body 760 having a proximal end 764 and a distal end 766 is laser cut with a plurality of slots 762 , each slot 762 having a first end 768 a and a second end 768 b . In some embodiments, two or more slots 762 form a circumferential ring 771 around flexible coupler 722 . In several embodiments, a plurality of circumferential rings 771 is laser cut into a tubular body 760 . The plurality of circumferential rings 771 may be staggered such that a first slot of a first circumferential ring is misaligned from a first slot of a second circumferential ring. The plurality of slots 762 are configured such that flexible coupler 722 flexes angularly while retaining good torque resistance and tensile displacement resistance. [0177] FIG. 35D depicts a flexible coupler 722 constructed from a tubular body 770 having a proximal end 774 and a distal end 776 . Tubular body 770 is laser cut with a spiral pattern, the spiral pattern having a plurality of interlocking ring portions, wherein a first interlocking ring portion 778 a interlocks with a complementary second interlocking ring portion 778 b . Flexible coupler 722 has an interlocking pattern designed to resist axial deformation (stretching) when placed in tension. FIG. 35E illustrates flexible coupler 722 also having interlocking ring portions 778 . In this embodiment, an axial element 784 is positioned across an interlocking feature 782 to improve the axial stiffness of flexible coupler 722 when subject to tensile loading. [0178] Although the above mentioned embodiments were discussed in connection with a tubular core member, the same properties may be applied to any other guiding member. The guiding member may incorporate any of the above mentioned properties alone, or in combination, to manipulate flexibility and column strength along the guiding member shaft. The embodiments may also be used in connection with the proximal filter or any other catheter-based system. [0179] In certain clinical scenarios, it may be desirable for the filter opening to circumferentially appose the vessel wall. This helps prevent debris from flowing past the filter. In a straight lumen, a filter can achieve good apposition with the vessel wall, thus preventing plaque or blood clots from flowing past the filter when it is deployed in a vessel. In contrast, when a filter is deployed in a curved lumen, the filter frame element can settle into a number of different rotational orientations in the lumen. In some clinical scenarios, when the filter is deployed in a curved lumen, it is possible for the filter frame element to pull away from the vessel wall particularly on the inner radius thus leading to poor apposition and blood leakage past the filter. [0180] In current settings, practitioners may seek to overcome this poor positioning by using contrast injections and fluoroscopic imaging in one or more views. The filter is then either re-sheathed and redeployed or rotated or repositioned without re-sheathing, a process that can dislodge plaque from the vessel wall or otherwise damage the vessel. Neither of these solutions is satisfactory due to the extended procedure time and the increased possibility of vessel damage due to increased device manipulation. [0181] In certain scenarios, it may be advantageous to add a tethering member to a filter assembly. FIGS. 36A-E illustrate tethering member 842 attached to proximal filter assembly 804 . Tethering member 842 is configured to draw proximal filter frame element 814 closer to the vessel wall in order to form a seal with the inner surface of the vessel. Proper apposition of proximal filter assembly 804 relative to the vessel wall prevents debris from flowing past proximal filter assembly 804 . This can be achieved with a flexible tethering member (e.g. monofilament polymer, braided polymer, suture, wire, etc.) or with a rigid or semi-rigid member such as nitinol, thermoplastic, stainless steel, etc. [0182] Tethering member 842 has a first end 844 and a second end 846 . In FIG. 36A , the first end 844 of tethering member 842 is affixed to proximal sheath 802 , while the second end 846 of tethering member 842 is affixed to proximal filter assembly 804 . In some embodiments, tethering member 842 is affixed to filter frame element 814 ; while in other embodiments, tethering member 842 is affixed to proximal filter 806 . FIGS. 36B-C illustrate how tethering member 842 laterally deflects the frame 814 and pulls filter frame element 814 toward the vessel wall when the operator retracts proximal sheath 802 . Proximally retracting tethering member 842 allows the operator to control the deflection and angle of proximal filter frame element 814 . In other embodiments, tethering member 842 can be actuated passively rather than actively (i.e. by the operator) by forming tethering member 842 from an elastic material or spring in order to elastically pull the edge of proximal filter frame element 814 toward the vessel wall. [0183] In still other embodiments, the second end 846 of tethering member 842 may be attached to a feature disposed along proximal filter 806 . For example, in FIG. 36E , the second end 846 of tethering member 842 is connected to a rib 848 formed on proximal filter 806 . In still other embodiments, the first end 844 of tethering member 842 may be attached to an elongate member such as a pull wire slidably disposed along the length of the catheter system to a control actuator in the control handle. This allows the operator to control the deflection of proximal filter frame element 814 independently from proximal sheath 802 . [0184] In certain embodiments, it may be preferable to attach a distal end of tethering member 842 to a single location on proximal filter assembly 804 . Alternatively, as shown in FIG. 36D , it may be preferable to attach the distal end of tethering member 842 to two or more positions on proximal filter assembly 804 . [0185] In order to facilitate sheathing and to minimize tangling when proximal filter assembly 804 is collapsed into proximal sheath 802 , tethering member 842 may be twisted to form a coil 849 , as shown in FIG. 37A . Twisted portion 849 retracts and stays out of the way when proximal filter assembly 804 is sheathed, and twisted portion 849 will untwist and straighten as the operator deploys proximal filter assembly 804 . The design is also helpful for controlling the slack in tethering member 842 during sheathing and unsheathing. Tethering member 842 may be formed from a heat deformable polymer and applying heat to deform the polymer into a twisted configuration. Tethering member may alternatively be formed from nitinol or any other material having suitable properties. In other embodiments, it may be preferable for tethering member 842 to form a coil ( FIG. 37B ), pre-formed to particular shapes ( FIG. 37C ), or have two or more tethering members ( FIG. 37D ). One or more tethering members may be formed into any other design that may decrease the likelihood that tethering member 842 will become tangled with other catheters or devices. [0186] Although the previously discussed tethering members have been discussed in connection with proximal filter assemblies, a tethering member may be used in connection with a distal filter, other filter devices, or any intraluminal device that may desirably be laterally displaced, tilted or otherwise manipulated into a desired orientation, such as to improve alignment including improving apposition with a vessel wall. [0187] In some clinical scenarios, it may be desirable to place a single filter in a blood vessel. Any of the above mentioned features of the dual filter embodiments may be applied to the single filter embodiments described below, including, but not limited to, filter design, sheath articulation, or guiding member flexibility or column strength. In addition, filter systems described herein can be utilized in connection with a variety of intravascular interventions. The embodiments described below will be discussed in connection with a TAVI procedure, but the filter systems may be used with other intravascular or surgical interventions such as balloon valvuloplasty, coronary artery bypass grafting, surgical valve replacement, etc. and should not be construed as limited to the TAVI procedure. [0188] In certain situations, it may be desirable to position the filter in the aorta, distal to the aortic valve but proximal to the brachiocephalic artery ostium, such that the entire arterial blood supply can be filtered. The aortic filter may also be positioned in the aorta, between the right brachiocephalic artery ostium and the left carotid artery ostium. In other scenarios, the aortic filter may be positioned between the left carotid artery ostium and the left subclavian artery ostium, while in still other clinical situations may make it preferable to position the aortic filter in the descending aorta, distal to the left subclavian artery ostium. In some cases, an aortic filter can be positioned in the aorta in combination with brachiocephalic and left carotid artery filters in order to capture all embolic debris. [0189] An aortic filter can be positioned at various locations along a catheter system. In one embodiment, the aortic filter can be positioned on a catheter separate from the TAVI or pigtail catheter and inserted through the left or right brachial artery or the right or left femoral artery. Using a separate aortic filter catheter decreases the overall diameter of the TAVI catheter and allows the operator to position the aortic filter independently from aortic valve. Further, the aortic filter will not dislodge plaque along the vessel wall when the TAVI catheter is repositioned or rotated. [0190] In another embodiment, the aortic filter can be positioned on the TAVI catheter shaft, proximal to the valve prosthesis. To decrease the size of the overall catheter system, the diameter of the TAVI catheter system proximal to the valve prosthesis may be reduced in size. This embodiment decreases the number of total devices in the operating environment, thus decreasing the likelihood that devices will get tangled. [0191] In yet another embodiment, the aortic filter may be positioned on the TAVI introducer. This embodiment enables the operator to position the aortic filter independently from the position of the TAVI catheter. The filter is also less likely to dislodge plaque along the vessel wall when the TAVI catheter is repositioned or rotated. Introducing the aortic filter on the TAVI introducer also decreases the total number of catheters into the operating environment. [0192] In still another embodiment, the aortic filter is positioned on a pigtail catheter shaft, proximal to the pigtail. Affixing the aortic filter to the pigtail catheter does not increase the overall diameter of the TAVI system or add any additional catheters into the operating environment. [0193] In one embodiment, the aortic filter is positioned on an extended pigtail introducer sheath. This embodiment enables the operator to position the aortic filter separately from the location of the pigtail without adding any additional catheters into the operating environment. Positioning the aortic filter on the pigtail introducer sheath also does not increase the overall diameter of the TAVI system. Further, the aortic filter will not dislodge plaque along the vessel while when the pigtail and/or TAVI catheter is repositioned or rotated. [0194] Various methods can be used to perform a TAVI procedure in connection with an aortic filter. In one method, the aortic filter is positioned as early as possible in the procedure at any location in the aorta previously described, and the aortic filter may be deployed using any of the above mentioned devices. The TAVI catheter may then be inserted through the filter and the TAVI implantation is performed. Afterward, the TAVI catheter and aortic filter are removed. [0195] In an alternative method, a guidewire is positioned through the aorta and the pigtail catheter is inserted into the aorta. A TAVI catheter can then be advanced to a position just proximal of where the aortic filter will be deployed. The aortic filter may be deployed at any position described above. Using any of the previously discussed embodiments, a catheter carrying an aortic filter deploys an aortic filter in the aorta. The aortic filter also forms a seal against both the TAVI catheter and the vessel wall such that debris cannot flow past the filter. After the aortic filter is deployed, the TAVI catheter is advanced to the implant location and the implant procedure is performed. When the procedure is over, the TAVI catheter is withdrawn just proximal to the filter such that the operator can retrieve the aortic filter. The aortic filter, TAVI, and pigtail catheters are then all withdrawn from the operating environment. These steps are not limited to the order in which they were disclosed. For example, the TAVI catheter may be advanced to the implant location before the aortic filter is deployed. [0196] FIG. 38A depicts a TAVI catheter 933 that is deployed across an aortic filter assembly 904 in the aorta 999 . In some scenarios, aortic filter assembly 904 may not fully appose the TAVI catheter shaft, thus leaving room for debris to flow between the TAVI catheter 933 and the vessel wall. In these scenarios, it may be preferential to configure aortic filter assembly 904 to appose TAVI catheter 933 and prevent substantially all debris from flowing past aortic filter assembly 904 without significantly degrading filter capture performance. It may also be preferential to modify aortic filter assembly 904 in scenarios where TAVI catheter 933 passes through aortic filter assembly 904 . [0197] FIG. 38B illustrates an aortic filter assembly 904 designed to pass over a guidewire 907 or other guiding member. Aortic filter assembly 904 may have a channel 909 on the exterior surface of aortic filter assembly 904 . Channel 909 is constructed such that a TAVI deployment catheter or other catheter may pass through channel 909 . The operator may also rotate aortic filter assembly 904 such that the TAVI catheter properly passes through channel 909 . The control handle may indicate the rotational location of channel 909 help the operator correctly orient aortic filter 904 . Alternatively, channel 909 may have at least one or two radiopaque markers to enable identification of channel 909 using fluoroscopy. [0198] FIG. 38C depicts aortic filter assembly 904 having a leading edge 911 and a trailing edge 913 . Aortic filter assembly 904 passes over a guidewire 907 or other guiding member. Leading edge 911 overlaps trailing edge 913 to form an overlapping portion 935 . The control handle may indicate the location of overlapping portion 935 so the operator can torque aortic filter assembly 904 to position overlapping portion 935 over the TAVI or other catheter shaft. Overlapping portion 935 may have a radiopaque marker to allow the operator to monitor aortic filter placement under fluoroscopy. [0199] FIG. 38D depicts an aortic filter assembly 904 designed to pass over a guidewire 907 or other guiding member. Aortic filter 904 has a first filter portion 915 and a second filter portion 917 , second filter portion 917 having a first edge 917 a , and a second edge 917 b . The first edge 917 a and the second edge 917 b of second filter portion 917 overlap first filter portion 915 to form a joint 914 . The control handle may indicate the location of joint 914 so the operator can torque aortic filter assembly 904 to position joint 914 against the shaft of the TAVI catheter. As the operator advances a catheter-based device across aortic filter 904 , second filter portion 917 caves inward such that joint 914 forms a seal around the catheter shaft. Aortic filter assembly 904 may include a radiopaque marker to allow the operator to identify joint 914 under fluoroscopy. [0200] FIGS. 39 A-C depict an aortic filter device having two or three or four or more aortic lobes or filters. Each aortic filter lobe 904 a,b,c is joined together along a first side 919 of each aortic filter lobe 904 a,b,c . Aortic filter lobes 904 a,b,c join together about a longitudinal axis of the aortic filter system. The aortic filter system is configured such that a TAVI catheter 933 or other catheter-based device may pass between a first aortic filter assembly 904 b and a second aortic filter assembly 904 c . The first and second aortic filters 904 b,c forming a seal around the TAVI catheter 933 , thus preventing debris from flowing past the aortic filter system. [0201] FIG. 40A depicts generally conical aortic filter assembly 904 resembling an umbrella. Aortic filter 904 may pass over a guidewire 907 or other guiding member. Aortic filter assembly 904 has a plurality of self-expanding tines 923 , each tine having a proximal end and a distal end. Each tine joins together at a first end 903 of aortic filter assembly 904 . In addition, a filter portion 925 is suspended between tines 923 . Filter portion 925 may be fairly inflexible or flexible to stretch over the TAVI catheter 933 or other catheter-based device. When an operator advances TAVI catheter 933 past aortic filter assembly 904 , TAVI catheter 933 passes between a first tine 923 and a second tine 923 such that a filter portion 925 stretches over TAVI catheter 933 to form a seal between filter portion 925 and TAVI catheter 933 . [0202] Alternatively, FIG. 40B depicts an aortic filter assembly 904 resembling a flower. In one embodiment, aortic filter assembly 904 has two or more petals 943 arranged in a circular array that allow TAVI catheter 933 or other catheter-based device to pass between petals 943 . Petals 943 may overlap one another to create a seal between adjacent petals 943 . Petals 943 also create a seal around TAVI catheter 933 as the catheter passes between petals 943 . The shape of each petal 943 may include an arch to better accommodate the circular shape of the aorta. Each petal 943 may have a length between two to six centimeters. Although in some embodiments, the length may be less than in two centimeters; while in still other embodiments, the length may be greater than six centimeters. In one embodiment, the individual petals are comprised of a frame 944 that is covered with a filter element 945 . The frame 944 may be constructed of a shape memory material such as Nitinol, or other material such as stainless steel, cobalt supper alloy (MP35N for example) that has suitable material properties. The filter element 945 may be constructed of a polyurethane sheet that has been pierced or laser drilled with holes of a suitable size. Other polymers may also be used to form the filter element, in the form of a perforated sheet or woven or braided membranes. Thin membranes or woven filament filter elements may alternatively comprise metal or metal alloys, such as nitinol, stainless steel, etc. [0203] Any of the aortic filter assemblies described above may also include frame element 914 formed from a material suitable to form a tight seal between aortic filter assembly 904 and TAVI catheter 933 or other catheter-based device as the filters fill under systolic blood pressure. [0204] FIGS. 41A-B depicts an aortic filter assembly 904 having an inflatable portion 927 defining a distal opening 912 of aortic filter 906 . In some embodiments, inflatable portion 927 forms a continuous ring. Inflatable portion 927 forms a seal against the vessel wall such that debris cannot pass between aortic filter assembly 904 and the vessel wall. Inflatable portion 927 may also form a seal against a TAVI catheter passed between aortic filter assembly 904 and the vessel wall. [0205] As depicted in FIG. 41A , inflatable portion 927 and filter element 906 may form a channel 929 on an exterior surface of aortic filter assembly 904 through which a catheter-based device may pass. Channel 929 forms a seal against the catheter such that debris may not flow between the aortic filter assembly 904 and the catheter. [0206] FIG. 41B illustrates an inflatable portion 927 having a gap 931 through which a catheter-based device may pass. Filter element 906 may also form a channel on the exterior surface of the aortic filter assembly 904 through which the catheter may pass. [0207] In an embodiment which includes an inflatable annulus or other support, the inflatable support is placed in fluid communication with a source of inflation media by way of an inflation lumen extending throughout the longitudinal length of the catheter shaft. Once the filter has been positioned at a desired site, the annulus can be inflated by injection of any of a variety of inflation media, such as saline. The inflation media may thereafter be aspirated from the filter support, to enable collapse and withdraw of the filter. The inflation media may include a radiopaque dye to help the operator locate the inflatable annulus under fluoroscopy. [0208] Although the filter systems described above were discussed in connection with a single filter system, the filter designs may also be used in connection with a dual filter system. [0209] FIG. 42 depicts one embodiment of a filter assembly that may be used in connection with any filter-based device, including the dual filter and single filter systems described above. Filter assembly 926 may comprise a filter membrane 936 , a filter frame element 928 , and at least one radiopaque marker. Filter membrane may 936 may be constructed from a polyurethane film or any other polymer or material exhibiting suitable properties. In some embodiments, a laser or other mechanism may be used to create at least one filter hole in the filter membrane through which blood may flow. The at least one filter hole is small enough such that a blood clot or piece of embolic debris exceeding a predetermined dimension cannot pass through. The filter membrane may be formed into a conical or other shape by heat sealing a first edge of the filter membrane to a second edge of the filter membrane, although other methods may be used to join a first edge of the filter membrane to a second edge of the filter membrane. In several embodiments, filter assembly 926 may also include flexible coupler 922 . [0210] A frame element 928 may be shaped from a Nitinol wire, but, as discussed in earlier paragraphs, the frame element may be shaped from any other suitable material or textured to exhibit desired properties. In some embodiments, at least one radiopaque marker is incorporated into filter assembly 926 . In one embodiment, a 90 / 10 platinum/iridium coil marker is positioned around frame element 928 and bonded with an adhesive. Alternatively, other types of radiopaque markers may be integrated into or affixed to frame element 928 . Other methods of affixing the radiopaque marker may also be used. [0211] In several embodiments, filter assembly 926 includes a strut tubing 924 . Strut tubing 924 may be constructed from PET heat shrink tube, polyimide tube, or any other material exhibiting suitable properties. In one embodiment, strut tubing 924 is affixed to one or more legs of frame element 928 with an adhesive, although other means for affixation may also be used. Additional mechanisms may also be used to reinforce the adhesive or other means of affixation. Alternatively, strut tube 924 may be slipped over one or more portions of the frame element 928 and may additionally be bonded in place. [0212] In some embodiments, filter membrane 936 may be attached to frame element 928 by heat-sealing a first portion of filter membrane 936 to a second portion of filter membrane 936 to form a sleeve through which frame element 928 may pass. An adhesive may be used to reinforce the bond between the frame element and the filter membrane. Other mechanisms may also be used to affix frame element 928 to filter membrane 936 . Additional mechanisms may also be used to reinforce the adhesive or other affixation mechanism. [0213] In some embodiments, frame element 928 is attached to a filter shaft 920 via a stainless steel crimp 998 , although other mechanisms may be used to affix frame element 928 to a filter shaft 920 . Additional affixation methods may also be used to reinforce the stainless steel crimp 998 or other mechanism. [0214] In several embodiments, a cannulated distal tip 940 having an atraumatic distal end with a guidewire exit port is joined to the distal end of filter shaft 920 . [0215] FIG. 43 illustrates a proximal portion of an exemplary filter system. The portion shown in FIG. 43 is generally the portion of the system that remains external to the subject and is used to control the delivery and actuation of system components. Proximal sheath 1010 is fixedly coupled to proximal sheath hub 1012 , which when advanced distally will sheath the proximal filter (as described herein), and when retracted proximally will allow the proximal filter to expand. The actuation, or control, portion also includes handle 1016 , which is secured to proximal shaft 1014 . When handle 1016 is maintained axially in position, the position of the proximal filter is axially maintained. The actuation portion also includes distal sheath actuator 1022 , which includes handle 1023 and deflection control 1020 . Distal sheath actuator 1022 is secured to distal shaft 1018 . As described herein, the distal articulating sheath is adapted to have three independent degrees of motion relative to the proximal sheath and proximal filter: rotation, axially translation (i.e., proximal and distal), and deflection, and distal sheath actuator 1022 is adapted to move distal sheath 1018 in the three degrees of motion. Distal sheath 1018 is rotated in the direction shown in FIG. 43 by rotating distal sheath actuator 1022 . Axial translation of distal sheath occurs by advancing actuator 1022 distally (pushing) or by retracting actuator 1022 proximally (pulling). Distal sheath 218 is deflected by axial movement of deflection control 1020 . Movement of deflection control 1020 actuates the pull wire(s) within distal sheath 1018 to control the bending of distal sheath 1018 . Also shown is guiding member 1024 , which is secured to the distal filter and is axially movable relative to the distal sheath to deploy and collapse the distal filter as described herein. The control portion also includes hemostasis valves 1026 , which in this embodiment are rotating. [0216] FIG. 44 illustrates an exemplary 2-piece handle design that can be used with any of the filter systems described herein. This 2-piece handle design includes distal sheath actuator 1046 , which includes handle section 1048 and deflection control knob 1050 . Deflection control knob 1050 of distal sheath actuator 1046 is secured to distal shaft 1054 . Axial movement of distal sheath actuator 1046 will translate distal shaft 1054 either distally or proximally relative to the proximal filter and proximal sheath. A pull wire (not shown in FIG. 44 ) is secured to handle section 1048 and to the distal articulatable sheath (not shown in FIG. 44 ). Axial movement of deflection control knob 1050 applies tension, or relieves tension depending on the direction of axial movement of deflection control knob 1050 , to control the deflection of the distal articulatable sheath relative to the proximal filter and proximal sheath 1044 , which has been described herein. Rotation of distal sheath actuator 1046 will rotate the distal sheath relative to the proximal filter and proximal sheath. The handle also includes housing 1040 , in which proximal sheath hub 1042 is disposed. Proximal sheath hub 1042 is secured to proximal sheath 1044 and is adapted to be moved axially to control the axial movement of proximal sheath 1044 . [0217] FIG. 45 illustrates another exemplary embodiment of a handle that can be used with any of the filter systems described herein. In this alternate embodiment the handle is of a 3-piece design. This 3-piece handle design comprises a first proximal piece which includes distal sheath actuator 1061 , which includes handle section 1063 and deflection control knob 1065 . Deflection control knob 1065 of distal sheath actuator 1061 is secured to distal shaft 1067 . Axial movement of distal sheath actuator 1061 will translate distal shaft 1067 either distally or proximally relative to the proximal filter and proximal sheath. A pull wire (not shown in FIG. 45 ) is secured to handle section 1063 and to the distal articulatable sheath (not shown in FIG. 45 ). Axial movement of deflection control knob 1065 applies tension, or relieves tension depending on the direction of axial movement of deflection control knob 1065 , to control the deflection of the distal articulatable sheath relative to the proximal filter and proximal sheath 1069 . Rotation of distal sheath actuator 1061 will rotate the distal sheath relative to the proximal filter and proximal sheath 1069 . The handle design further includes a second piece comprising central section 1060 which is secured to proximal shaft 1071 . A third distal piece of this handle design includes housing 1062 . Housing 1062 is secured to proximal sheath 1069 . Housing 1062 is adapted to move axially with respect to central section 1060 . With central section 1060 held fixed in position, axial movement of housing 1062 translates to axial movement of proximal sheath 1069 relative to proximal shaft 1071 . In this manner, proximal filter 1073 is either released from the confines of proximal sheath 1069 into expandable engagement within the vessel or, depending on direction of movement of housing 1062 , is collapsed back into proximal sheath 1069 . [0218] FIG. 46 depicts another embodiment of a control handle. The control handle has a proximal filter control 1100 and a distal filter control 1102 . To deploy the device, the distal shaft of the catheter is fed over a guidewire and manipulated into position in the patient's anatomy. To deploy the proximal filter, the proximal filter sheath control 1120 is withdrawn proximally while holding the proximal filter handle 1118 stationary. The proximal filter sheath control 1120 is a sliding control; however, any other control such as a rotating knob, a pivoting lever, etc. may be used to withdraw the sheath. [0219] When the proximal filter is properly deployed, the distal filter contained in the distal sheath is advanced distally and positioned in the target location by advancing the distal filter control 1102 while holding the proximal filter control 1100 stationary. During this positioning process, the distal filter control 1102 can be advanced, retracted or rotated relative to the proximal filter control 1100 , and as needed, the deflection of the distal sheath may be controlled by actuating the distal sheath deflection control 1112 relative to the distal filter sheath handle 1110 . The distal sheath deflection control 1112 is a pivoting control; however, any other control such as a rotating knob, a sliding knob, etc. may be used to deflect the sheath. Once the sheath containing the collapsed distal filter is positioned correctly, the position of the distal filter control 1102 is locked relative to the proximal filter control 1100 by tightening the proximal handle hemostasis valve 1116 . Next, the distal filter may be deployed by advancing the guiding member 1108 by grasping the distal filter Luer fitting 1104 until the filter is deployed. The position and orientation of the distal filter may be adjusted by advancing, retracting or rotating the distal filter Luer fitting 1104 relative to the distal filter sheath handle 1110 . Finally, the position of the distal filter may be fixed relative to the distal filter sheath handle 1110 by tightening the distal handle hemostasis valve 1106 . To remove the device upon completion of the procedure, the aforementioned procedure is reversed. [0220] FIGS. 47A through 47I illustrate cross-sections through the control handle illustrated in FIG. 46 , taken along the section lines indicated in FIG. 46 . [0221] FIGS. 47A-B depict cross-sectional areas of proximal filter control 1100 . The distal shaft 1108 is disposed through a lumen defined by the articulating distal sheath 1114 . In these figures, the articulating distal sheath 1114 is disposed through a lumen defined by the proximal filter shaft 1124 , and the proximal filter shaft is disposed through a lumen defined by the front handle 1118 . [0222] FIG. 47C depicts a cross-sectional area of a distal section of distal filter control 1102 . In FIG. 47C , articulating distal sheath 1114 is disposed through a lumen defined by the rear handle 1110 as shown in FIG. 47C . FIG. 47D shows a cross-sectional view proximal to the cross-section shown in FIG. 47C . In FIG. 47D , guiding member 1108 is disposed through a lumen defined by the rear handle 1110 . Guiding member 1108 defines a lumen 1128 through which a guidewire may pass. FIG. 47E shows a cross-sectional view proximal to the cross-section shown in FIG. 47D . The guiding member 1108 is coaxial with a stainless steel hypotube 1130 . Hypotube 1130 reinforces the guiding member 1108 . [0223] FIG. 47F depicts a longitudinal cross-section of proximal filter control 1100 . At the distal end of proximal filter control 1100 , there is a nose piece 1132 holding the front handle 1118 together. Proximal to nose piece 1132 there is a proximal filter sheath control 1120 to actuate the proximal filter sheath and deploy the proximal filter. The proximal filter sheath control is associated with a locking mechanism 1126 to prevent unintentional filter deployment and to actuate a sealing mechanism to prevent blood leakage. The locking mechanism 1126 comprises a locking element 1134 , an elastomeric seal 1138 , a spring 1136 , and a nut 1140 for holding locking mechanism 1126 together. In certain embodiments, squeezing the proximal filter sheath control 1120 will release the locking element 1134 between the proximal sheath 1122 and proximal filter shaft 1124 . [0224] FIGS. 47G-H depicts a longitudinal cross section of distal filter control 1102 . At a distal section of the distal filter control 1102 , there is a mechanism to actuate articulating distal sheath 1114 . The actuation mechanism includes an axially movable deflection lever 1112 pivoting on distal sheath pivot 1146 . The distal sheath deflection lever 1112 is connected to the distal sheath pull wire at attachment point 1150 . The pull wire is disposed through channel 1148 . Proximal to rear handle 1110 there is a distal handle hemostasis valve 1106 . Distal handle hemostasis valve 1106 comprises elastomeric seal 1152 and HV nut 1154 . Distal filter shaft 1108 and hypotube 1130 extend proximally from distal filter control 1102 and terminate at distal filter luer lock fitting 1104 . [0225] An alternative control handle uses a rotating screw drive mechanism to deflect a distal end of a distal articulating sheath is shown in FIG. 48 . In certain clinical scenarios, it may be desirable to include a mechanism that prevents the articulating sheath from unintentionally deflecting when the operator releases the handle. The mechanism incorporates a lead screw 1214 which is inherently self-locking in that tip deflection will be locked wherever the handle control is released by the operator. A rotating screw drive mechanism provides an easy to manufacture design to control the pivot of the articulating sheath. The rate of deflection of the tip is controlled by the pitch of the screw threads 1218 , thus rapid deflection of the tip, which can lead to unintentional vessel damage, can be prevented. [0226] While specific embodiments have been described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from that which is disclosed. It should be understood that various alternatives to the embodiments described herein may be employed in practicing the disclosure.

1a

FIELD OF THE INVENTION The present invention pertains generally to methods for performing intrastromal ophthalmic laser surgery. More particularly, the present invention pertains to laser surgery wherein stromal tissue is cut on concentric cylindrical surfaces, with the surfaces being oriented parallel to, and centered on, the visual axis of an eye. The present invention is particularly, but not exclusively, useful as a method for performing intrastromal ophthalmic laser surgery wherein reshaping of the cornea is accomplished by inducing a redistribution of bio-mechanical forces in the cornea. BACKGROUND OF THE INVENTION The cornea of an eye has five (5) different identifiable layers of tissue. Proceeding in a posterior direction from the anterior surface of the cornea, these layers are: the epithelium; Bowman's capsule (membrane); the stroma; Descemet's membrane; and the endothelium. Behind the cornea is an aqueous-containing space called the anterior chamber. Importantly, pressure from the aqueous in the anterior chamber acts on the cornea with bio-mechanical consequences. Specifically, the aqueous in the anterior chamber of the eye exerts an intraocular pressure against the cornea. This creates stresses and strains that place the cornea under tension. Structurally, the cornea of the eye has a thickness (T), that extends between the epithelium and the endothelium. Typically, “T” is approximately five hundred microns (T=500 μm). From a bio-mechanical perspective, Bowman's capsule and the stroma are the most important layers of the cornea. Within the cornea, Bowman's capsule is a relatively thin layer (e.g. 20 to 30 μm) that is located below the epithelium, within the anterior one hundred microns of the cornea. The stroma then comprises almost all of the remaining four hundred microns in the cornea. Further, the tissue of Bowman's capsule creates a relatively strong, elastic membrane that effectively resists forces in tension. On the other hand, the stroma comprises relatively weak connective tissue. Bio-mechanically, Bowman's capsule and the stroma are both significantly influenced by the intraocular pressure that is exerted against the cornea by aqueous in the anterior chamber. In particular, this pressure is transferred from the anterior chamber, and through the stroma, to Bowman's membrane. It is known that how these forces are transmitted through the stroma will affect the shape of the cornea. Thus, by disrupting forces between interconnective tissue in the stroma, the overall force distribution in the cornea can be altered. Consequently, this altered force distribution will then act against Bowman's capsule. In response, the shape of Bowman's capsule is changed, and due to the elasticity and strength of Bowman's capsule, this change will directly influence the shape of the cornea. With this in mind, and as intended for the present invention, refractive surgery is accomplished by making cuts on predetermined surfaces in the stroma to induce a redistribution of bio-mechanical forces that will reshape the cornea. It is well known that all of the different tissues of the cornea are susceptible to Laser Induced Optical Breakdown (LIOB). Further, it is known that different tissues will respond differently to a laser beam, and that the orientation of tissue being subjected to LIOB may also affect how the tissue reacts to LIOB. With this in mind, the stroma needs to be specifically considered. The stroma essentially comprises many lamellae that extend substantially parallel to the anterior surface of the eye. In the stroma, the lamellae are bonded together by a glue-like tissue that is inherently weaker than the lamellae themselves. Consequently, LIOB over layers parallel to the lamellae can be performed with less energy (e.g. 0.8 μJ) than the energy required for the LIOB over cuts that are oriented perpendicular to the lamellae (e.g. 1.2 μJ). It will be appreciated by the skilled artisan, however, that these energy levels are only exemplary. If tighter focusing optics can be used, the required energy levels will be appropriately lower. In any event, depending on the desired result, it may be desirable to make only cuts in the stroma. On the other hand, for some procedures it may be more desirable to make a combination of cuts and layers. In light of the above, it is an object of the present invention to provide methods for performing ophthalmic laser surgery that result in reshaping the cornea to achieve refractive corrections for improvement of a patient's vision. Another object of the present invention is to provide methods for performing ophthalmic laser surgery that require minimal LIOB of stromal tissue. Still another object of the present invention is to provide methods for performing ophthalmic laser surgery that avoid compromising Bowman's capsule and, instead, maintain it intact for use in providing structural support for a reshaped cornea. Yet another object of the present invention is to provide methods for performing ophthalmic laser surgery that are relatively easy to implement and comparatively cost effective. SUMMARY OF THE INVENTION In accordance with the present invention, methods for performing intrastromal ophthalmic laser surgery are provided that cause the cornea to be reshaped under the influence of bio-mechanical forces. Importantly, for these methods, a tissue volume for operation is defined that is located solely within the stroma of the cornea. Specifically, this operational volume extends posteriorly from slightly below Bowman's capsule (membrane) to a substantial depth into the stroma that is equal to approximately nine tenths of the thickness of the cornea. Thus, with the cornea having a thickness “T” (e.g. approximately 500 μm), the operational volume extends from below Bowman's capsule (e.g. 100 μm) to a depth in the cornea that is equal to approximately 0.9 T (e.g. approximately 450 μm). Further, the operational volume extends radially from the visual axis of the eye through a distance of about 5.0 mm (i.e. the operational volume has a diameter of around 10.0 mm). In general, each method of the present invention requires the use of a laser unit that is capable of generating a so-called femtosecond laser beam. Stated differently, the duration of each pulse in the beam will approximately be less than one picosecond. When generated, this beam is directed and focused onto a series of focal spots in the stroma. The well-known result of this is a Laser Induced Optical Breakdown (LIOB) of stromal tissue at each focal spot. In particular, and as intended for the present invention, movement of the focal spot in the stroma creates a plurality of cuts, with each cut being made on portions of a respective cylindrical surface. Geometrically, the respective cylindrical surfaces on which cuts are made are concentric, and they are centered on the visual axis of the eye. And, they can be circular cylinders or oval (elliptical) cylinders. Further each cylindrical surface has an anterior end and a posterior end. To maintain the location of the cylindrical surface within the operational volume, the posterior end of the cut is located no deeper in the stroma than approximately 0.9 T from the anterior surface of the eye. On the other hand, the anterior end of the cylindrical cut is located in the stroma more than at least eight microns in a posterior direction from Bowman's capsule. These “cuts” will each have a thickness of about two microns. In a preferred procedure, each cut is approximately two hundred microns from an adjacent cut, and the innermost cut (i.e. center cut) may be located about 1.0 millimeters from the visual axis. There can, of course be many such cylindrical cuts (preferably five), and they can each define a substantially complete cylindrical shaped wall. Such an arrangement may be particularly well suited for the treatment of presbyopia. In a variant of this procedure that would be more appropriate for the treatment of astigmatism, portions of the cylindrical surfaces subjected to LIOB can define diametrically opposed arc segments. In this case each arc segment preferably extends through an arc that is in a range between five degrees and one hundred and sixty degrees. Insofar as the cuts are concerned, each pulse of the laser beam that is used for making the cut has an energy of approximately 1.2 microJoules or, perhaps, less (e.g. 1.0 microJoules). For additional variations in the methods of the present invention, in addition to or instead of the cuts mentioned above, differently configured layers of LIOB can be created in the stromal tissue of the operational volume. To create these layers, LIOB is performed in all, or portions, of an annular shaped area. Further, each layer will lie in a plane that is substantially perpendicular to the visual axis of the eye. For purposes of the present invention the layers are distanced approximately ten microns from each adjacent layer, and each layer will have an inner diameter “d i ”, and an outer diameter “d o ”. These “layers” will have a thickness of about one micron. As indicated above, the present invention envisions creating a plurality of such layers adjacent to each other, inside the operational volume. In yet another variation of the present invention, “radial cuts” can be made in the stroma. Specifically, the radial cuts will be located at a predetermined azimuthal angle θ and will be substantially coplanar with the visual axis of the eye. Each radial cut will be in the operational volume described above and will extend outwardly from the visual axis from an inside radius “r i ” to an outside radius “r o ”. Further, there may be as many “radial cuts” as desired, with each “radial cut” having its own specific azimuthal angle θ. As intended for the present invention, all “cuts” and “layers” (i.e. the cylindrical cuts, the annular layers, and the radial cuts) will weaken stromal tissue, and thereby cause a redistribution of bio-mechanical forces in the stroma. Specifically, weaknesses in the stroma that result from the LIOB of “cuts” and “layers” will respectively cause the stroma to “bulge” or “flatten” in response to the intraocular pressure from the anterior chamber. As noted above, however, these changes will be somewhat restrained by Bowman's capsule. The benefit of this restraint is that the integrity of the cornea is maintained. Note: in areas where layers are created, there can be a rebound of the cornea that eventually results in a slight bulge being formed. Regardless, with proper prior planning, the entire cornea can be bio-mechanically reshaped, as desired. With the above in mind, it is clear the physical consequences of making “cuts” or “layers” in the stroma are somewhat different. Although they will both weaken the stroma, to thereby allow intraocular pressure from aqueous in the anterior chamber to reshape the cornea, “cuts” (i.e. LIOB parallel and radial to the visual axis) will cause the cornea to bulge. On the other hand, “layers” (i.e. LIOB perpendicular to the visual axis) will tend to flatten the cornea. In any event. “cuts,” alone, or a combination of “cuts” with “layers” can be used to reshape the cornea with only an insignificant amount of tissue removal. In accordance with the present invention, various procedures can be customized to treat identifiable refractive imperfections. Specifically, in addition to cuts alone, the present invention contemplates using various combinations of cuts and layers. In each instance, the selection of cuts, or cuts and layers, will depend on how the cornea needs to be reshaped. Also, in each case it is of utmost importance that the cuts and layers be centered on the visual axis (i.e. there must be centration). Some examples are: Presbyopia: Cylindrical cuts only need be used for this procedure. Myopia: A combination of cylindrical cuts (circular or oval) and annular layers can be used. In this case a plurality of cuts is distanced from the visual axis beginning at a radial distance “r c ”, and a plurality of layers is located inside the cuts. Specifically, “d i ” of the plurality of layers can be zero (or exceedingly small), and “d o ” of the plurality of layers can be less than 2r c (d 0 <2r c ). In an alternative procedure, radial cuts can be employed alone, or in combination with cylindrical cuts and annular layers. If used, the radial cuts are each made with their respective azimuthal angle θ, inside radius “r i ” and outside radius “r o ”, all predetermined. Hyperopia: A combination of cylindrical cuts and annular layers can be used. In this case, the plurality of cuts is distanced from the visual axis in a range between and inner radius “r ci ” and an outer radius “r co ”, wherein r co >r ci , and further wherein “d i ” of the plurality of layers is greater than 2r co (d o >d i >2r co ). Astigmatism: Cylindrical cuts can be used alone, or in combination with annular layers. Specifically arc segments of cylindrical cuts are oriented on a predetermined line that is perpendicular to the visual axis. Layers can then be created between the arc segments. Whenever a combination of cuts and layers are required, the energy for each pulse that is used to create the cylindrical cuts will be approximately 1.2 microJoules. On the other hand, as noted above, the energy for each pulse used to create an annular layer will be approximately 0.8 microJoules. BRIEF DESCRIPTION OF THE DRAWINGS The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: FIG. 1 is a cross-sectional view of the cornea of an eye shown in relationship to a schematically depicted laser unit; FIG. 2 is a cross-sectional view of the cornea showing a defined operational volume in accordance with the present invention; FIG. 3 is a perspective view of a plurality of cylindrical surfaces where laser cuts can be made by LIOB; FIG. 4 is a cross-sectional view of cuts on the plurality of cylindrical surfaces, as seen along the line 4 - 4 in FIG. 3 , with the cuts shown for a typical treatment of presbyopia; FIG. 5A is a cross-sectional view of the plurality of cylindrical surfaces as seen along the line 5 - 5 in FIG. 3 when complete cuts have been made on the cylindrical surfaces; FIG. 5B is a cross-sectional view of the plurality of cylindrical surfaces as seen along the line 5 - 5 in FIG. 3 when partial cuts have been made along arc segments on the cylindrical surfaces for the treatment of astigmatism; FIG. 5C is a cross-sectional view of an alternate embodiment for cuts made similar to those shown in FIG. 5B and for the same purpose; FIG. 6 is a cross-sectional view of a cornea showing the bio-mechanical consequence of making cuts in the cornea in accordance with the present invention; FIG. 7 is a perspective view of a plurality of layers produced by LIOB in accordance with the present invention; FIG. 8 is a cross-sectional view of the layers as seen along the line 8 - 8 in FIG. 7 ; FIG. 9A is a cross-sectional view of a combination of cuts and layers as seen in a plane containing the visual axis of the eye, with the combination arranged for a treatment of hyperopia; FIG. 9B is a cross-sectional view of a combination of cuts and layers as seen in a plane containing the visual axis of the eye, with the combination arranged for a treatment of myopia; FIG. 9C is a cross-sectional view of a combination of cuts and layers as seen in a plane containing the visual axis of the eye, with the combination arranged for a treatment of astigmatism; and FIG. 9D is a top plan view of radial cuts that are coplanar with the visual axis. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring initially to FIG. 1 , it will be seen that the present invention includes a laser unit 10 for generating a laser beam 12 . More specifically, the laser beam 12 is preferably a pulsed laser beam, and the laser unit 10 generates pulses for the beam 12 that are less than one picosecond in duration (i.e. they are femtosecond pulses). In FIG. 1 , the laser beam 12 is shown being directed along the visual axis 14 and onto the cornea 16 of the eye. Also shown in FIG. 1 is the anterior chamber 18 of the eye that is located immediately posterior to the cornea 16 . There is also a lens 20 that is located posterior to both the anterior chamber 18 and the sclera 22 . In FIG. 2 , five (5) different anatomical tissues of the cornea 16 are shown. The first of these, the epithelium 24 defines the anterior surface of the cornea 16 . Behind the epithelium 24 , and ordered in a posterior direction along the visual axis 14 , are Bowman's capsule (membrane) 26 , the stroma 28 , Descemet's membrane 30 and the endothelium 32 . Of these tissues, Bowman's capsule 26 and the stroma 28 are the most important for the present invention. Specifically, Bowman's capsule 26 is important because it is very elastic and has superior tensile strength. It therefore, contributes significantly to maintaining the general integrity of the cornea 16 . For the methods of the present invention, Bowman's capsule 26 must not be compromised (i.e. weakened). On the other hand, the stroma 28 is intentionally weakened. In this case, the stroma 28 is important because it transfers intraocular pressure from the aqueous in the anterior chamber 18 to Bowman's membrane 26 . Any selective weakening of the stroma 28 will therefore alter the force distribution in the stroma 28 . Thus, as envisioned by the present invention, LIOB in the stroma 28 can be effectively used to alter the force distribution that is transferred through the stroma 28 , with a consequent reshaping of the cornea 16 . Bowman's capsule 26 will then provide structure for maintaining a reshaped cornea 16 that will effectively correct refractive imperfections. While referring now to FIG. 2 , it is to be appreciated that an important aspect of the present invention is an operational volume 34 which is defined in the stroma 28 . Although the operational volume 34 is shown in cross-section in FIG. 2 , this operational volume 34 is actually three-dimensional, and extends from an anterior surface 36 that is located at a distance 38 below Bowman's capsule 26 , to a posterior surface 40 that is located at a depth 0.9 T in the cornea 16 . Both the anterior surface 36 and the posterior surface 40 essentially conform to the curvature of the stroma 28 . Further, the operational volume 34 extends between the surfaces 36 and 40 through a radial distance 42 . For a more exact location of the anterior surface 36 of the operational volume, the distance 38 will be greater than about eight microns. Thus, the operational volume 34 will extend from a depth of about one hundred microns in the cornea 16 (i.e. a distance 38 below Bowman's capsule 26 ) to a depth of about four hundred and fifty microns (i.e. 0.9 T). Further, the radial distance 42 will be approximately 5.0 millimeters. FIG. 3 illustrates a plurality of cuts 44 envisioned for the present invention. As shown, the cuts 44 a , 44 b and 44 c are only exemplary, as there may be more or fewer cuts 44 , depending on the needs of the particular procedure. With this in mind, and for purposes of this disclosure, the plurality will sometimes be collectively referred to as cuts 44 . As shown in FIG. 3 , the cuts 44 are made on respective cylindrical surfaces. Although the cuts 44 are shown as circular cylindrical surfaces, these surfaces may be oval. When the cuts 44 are made in the stroma 28 , it is absolutely essential they be confined within the operational volume 34 . With this in mind, it is envisioned that cuts 44 will be made by a laser process using the laser unit 10 . And, that this process will result in Laser Induced Optical Breakdown (LIOB). Further, it is important these cylindrical surfaces be concentric, and that they are centered on an axis (e.g. the visual axis 14 ). Further, each cut 44 has an anterior end 46 and a posterior end 48 . As will be best appreciated by cross-referencing FIG. 3 with FIG. 4 , the cuts 44 (i.e. the circular or oval cylindrical surfaces) have a spacing 50 between adjacent cuts 44 . Preferably, this spacing 50 is equal to approximately two hundred microns. FIG. 4 also shows that the anterior ends 46 of respective individual cuts 44 can be displaced axially from each other by a distance 52 . Typically, this distance 52 will be around ten microns. Further, the innermost cut 44 (e.g. cut 44 a shown in FIG. 4 ) will be at a radial distance “r c ” that will be about 1 millimeter from the visual axis 14 . From another perspective, FIG. 5A shows the cuts 44 centered on the visual axis 14 to form a plurality of rings. In this other perspective, the cuts 44 collectively establish an inner radius “r ci ” and an outer radius “r co ”. Preferably, each cut 44 will have a thickness of about two microns, and the energy required to make the cut 44 will be approximately 1.2 microJoules. As an alternative to the cuts 44 disclosed above, FIG. 3 indicates that only arc segments 54 may be used, if desired. Specifically, in all essential respects, the arc segments 54 are identical with the cuts 44 . The exception, however, is that they are confined within diametrically opposed arcs identified in FIGS. 3 and 5B by the angle “α”. More specifically, the result is two sets of diametrically opposed arc segments 54 . Preferably, “α” is in a range between five degrees and one hundred and sixty degrees. An alternate embodiment for the arc segments 54 are the arc segments 54 ′ shown in FIG. 5C . There it will be seen that the arc segments 54 ′ like the arc segments 54 are in diametrically opposed sets. The arc segments 54 ′, however, are centered on respective axes (not shown) that are parallel to each other, and equidistant from the visual axis 14 . FIG. 6 provides an overview of the bio-mechanical reaction of the cornea 16 when cuts 44 have been made in the operational volume 34 of the stroma 28 . As stated above, the cuts 44 are intended to weaken the stroma 28 . Consequently, once the cuts 44 have been made, the intraocular pressure (represented by arrow 56 ) causes a change in the force distribution within the stroma 28 . This causes bulges 58 a and 58 b that result in a change in shape from the original cornea 16 into a new configuration for cornea 16 ′, represented by the dashed lines. As intended for the present invention, this results in refractive corrections for the cornea 16 that improves vision. In addition to the cuts 44 disclosed above, the present invention also envisions the creation of a plurality of layers 60 that, in conjunction with the cuts 44 , will provide proper vision corrections. More specifically, insofar as the layers 60 are concerned, FIG. 7 shows they are created on substantially flat annular shaped surfaces that collectively have a same inner diameter “d i ” and a same outer diameter “d o ”. It will be appreciated, however, that variations from the configurations shown in FIG. 7 are possible. For example, the inner diameter “d i ” may be zero. In that case the layers are disk-shaped. On the other hand, the outer diameter “d o ” may be as much as 8.0 millimeters. Further, the outer diameter “d o ” may be varied from layer 60 a , to layer 60 b , to layer 60 c etc. From a different perspective, FIG. 8 shows that the layers 60 can be stacked with a separation distance 62 between adjacent layers 60 equal to about ten microns. Like the cuts 44 disclosed above, each layer 60 is approximately one micron thick. As mentioned above, the energy for LIOB of the layers 60 will typically be less than the laser energy required to create the cuts 44 . In the case of the layers 60 the laser energy for LIOB of the cuts 44 will be approximately 0.8 microJoules. For purposes of the present invention, various combinations of cuts 44 and layers 60 , or cuts 44 only, are envisioned. Specifically, examples can be given for the use of cuts 44 and layers 60 to treat specific situations such as presbyopia, myopia, hyperopia and astigmatism. In detail, for presbyopia, a plurality of only cuts 44 needs to be used for this procedure. Preferably, the cuts 44 are generally arranged as shown in FIGS. 4 and 5A . Further, for presbyopia it is typical for there to be five individual cuts 44 that extend from an inner radius of about 1 mm to an outer radius of about 1.8 mm, with a 200 micron separation between adjacent cuts 44 . When hyperopia/presbyopia need to be corrected together, the cuts 44 will then preferably extend further to an outer radius of about 2.3 mm. For hyperopia, a combination of cylindrical cuts 44 and annular layers 60 can be used as shown in FIG. 9A . In this case, the plurality of cuts 44 is distanced from the visual axis 14 in a range between and inner radius “r ci ” (e.g. r ci =1 mm) and an outer radius “r co ” (e.g. r co =3 mm), wherein r co >r ci , and further wherein “d i ” of the plurality of layers 60 is greater than 2r co (d o >d i >2r co ). For myopia, a combination of cylindrical cuts 44 and annular layers 60 can be used as generally shown in FIG. 9B . In this case a plurality of cuts 44 is distanced from the visual axis 14 beginning at a radial distance “r c ”, and a plurality of layers 60 , with decreasing outer diameter “d o ” in a posterior direction, is located inside the cuts 44 . More specifically, for this case “d i ” of the plurality of layers 60 can be zero (or exceedingly small), and “d o ” of each layer 60 in the plurality of layers 60 can be less than 2r c (d o <2r c ). And finally, for astigmatism, the portions of cylindrical cuts 44 that form arc segments 54 can be used alone (see FIGS. 5B and 5C ), or in combination with annular layers 60 (see FIG. 9C ). Specifically arc segments 54 of cylindrical cuts 44 are oriented on a predetermined line 64 that is perpendicular to the visual axis 14 . Layers 60 can then be created between the arc segments 54 , if desired (see FIG. 9C ). In a variation of the methodologies noted above, the present invention also envisions the creation of radial cuts 66 . The radial cuts 66 a and 66 b shown in FIG. 9D are only exemplary, and are herein sometimes referred to individually or collectively as radial cut(s) 66 . Importantly, the radial cuts 66 are coplanar with the visual axis 14 , and they are always located within the operational volume 34 . As shown in FIG. 9D , each radial cut 66 is effectively defined by the following parameters: a deepest distance into the stroma 28 , Z (distal) , a distance below Bowman's capsule 26 , Z (proximal) , an inner radius, “r i ”, an outer radius “r o ”, and an azimuthal angle “θ” that is measured from a base line 68 . By setting values for these parameters, each radial cut 66 can be accurately defined. For example, as shown in FIG. 9D , the radial cut 66 a is established by the azimuthal angle θ 1 , while the radial cut 66 b has an azimuthal angle θ 2 . Both of the radial cuts 66 a and 66 b have the same inner radius “r i ” and the same outer radius “r o ”. The Z (distal) and Z (proximal) will be established for the radial cuts 66 a and 66 b in a similar manner as described above for the cylindrical cuts 44 . While the particular Method for Intrastromal Refractive Surgery as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] In vertebroplasty, the surgeon seeks to treat a compression fracture of a vertebral body by injecting bone cement such as PMMA into the fracture site. One clinical report describes mixing two PMMA precursor components (one powder and one liquid) in a dish to produce a viscous bone cement; filling 10 cc syringes with this cement, injecting it into smaller 1 cc syringes, and finally delivering the mixture into the desired area of the vertebral body through needles attached to the smaller syringes. [0002] The conventional access needle used in a vertebroplasty procedure is a simple straight cannula extending along a single longitudinal axis, and has a handle formed near its proximal end. A single delivery port made from a luer connection is typically located at the proximal end of the cannula. The distal end of an injection syringe is typically attached to this delivery port via the luer connection. Typically, a stylet may also be placed within the cannula from the proximal end of the cannula in order to stabilize the cannula during insertion into the vertebral bone. [0003] Because of the single axis nature of this conventional design, the injection syringe is typically connected to the proximal port of the cannula so that the injection syringe is also aligned along the same longitudinal axis. When this assembly is placed upon the prone patient's back, it typically sticks straight up in a vertical direction. Actuation of a vertically-disposed and vertically-displaced delivery syringe may be ergonomically challenging to the surgeon or clinician. [0004] U.S. Pat. No. 6,916,292 (“Morawski”) discloses a bone biopsy needle having a single access port and a cannula that does not extend along a straight longitudinal axis, but rather curves near the proximal end. Because of its curved nature, this needle can not accommodate the insertion of a conventional straight stylet. The stylet is particularly important in percutaneous vertebroplasty procedures, as tracts of implant materials may be left in the body in unwanted locations if the access needle has not been cleared. [0005] U.S. Pat. No. 6,302,852 (“Fleming III”) discloses a bone marrow biopsy needle including an outer cannula having a proximal end, a distal end, a hollow section therebetween and a handle portion associated with the proximal end, and an inner rod having a proximal end, a distal end and a handle cap. The handle portion further includes a grip enhancement member which is formed from a material distinct from at least a portion of the handle portion, such as rubber. The grip enhancement member may take the form of insert members which fit into cavities in the handle portion of the outer cannula. The grip enhancement member not only enhances the gripping surface of the bone marrow biopsy needle, but also provides cushioning for a user and adds weight to the handle portion to facilitate weight distribution throughout the outer cannula handle. [0006] U.S. Pat. No. 6,875,183 (“Cervi”) discloses a biopsy needle for sampling bone marrow tissue, comprising a handle, and tissue sampling means comprising a sampling tube with a bore therein to receive a tissue sample, the outer surface of the sampling tube having an abrading formation extending in an axial direction along the tube, for abrading the sampled tissue, to permit the cannula tip to be laterally displaced whilst the tube is inserted into the bone marrow tissue. A biopsy needle for sampling bone marrow tissue, comprising a handle, tissue sampling means comprising a sampling tube with a bore therein to receive a tissue sample, and coupling means, separable from the needle, for coupling the needle to a rotary motor drive, whereby the needle is adaptable to both manual insertion and motor-assisted insertion. [0007] U.S. Pat. No. 6,582,439 (“Sproul”) discloses an orthopedic surgical kit for inserting a biological material into the cancellous portion of bone by a minimally invasive technique has several components which are manually operated using a universal handle. The kit includes a docking needle used as a guide for placing a cannula in a bone. The cannula is filled with a biological material, for support or treatment of the bone, and the material is expressed from the cannula by a plunger. SUMMARY OF THE INVENTION [0008] One object of the present invention is to provide the surgeon a more ergonomic means of delivering a viscous material through a needle. [0009] The invention provides a more ergonomic approach to delivery of viscous materials used in percutaneous vertebroplasty and kyphoplasty procedures. The needle of the present invention includes a second off-angle cannula whose proximal end is used as the delivery port for an injection syringe. The distal end of this second needle then merges with the first cannula at an angle within the handle of the needle to provide fluid connection with the first cannula. This new needle provides a more horizontal posture to the injection syringe upon its connection with the off angle cannula and therefore provides a better ergonomic and tactile feel for implant delivery. [0010] Therefore, in accordance with the present invention, there is provided an injection needle for use in percutaneous vertebroplasty, comprising: a. a substantially longitudinal first tube having a throughbore, a proximal end portion defining a proximal end opening and a distal end portion defining a distal end opening, b. a handle surrounding the proximal end portion of the first tube and having an outer surface, wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and a second tube located at least partially within the handle and having a throughbore, a distal end in fluid connection with the first tube at a junction, and a proximal end defining a proximal end opening that opens onto the outer surface of the handle. DESCRIPTION OF THE FIGURES [0013] FIG. 1A shows a cross-section of the needle of the present invention. [0014] FIG. 1B , shows a cross-section of a needle, wherein the second tube is directed upwards from the first tube. [0015] FIG. 1C shows a cross-section of needle of FIG. 1A with a stylet partially inserted therein. [0016] FIG. 2 shows a cross-section of a needle of the present invention having a modular handle. [0017] FIGS. 3A and 3B shows perspective views of the needle and syringe of the present invention in their respective assembled and exploded forms. DETAILED DESCRIPTION OF THE INVENTION [0018] Now referring to FIGS. 1A , there is provided an injection needle 1 for use in percutaneous vertebroplasty, comprising: a) a substantially longitudinal first tube 2 having a throughbore 4 , a proximal end portion 3 defining a proximal end opening 5 and a distal end portion 7 defining a distal end opening 9 , b) a handle 11 surrounding the proximal end portion of the first tube and having an outer surface 13 , wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and c) a second tube 21 located at least partially within the handle and having a throughbore 23 , a distal end 25 in fluid connection with the first tube at a junction 27 , and a proximal end 29 defining a proximal end opening 31 that opens onto the outer surface of the handle. [0022] In some embodiments, the tube component of the present invention can be formed of a material that is distinct from the surrounding handle. In other embodiments, the tube is formed by simply making a throughbore in the surrounding handle. [0023] When assembled, the needle comprises a bone access port at its distal end, and two ports on its proximal end. The proximal end of the needle includes a first pathway to the bone access port to accommodate a stylet and a second pathway to the bone access port for attachment of a cement injection system. The second pathway is more horizontally disposed than the first pathway, allowing for improved positioning and ergonomics during delivery of the viscous implant material. The first and second tubes meet at a junction and form an angle α. FIG. 1A shows a substantially horizontal attachment of the delivery system to the handle (α=90°); however, a more ergonomic approach may have the second pathway directed at an angle (i.e., angled up (α>90°) or down (α<90°)) from the horizontal. [0024] Now referring to FIG. 1B , there is provided an embodiment of the present invention wherein the second tube 30 is directed upwards from the first tube 32 whereby angle α is greater than 90 degrees. [0025] In other embodiments, the second pathway is directed at a lateral angle (i.e., to the left or right of the handle). In other embodiments, the angle is rotatably adjustable. [0026] This invention provides multiple pathways to the bone access port of an access needle for PV procedures, one of which is an access pathway for a straight stylet. It advantageously provides the surgeon with better positioning in relation to the proximal injection port during delivery of the implant material, while at the same time including the required stylet access for PV procedures. [0027] The proper orientation of the proximal access port and delivery system may also eliminate the need for the extension tubing. Since the angled design of the present invention displaces the surgeon's hands laterally (in relation to the longitudinal axis of the second tube), it may also allow the surgeon's hands to be moved out of the fluoroscopy field during implant delivery without the use of an extension tube. Because extension tubes often impose additional pressure requirements upon the injection device, the elimination of the extension tube may reduce the pressure requirements to deliver the viscous implant material. [0028] In some embodiments, a one-way valve or silicone plug is provided to prohibit backflow of implant material through the second proximal pathway. Typically, the one-way valve is located in the first tube at a location proximal of the junction. Alternatives to a one-way valve or silicone plug include a thumb-trigger that opens the second pathway when depressed, or a ball-plunger that retracts when the stylet is placed within the second pathway. [0029] In order to prevent injection of material while the stylet is in place, the handle includes a feature to fully or partially cover the luer connection 33 (shown open in FIG. 1A ) associated with the injection port. An ergonomic handle component is provided that is able to separate into a delivery section and a stylet to partially or fully cover the luer connector to the delivery device so that implant material may not be injected while the stylet is in place. Thereafter, when the stylet is removed, there is full exposure of the luer connection. [0030] In order to improve ergonomics, the luer connector to the delivery system may be placed at an angle to the handle or adapted to allow rotation to a preferred position. The use of allowable rotation provides a single beveled needle to be optimally oriented (typically anteriorly) while allowing the proximal inlet port to be oriented towards the surgeon. This not only provides improved ergonomics, it also may allow for elimination of extension tubing from the system. [0031] Therefore, in accordance with the present invention, there is provided (claim 12 ) an injection needle for use in percutaneous vertebroplasty, comprising: a. a substantially longitudinal first tube having a throughbore, a proximal end portion defining a proximal end opening and a distal end portion defining a distal end opening, b. a handle surrounding the proximal end portion of the first tube and having an outer surface, wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and c. a rotatable luer connection disposed at the distal end opening of the first tube [0035] In order to increase surgeon visibility to the bone access site, the stylet may be removed from the handle. In so doing, most of the bulk of the handle is likewise removed. [0036] Also, the handle may include two or more components that contain the stylet and the delivery access tube to the vertebral body. The handle may have a luer connection in the injection system that is partially or full contained within the removal stylet component. [0037] Therefore, and now referring to FIG. 1C , in accordance with the present invention, there is provided an injection needle for use in percutaneous vertebroplasty, comprising: a) a substantially longitudinal outer tube 2 having a throughbore 4 , a proximal end portion 3 defining a proximal end opening 5 and a distal end portion 7 defining a distal end opening 9 , b) an outer handle 11 surrounding the proximal end portion of the outer tube and having a proximal surface 15 having a recess 17 , wherein the proximal end opening of the outer tube opens onto the proximal surface of the handle within the recess, c) a substantially longitudinal inner stylet 41 having a proximal end portion 43 and a distal end portion 45 , and d) an inner handle 51 surrounding the proximal end portion of the inner stylet, wherein the inner stylet is received within the throughbore of the outer tube, and wherein the inner handle fits substantially within the recess of the outer handle. [0042] Preferably, the inner handle has a proximal surface 53 , the proximal surface of the the outer handle forms a first plane, and the proximal surface of the inner handle lies substantially the first plane when the inner stylet is received within the throughbore of the outer tube [0043] During the delivery of the cement and subsequent fluoroscopic assessment thereof, it appears that the large dimensions of the handle may sometimes obstruct the clinician's view of the injection site. This obstruction may be particularly problematic when the surgeon seeks to use the stylet as a tamp for tamping the bone cement that remains in the delivery tube. Therefore, in some embodiments of the present invention, the handle is manufactured as a modular component of the injection needle. The handle can be modularized by providing a first luer attachment at the distal end of the substantially longitudinal first tube, and a second luer attachment adapted to mate with the first luer attachment upon the delivery tube. Now referring to FIG. 2 , in accordance with the present invention, there is provided (claim 28 ) an injection needle for use in percutaneous vertebroplasty, comprising: a) a substantially longitudinal first tube 71 having a throughbore, a proximal end portion 73 defining a proximal end opening and a distal end portion 75 defining a distal end opening having a first luer connection thereon 77 , and b) a handle 81 surrounding the proximal end portion of the first tube and having an outer surface 83 , wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and c) a delivery tube 85 having a throughbore and a proximal end portion 87 defining a proximal end opening having a second luer connection 89 thereon that mates with the first luer connection. In use, the surgeon can inject cement through the needle, and then remove the handle in order to have better visualization of the operative site when using the stylet. Alternatively, the surgeon can inject the cement through the delivery tube 85 and second luer 89 without the handle attached. [0047] During the manufacturing of long tubes or needles used in PV, there may be manufacturing remnant materials inherently remaining within the tube or on the stylet. This is typically seen as grey material within the cement during injection. While cleaning with brushes or high pressure fluids assists in removing some of the remnant material, there is typically some remnant material left behind. The present invention seeks to reduce the delivery to the patient of debris remaining from the manufacturing process. This is accomplished by providing a coating on the inside surface of the needle to encapsulate or cover the inside of the tube (or outside surface of the stylet). The inner surface of the needle may be coated with a variety of materials (i.e. PTFE (Teflon), or its surface may be conditioned by a variety of manufacturing methods (such as electropolishing or plating) that may cover up undesirable manufacturing debris present upon the inside of the needle, thereby precluding their delivery to the patient. In addition, such a coating may reduce the friction on the inner surface of the cannula, thereby easing the flow of the cement passing through the needle and requiring less pressure to deliver the implant material. [0048] Therefore, in accordance with the present invention, there is provided (claim 13 ) injection needle for use in percutaneous vertebroplasty, comprising: a) a substantially longitudinal first tube having an inner surface defining a throughbore, a proximal end portion defining a proximal end opening and a distal end portion defining a distal end opening, b) a handle surrounding the proximal end portion of the first tube and having an outer surface, wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and wherein the inner surface of the first tube is coated, electropolished or electroplated. [0051] Now referring to FIGS. 3A-3B , in use, the device of the present invention is connected to a syringe contain a bone paste, and the paste is injected into the bone via the needle. The bone paste used in the vertebroplasty procedure may be any material typically used to augment vertebral bodies. [0052] Therefore, in accordance with the present invention, there is provided (claim 20 ) a device for use in percutaneous vertebroplasty, comprising: a) an injection needle 1 comprising: i) a substantially longitudinal first tube 2 having a throughbore, a proximal end portion defining a proximal end opening 5 and a distal end portion 7 defining a distal end opening 9 , ii) a handle 11 surrounding the proximal end portion of the first tube and having an outer surface 13 , wherein the proximal end opening of the first tube opens onto the outer surface of the handle, and ii) a second tube 21 located at least partially within the handle and having a throughbore, a distal end in fluid connection with the first tube at a junction, and a proximal end defining a proximal end opening 31 , and b) a syringe 61 fluidly connected to the proximal end opening of the second tube. [0058] In some embodiments, the syringe can be replaced with a delivery device having a material reservoir and tubing adapted to deliver the cement from the reservoir to the proximal end opening of the second tube. [0059] Preferred bone pastes include bone cements (such as acrylic-based bone cements, such as PMMA-based bone cements), pastes comprising bone particles (either mineralized or demineralized or both; and either autologous, allogenic or both), and ceramic-based bone cements (such as HA and TCP-based pastes).

1a

BACKGROUND The present application relates to imaging systems, particularly diagnostic imaging systems. It finds particular application in conjunction with an integrated three-dimensional rotational angiographic (3DRA) and computerized tomographic (CT) diagnostic imaging system and will be described with particular reference thereto. However, it should be appreciated, that the present application may also find application in conjunction with other types of multi-modality diagnostic imaging systems. The present application-is particularly useful for visualizing blood vessel structures around and inside the skull. For diagnostical purposes in a clinical environment, the separate visualization of the various represented tissue types when employing a radiological acquisition method can provide useful information about the clinical picture of a patient. With different radialogic methods being specialized on the visualization of one or a few kinds of tissues, the goal of displaying only useful information is normally achieved by choosing the adequate acquisition method. However, some tissue types tend to have similar properties regarding suitable acquisition methods, although their respective function inside the human body is completely different, e.g. blood vessels and bone structure. For the reason of different functions of the tissue concerned, it is desirable to represent them in a distinct manner, either by color coding according to tissue type or by masking all tissue types but the one the operator is interested in. The problem of overlapping property distributions for different types of tissue is particularly present in three-dimensional rotational angiography. In general, in 3DRA no absolute correct density values will be available due to insufficient calibration and reconstruction procedures. In this method, the segmentation of artery/vessel information in the 3DRA volume is hindered by the fact that the artery/vessel densities are in the same range as bone material, due to beam hardening caused by the skull. Furthermore, the high density data of the skull in the CT volume, which is typically used for orientation of the CT slices, prevents a clear view on the arterial structures, when both volumes are combined. While Computer Tomography (CT) is known to provide high contrast between bony structures and soft tissue (e.g. skull as opposed to brain), the use of three-dimensional rotational angiography (3DRA) for extraction of 3-D vessel information is hindered by the fact, that the intensity distribution of high intensity bone overlaps with the intensity distribution of contrast filled vessels. This effect is especially due to the phenomenon of beam-hardening caused by the skull, in combination with insufficient calibration and reconstruction procedures. U.S. Pat. No. 5,832,134 to Avinash and Alyassin discloses a method for removing dominating structures for enhancing visualization of desired structures that circumvents the time consuming human-operator interaction. The basic idea of the application disclosed therein is to distinguish between highly connected regions on the one hand and more weakly connected regions. Regions, that are strongly connected correspond to bony structures, whereas regions, that are less strongly connected correspond to vessels. The introduction of this property makes available a new feature for an improved automatic segmentation of unwanted bone structure from the interesting vessel information. However, the method only interprets the inherently unsuitable data material provided by the three-dimensional rotational angiographic acquisition method in a different manner and does not revert to more suitable information sources. Furthermore, the morphological algorithms described therein, e.g. connectivity analysis, and voxel dilation, depend greatly on an optimal parameterization, which in turn is dependant from geometrical conditions, e.g. acquisition resolution or size of the object. SUMMARY Considering the above, it is an object of the application to provide a system and a method for visualization of biological tissue using two acquisition devices for higher information content. Provided is a system for visualization of biological tissue, according to the 30 application comprising a first device for obtaining a first set of data including information as to a three-dimensional location and as to physical properties in that location, and a second device for obtaining a second set of data including information as to a three-dimensional location and as to physical properties in that location. The system further comprises a data receiving and processing unit connected with the first and second devices for receiving respective sets of data for altering one set of data based on information of the other set of data, and visual output means. Acquiring an object under different acquisition conditions yields two or more related data sets. Usually, these data sets contain complementary information and one of the data sets may be more appropriate for a given task to be performed. If the object to be visualized is comprised of biological tissue, different acquisition conditions may yield data sets that are particularly well suited for visualizing different types of biological tissue. Besides being visualized, the data sets can be altered during processing. Dependant on what kind of modification on a data set is to be performed, the way, in which the data must be altered for an optimal result, can be determined using the other data set, if that data set contains information, that is well suited for the modification at hand. The data receiving and processing unit may comprise means for registering both three-dimensional image data sets in particular obtained from the first and second devices, respectively. Means for registration are charged with matching the two data sets with regard to position, size and orientation. Since the two data sets involved usually have different acquisition angles, distances and/or resolutions, registering them is necessary for storing both data sets with regard to a common co-ordinate system. An effective registration is a prerequisite for further data processing. According to a preferred embodiment of the application, the system comprises means for applying a threshold to and filtering at least one of said data sets situated upstream of said means for registering. The means for registration can yield erroneous results, if the incoming data contains errors. Those errors are usually caused by artefacts originating in the acquisition process. An example of artefacts produced during the acquisition process are voxels that are filled with air, but are assigned a value that indicates a solid matter. If the other acquisition method is less prone to produce such artefacts, or produces different artefacts than those produced by the first acquisition method, then a registration algorithm risks to fail, because it calculates the positions, scales and orientations of the target object in each of the two data sets under the assumption, that the prevailing number of voxels with a high absorption coefficient value are part of the target object. The effectiveness of the means for registration can be restored by a thresholding method. Indeed, when the voxel values outside the skull are set to zero by thresholding on a value between the erroneous air voxel values and the grey matter or brain tissue values, the means for registration deliver data essentially artefact free. Alternatively, the system may comprise means for identifying a predefined volume in both data sets. These means determine sections of the volumes to be used by upstream registration means, therefore erroneous voxels outside the skull can be discarded. Preferably, the physical property determined at a particular location can serve for the determination of the type of tissue. Besides determining the range of the target object, the physical property delivers valuable information about the type of tissue present at a particular location. Therefore, the sampled value of a physical property serves for the determination of the type of tissue. The means for altering preferably uses masking information obtained from located areas of special properties. Once a valid segmentation has been calculated, based on special scanned properties of the tissue, and consequently areas of different types of tissue have been identified, it is possible to mask those areas corresponding to different types of tissue selectively, based on a choice made by an operator of the system. Therefore, this location-dependant tissue type information can be used by downstream means for data processing, such as means for masking certain regions and/or tissues that are of no or little interest for a particular application. The system may further comprise means for obtaining a sectional view of the first, second and/or a third combined three-dimensional image data set with a preselected geometrical plane. When representing three-dimensional volumes featuring a spacial density of some property via a flat display device, a major problem is the ambiguity of the location of a given point. A human observer usually considers points of reference for orientation, which requires the ability of three-dimensional imagination. A simply shaped sectional view of the data to be displayed can facilitate this task imposed to the user. Another problem is the occultation of areas of interest by those of less interest. For those reasons, displaying too much data becomes counterproductive, even when by definition uninteresting areas are masked out prior to displaying the data. According to a preferred embodiment, the system further comprises means for rendering data transparent based on location, property, optionally in a preselected volume like a slice. Therefore, a selection of the data, that is actually to be displayed via the means of visualization, can be made. At the same time, a selection of the displaying mode of various kinds of data has to be made as well, one of the modes being transparency. The selection of what data is to be displayed, and at which degree of transparency, is based on location, property, and the shape the section in which data is to be displayed. The display section preferably has a simple geometrical shape, such as a slice or a cube. Visualization of combined three-dimensional image data sets can be performed along a predefined path, in particular corresponding to a blood vessel. By restricting the volume to be analyzed by a human expert, details are more readily appreciated. However, when ample areas are to be analyzed, a conflict of interests arises. The conflict can be resolved by spreading the observation area over time, i.e. by showing a sequence of related images, each of which is centered around a slightly different location than the preceding ones. To the human expert charged with the interpretation with regard to conspicuous details hinting towards a disease, this sequence appears much like a movie with changing camera position. The sequence of positions defines a path for the movement, that can for example coincide with a blood vessel Furthermore, the application discloses a method for visualization of biological tissue, comprising the steps of: acquiring a first data set corresponding to a three-dimensional data acquisition based on a first acquisition method; acquiring a second data set corresponding to three-dimensional data acquisition based on a first acquisition method; acquiring a second data set corresponding to three-dimensional data acquisition based on a second acquisition method; extracting information from one of said data sets; and altering the respective other data set based on said extracted information. The method starts with the acquisition of two data sets, produced by two suitable acquisition methods for the scanning of three-dimensional volumes. Taking advantage of the different imaging characteristics of various acquisition methods, the method extracts information concerning a property to be examined from the one of the two data sets that represents more clearly the desired property and makes this information available for the respective other data set. Based on the extracted information, the method is capable to alter the respective other data set. This is particularly useful for masking or hiding specific regions, if, based on the respective other data set alone, these regions to be hidden cannot be clearly distinguished from regions that are not to be hidden, for the corresponding acquisition method has a lower level of selectivity for the tissues involved. According to a preferred embodiment, the method proceeds in a succeeding step with the registration of the data sets, i.e. calibrating the data sets with respect to position, orientation and scale. Preferably, this step is performed after the step of acquiring a second data set and prior to the information extraction step. The method's first acquisition method preferably is a computer tomographic method. Computer tomography (CT) is typically used for the visualization of low contrast soft tissue such as brain material. The method's second acquisition method preferably is a three-dimensional rotational angiographic method. Three-dimensional rotational angiography (3DRA) is effectively used for visualization of high contrast artery/vessel structures. Other radiological and non-radiological methods can benefit from the method described herein, as well. The method may further comprise the step of applying a threshold to and filtering of the three-dimensional rotational angiography data prior to the step of registering the two data sets. In order to avoid deficient registration results, data can be preconditioned prior to the step of registration. Possible preconditioning comprises applying a threshold to the values of the acquired physical property in order to recognize voxels, that fell victim to acquisition principle caused artefact occurrence. A preferred method further comprises a step of identifying a predefined evaluation volume in both data sets and returning a corresponding subset to said registration means for subsequent registration prior to the step of registering the two data sets. This preconditioning comprises limiting the valid volume for registration to a volume that is known to mainly contain relevant target object information that is, up to a certain extend, represented similarly in both data sets. Indeed, only a fraction of the entire volume has to be examined for registration purposes, if it can be guaranteed, that the relation between the two data sets is rigid, i.e. can be described by means of an affine transformation. The method according to a preferred embodiment further comprises a step of obtaining a sectional view of the first, second and/or a combination of both three-dimensional image data sets with a preselected geometrical plane. In order for a human expert to analyze the acquired data, it has to be displayed. The interpretation of the displayed volume data is greatly facilitated, when a sectional view of the data is provided in a meaningful manner, i.e. uninteresting parts of the volume are cut away by the section along a preselected geometrical plane. The method may further comprise a step of rendering data transparent based on location, characteristic and/or sectional view. A possibility to deal with data, that should be displayed, e.g. in order to enable the human observer to orient himself, but does not constitute the most important data to be visualized, is to render the respective areas transparent up to a certain degree. By doing so, more relevant data is still visible through the partly transparent parts of the rendered volume. The decision, which parts of the volume are to be rendered partly transparent is based on location, characteristic, sectional view and other possible properties. Preferably, the method further comprises the step of displaying the combined three-dimensional data set along a predefined path, in particular a blood vessel. Consequently, the method provides a way to visualize ample volumes without sacrifying easy visual interpretation by displaying a sequence of sectional views, each view centered around a different location, that is part of a predefined path. The path can for example correspond to a blood vessel, so that a human observer has the impression of traveling along this particular blood vessel. The vessel being visualized together with the volume in its vicinity provides an efficient way of representing large quantities of data for downstream expert evaluation. Merging data originating from different acquisition methods for analysis and visualization, each acquisition method being particularly qualified for a distinct diagnostical task and/or type of tissue, has the advantage that all methods benefit from interim results determined by a method, that is particularly well suited for a particular, required operation. BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects of the application will become apparent from and elucidated with reference to preferred embodiments described hereinafter with reference to the accompanying drawings, wherein: FIG. 1 is a block diagram of a system according to a preferred embodiment of the application; FIG. 2 shows the result of a conventional segmentation of a brain scan as to display artery/vessel information exclusively; FIG. 3 shows the result of a segmentation of a 3 DRA brain scan as described in the application; FIG. 4 shows the result of a segmentation of a brain scan as described in the application of FIG. 3 together with additional computer tomography data, represented as a transparent slice with an opaque bottom; and FIG. 5 shows an example of a registration region. DETAILED DESCRIPTION The present application is a system and method for flexible fusion of two data sets representing three-dimensional densities of a physical properties. According to a preferred embodiment of the present application, two data sets, which both represent the same object, but were generated using different acquisition methods, are combined in such a way, that the advantages of a particular acquisition method can be of use for a data set that was acquired using a different radiological method. For sake of clarity, the present application is explained here with reference to a preferred embodiment employing two diagnostical radiological methods in particular, these two methods being three-dimensional rotational angiography (3DRA) on the one hand and computer tomography (CT) on the other hand. CT is typically used for visualization of low contrast soft tissue such as brain material, while 3DRA is effectively used for visualization of high contrast artery/vessel structures. Since 3DRA and CT volumes provide complementary information to the clinical users, it is desirable to present this information to them as effectively as possible. Referring to FIG. 1 , using a computer tomography acquisition device CT, a data set corresponding to the three-dimensional spacial distribution of a physical property inside an examination volume is acquired. In the case of CT, the physical property is the attenuation coefficient with regard to x-rays. The same object, which in a clinical environment is usually a patient, undergoes a second acquisition, this time using a 3DRA acquisition device 3DRA. This technique relies on the same physical principle, namely measuring the attenuation coefficient distribution with regard to x-ray radiation, but differs from CT in the shape of the sensor and the acquisition geometry. In particular, 3DRA employs a central projection onto a two-dimensional radiation detector, whereas CT uses substantially one-dimensional detector arrays. 3DRA datasets generally do not contain absolute calibrated density values, due to insufficient calibration and reconstruction procedures. Both acquired data sets are transmitted to a data receiving and processing unit DPU. The data receiving and processing unit DPU receives the two data sets as inputs and forwards them to several sub-units. With reference to the 3DRA-generated data, the pre-processing unit PRP eliminates unwanted artefacts inherent to the 3DRA technique and improves the performance of downstream data processing units. The pre-processing unit PRP can be incorporated with either the data receiving and processing unit DPU as depicted in FIG. 1 or the 3DRA acquisition device 3DRA. The pre-processed 3DRA data set is then transmitted to both, an artery/vessel segmentation unit ASEG and a registration unit REG, charged with the registration of the CT data set and the 3DRA data set. The other input for the registration unit REG is supplied with the data set generated by the CT acquisition device CT. The registration unit ensures, that both data sets are placed in a common co-ordinate system in such a manner, that an object contained in both data sets will be located in the same location regarding each data set. In the described embodiment, the 3DRA-generated data set remains constant, while the CT-generated data set is shifted, scaled and rotated in such way, that a maximum of congruence in position, size and orientation is achieved. The accordingly altered CT-generated data set is transmitted to two destinations, one of which is a unit for rendering a transparent volume slice SREN, and the other is a unit for bone/skull segmentation SSEG. The latter proceeds to segmenting skull/bone information from the CT-generated data set, the result of which will be made available to a 3D masking unit MSK. Another input of this unit is provided by the artery segmentation unit ASEG, that has segmented artery/vessel information from the 3DRA-generated data set. Due to the similar acquisition characteristics of artery/vessel tissue and the skull in the case of 3DRA, the segmented artery/vessel information still contains a considerable quantity of voxels corresponding to the skull and bones. The 3D masking unit MSK merges the two data sets provided by unit SSEG and unit ASEG, respectively, in order to blind out any skull information in the 3DRA-generated data set. In particular, the segmented skull/bone information extracted from the CT-generated data set is used as a mask, applied to the segmented artery/vessel information. Notice that, due to the different voxel densities, straightforward subtraction will not work in general. An interpolation method, taking into account several voxels of the masking information for one voxel of the evaluation data set, or vice versa, depending on the location in the scanned volume of the voxels, has to be considered, instead. The resulting information contains by and large only the desired artery/vessel information. In order to be able to display this information in an efficient way to clinical users, the data set has to be passed to a 3D rendering unit AREN, being a part of the visual output means VIS. Based on a user selected viewpoint, illumination, the data set to be displayed and other parameters, a view of the 3D data is generated by 3D rendering AREN by a projection onto 2D space. This 2D-projection is suited to be displayed by a frame buffer display FBD. If the clinical user is further interested in the condition of the surrounding tissue in the vicinity of an observed blood vessel, e.g. to be able to evaluate any correlated symptoms, the system reverts to the CT-generated data, which has better capabilities in this domain. To this end, the same data feeding the skull/bone segmentation unit SSEG is also applied to a unit for transparent volume slice rendering SREN. Since large volumes are difficult for a user, even if well trained, to grasp, it is preferred, that the additionally displayed CT data is rendered in form of a slice or another simple three-dimensional geometric shape. Control of the position, orientation, size, transparency and other properties of the slice is performed by a volume-slice control unit VSC, either automatically or by interpreting commands issued by the user. By rendering the slice or the equivalent geometrical shape transparent, the problem, that the CT image covers a lot of the arterial/vessel information is resolved. However, transparent rendering will heavily influence the contrast of the CT information, which is clinically unacceptable. A remedy is to add non transparent, multi-planar reformatting (MPR) rendering of the top or bottom planes to the transparent rendered volume slice, in order to get the required high contrast in these planes. This is achieved by a second unit for rendering, the cap MPR rendering unit CREN. Depending on the view angle, either the top or the bottom plane is rendered non transparent. The operation of the visual output means VIS is controlled by a viewing control unit VC. Via this means, the user can interact with the system for modifying view point, zoom etc. The user can further place a virtual probe in a specific location, causing the means for visualization to represent the surrounding tissue in the vicinity of the probe location. By letting the clinical users modify the position and/or orientation of the CT slices, relative to the viewing of the artery/vessel structures, they will have a flexible and clear view of the pathologies at hand. For example, the probe can be placed on an artery vessel by a clinical user, who has an insight on the CT information in the plane orthogonal to the direction of flow. Now with reference to FIG. 2 , the result of artery/vessel information based solely on 3DRA data is shown. It becomes apparent, that besides the desired artery/vessel information considerable areas corresponding to the skull are contained in the displayed scan. Referring now to FIG. 3 , the result of masking the segmented artery/vessel data set shown in FIG. 2 with the data set containing the segmented skull, based on the CT image, is represented. It becomes apparent, that a considerable improvement is obtained over segmentation based solely on 3DRA-generated data. Now with reference to FIG. 4 , a combined 3DRA-CT image is shown, in which a slice containing CT data, and correspondingly representing the skull and soft tissue, is rendered transparent. The bottom plane of this slice, however, is rendered non transparent, as to make more clearly apparent soft tissue. Since a clinical user can adjust the viewpoint, the fact, that some of the 3DRA data is temporarily obscured by the non transparent plane, can easily be dealt with by redefining another viewpoint. Now with reference to FIG. 5 , an example of a region of registration is depicted. In order for the registration to yield high quality results, it is not necessary, that the entire volume is evaluated. It must rather be guaranteed, that unequivocal points of reference can be determined and located in both data sets. These points of reference can either be anatomical landmarks or artificial markers, that are applied to the patient. The location of the points of reference can be determined manually or automatically. Exemplary, FIG. 5 shows a patient's head 510 . A simple region to be used for registration is represented by the tetrahedron 520 , where each of its four vertices 522 , 524 , 526 , 528 corresponds to an anatomical landmark or a marker. Of course, other shapes can be used as well. In another embodiment, the skull, which usually clearly distinguishable in both kinds of images, can serve as a limiting boundary for the registration region, which generalizes the concept of anatomical landmarks. In another preferred embodiment, a clinical user can put a probe on an artery/vessel and have an insight on the CT information on the plane orthogonal to the direction of flow. In another preferred embodiment, the user can, by specifying a begin and end probe, trace through a path being able to see the sequence of CT-slices in the direction of flow. In a further embodiment, the order of certain operations could be changed. For example, the artery/vessel segmentation could benefit from previously executed masking of skullbone regions from the 3DRA-generated data set using the CT data. In terms of FIG. 1 , this would mean, that blocs ASEG and MSK would be rearranged in the reverser order. Furthermore, several units can be combined into one unit, such as a processor. The application is not limited to the mentioned radiological methods, but extends to other methods that can be combined in the described fashion as well. The application is of course not limited to the described or shown embodiments, but generally extends to any embodiment, which falls within the scope of the appended claims as seen in light of the foregoing description and drawings. While a particular feature of the application may have been described above with respect to only one of the illustrated embodiments, such features may be combined with one or more features of other embodiments, as may be desired and advantageous for any given particular application. From the above description of the application, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims. Any reference signs in the claims do not limit the scope of the application. The term “comprising” is to be understood as not excluding other elements or steps and the term “a” or “an” does not exclude a plurality.

1a

CROSS-REFERENCED TO RELATED APPLICATIONS [0001] Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. BACKGROUND OF THE INVENTION [0003] I. Field of the Invention [0004] The present invention relates to medical implants. More particularly, this invention relates to suture anchors used to attach soft tissue to bone. [0005] II. Related Art [0006] Surgeons have employed various types of suture anchors for decades for a variety of surgical applications. Suture anchors provide a surgeon with a means for attaching two pieces of tissue together so that they may heal. The tissues typically are tendon, ligament, or bone. [0007] Prior to the development of suture anchors, surgeons would typically pass the suture material directly through bone utilizing sharp, trocar-tipped needles. Clamps or other similar instruments were sometimes used instead of sutures. In either case, a rather large surgical exposure was required resulting in increased surgical morbidity to the patient and longer healing times. The advent of suture anchors allowed the refinement of a variety of surgical procedures. Rather than using a conventional, open approach requiring a large incision, the use of suture anchors permitted the surgeon to employ a minimally invasive arthroscopic approach leading to less surgical morbidity and potentially faster healing rates for patients. [0008] Suture anchors typically comprise two components—the body of the anchor and a suture material to be anchored to the bone. The body of the anchor can be made of a variety of different materials that are biocompatible, easily sterilized and strong enough to withstand the forces that may be exerted on the anchor. Such materials include, without limitation, titanium, alloys of stainless steel, polyether-ether ketone (PEEK), poly-1-lactic acid, and other biocompatible materials. An example of a material used to form the sutures is a polyester braid. The suture material is used to join tissue to the anchor body and the anchor body couples the suture material to a bone, providing an “anchor point” to the bone. [0009] Prior art suture anchors typically have one of several designs that permit the body of the suture anchor to be secured to the bone. Most of these designs incorporate a solid body with exterior threads or ridges. When the anchor is a solid body incorporating exterior threads, a pilot hole is typically drilled into the bone and then the anchor body is screwed into the pilot hole and the threads prevent the anchor body from pulling out of the bone. Similarly, when a solid anchor body having ridges is employed, a pilot hole is drilled and the anchor body is impacted into the bone such that the ridges prevent the anchor body from being pulled out. Some anchor bodies are designed to expand such that the entire body or an element of the body expands as the anchor body is driven into the bone to prevent the anchor body from being pulled out of the bone. [0010] Commercial suture anchors may come preloaded with the suture material. Alternatively, loading the suture anchor with the suture material may be performed by the surgeon. When the suture anchor comes preloaded, the anchor body is typically placed into the bone at an anchor point and then the suture material is passed through or around a piece of tissue to be joined to the bone at the anchor point. The sutures are then tied, securing the piece of tissue to the anchor body which has already been placed in the bone at the anchor point. When the suture anchors are not preloaded with suture material, free sutures are typically passed by the surgeon through or around a piece of tissue that the surgeon wishes to anchor to the bone. The sutures are then fed through the anchor body and the anchor body is impacted into the bone pulling the tissue down to the anchor point. [0011] The sutures are secured within the anchor body in various manners. In some situations, this fixation is made without tying knots and the anchor is referred to as a “knotless” anchor. When knotless anchors are used, an internal locking mechanism is provided such that the sutures are locked to the anchor body via the locking mechanism. The locking mechanism typically operates by pinching the sutures. In other cases, the sutures are extended between the bone and the external surfaces of the anchor body such that when the anchor body is inserted into the bone at the anchor point, the sutures are pinched between the bone and the anchor body. [0012] While a number of surgical procedures have been successfully performed using prior art suture anchors, surgeons sometimes encounter difficulties implanting such suture anchors arthroscopically. Thus, to complete the surgical procedure, a large surgical exposure is created. This serves to increase trauma, pain, risk of nerve and tissue damage, and healing time. Further, during recovery and before healing is complete, excessive forces may be applied to the sutures and anchor body by the tendon, ligament or bone which can result in the suture anchor dislodging from the bone or the sutures dislodging from the anchor body. Additional surgical repair is required should such dislodging occur. Still further, upon removal or dislodging of currently existing suture anchors, a cylindrical defect is left in the host bone. Such a defect may serve as an impediment to placement of new anchors for revision surgery. Additionally, many “knotless” suture anchors have complex internal locking mechanisms that may present technical difficulties for the surgeon performing the procedure during actuation of the locking mechanism. As such, there is a real need for an improved suture anchor which can be readily and easily implanted arthroscopically, is simple to use, will be securely bound to the bone, and at the same time will securely couple the sutures to the anchor body and bone. SUMMARY OF THE INVENTION [0013] An improved suture anchor design provides an anchor body having an open top, an open bottom, and a generally cylindrical wall extending between the open top to the open bottom. The cylindrical wall defines inner engagement surfaces surrounding a channel extending from the open top to the open bottom and an outer engagement surface. Use of the suture anchor incorporating these features permits the anchor body to be used with a uniquely shaped recess prepared in the bone. Such a recess extends inwardly from an exposed surface of the bone at the desired point of attachment (i.e., the anchor point) and comprises a cylindrical hole extending inwardly from the exposed surface to a base. The cylindrical hole surrounds a bone core extending from the base toward the exposed surface of the bone. [0014] Such a recess has at least two engagement surfaces, specifically an outer bone surface at the outside of the cylindrical wall and also an inner bone surface, i.e., surface of the bone core. The anchor body is adapted to permit the cylindrical wall (or at least a portion thereof) to be inserted into the cylindrical hole of the recess such that the bone core resides in the channel of the anchor body. As such, the outer engagement surface of the anchor body engages the outer bone surface of the recess and the inner engagement surface of the anchor body engages the bone core. This serves to substantially increase the surface area of the bone engaged by the anchor body for increased holding power. This also results in substantially less bone material being removed when forming the recess than is the case with traditional solid body bone anchors. [0015] In some embodiments the anchor body may have vents through the walls of the anchor to permit vascular flow and bone growth between the bone along the external engagement surface of the anchor and the central bone core against the internal engagement surface. Bone growth through these vents would serve to further reinforce anchor fixation to bone, preventing dislodgement. [0016] To further increase the holding power of the bone anchor, ridges or threads may be provided on either the outer engagement surface of the anchor body, the inner engagement surface of the anchor body or both the inner and outer engagement surfaces of the anchor body. Various structures may be coupled to the anchor body to permit preloading of the anchor body with suture material. [0017] More specifically, in one embodiment the anchor body may be designed to be impacted directly into the recipient recess with external ridges present oriented in such a manner as to achieve a friction fit between the external engagement surface of the anchor and the surrounding bone, thereby resisting extraction or pullout of the anchor body. In other embodiments, internal ridges may also be added to the internal surface of the device to provide a similar friction fit between the internal engagement surface of the anchor and the central core of bone. The anchor body may alternatively, in other embodiments, be designed to be screwed into place with threads present on the external engagement surface of the anchor that will engage the surrounding bone. Internal threads may also be added to the internal engagement surface of the device to provide a similar threaded purchase against the central core of bone. The pitch of the internal threads would match that of the external threads to permit the anchor body to advance in the same fashion with engagement of both external and internal threads. [0018] Various structures may be coupled to the anchor body to permit loading of the anchor body with suture material. For example, with a threaded design in which threads are fashioned along the external surface of the anchor body, permitting the anchor to be screwed into the recipient cylindrical socket, a short, hollow, cylindrical cap may be loaded with suture and positioned at the distal tip of the anchor such that in the process of screwing the anchor body into place the cap is driven into and secured in the bone at the distal end of the anchor body. [0019] Using the hollow anchor body described above with a hollow center that embraces a bone core is particularly advantageous when employing a knotless suturing technique. The suture material is held more securely to the anchor body and the bone because the suture material is not only captured between the outer engagement surface of the anchor body and the outer bone surface, but is also captured between the inner engagement surface of the anchor body and the central bone core. These two areas of engagement may be provided by creating a loop of suture material which is adapted to reside between the outer engagement surface of the anchor body and the outer bone surface with other portions of the suture material extend into and through the channel of the suture anchor such that these portion is of the suture material reside between the inner engagement surface of the anchor body and bone core. The suture material may pass through the open bottom of the anchor body. Alternatively, an orifice or passageway may be provided through the cylindrical wall between the inner engagement surface and the outer engagement surface adjacent the open bottom of the anchor body. Such an orifice or passageway reduces the risk that the suture material will be cut by the bottom of the anchor body as it is driven into the bone recess formed at the anchor point. The suture material may also be passed through an orifice or passageway in a short, hollow, cylindrical cap that engages the distal tip of the anchor body in a manner as described above. [0020] The suture anchor may be provided as part of a kit that also includes a tool for forming a recess in the bone at an anchor point of the type described above. For those embodiments of the anchor device possessing threads along the engagement surface(s), the kit may also include a tool for forming and tapping a recess in the bone at an anchor point of the type described above. The kit may also include an insertion tool for advancing the anchor body into the recess until the open bottom of the anchor body reaches the base of the recess with the bone cores residing within and extends up through the channel of the anchor body. [0021] Alternatively, in some embodiments, the distal tip of the anchor body (or a distal cap associated therewith) may be reinforced with a sharpened ring of metal alloy that permits the anchor body to form its own recess as it is being impacted into the recipient bone, without the need for prior formation of the recess. In such embodiments, the anchor body would be considered “self-punching” as it would form its own recess. [0022] The anchor body and insertion tool are, of course, adapted to permit the anchor body to be coupled to the insertion tool during the insertion process and then decoupled from each other to permit extraction of the insertion tool while leaving in place the anchor body and any sutures attached thereto. The insertion tool may include a channel that is in communication with the channel of the anchor body when the two are joined together. The insertion tool may also have a separate passageway extending from its channel out of a portion of the wall of the insertion tool. As such, suture material may be fed (i) in through the orifice in the wall of the anchor body, (ii) up through the channel of the anchor body, (iii) into the channel of the insertion tool, and then (iv) out through the passageway of the insertion tool such that, upon insertion of the anchor body, the suture material is pinched between not only the anchor body and the outer bone surface, but also between the anchor body and the bone core. A wire loop or loops may be provided to facilitate the passage of suture material through said passageways. [0023] Other features and advantages of the present invention will become apparent from the following detailed description of the invention, which refers to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0024] The foregoing features, objects and advantages of the invention will become apparent to those skilled in the art from the following detailed description and with reference to the following drawings in which like numerals and the several views refer to corresponding parts. [0025] FIG. 1 is a cross-section of a piece of bone showing a recess formed therein at an anchor point. [0026] FIG. 2 is a top view of a piece of bone showing a recess form therein at an anchor point. [0027] FIG. 3 is a side elevational view of a first embodiment of an anchor body. [0028] FIG. 4 is a top view of the anchor body of FIG. 3 . [0029] FIG. 5 is a bottom view of the anchor body of FIG. 3 . [0030] FIG. 6 shows the anchor body of FIG. 3 implanted in a piece of bone at an anchor point, the bone being shown in cross-section. [0031] FIG. 7 is a side elevational view of a second embodiment of an anchor body. [0032] FIG. 8 shows the anchor body of FIG. 7 implanted in a piece of bone at an anchor point, the bone being shown in cross-section. [0033] FIG. 9 is a side elevational view of a third embodiment of an anchor body. [0034] FIG. 10 is a top view of the anchor body of FIG. 9 . [0035] FIG. 11 is a bottom view of the anchor body of FIG. 9 . [0036] FIG. 12 shows the anchor body of FIG. 9 implanted in a section of bone at an anchor point, the section of bone being illustrated in cross-section. [0037] FIG. 13 is a side elevational view of a fourth embodiment of an anchor body. [0038] FIG. 14 shows the anchor body of FIG. 13 implanted in a section of bone at an anchor point, the bone being shown in cross-section. [0039] FIG. 15 is side elevational view of a fifth embodiment of an anchor body. [0040] FIG. 16 is a top view of the anchor body shown in FIG. 15 . [0041] FIG. 17 shows the anchor body of FIG. 15 aligned with the recess of FIGS. 1 and 2 (left) and implanted in the recess (right). [0042] FIG. 18 is a view of a sixth embodiment of an anchor body and distal cap wherein the anchor body and cap are aligned with the recess of FIGS. 1 and 2 (left), are aligned with the recess and joined together (center) and implanted in the recess (right). [0043] FIG. 19 is a cross-section of a portion of the cylindrical wall of an anchor body having both external and internal threads or ridges. [0044] FIG. 20 is a perspective view of a recess forming tool adapted to form a recess in a bone of the type shown in FIGS. 1 and 2 . [0045] FIG. 21 shows an anchor body insertion tool. [0046] FIG. 22 shows and anchor body insertion tool and an anchor body. [0047] FIG. 23 shows the anchor body insertion tool and anchor body of FIG. 22 joined together. [0048] FIG. 24 shows an anchor body and insertion tool with a loop of suture material fed through the anchor body and insertion tool. [0049] FIG. 25 shows in cross-section an anchor body positioned within a recess at an anchor point and a piece of suture material secured in place at the anchor point by the anchor body. [0050] FIG. 26 shows a seventh embodiment of an anchor body aligned with the recess of FIGS. 1 and 2 (left), partially implanted (center), and fully implanted in the recess (right). DETAILED DESCRIPTION [0051] In the following detailed description, references made to various exemplary embodiments in which the invention may be practiced. These embodiments are described with sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be employed, and that structural and other changes may be made without departing from the spirit or scope of the present invention. [0052] This description of the preferred embodiment is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. In the description, relative terms such as “lower”, “upper”, “horizontal”, “vertical”, “above”, “below”, “up”, “down”, “top” and “bottom”, “under”, as well as derivatives thereof (e.g., “horizontally”, “downwardly”, “upwardly”, “underside”, etc.) should be construed to refer to the orientation as then described or as shown in the drawings under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms such as “connected”, “connecting”, “attached”, “attaching”, “joined”, and “joining” are used interchangeably and refer to one structure or surface being secured to another structure or surface or integrally fabricated in one piece unless expressly described otherwise. [0053] FIGS. 1 and 2 illustrate a recess that is formed at an anchor point in a section of bone when the various embodiments described below are employed. More specifically, these drawings show, in cross-section, a portion 1 of bone having an exposed surface 2 . Formed into the bone 1 from the exposed surface 2 is a cylindrical hole 4 having a base 6 . The cylindrical hole 4 surrounds a bone core 8 . As such, the recess has an inner bone surface 10 and an outer bone surface 12 . Such a recess may be forms using any of a variety of tools. An example of such a recess forming tool 110 is shown in FIG. 20 . The recess forming tool 110 has a hollow cylindrical body 112 extending between a cutting edge 114 and a driving end 118 . The cutting edge 114 may be serrated as shown or may be a single sharpened edge. The cutting edge surrounds an opening 116 . The recess forming tool 110 may be employed as a punch or coupled to a rotary tool and used like a hole saw. [0054] FIGS. 3-6 illustrate a first embodiment of an anchor body 20 which is designed to be inserted into the recess shown in FIGS. 1 and 2 as is best illustrated in FIG. 6 . The anchor body 20 has an open top 22 , an open bottom 24 and a generally cylindrical wall 26 which extends between the open top 22 and the open bottom 24 . The cylindrical wall 26 includes a central channel 28 which extends from the open top 22 to the open bottom 24 . The channel 28 defines an inner engagement surface 30 . The outside of the cylindrical wall 26 defines and outer engagement surface 32 . [0055] The embodiment shown in FIGS. 3-6 also includes a pair of first orifices 34 which are axially aligned and extend through the cylindrical wall 26 between the inner engagement surface and the outer engagement surface. These first orifices 34 each provide an additional access pathway to the channel 28 of anchor 20 . The cylindrical wall 26 has a recess 36 which extends upwardly from each of the first orifices 34 . The fact that there are two such orifices 34 and two such recesses 36 is best illustrated in FIG. 4 . The orifices 34 make it possible to pass suture material (not shown in FIGS. 3-6 ) through the cylindrical wall 26 . Such suture material also extends up through the recesses 36 when the cylindrical suture anchor is positioned as shown in FIG. 6 . The suture material may be formed into any suitable suture member. As used herein, “suture member” refers to any suture, any suture tape or other flexible, strong, elongate material which may be used interchangeably with either a traditional suture or suture tape. [0056] To make it easier to align and insert the anchor body 20 shown in FIG. 3 , the bottom portion of the anchor body 20 has a tapered section 42 . Further, the top portion of anchor body 20 includes a flange 38 surrounding a narrowed projecting portion 40 . These are used to couple the anchor body 20 to an insertion tool 60 as illustrated in FIGS. 21 and 22 and discussed in greater detail below. [0057] As illustrated in FIG. 6 , the anchor body 20 is intended to be inserted within the cylindrical hole 4 such that the bone core 8 extends up through the channel 28 of suture anchor 20 . A portion of the bone core 8 is visible through the first orifice 34 . [0058] FIG. 6 shows the open bottom 24 of the suture anchor 20 resting on the base 6 of the cylindrical hole 4 . The open top 22 of the anchor body 20 is substantially flush with the exposed surface 2 of the bone 1 . Those of ordinary skill in the art will recognize that in some applications it may be desirable to recess the anchor body 20 below the exposed surface 2 of the bone. In other surgical applications, it may be desirable to leave a portion of the suture anchor 20 exposed. [0059] While sutures are not shown in FIGS. 3-6 , one skilled in the art should understand that these sutures would pass through the aligned orifices 34 on the front and back of the anchor body 20 and then extend up through the recesses 36 which extend upwardly from these orifices 34 on the front and back of the anchor body 20 . The sutures can then be used to attach a ligament, tendon or other structure to the bone. The anchor body 20 shown in FIGS. 3-6 may be preloaded with sutures to form the suture anchor. [0060] FIGS. 7 and 8 show an alternative embodiment similar to that shown in FIGS. 7 and 8 . In the embodiment of FIGS. 7 and 8 , the first orifice has been replaced an orifice 44 closer to the bottom of the anchor body 20 . In FIG. 8 , the bone core is visible through this orifice 44 . While only one such orifice 44 is shown in the drawings, one skilled in the art will recognize that additional orifices may be provided. As will be discussed in greater detail below with reference to FIGS. 23 and 24 , the arrangement shown in FIGS. 7 and 8 is well suited for a knotless suture application. [0061] FIGS. 9-12 show an embodiment of an anchor body 20 similar to that shown in FIGS. 3-6 . In the embodiment of FIGS. 9-12 , ridges 50 extend from the outer engagement surface of the cylindrical wall 26 of anchor body 20 . These ridges 50 assist in binding the anchor body 20 to the bone. As best illustrated in FIG. 12 , the ridges 50 engage the outer bone surface 12 to lock the anchor body 20 in place after it has been inserted into the cylindrical hole 4 and pushed down against the base 6 of the cylindrical hole 4 . When the embodiment of FIGS. 9-12 is employed, the anchor body 20 is impacted into position such that the bone core 8 extends through the open bottom 24 and channel 28 . A portion of the bone core 8 is visible through orifice 34 in FIG. 12 . A similar embodiment to that shown in FIGS. 9 and 12 is shown in FIG. 26 . In this and other embodiments the anchor body 20 may be provided with vents 35 through the wall of the anchor body 20 to permit vascular flow and bone growth between inner bone surface 10 and the outer bone surface 12 , i.e., the bone of the bone core 8 along the internal engagement surface of the anchor body 20 and the bone against the external engagement surface of the anchor body 20 . Bone growth through these vents serves to further reinforce anchor fixation to bone, preventing dislodgement. [0062] FIGS. 13 and 14 show an embodiment similar to that shown in FIGS. 7 and 8 . As illustrated in FIGS. 13 and 14 , ridges 50 have added to the outer engagement surface 32 of the cylindrical wall 26 . These ridges 50 are adapted to engage the outer bone surface 12 to secure the anchor body 20 within the cylindrical hole 4 formed in the bone 1 as shown in FIG. 14 . [0063] In lieu of ridges 50 of the embodiments illustrated in FIGS. 9-14 , the cylindrical wall 26 of the anchor body 20 may be provided with exterior threads. Such threads 52 are illustrated in the embodiments shown in FIGS. 15-18 . The threads 52 are self-tapping such that when the anchor body 20 is screwed into the end of the cylindrical hole 34 , mating threads are formed in the bone itself which cooperate with the threads 52 to help capture the anchor body 20 in place within the cylindrical hole 4 . In the embodiment shown in FIG. 18 , the projecting portion 40 has a tool receiving notch 41 discussed below. [0064] FIG. 19 shows an additional feature of the anchor body 20 which may be employed with any of the previously described embodiments. Specifically, the cylindrical wall 26 may be provided with both exterior ridges or threads 50 / 52 and interior threads or ridges 54 . When two sets of threads are employed, both sets of threads are self-tapping. As such, when the anchor body 20 is screwed into the cylindrical hole 4 , mating threads are formed in both the outer bone surface 12 and the inner bone surface 10 (i.e., the exterior of the bone core 8 to provide even more holding power. Of course, one skilled in the art should understand that in lieu of such interior and exterior threads, interior and exterior ridges may be provided to achieve similar holding power. [0065] While anchor bodies of the type described above may be manufactured and packaged separately, it is also possible to provide to such anchor bodies as part of a kit. The kit may also include the suture material, a tool for forming the cylindrical hole 4 in the bone 1 while leaving the bone core 8 in place at the anchor point, and an insertion tool. The tool forming the hole can be a punch or drill designed to form the cylindrical hole 4 while leaving the bone core 8 in place. [0066] An insertion tool is illustrated in FIGS. 22-24 . The insertion tool 60 includes a handle section extending from a first end of an engagement section 64 . The second end 68 of the engagement section 64 is open and a second channel 66 extends from this open end to a passageway 74 . Passageway 74 extends from the channel 66 through the outer surface 72 . The open end 68 of the tool also has an engagement surface 70 . [0067] As illustrated in FIGS. 22 through 24 , the opening in the end 68 of the engagement section 64 is large enough to receive the projection 40 of the anchor body 20 . Further, end 68 of the insertion tool 60 includes an engagement surface 70 which engages the flange 38 of the suture anchor when the handle is coupled to the anchor body 20 . An impaction force can then be applied using a mallet (not shown) via the handle 62 to drive the anchor body 20 into the cylindrical hole 4 in the bone. One skilled in the art will also recognize that the channel 66 of the engagement section 64 of the handle 60 and the projection 40 of the suture anchor 20 may be keyed such that rotation of the handle serves to rotate the suture anchor 20 . Such keying will, of course, be advantageous and necessary when threads 52 and/or 54 are provided as opposed to ridges 50 . A slightly modified insertion tool is illustrated in FIG. 21 and discussed below. [0068] Again, the anchor body 20 shown in FIGS. 22 through 24 will typically be preloaded with suture material. FIG. 24 shows an anchor 20 which will typically be used to achieve knotless attachment of the suture material. In FIG. 23 the suture material is labeled 80 . The suture material 80 includes a loop 81 . The suture material 80 extends from both sides of this loop 81 such that the ends 82 and 83 of suture material 80 may be passed through the orifice 44 and channel 28 of the anchor body 20 and then out through the open top 22 of the anchor body 20 . The ends 82 and 83 of the suture material 80 are then fed through (i) the opening in the end 68 of the insertion tool 60 , (ii) the second channel 66 of the insertion tool 60 and back out through the passageway 74 of insertion tool 60 . The free ends 82 and 83 of the suture material 80 may then be used to attach a ligament, tendon. [0069] FIG. 25 is provided to show how the suture material 80 is held in place. As illustrated, after the insertion tool 60 has been used to force the anchor body 20 into the cylindrical hole 4 , the loop 81 of the suture material resides and is pinched between the outer bone surface 12 formed by creating the cylindrical hole 4 in the bone 1 and the outer engagement surface 32 of the cylindrical wall 26 of the anchor body 20 . The suture material extends from the loop 81 through the orifice 44 and into the channel 28 of the anchor body 20 . Specifically, the suture material 80 extends and is pinched between the inner bone surface 10 (i.e., the surface of the bone core 8 ) and the inner wall 30 of the anchor body 20 . The suture material 80 then extends out of the open top 22 of the anchor body 20 . The free ends 82 and 83 may then be used to attach ligaments, tendons or the like to the bone, and because the portion of the suture material 80 residing within the cylindrical hole and suture anchor is so tightly pinched both between the outer bone surface 12 and the outer engagement surface 32 as well as between the inner bone surface 10 and the inner engagement surface 30 , the suture material 80 is firmly coupled in place by the anchor body 20 and the bone. [0070] The anchor body embodiment of FIG. 18 will now be described in further detail. Anchor body 20 has, at least, external threads 52 . This anchor body is, again, hollow and adapted to fit in the cylindrical hole 4 and surround a bone core 8 . The external threads 50 are adapted to engage the outer bone surface 12 . If inner threads such as those illustrated in FIG. 19 are provided, the inner threads 54 are adapted to engage the inner bone surface 10 (i.e., the exterior of the bone core 8 ) to provide even more holding power. Located at the bottom of the anchor body 20 shown in FIG. 18 is a cylindrical extension 92 projecting distally from a flange 93 . Located at the proximal end of the bone anchor 20 is a proximal projection 40 having a slot 41 extending distally from the proximal end of the anchor body 20 . [0071] Also shown in FIG. 18 is a short, hollow, cylindrical cap 94 which may be loaded with suture material 80 comprising one or more suture members and positioned at the distal tip of the anchor body 20 . More specifically, cap 24 has a hollow cylindrical wall 96 adapted to receive cylindrical extension 92 . The cylindrical wall 96 has a proximal end 97 which engages the flange 93 when the cap 94 is coupled to the anchor body 20 . The cap 94 also has a pair of outwardly extending wings 98 adapted to engage the outer bone surface 12 . Like the anchor body 20 , the cap is also adapted to surround the bone core 8 . An orifice 100 extends through the wall 96 of the cap 94 to permit suture material 80 to be passed through the wall 96 similar to the manner shown in FIGS. 24 and 25 . Prior to implantation of the anchor body 20 in the bone 1 , the cap 94 is mated to the anchor body 20 . The anchor body 20 and cap 94 are held together by a firm friction fit between cylindrical extension 92 and cylindrical wall 96 . The assemble is then aligned with the cylindrical hole 4 and bone core 8 and pushed into the cylindrical hole 4 until the threads 52 reach the cylindrical hole 4 . The anchor body 20 is then screwed into place. As the anchor body is screwed into place, the cap is driven into and secured in the bone at the distal end of the anchor body 20 . Furthermore, in some embodiments the cap permits the flange of the cylindrical extension 92 of anchor body 20 to rotate freely within the cap 94 , without necessarily generation rotation of the cap itself. Thus, the cap 94 is driven deeper into the prepared recess without rotating. [0072] Various tools may be used to implant the anchor body 20 and cap 94 shown in FIG. 18 . One such tool 60 is shown in FIG. 21 . This tool is nearly identical to the impaction tool 60 shown in FIGS. 22 through 24 . The sole difference is that a plate 69 has been added which extends across the second end 68 of the engagement section. This plate is adapted to be received within the slot 41 of the anchor body 20 shown in FIG. 18 . This allows the tool first to be used to impact the anchor body 20 and cap 94 into the cylindrical hole 4 until the threads 52 engage the cylindrical hole, and then to be used to rotate the anchor body 20 to drive the anchor body 20 and cap 94 into their final implanted position within the cylindrical hole 4 and surrounding the bone core 8 . Other tools, such as an ordinary screw driver, could also be fitted in the slot 41 to perform these functions. However, the tool 60 illustrated in FIG. 21 offers better control. Also, the cylindrical wall 66 is adapted to frictionally engage the projection 40 to temporarily hold the tool 60 to the anchor body 20 in a similar manner to the way the cap 94 is frictionally held to the cylindrical extension 92 . Thus, during implantation, the surgeon is able to hold, with one hand and in assembled relation, the entire assembly comprising the anchor body 20 , cap 94 , suture material 80 and tool 60 . [0073] Implantation of the anchor body 20 may also be simplified by providing the distal tip of the anchor body (e.g., 24 in FIG. 3 ) or a distal cap (e.g., 94 in FIG. 18 ) associated therewith which is reinforced with or formed of a sharpened ring of metal alloy that permits the anchor body (or cap) to form its own recess as it is being impacted into the recipient bone. This eliminates the need for prior formation of the recess. In such embodiments, the anchor body would be considered “self-punching” as it would form its own recess. [0074] The foregoing description is intended to explain the various features and advantages, but is not intended to be limiting. The scope of the invention is defined by the following claims which are also intended to cover a reasonable range of equivalents.

1a

BACKGROUND OF THE INVENTION The invention is directed to a steam generator for creating steam for use in cooking equipment, particularly for table-top or footed equipment working in combined operation using hot air and hot steam for gastronomy, industrial kitchens and the like. The generator comprises a water-filled boiler that in turn comprises an automatically level-regulated water admission, a steam discharge for the automatic introduction of hot steam into the cooking space of the cooking equipment as needed and a heating mechanism operating in intervals, for example, in the form of heat exchanger surfaces which are heated electrically or with gas heating, and a decalcification means having a water outlet means arranged close to the floor and to the side wall of the boiler for at least partially emptying the boiler as needed for the purpose of flushing off lime particles that have flaked off and have been collected at the floor of the boiler. There is the problem in such steam generators, which are normally exposed to high thermal stresses as a consequence of intense employment of the appertaining cooking equipment, and this problem is that thick lime deposits form over time both at the heat exchanger surfaces of the heating means--i.e., at the corresponding heating rods or heating coils of electrically operated equipment and at the corresponding heat exchanger tubes in the case of gas-operated equipment. Lime deposits also occur at the boiler walls. These lime deposits must be removed from time to time since they impede the heat transmission at the heat exchanger surfaces; however, they must also be removed from the inside surfaces of the boiler since they can have negative influences on the quality of the generated steam because certain substances that, for example, can influence the properties of the generated steam in a negative way in view of the taste of the products to be cooked can become concentrated in these lime deposits. It is known to remove the lime deposits in that the user of the cooking equipment dissolves the lime deposits at more or less regular intervals by introducing a chemically acting decalcification means into the boiler and heating outside of normal operation. These lime deposits, for example, are then discharged through a drain cock specifically provided for this purpose while emptying the boiler. A certain decalcification effect can also be achieved without introducing a chemically acting decalcification agent. U.S. Pat. No. 1,616,372 discloses a cleaning mechanism for heating equipment that is composed of a flat chamber that is arranged at the floor of the heating equipment and is provided with a plurality of openings that are arranged such that, when a valve that is in communication with the cleaning chamber is open, the out-flowing agent can eliminate the deposits in the heating device through the cleaning chamber. What is thereby exploited is that a certain over-pressure prevails in the heating equipment. The decalcification effect, however, is not satisfactory. This is due, first, to the fact that it is necessary for the user to in fact effect the decalcification at certain intervals by actuating the drain cock, a measure that is frequently omitted as a consequence of carelessness. Further, the pressure arising in the equipment of the initially stated species is quite inadequate for reliably eliminating the sediment particles. Moreover, only lime particles that are easily detached from the heat exchangers, or, respectively, from the inside surfaces of the boiler proceed into the cleaning container. Firmly adhering lime particles continue to lead to the impediments that were set forth above. It is also known to employ a drain cock as water outlet means in order to eliminate the lime particles from time to time that collect at the floor of the boiler in the form of small particles. However, the flow that arises when emptying the boiler is definitely not adequate to convey the lime particles deposited at the floor of the boiler out through the drain cock. On the contrary, the drain cock is usually already plugged briefly after the start of a decalcification process, i.e., after the drain cock is opened, so that the lime deposits cannot be reliably eliminated. Further, the lime particles entering into the interior of the drain cock and into its closing mechanism plug these up to an increasing degree due to the lack of an adequate rate of flow of the out-flowing water, so that an effective decalcification is no longer guaranteed after a relatively short operating time. SUMMARY OF THE INVENTION It is therefore an object of the invention to create a steam generator of the stated species that automatically guarantees an improved elimination of the disturbing lime without intervention of the user. To accomplish these objects, the present invention is directed to an improvement in a steam generator for cooking equipment, particularly for table-top or footed equipment for gastronomy, industrial kitchens or the like working in combination with hot air and hot steam, the generator comprising a water-filled boiler having an automatic, level-regulated water admission, a steam discharge for automatic introduction of hot steam into the cooking chamber of the cooking equipment as needed, said generator having heating means operating at intervals, for example in the form of heat exchanger surfaces that are electrically heated or heated with gas heating, and having decalcification means for removing lime particles from the boiler including water drain means arranged close to the floor and to the side wall of the boiler for, as needed, at least partial emptying of the boiler for the purpose of flushing out lime particles that have flaked off and collect at the floor of the boiler. The improvements are the water drain means comprises first means for generating a flow in the steam generator that automatically kicks in at preferably adjustable intervals dependent on the operating duration and/or operating temperature of the heating means, said first means supplying the water to an elimination device. The new steam generator has the first means for generating a flow that permeates the steam generator is formed therein and supplies the water to an elimination device. In a preferred embodiment, the first means for generating a flow comprises the elimination device and is fashioned as a siphon or suction tube having a drain provided at the floor of the boiler. It is thus possible to close the water column in the siphon by intentionally over-filling the steam generator, as a consequence the siphon is actuated to completely empty the steam generator. It is also preferred that the first means for generating a flow is a scouring or flushing pump, whereby a scouring or flushing admission that is connectable and disconnectable in common with the pump is arranged close to the floor of the boiler at a location close to the boiler wall lying essentially diametrically opposite the pump. It can thereby be provided that the scouring pump and/or the scouring admission penetrate the boiler wall close to the floor of the boiler. Further, it may also be provided that the heating means is arranged above the level of the scouring pump and of the scouring admission while leaving a flushing path that is essentially free of flow impediments. It can also be provided that flow guiding devices, for example flow baffles or the like, are arranged in the flow path between the scouring pump and the scouring admission. In its idle position, the scouring pump can form a flow connection between the boiler and the water admission of the cooking equipment. It is also proposed that the water admission has an over-pressure discharge that is in communication with the atmosphere above the water level in the boiler. It is especially preferred when the floor of the boiler proceeds at a slope from the scouring admission to the scouring pump. This embodiment is based on the surprising perception that the claimed combination of a scouring or flushing pump and of a scouring or flushing admission that is situated at a position of the boiler lime diametrically opposite the position of the scouring pump succeeds in reliably flushing the lime particles collecting a the floor of the boiler as a consequence of the strong flow and as a consequence of the forced conveying with the scouring pump. The pump itself, fashioned, for example, as a rotatory pump, preferably serves as a part of the water admission while maintaining a free flow connection between the water and the boiler and the water admission in the "normal condition" in which it is thus not working and as a result whereof the interior of the pump is kept completely free of lime particles. Whenever the pump kicks in, thus, lime particles are not situated inside the pump, these otherwise possibly impeding a faultless start. The discharge of the scouring pump is preferably connected with the condensate drain of the cooking equipment that is already present, so that no additional drain is required. In order to assure that the decalcification means is only actuated when there is no normal operation of the cooking equipment, it is advantageous when a suitable control adjustment sees to it that the scouring pump and the scouring admission can only be actuated when the water temperature inside the boiler amounts, for example, to less than 50° C. and the cooking equipment was shut off for a period of time, for example, for at least eight hours. An embodiment of the invention is particularly advantageous wherein the connection of the scouring pump to the water admission simultaneously acts as over-pressure valve for the cooking space, as a result whereof an additional over-pressure valve in the cooking space can be foregone. A further preferred embodiment of the invention is characterized in that a flow-generating or first means is provided that causes the boiler water to flow, preferably in pulsating and/or periodically changing fashion, during the operation of, in particular, the steam generator and that the flow entrains lime particles that have already been deposited as well as lime particles that are still situated in the boiler water and conveys them to the elimination means fashioned as a sediment container. It can thereby be provided that the flow-generating means comprises a steam pump connected to the steam generator. This steam pump comprises a cooling means, and that the sediment container is arranged in the lower region of the steam pump. The invention may also provide that the flow-generating means comprises a mechanically operated pump. The steam pump set forth above can be integrated in the steam generator or can be fashioned as a separate unit whereby the steam pump communicates with the steam generator via a water connection and via a steam connection. The coolant means comprises a coolant admission that can be identical with the water admission for the steam generator. When the coolant is delivered to the steam pump in a controlled fashion, the agent situated therein, namely steam and water, cools and, as a consequence of the cooling, an under-pressure is generated in the steam pump. This under-pressure in turn effects a strong flow of the water situated in the steam generator into the steam pump. Particles entrained by the flow will sink into the sediment container due to their dead weight. In addition, the coolant cools the water situated in the steam pump, so that this cooled water is over-saturated with lime and an intense formation of lime particles in the steam pump occurs. These particles likewise settle into the sediment container and can be removed from the container. In the steam generator of the present invention, the lime layer formed on the surfaces of the steam generator are eroded or flaked off due to the erosive effect of the water flowing in pulsating fashion as a result of the flow of the water in the steam generator. The cleaning effect thus goes beyond a mere cleaning of the water and also covers deposits in the heating means and on the inside walls of the boiler. Further features and advantages of the invention will be apparent from the following description wherein the invention is set forth by way of example with reference to embodiments shown in the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a vertical cross sectional view of a first exemplary embodiment of a steam generator of the present invention; FIG. 2 is a schematic cross sectional view of a second exemplary embodiment of the steam generator; FIG. 3 is a side view with portions broken away of a third exemplary embodiment of the steam generator FIG. 4 is a schematic view of a fourth exemplary embodiment of the steam generator with water flowing in pulsating fashion and with an integrated steam pump; and FIG. 5 is a schematic view of a fifth exemplary embodiment of the steam generator having water flowing in pulsating fashion and having a separate steam pump. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a steam generator 1 that is essentially composed of a boiler 8 in which heating tubes 12 are arranged. The boiler 8 is filled with water up to the normal water level 7, and this water is heated by the heating tubes 12. A floor opening 19, that serves both as water admission as well as water discharge in this embodiment of the invention, is provided at the floor of the boiler 8. A suction tube or siphon 5, that is likewise filled with water up to the normal water level 7 during normal operation, is connected to the floor opening 19. A fresh water admission 4, that is situated below the normal water level 7, is provided in the suction tube 5. The normal water level 7 is monitored by a normal water level sensor 52. The steam generated in the steam generator 1 collects in the steam space 92 and can be discharged through the steam exit connectors 91. The suction tube 5 is essentially composed of two legs 54, 55 proceeding parallel to one another that are connected to one another at their upper end in a communicating fashion by a U-shaped connection. A suction tube discharge 57 that is situated below the level of the floor opening 19 is provided on the leg 55. For cleaning or, respectively, emptying the steam generator 1, the boiler 8 is filled with water above the normal water level 7 up to an over-filled water level 18. This over-filled water level 18 lies above the upper apex 56 of the suction tube 5 and will cause a priming of the siphon 5, which will then complete an emptying of the steam generator. The over-filled water level 18 is monitored by an over-filled water level sensor 53. The sensors 52 and 53 have a common grounded electrode 51 that lies at the housing of the boiler 8. In this embodiment of the steam generator the heating tubes 12 are arranged projecting vertically upward into the boiler 8. They are conducted toward the outside through the floor of the boiler 8 next to the floor opening 19. The flow generated by the draining via a suction tube 5 thus proceeds essentially parallel to the side walls of the boiler 8 and parallel to the heating tubes 12. At the same time, however, it is also conceivable to horizontally arranged the heating tubes 12 in the boiler 8, whereby they may also potentially project beyond the floor opening 19. An additional eddy flow around the heating tubes 12 is thereby produced, this will promote the flaking of lime from the heating tubes. FIG. 2 shows an embodiment of the steam generator 1 wherein the boiler 8 is provided with a dome-like upper part 9 from which steam can be discharged via a steam exit connector 91. The water situated in the boiler 8 is heated with horizontally disposed heating tubes 12. The temperature of the heating tubes 12 is acquired via a temperature sensor 13. The normal water level 7 is set by a normal water level sensor 52 via the fresh water admission 4 on the basis of an admission solenoid that is not shown here. The fresh water proceeds through the floor opening 19 into the boiler 8 of the steam generator 1 via a pump pressure hose 41, a flushing or scouring pump 10 as well as the pump connection 42. An electronic control circuit (not shown here) monitors the on-time of the steam generator 1 or the activation of the equipment and carries out an interrogation of the temperature sensor 13. When the temperature value shows that the heating tubes 12 are not being operated, the scouring pump 10 is actuated and the water admission is simultaneously released via a flushing or scouring admission 14 that is arranged at the wall of the boiler 8 close to the floor diametrically opposite the scouring pump 10. The scouring admission 14 can comprise a rinsing nozzle or jet 15 to increase the out-flow rate of the water being effected. For example, the control of the scouring admission 14 can ensue via a rinsing solenoid. The lime deposits on the floor of the boiler 8, which deposits are from the water and from flakings from the heating elements, have their major parts force-conveyed by the jet from the rinsing nozzle 15 through the floor opening 19 and into the pump connection 42. The scouring pump 10 conveys the water that contains lime particles to a drain 21 which is outside the device via the pump pressure hose 41 and via the device discharge 20. An emergency drain opening 11, that allows the water to be drained if the scouring pump 10 should fail, is provided at the lowest point of the pump connection 42. In this embodiment, the outlay for maintaining the steam generator is minimized, as are the required activities of the user since the cleaning process is carried out in a fully automated fashion. The steam generator 1 of FIG. 3 again comprises a boiler 8 from whose dome-like upper part 9 hot steam is introduced as needed into the cooking chamber of a cooking device [now shown] via the steam exit connector 91. A scouring or flushing pump 10 in the form of an electrically actuatable rotatory pump is arranged close to the floor 8a of the boiler 8. This rotatory pump, in the idle condition, produces an open flow connection between the water situated in the boiler and a water admission (not shown) that in turn communicates with the atmosphere above the level of the water situated in the boiler 8. Electrically heatable heating tubes 12 are arranged inside the boiler 8. A scouring or flushing admission 14, that is actuatable in common with the scouring pump 10 in a fashion set forth below, is situated at that side of the boiler 8 diametrically opposite the scouring pump 10. A mount 16 serves the purpose of attaching the steam generator 1 to the cooking equipment and does not form part of the invention. What is important, however, is that the floor 8a of the boiler 8 slopes from the scouring admission 14 to the scouring pump 10 in an especially advantageous way, and guarantees that flaking lime particles, etc. collect on the floor of the boiler 8 preferably in the flow path between the scouring admission 14 and the scouring pump 10 and close to the pump. The steam generator operates in the following way: the water level 7 inside the boiler 8 is held constant with an appropriate level control in a known way, i.e., measures are undertaken to see that so much water is resupplied into the boiler 8 over and over again via the flow connection through the scouring pump 10 that is open in the non-decalcifying mode so that a constant water level is observed dependent on steam consumption of the steam equipment. In the non-operating condition of the steam generator, i.e., when no steam is required for cooking in the cooking equipment, the scouring pump 10 kicks in at adjustable intervals upon simultaneous opening of the water admission by the scouring admission 14. As a consequence of this, lime particles that have collected on the floor 81 as a consequence of thermic cycling, etc., due to flaking and the like are reliably flushed out upon formation of an intense water flow along the floor of the boiler 8. The length of the intervals between the individual decalcification processes as well as, potentially, the length of the individual flushing events can be prescribed, namely dependent on the operating time and temperature of the steam generator that have occurred. FIG. 4 shows a steam generator 1 having an integrated steam pump 60. The steam generator 1 is filled with water up to the normal water level 7. The water is heated by heating tubes (not shown) or the like and is evaporated into the steam space 92 from where it can be discharged via a steam exit connector 91. The steam pump 60 is composed of a part of the cylindrical boiler 8, whereby one wall of the steam pump 60 is formed of at least one part of a wall of the boiler 8 of the steam generator 1 and represents a partition 65 between the steam generator 1 and steam pump 60. The partition 65 comprises a steam connection 63 in the form of an opening in the upper region of the steam pump 60 or, respectively, of the steam space 92 and also comprises a water connection 62 close to the floor of the boiler 8, likewise in the form of an opening. The steam generator 1 and the steam pump 60 are in communication with one another via these openings 62, 63. A sediment container 61 whose opening area extends over the entire bottom area of the steam pump 60 is provided under the steam pump 60. The sediment container 61 is completely filled with water because of the connecting opening 62 to the steam generator 1, whereas the steam pump 60 is filled with water up to the normal water level 7, i.e., up to the same height as the steam generator 1. A cooling means 2 is provided in the upper region of the steam pump 60. This cooling means 2 can be a surface cooler having a cooling circulation separated from the steam pump 60 or, as shown here, can be a direct water cooler with the delivery of cold water via the fresh water admission 4 directly into the upper space of the steam pump 60. The delivery of fresh water or cold water is controlled by a valve 43. When cold water is then introduced into the steam pump 60, the steam condenses in the upper region of the steam pump 60 and generates an under-pressure or vacuum which causes the water and the steam to be suctioned from the steam generator 1 into the steam pump 60. Due to the flow that occurs in this fashion, the particles situated in the water of the steam generator are also entrained and intercepted and collected in the sediment container 61. The fresh water introduced into the steam pump 60 continues to mix with the water in the steam pump 60 and cool it, so that an over-saturated lime solution occurs in the steam pump 60 and, thus, an intense formation of lime particles will occur in the steam pump 60. Due to the pressure equalization in the upper region of the steam pump 60, the water flows out of the pump via the opening of the sediment container into the boiler, whereby the lime particles situated in the water are deposited in the sediment container 61, so that a major part of the lime contained in the introduced water does not proceed back into the steam generator 1 at all. The water flowing out of the steam generator 1 into the steam pump 60 has an erosive action on the side walls and on the bottom surface of the boiler 8, as a result lime residues and agglomerations will be eroded. Since the sediment container 61 covers the entire bottom area of the steam pump 60, it is assured that the major part of the lime particles proceeding into the steam pump 60 ar precipitated out into the sediment container 61. FIG. 5 shows a steam generator 1 having a separately fashioned steam pump 60, wherein the steam pump 60 communicates with the generator 1 by a water connection 62 and a steam connection 63 that are both fashioned as pipes or the like. The space between the steam generator 1 and the steam pump 60 can be filled out with insulating material. The separate arrangement of the steam generator 1 and steam pump 60 assures that a good thermic separation is present between the two units, and this will promote the effect to be achieved by the cooling. The steam pump 60 is again an essentially cylindrical member that is filled with water up to the normal water level 7, just like the steam generator 1. A fresh water admission 4 for cold water is again provided in the upper region of the steam pump 60, whereby the water admission is controlled via a valve 43. The function sequence and action correspond to the embodiment of FIG. 4. Although various minor modifications may be suggested by those versed in the art, it should be understood that we wish to embody within the scope of the patent granted hereon all such modifications as reasonably and properly come within the scope of our contribution to the art.

1a

This application is a divisional of U.S. patent application Ser. No. 07/978,144, filed Nov. 16, 1992, now abandoned, which, in turn, is a continuation of U.S. patent application Ser. No. 07/684,258, filed Apr. 12, 1991, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to compositions containing azo dye compounds which exhibit antiviral activity and methods for using the same. The azo dye compounds have the ability of inhibiting the binding of HIV rgp120 to CD4 cells on peripheral blood lymphocytes. 2. Description of Related Art A variety of compounds have been shown to be able to block the binding of HIV to its cellular receptor, CD4. These include soluble CD4 (Smith, D. H. et al, "Blocking of HIV-1 infectivity by a soluble, secreted form of CD4 antigen," Science 238 1704-1707 (1987), synthetic fragments of CD4 (Lifson et al, "Synthetic CD4 peptide derivatives that inhibit HIV infection and cytopathicity," Science 241 712-716 (1988)). Other anti-HIV compounds include dextran sulfate (Ito et al, "Inhibitory effect of dextran sulfate and heparin on the replication of human immunodeficiency virus (HIV) in vitro," Antivir. Res. 7 361-367 (1987)), aurintricarboxylic acid (ATA), Evans Blue (EB) (Balzarini et al, "Aurintricarboxylic acid and Evans Blue represent two different classes of anionic compounds which selectively inhibit the cytopathogenicity of human T-cell lymphotropic virus type III/lymphadenopathy-associated virus," Biochem. Biophys. Res. Commun. 136 64-71 (1986a)), and Direct Yellow 50 (Balzarini et al, "Comparative inhibitory effects of suramin and other selected compounds on the infectivity and replication of human T-cell lymphotropic virus (HTLV-III)/lymphadenopathy-associated virus (LAY)," Int. J. Cancer 37 451-457 (1986b)). It has also previously been shown that ATA and EB act by binding to CD4 and blocking the binding of HIV rgp120 (Weaver et al, "Polyionic compounds selectively alter availability of CD4 receptors for HIV coat protein rgp120," AIDS Res. Human Retrovir. 6 1125-1130 (1990)). Research has also been conducted concerning compounds with potential antiherpes activity, such as the dye Trypan blue (Alarcon et al, "Screening for new compounds with antiherpes activity," Antiviral Research, 4 (1984), pp. 231-243; and Thorne et al, "Inactivation of Measles and Herpes Simplex Viruses by Trypan Blue," J. gen. Viral. (1983), 64, pp. 1365-1368), as well as Indigocarnine and Paraorange (Westin et al, "Aromatic Sulfonic Acids as Inhibitors: Structure-Activity Study using Rhino, Adeno 3, Herpes Simplex, and Influenza Viruses," J. of Med. Chem., 1971, Vol. 14, No. 7, pp. 596-600). The dye Congo Red and derivatives thereof have been investigated for potential anti-AIDS activity (Mohan et al, "Potential Anti-AIDS Agents. Synthesis and Antiviral Activity of Naphthalenesulfonic Acid Derivatives against HIV-1 and HIV-2," J. Med. Chem., 1991, 34, pp. 212-217). Also a number of azo dyes were demonstrated to exhibit protective properties in mice infected by equine encephalomyelitis virus (Hurst et al, Brit. J. Pharmacol., 7, p. 455 (1952)). In view of the above, it remains desirable to discover additional antiviral agents which are effective against the HIV virus. SUMMARY OF THE INVENTION Therefore, it is an object of the present invention to provide compositions containing azo dye derivatives which exhibit antiviral activity. It is also an object of the present invention to provide compositions containing azo dye derivatives which are effective against the human immunodeficiency virus. It is another object of the present invention to provide a method of treating viral infections of a host in need thereof by administering an antiviral effective amount of an azo dye derivative. Another object of the present invention is to provide a method for treating the human immunodeficiency virus by administering to a patient an effective amount of a composition containing azo dye derivatives. It is yet another object of the present invention to provide a diagnostic assay using azo dye compounds. The foregoing objects and others are accomplished in accordance with the present invention by providing a composition containing certain azo dye derivatives and a pharmaceutically acceptable excipient. In another embodiment of the present invention, a method is provided for treating viral infections of a host in need thereof by administering an antiviral effective amount of a composition containing certain azo dye derivatives and a pharmaceutically acceptable excipient. In another embodiment of the present invention, a diagnostic method is provided for assaying CD4 cells by using azo dye compounds. Further scope of the applicability of the present invention will become apparent from the detailed description and drawings provided below. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. BRIEF DESCRIPTION OF THE DRAWING The invention is further illustrated in the accompanying drawing wherein: FIG. 1 is a graph showing the dose response of the blocking of binding of αCD4-FITC to CD4 on PBL by the azo dyes. DETAILED DESCRIPTION OF THE INVENTION The azo dye derivatives employed in the present invention generally have the ability of inhibit the binding of HIV rpg120 to CD4 on peripheral blood lymphocytes. These compounds are generally listed in Table A below. TABLE A__________________________________________________________________________Cmpd. Name Structure__________________________________________________________________________1 FD1 ##STR1##2 C.I. Direct Blue 1 ##STR2##3 C.I. Direct Yellow 26 ##STR3##4 C.I. Acid Red 89 ##STR4##5 C.I. Direct Red 75 ##STR5##6 C.I. Acid Blue 116 ##STR6##7 C.I. Acid Red 115 ##STR7##8 C.I. Direct Red 79 ##STR8##9 C.I. Acid Black 3 ##STR9##10 C.I. Mordant Black 50 ##STR10##11 C.I. Acid Black 36 ##STR11##12 C.I. Acid Red 47 ##STR12##13 C.I. Direct Blue 23 ##STR13##14 C.I. Direct Blue 164 ##STR14##15 C.I. Acid Red 170 ##STR15##16 Acid Dye ##STR16##17 C.I. Direct Red 85 ##STR17##18 C.I. Direct Violet 81 ##STR18##19 C.I. Direct Brown 152 ##STR19##20 C.I. Direct Red 49 ##STR20##21 C.I. Direct Violet 62 ##STR21##22 C.I. Direct Orange 49 ##STR22##23 C.I. Direct Orange 69 ##STR23##24 C.I. Direct Yellow 34 ##STR24##25 C.I. Direct Brown 126 ##STR25##__________________________________________________________________________ Preferred azo dye compounds are Compound Nos. 1-8. Especially preferred azo dye compounds are Compound Nos. 3 and 8. All of the above compounds in Table A are known compounds and are described in Color Index, 3rd ed., vol. 4, Society of Dyers and Colorists, Yorshire BD1-2JB, England (1980) which also discloses further information about how to make or obtain these dye compounds. The azo dye derivatives of Table A may be employed in accordance with the present invention against various viruses, such as members of the HTLV family including HTLV I, HTLV II, HTLV IV, HTLV V, HIV-1 and HIV-2. The azo dye compounds of the present invention may also be employed in a diagnostic method for assaying CD4 cells by employing the azo dye compounds employed in the present invention which may bind to the CD4 cells. The azo dye derivatives employed in the present invention may be made into pharmaceutical compositions by combination with appropriate pharmaceutically acceptable carriers or diluents, and may be formulated into preparations in solid, semi-solid, liquid or gaseous forms such as tablets,. capsules, powders, granules ointments, solutions, suppositories, injections, inhalants, and aerosols in the usual ways for their respective route of administration. The following methods and excipients are merely exemplary and are in no way limiting. In pharmaceutical dosage forms, the azo dye derivatives employed in the present invention may be used in the form of their pharmaceutically acceptable salts, and also may be used alone or in appropriate association, as well as in combination with other pharmaceutically active compounds. In the case of oral preparations, the azo dye derivatives may be used alone or in combination with appropriate additives to make tablets, powders, granules or capsules, e.g. with conventional additives such as lactose, mannitol, corn starch or potato starch; with binders such as crystalline cellulose, cellulose derivatives, acacia, corn starch or gelatins; with disintegrators such as corn starch, potato starch or sodium carboxymethylcellulose; with lubricants such as talc or magnesium stearate; and if desired, with diluents, buffering agents, moistening agents, preservatives and flavoring agents. Furthermore, the azo dye derivatives employed in the present invention may be made into suppositories by mixing with a variety of bases such as emulsifying bases or water-soluble bases. The azo dye derivatives employed in the present invention may be formulated into preparations for injections by dissolving, suspending or emulsifying them in an aqueous or non-aqueous solvent, such as vegetable oil, synthetic aliphatic acid glycerides, esters of higher aliphatic acids or propylene glycol; and if desired, with conventional additives such as solubilizers, isotonic agents, suspending agents, emulsifying agents, stabilizers and preservatives. In the cases of inhalations or aerosol preparations, the azo dye derivatives employed in the invention in the form of a liquid or minute powder may be filled up in an aerosol container with gas or liquid spraying agents, and if desired, together with conventional adjuvants such as humidifying agents. They may also be formulated as pharmaceuticals for non-pressured preparations such as in a nebulizer or an atomizer. The amount of the azo dye derivatives employed in the present invention to be used varies according to the degree of the infection encountered, and the stages of the disease. A suitable dosage is that which will result in concentration of the azo dye derivative (in blood and/or tissues harboring virus) which are known to inhibit the virus, e.g. about 0.1 to 150 μg/ml, and more preferably about 10-30 μg/ml. The preferred dosage is that amount sufficient to render a host asymptomatic to the particular viral infection. Unit dosage forms for oral administration such as syrups, elixirs, and suspensions wherein each dosage unit, e.g., teaspoonful, tablespoonful, contains a predetermined amount of the azo dye derivatives employed in the present invention can be by a pharmaceutically acceptable carrier, such as Sterile Water for Injection, USP, or by normal saline. The azo dye derivatives employed in the present invention can be utilized in aerosol formulation to be administered via inhalation. The azo dye derivatives employed in the present invention can be formulated into pressurized acceptable propellants such as dichlorodifluoromethane, propane, nitrogen and the like. The term "unit dosage form" as used herein refers to physically discrete units suitable as unitary dosages for human and animal subjects, each unit containing a predetermined quantity of the azo dye derivatives calculated in an amount sufficient to produce the desired effect in association with a pharmaceutically acceptable, diluent, carrier or vehicle. The specifications for the novel unit dosage forms of the present invention depend on the particular compound employed and the effect to be achieved, and the pharmacodynamics associated with each compound in the host. The pharmaceutically acceptable excipients, for example, vehicles, adjuvants, carriers or diluents are readily available to the public. Any necessary adjustments in dose can be readily made to meet the severity of the infection and adjusted accordingly by the skilled practitioner. EXAMPLES Materials and Methods Reagents Evans Blue, aurin tricarboxlyic acid (ATA), and Direct Yellow 50 (Colour Index # 29025) were from Sigma Chemical Co (St. Louis, Mo.). Direct Blue 1 (Colour Index # 24410), Direct Yellow 26 (Colour Index # 25300), Direct Red 75 (Colour Index # 25380), and Acid Blue 116 (Colour Index #26380) were from Matheson Coleman Co (E. Rutherford, N.J.). Acid Red 115 (Colour Index # 27200), Acid Red 89 (Colour Index # 23910), and Direct Red 79 (Colour Index # 29065) were from Sandoz Inc. Monoclonal anti-CD4-FITC (anti-Leu3a) was from Becton Dickinson (Mountain View, Calif.). Recombinant HIV coat protein (rgp120) and monoclonal anti-rgp120-FITC were generous gifts from Genentech Inc, San Francisco, Calif.). Binding Assays Human peripheral blood lymphocytes (PBL) were prepared by density gradient centrifugation as previously described (Weaver et al., 1990). The effect of drugs on the binding of anti-CD4-FITC (αCD4), anti-CD3-FITC (αCD3), anti-CD8-FITC (αCDS), or HIV coat protein rgp120 was measured as previously described (Weaver et al., 1990). Briefly, cells were treated with a drug (10' RT) and then FITC labeled antibody or rgp120 followed by anti-rgp120-FITC. Binding was measured by quantitating cell bound fluorescence using flow cytometry. Some binding assays were run in phenol red free RPMI 1640/5% serum instead of the usual PBS to determine effectiveness under cell culture conditions. Viability Assay The effect of compounds on the viability of PBL was determined after culturing PBL for 72 hr at 37° C. Some cells were stimulated with 1 μl/ml of anti-T-cell receptor antibody for this time period. Cells were then washed 1× in PBS and resuspended in PBS with 3 μg/ml propidium iodide. After 10 min incubation cells were analyzed by flow cytometry. Live cells were defined as those excluding propidium iodide. ViraI Assays The effect of various drugs on growth of HIV isolate LAV-1 BR in PHA stimulated human PBL was measured using two assays. Reverse transcriptase activity was measured in disrupted virions from the cell free supernatant as previously described (Anand et al, "Interaction between rifabutin and human immunodeficiency virus type-1: inhibition of replication, cytopathic effect and reverse transcriptase in vitro," Antimicrob. Agents Chemother. 32 684-688 (1988)). Production of HIV p24 protein was measured from cell lysates using HIV p24 enzyme linked immunosorbent assay kits (Cellular Products, Buffalo, N.Y.) as previously described (Anand et al, "Sodium pentosan polysulfate (PPS), an anti-HIV agent also exhibits synergism with AZT, lymphoproliferative activity and virus enhancement," AIDS Res. Human Retrovir. 6 679-689 (1990)). Results Inhibition of Binding of αCD4 to CD4 Since anti-Leu3a (αCD4) and rgp120 bind to the same site on the CD4 molecule, interference in binding of αCD4 can be used to screen compounds for possible anti-HIV activity. EB or ATA are used as positive controls since they have been shown previously to block eCD4 and rpg120 binding (Weaver et al, "Polyionic compounds selectively alter availability of CD4 receptors for HIV coat protein rgp120," AIDS Res. Human Retrovir. 6 1125-1130 (1990)). Table 1 shows the results of screening the dye compounds listed in Table A for their ability to interfere in binding of αCD4 to PBL. Six of the dyes tested show significant ability to block αCD4 binding. Three compounds, Acid Blue 116, Acid Red 115, and Direct Red 79 were selected for more complete analysis. TABLE 1______________________________________Some dyes inhibit the binding of αCD4 to PBLCompound Concentration % Control Binding.sup.1______________________________________Evans Blue 1 μM 1FD1 5 μM 102Direct Blue 1 10 μM 1Acid Red 89 7 μM 6Direct Yellow 26 12 μM 84Direct Yellow 50 50 μM 42Direct Red 75 10 μM 70Acid Blue 116 7 μM 0Acid Red 115 6 μM 2Direct Red 79 10 μM 13______________________________________ .sup.1 Results in % logarithmic mean channel number of αCD4FITC binding in PBS. Inhibition of Binding of HIV rgp120 to CD4 The results shown in Table 2 confirm that the three dyes selected on the basis of their interference with αCD4 binding can also block binding of rgp120. Their relative efficacy appears to be similar in both assays. TABLE 2______________________________________Inhibition of HIV rgp120 binding by dyes.Compound Concentration % Control Binding.sup.1______________________________________Evans Blue 1 μM 8Acid Blue 116 7 μM 9Acid Red 115 6 μM 10Direct Red 79 10 μM 30______________________________________ .sup.1 Results in % logarithmic mean channel number of rgp120 binding detected by binding of αrpg120FITC in PBS. Specificity of Inhibition of Binding We have analyzed the specificity of these compounds by testing their ability to interfere with the binding of two other monoclonal antibodies, αCD3 and αCD8. The results in Table 3 show that Acid Blue 116 reduces binding of both antibodies by about 1/2, Acid Red 116 interferes with αCD3 but not αCD8, and Direct Red 79 does not affect binding of either antibody. The increase in binding of αCD3 on Direct Red 79 treated cells may reflect nonspecific binding. TABLE 3______________________________________Specificity of inhibition of binding of monoclonal antibodies by dyes. % Control Binding.sup.1Compound Concentration αCD4 αCD3 αCD8______________________________________Evans Blue 1 μM 1 -- --Acid Blue 116 4 μM 1 44 54Acid Red 115 6 μM 2 41 90Direct Red 79 20 μM 22 124 106______________________________________ .sup.1 Results in % logarithmic mean channel number of αCD4FITC, αCD3FITC, or αCD8FITC binding in PBS. Dose Response of Inhibition FIG. 1 shows the dose response curves for the three dyes. The solid symbols are for incubation in PBS and the open are for incubation in complete cell culture medium (RPMI 1640 w/5% serum). Circles are Acid Blue 116; Triangles are Acid Red 115; and Squares are Direct Red 79. In the presence of serum about 100× more dye is needed for efficacy, this may be due to the dyes binding to serum proteins. For Acid Blue 116 and Acid Red 115, these concentrations are near their limits of solubility in aqueous solutions. Effect of Compounds on Viability On the basis of specificity and dose response in serum containing medium Direct Red 79 was selected for further testing. First the effect of this dye on cell viability was tested. Table 4 shows that Direct Red 79 has no effect on the viability of PBL after 72 hr of continuous culture. ATA was used as a positive control since it does not bind to serum proteins (not shown). Table 5 shows that Direct Red 79 has a limited effect on the proliferation of αTCR stimulated PBL. TABLE 4______________________________________Effect of Direct Red 79 on viability of PBL after 72 hr culture.Treatment Concentration % Viable Cells.sup.1______________________________________None -- 90ATA 10 μM 86Direct Red 79 400 μM 89______________________________________ .sup.1 Viability determined by ability to exclude propidium iodide as measured by flow cytometry. TABLE 5______________________________________Effect of dyes on viability of PBL after 72 hrculture of anti-TCR stimulation.Treatment Concentration % Viable Cells.sup.1______________________________________None -- 78Direct Red 79 100 μM 54______________________________________ .sup.1 Viability determined by ability to exclude propidium iodide as measured by flow cytometry. Effect of Compounds on HIV Replication in vitro We tested the ability of Direct Red 79 to affect HIV replication in vitro using two assays. First we determined that the compound is able to strongly inhibit the production of reverse transcriptase activity after six days of culture (Table 6). Next, to eliminate the possibility that the dye was directly inhibiting the RT we measured the amount of intracellular HIV p24 protein. Table 7 shows that the dye is able to strongly decrease p24 production. TABLE 6______________________________________The effect of Direct Red 79 on HIV reversetranscriptase activity after six day culture.TreatmentCount CPM RT.sup.1 % Inhibition No. Cells______________________________________Cells only 76 -- --HIV only 2026 -- --DMSO 6338 0 2.00 × 10.sup.6 /mlATA (1 μM) 109 97 0.15 × 10.sup.6 /mlDirect Red 79 (100 μM) 145 97 1.89 × 10.sup.6 /ml______________________________________ .sup.1 Counts per minute [.sup.3 H]-TTP incorporated into TCA precipitabl material by reverse transcriptase after two hours incubation. TABLE 7______________________________________The effect of Direct Red 79 on production ofintracellular HIV p24 as measured by ELISA.Treatment pg/ml HIV p24______________________________________Cells only 0Virus only 2556DMSO 1222ATA (2.5 μg/ml) 0ATA (0.25 μg/ml) 111Direct Red 79 (5 μg/ml) 333______________________________________ The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

1a

This is a Continuation of application Ser. No. 07/028,714, filed Mar. 20, 1987, now U.S. Pat. No. 4,804,333, issued Feb. 14, 1989, which is a Continuation of Ser. No. 06/675,949, filed Nov. 28, 1984, now U.S. Pat. No. 4,652,063, issued Mar. 24, 1987. CROSS REFERENCE TO RELATED APPLICATION U. S. Design Application Ser. No. 648,642, filed Sept. 7, 1984 in the names of the same inventors as in the present application. BACKGROUND OF THE INVENTION This invention relates to an electrified vacuum cleaner hose adapter, and more particularly to a hose adapter having a handle portion which is gripable by a user, and which interconnects an electrified vacuum cleaner hose with an electrified vacuum wand and working implement, such as a rug beater or the like. In many instances, various manufacturers of vacuum cleaners make specialized interconnecting devices which are not readily obtainable, or which are obtainable only at relatively high price. On the other hand, many manufacturers make generic replacement parts which are adapted for use with many different types of vacuum cleaners, but not for all. It is the main object of the present invention to provide an electrified vacuum cleaner hose adapter which permits using conventional, relatively low-priced generic type electric hoses in combination with electrified vacuum cleaner attachments such as wands having rug-beaters at the end thereof. SUMMARY OF THE INVENTION According to the present invention, an electrified vacuum cleaner hose adapter for interconnecting an electrified vacuum cleaner hose with an electrified wand or accessory, comprises a generally tubular handle portion which has a first generally tubular portion integral with a second tubular portion, the first and second tubular portions having longitudinal axes which are at an angle with each other; an inlet member coupled to said handle portion and including a tubular section extending from one end of the handle portion and which is receivable in an opening of an electrified vacuum cleaner hose; and an outlet member coupled to the handle portion and including a tubular section extending from the other end of the handle portion and which is receivable in an opening of an electrified vacuum cleaner wand or accessory. The adapter further comprises a first connector connected to the end portion of the handle portion adjacent the inlet member and having electrical contacts for matingly and electrically connecting with an electrical connector of the electrified vacuum cleaner hose; a second connector connected to the end portion of the handle portion adjacent the outlet member and having electrical contacts for matingly and electrically connecting with an electrical connector of the electrified wand or accessory; a pair of electrical conductors extending between and electrically connecting the first and second connectors; and a channel-shaped manually grippable member connected to the handle portion and protruding from the handle portion over a substantial portion of the length of the handle portion and extending between the first and second connector means and defining a channel-shaped covered passage between the connectors, the electrical conductors extending within the covered passage so as not to be exposed to the outside of the covered passage, the protruding portion of the channel-shaped member at least partly defining the covered passage and defining a manually grippable, slip resistant portion of the adapter when the user's hand is gripped around the adapter. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a vacuum cleaner hose adapter according to the present invention; FIG. 2 is a side elevational view thereof; FIG. 3 is a bottom view thereof; FIG. 4 is an end view thereof as seen along the line 4--4 in FIG. 2; FIG. 5 is a left end elevational view thereof with respect to FIG. 2; FIG. 6 is a right end elevational view thereof with respect to FIG. 2; FIG. 7 is a sectional view thereof showing the internal mechanisms and electrical interconnecting means; FIG. 8 is a section taken along line 8--8 in FIG. 7; FIG. 9 is a sectional view taken along line 9--9 in FIG. 7; FIG. 10 illustrates a modified connector member; and FIG. 11 illustrates another embodiment of the outlet member. DETAILED DESCRIPTION Referring to FIGS. 1-6, the electrified vacuum cleaner hose adapter of the present invention generally comprises a substantially tubular handle portion 10 (preferably made of plastic material), a substantially tubular inlet member 12 (preferably made of metallic material) and a substantially tubular outlet member 14 (preferably made of metallic material). A slidable air throttle control 16 is provided for selectively opening and closing an opening 18 in the hose adapter. The air throttle control is generally conventional and does not form a novel feature of the present invention. At the lower portion of the handle portion 10 a channel-type housing 20 is provided with electrified female plugs 22, 24 extending from opposite ends thereof. The housing 20 is preferably retained within notches or cut-outs formed in the handle portion 10 (to be described later) and is secured in place by means of screws 26,28, as best seen in FIG. 3. In use, the inlet member 12 is inserted into a receiving opening of an electrified vacuum cleaner hose which has an electrical connector at the end thereof which electrically and mechanically matingly engages with the plug 24. The parts are preferably adhesively or otherwise fixedly connected together so that the electrified hose and the adapter of the present invention are secured together as an integral unit. The interconnection is preferably by means of an adhesive, but may be by means of screws or other interconnecting elements, as desired. The left hand end or outlet member 14 is insertable into a receiving opening in a vacuum cleaner wand which has a connector at the receiving end thereof, the connector of the wand mating with connector 22 physically and electrically to provide electrical power from the electrified hose, through the adapter of the present invention, and to the wand, which has an electrical implement at the remote end thereof, such as a rug beater. The interconnection of outlet member 14 with the wand is preferably not made permanent. In general usage, the wand is disconnected from the adapter of the present invention for ease of storage of the various parts. Since the electrical connector 22 at the outlet end of the adaptor of the present invention is a female connector, there is no danger of electric shock or the like when the wand is disconnected from the outlet member 14 of the adapter. Since the inlet member 12 is fixedly and permanently received in the hose, there is no danger of electric shock from any exposed electrical connector parts. Referring to FIGS. 7-9, the invention will be described further in greater detail. The handle portion 10 is preferably made of a plastic material (ABS) and is generally of a bent tubular shape. The forward end of the handle portion 10 receives an outlet member 14, which is preferably a tubular metallic member, which is secured within the handle portion 10 preferably by means of a rivet 30, as shown in FIG. 7. Alternatively, the outlet tube 14 may be bonded to the forward end of the handle portion 10, and a rivet can be used to strengthen the bonded interconnection. Similarly, the inlet member 12 is a generally tubular metallic member and is preferably molded directly to the interior of handle portion 10, as shown in FIG. 7. The other surface of portion 12 may be roughened or otherwise conditioned to improve adhesion to handle portion 10 during and after molding. The handle portion 10 has a protrusion 32 extending downwardly therefrom at the outlet end portion thereof, and a protrusion 34 extending downwardly therefrom at the inlet end portion thereof. As seen in FIGS. 8 and 9, the handle portion 10 has grooves 36, 38 formed along the surface thereof between the protrusions 32, 34, and in which the generally U-shaped channel-shaped housing 20 is received. The housing 20 is fixedly and removably connected to the handle portion 10 preferably by means of screws 26, 28. Other connecting means, such as rivets, adhesives or the like, could be used to connect the housing 20 with the handle portion 10. Screws 26, 28 (or rivets) are preferred since not only do these members serve to connect the housing 20 with the handle portion 10, but they also serve to retain the connectors in position in the longitudinal direction of the adapter. The connectors 22,24 have cut-out portions 25,27, respectively, which matingly engage with the protrusions 32,34 of the handle member 10. This mating engagement effectively "locks" and retains the connectors 22,24 in place, and the screws 26,28 serve to securely retain the members in their fixed, locked position. The protrusions 32,34 have different shapes, so that the respective connectors 22,24 are engageable with only a given one of the protrusions 32,34. Protrusion 32 is generally cylindrical and protrusion 34 is generally trapezoidal with flat sides 34'. The flat sides 34' reduces twisting of the connector on the protrusion. The sides of the protrusion 32 may also be flat for the same reason. The handle portion 10 also has stop members 60, 62 molded integrally therewith, against which the rear surfaces of the connectors 22,24, respectively engage. These "stop" members 60,62 inhibit the connectors 22, 24 from moving backward during engagement thereof with their respective mating connectors on the vacuum cleaner hose and wand. The stop members 60,62 are also preferably substantially flat in the plane perpendicular to the page of FIG. 7, and engage with substantially flat rear end surfaces of the connectors 22,24, thereby also preventing twisting of the connectors relative to the handle portion 10, during engagement thereof with mating connectors, and also during use of the device. Extending between connectors 22,24 is a pair of wires 44 which respectively interconnect the pair of receptacles of the connectors 22,24. Thus, electrical power received from a vacuum cleaner hose which is connected at the inlet end 12 is transferred to the receptacles of the connector 24, through the wires 44, to the pin receptacles of the connector 22, and then to the vacuum cleaner wand and electrical accessory through interconnection with the connector 22. While the connectors 22,24 are shown as being female connectors, it should be clear that male connectors may be used for one or both of the connectors 22. To increase safety, in some instances it may be desirable to use a male connector in place of connector 24, which will mate with a live female connector of the electrified vacuum cleaner hose. In the unlikely event of the adapter of the present invention becoming disconnected from the electrified hose, this would prevent exposure of live connectors at the end of the electrified vacuum cleaner hose. The channel-shaped housing 20 has substantially flat side walls 21 which contact substantially flat side walls of the connectors 22,24, as seen in FIGS. 8 and 9. This engagement helps stabilize the connectors 22,24 to further inhibit twisting of the connectors either during interconnection or during use of the device. By virtue of the engagement of the connectors with the respective protrusions 32,34, the end-stops 60,62, the side wall engagement with the channel sides 21 and the locking engagement with the screws 26,28, the connectors 22,24 are firmly held in place to inhibit breakage or movement relative to the adaptor, either during interconnection with other connectors, or during use of the device by a user, even under extreme use and handling conditions. The arrangement of the present invention not only provides proper electrical connection to enable interconnecting a conventional generic-type hose with a vacuum cleaner electrified wand, but also provides a handle member 10 with a convenient hand gripping portion 50 (see FIG. 7). In use, the user's hand grips the handle portion 10 around the area 50, with the fingers of the hand extending over and around housing 20. The downwardly extending portion 51 of the housing 20 serves as a "stop" to prevent the user's hand from inadvertently slipping rearwardly on the handle portion 10, and the forward downwardly extending portion 52 of the housing 22 serves effectively as a "stop" to prevent slipping of the user's hand past the angularly curved forward portion of the adapter. The housing 20 also extends downwardly of the handle portion 10 (see FIGS. 2 and 7). This provides a protruding gripping portion to prevent slipping of the user's hand circumferentially of the handle portion 10. By virtue of the above arrangement of the housing 20 relative to the handle member 10, a convenient and secure gripping of the adaptor of the present invention is achieved, even when the user's hands are dirty, or slippery due to perspiration, grease or the like. Thus, the protruding housing serves not only as a convenient grip-improving member and slippage reducing member, it also serves as the hollow housing for passing the wire between the connectors, without requiring that the air passage through the adaptor of the present invention be reduced to accommodate the wires 44. Since the housing 20 is removably secured to the handle portion 10, the connectors and wire may be replaced, if necessary. Another important feature of the present invention is the angular disposition between the outlet member 14 and the inlet member 12. As seen in FIG. 2, the angle between the center lines of members 12 and 14 is preferably approximately 27°. This provides a very convenient operating angle between the hand gripping portion 50 of the handle portion 10 and the wand which connects to outlet member 14. Other similar angles, such as from about 25 to 30° may be used. The prior art angular relationship of 45° has been found to be inconvenien and more difficult to use. FIG. 10 shows a modified embodiment wherein the connector 22' is enlarged at the portion thereof which extends outwardly from channel 20. This improves the interengagement of the connector 22' with the channel 20 and increases the strength of the resultant arrangement. The connector 22' is shown slightly spaced from the channel member 20 in FIG. 10 for clarity, but in practice, the space 55 does not exist-the connector is preferably in contact with the end of the channel 20. Similarly, the connector 24 at the other end of the adapto can be enlarged at the portion thereof which extends outwardly of the channel. FIG. 11 shows another embodiment of an outlet member 14 to enable the device to be usable with various specific types of vacuum cleaner wands. Referring to FIG. 11, the outlet member 64, the tip end of which is shown for ease of illustration, comprises a spring-mounted button member 66, which engages into a corresponding opening of a vacuum wand (not shown). The button 66 is integral with a leaf spring member 68 which is connected at a depression 70 of outlet member 66 via a rivet 72. The button member 66 springs downwardly in the direction of the arrow 74 during engagement with the vacuum cleaner wand, and springs outwardly when it is in registration with the corresponding opening or hole (not shown) of the vacuum cleaner wand.

1a

FIELD OF THE INVENTION [0001] The present invention is related to radiation therapy systems using multi-leaf collimators, and is particularly related to a leaf sequencing algorithm for treating moving targets and a method of implementing such an algorithm. BACKGROUND OF THE INVENTION [0002] Radiation therapy for cancer treatment has been in use for several decades. Modern radiation therapy systems typically generate high intensity x-rays by bombarding a suitable target with high energy electrons. X-rays are emitted from the target in a generally conical pattern and are initially confined to a generally rectangular beam by moveable, x-ray blocking “jaws” in the head of the system. Typically, the patient is positioned about 1 meter from the x-ray target and, when fully open, the jaws define a square treatment area that is about 40 cm×40 cm at the patient plane. However, in many instances it is important to irradiate only a precisely defined volume conforming to a tumor, thus the target site must be irradiated from multiple angles. Rarely, however, can the system jaws alone be used to implement a suitable treatment plan. While the use of x-rays is the predominant technique for radiation therapy, high energy particles, such as electrons and protons, are also sometimes used. Accordingly, as used herein the term radiation therapy is intended to encompass all such techniques, and the present invention has application to all such techniques. Thus, when reference is made herein to x-rays or radiation, such terms should be also understood to encompass high energy particles. [0003] Multi-leaf collimators (MLCs), such as described in the co-assigned U.S. Pat. No. 4,868,843, issued Sep. 19, 1989, to Nunan, (the disclosure of which is incorporated by reference), have been almost universally adopted to facilitate shaping of the radiation beam so that the beam conforms to the site being treated, i.e., the leaves are adjusted so that the beam conforms to the shape of the tumor from the angle of irradiation. Subsequent to its introduction, the MLC has also been used to perform a technique known as “Intensity Modulated Radiotherapy” (IMRT), which allows control over the radiation doses delivered to specific portions of the site being treated. In particular, IMRT allows the intensity distribution of the radiation reaching the patient to have almost any arbitrary distribution. IMRT can be implemented by iteratively positioning the leaves of the MLC, which form an aperture through which radiation is delivered, to provide desired field shapes which collectively deliver the desired dose distribution. IMRT techniques can either be static (“point and shoot”), in the sense that the leaves do not move when the beam is on or, alternatively, as in systems sold by the assignee of the present invention, be implemented using a “sliding window” approach, in which the leaves of the MLC are moved continuously when the beam is on. IMRT is typically implemented by using an elongated aperture or window that is oriented perpendicular to the direction of leaf motion, as depicted in FIG. 5 . Specifically, in sliding window IMRT the overall speed of leaf motion and the separation of leaf pairs are independently adjusted as the window moves, such that different portions of the treatment field are irradiated with different doses of radiation through an aperture that changes shape as it is being moved. [0004] Radiation therapy is generally implemented in accordance with a treatment plan which typically takes into account the desired dose of radiation that is prescribed to be delivered to the tumor, as well as the maximum dose of radiation which can be delivered to surrounding tissue. Various techniques for developing treatment plans are well known. Preferably, the computer system used to develop the treatment plan provides an output that can be used to control the radiation therapy system, including the MLC leaf movements. Typically, the desired dose prescribed in a treatment plan is delivered over several sessions, called fractions. [0005] Tumors and surrounding tissue, including critical organs, may move in a periodic fashion while a site is being irradiated, for example, as a result of normal respiratory motion. (As used herein “periodic” is meant to have a broad meaning and includes any repeated motion, such as breathing motion, even if irregular.) Heretofore, no effort has been made to take such movement into account when developing a treatment plan and, therefore, movement in the treatment field can have a significant impact on the effectiveness of a treatment plan. A treatment plan that does not take such movement into account may result too much or too little radiation reaching the intended target region and/or too much radiation reaches surrounding tissue. The extent of the problem caused by the mismatch varies, and can range, in extreme cases, from very little radiation delivered to the target to a delivery of several times the intended dose. Other types of deviations from the prescribed radiation delivery may occur, causing additional problems with the effectiveness of the treatment plan. [0006] The quantity of incident radiation, or fluence, delivered is a sum of the radiation allowed through the aperture over the course of the exposure. In the worst case scenario, the target region may receive several times the prescribed dose when the target region movement is in phase with the aperture movement. On the other hand, if movement of the target region is out of phase with the window movement, the tumor may receive a lower than prescribed dose, or no dose. In practice, interplay between these movements has been reported to generate differences of greater than 10% between the delivered and the planned dose distributions for a single fraction. Obtaining the desired biological response in the target region depends upon delivery of the intended fractional dose, thus achieving the planned dose distribution is critical to success of the treatment. SUMMARY OF THE INVENTION [0007] The present invention provides a method of performing intensity modulated radiotherapy (IMRT) for a moving target that reduces the undesirable effects between the beam from a multi-leaf collimator (MLC) and a target region that moves periodically along a path or trajectory. [0008] The inventors have determined that the extent of the moving target problem depends largely on how the target region and the radiation beam delivered through the MLC move in relation to each other. Because the features of the radiation beam (e.g., shape, position, movement) are determined by the leaf sequence, the inventors have further determined that the extent of adverse effects due to mismatch depend on the relationship between the movement of the target region and of the leaves. The target region and the leaves may move at similar or dissimilar speeds and may, or may not be, in phase. [0009] According to a preferred method of the present invention, the trajectory of target motion is, preferably, oriented to be perpendicular to the leaves of the MLC, such that movement of the leaves, and the aperture created by the MLC leaves, is perpendicular to the trajectory of the moving target. The aperture in the MLC through which radiation passes is typically elongate in a direction that is parallel to the target trajectory. The method of the invention produces a much narrower range of variation from the prescribed dose for a given area, which is a significant improvement over prior art models where the dose can be much higher or lower than the intended maximum dose, as discussed above. As a result, the moving target receives a fluence that is closest to the desired fluence. [0010] In summary, the present invention is directed to the generation and use of leaf sequences in a treatment plan where, within each slice on the MLC plane, if a point receives radiation, then all other points irradiated through the same slice that are supposed to receive the same amount or more fluence receive radiation at the same time as that point. Essentially, this approach allows the radiation dose to be built up within each slice such that higher doses of radiation are delivered to gradually smaller regions of the slice, until the maximum for the slice is reached. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1A is a representation of a moving target and the region through which the target moves. FIG. 1B is a representation of the radiation reaching the area of FIG. 1A through an MLC aperture that is not optimized to take into account target motion. [0012] FIGS. 2A and 2B show time lapse representations of the un-optimized sliding window IMRT with apertures parallel to target movement. [0013] FIG. 3 is a representation of radiation reaching the area of FIG. 1A through an MLC aperture according to an embodiment of the present invention. [0014] FIGS. 4A and 4B show time lapse representations of sliding window IMRT according to an embodiment of the present invention. [0015] FIG. 5 is a representation of an MLC showing the leaves forming an aperture. [0016] FIGS. 6A and 6B are a topographical visualization of a hypothetical fluence map delivered to a target region ( 6 A) and along one slice in that region ( 6 B). [0017] FIG. 7 is a representation of a target region having optimized fluence. DETAILED DESCRIPTION [0018] Radiation therapy begins with the development of a treatment plan for delivering a prescribed dose of radiation to a tumor while minimizing the dose of radiation delivered to surrounding tissue. The treatment plan prescribes the amount of fluence each portion of target region should receive, but there are many leaf sequences (i.e., many combinations of leaf movements) that can be used to produce a given fluence. Moreover, treatment plans typically provide for irradiating the target from multiple angles. Heretofore, treatment planning has proceeded on the basis that the treatment volume is stationary while the patient is being irradiated, i.e., target motion was not taken into consideration. Thus, prior art treatment planning made no effort to optimize leaf movements in relation to target motion. As discussed above, the present invention is directed to the problem which arises when the treatment volume moves while being irradiated. In one aspect, the present invention addresses the problem by taking into account the interplay effects between leaf movements and target movements, as discussed herein. [0019] As noted, the treatment volume may move in a periodic fashion along a trajectory. For purposes of the present invention the trajectory of motion is modeled as a single path, even if there is some variation in the actual motion. In most instances, the trajectory of any point in the treatment area can reasonably be approximated by a line segment, although the present invention is not limited to motion along linear trajectories. This trajectory can be projected onto the MLC plane, which is the plane is defined by the face of the MLC closest to the patient. This MLC plane is substantially orthogonal to the center of the radiation beam. FIG. 1A shows a “snapshot” of a portion of a treatment area 4 that moves (sometimes referred to herein as a moving target). Area 4 may be thought of as a tumor or portion of a tumor which is prescribed to receive a certain fractional dose of radiation. The area surrounding target 4 may be, for example, a different region of the tumor for which a different fractional dose is prescribed. Motion of the moving target 4 along a trajectory (as illustrated by the arrows) defines a larger region 2 through which the target moves in a periodic manner. Such motion may be caused, for example, by respiration. In FIG. 1A , the trajectory is a line segment. In many instances, even if the moving target does not follow a linear trajectory, it is possible to obtain the benefits of the present invention by approximating the trajectory as a line. Use of a linear trajectory is simple and convenient, and provides most of the advantages of the present invention when applied to actual treatment cases. More generally the trajectory can be curved, as discussed in further detail below. [0020] FIG. 1B is a “snapshot” representation of the radiation beam 8 projected onto a portion of region 2 through an aperture in an MLC created by opposing leaf pairs. In an unoptimized treatment plan radiation beam 8 may move in a direction that is parallel to the trajectory of the moving target (as indicated by the arrow). In other words, the MLC aperture is orthogonal to the trajectory of target motion. The movement of radiation beam 8 can be in connection with either a sliding window IMRT technique or a point and shoot technique. [0021] FIGS. 2A and 2B illustrate in further detail the interplay effects in an un-optimized sliding window IMRT system. Both figures show a target 4 moving within region 2 along a trajectory, where the sliding window aperture, and hence radiation beam 8 , moves at approximately the same rate. In both cases, direction of movement of beam 8 is generally parallel to the direction of movement of the target 4 and in both figures beam 8 moves from bottom to top. FIG. 2A , shows three positions of target 4 and the radiation beam 8 as they move through area 2 , indicated by time markers t 1 , t 2 and t 3 . In FIG. 2A , since the target 4 moves from top to bottom, while the beam 8 moves from bottom to top at approximately the same speed, the movement results in the target 4 and the beam 8 intersecting generally in the center of region 2 , as shown at time marker t 2 . In this case, movement of the aperture thus provides a dose to target 4 that is approximately equal to the prescribed dose. [0022] In contrast, FIG. 2B shows three positions of the target 4 as both it and beam 8 move from bottom to top at the same speed. Thus, the motions of target 4 and beam 8 are “in phase” with one another. In comparison to FIG. 2A , the movement shown in FIG. 2B results in the continued overlap of beam 8 with target 4 throughout the entire time radiation is delivered to area 2 . This provides a dose that is much greater than the prescribed dose. Indeed, in the situation depicted in FIG. 2B , the dose is several times the prescribed dose. FIGS. 2A and 2B exaggerate the interplay effect due to the fact that the target and beam move at substantially the same speed. Moreover, this makes the phase, i.e., the starting position of the target relative to the beam, critical. Nonetheless, those skilled in the art will understand that the problem of interplay effects due to target motion will cause unoptimized results in many other circumstances. [0023] Unlike the unoptimized MLC orientation of FIGS. 1B , 2 A and 2 B, the present invention orients the MLC to use apertures that are generally parallel to the trajectory of the target movement. One consequence of this orientation is that the apertures are generally longer in the direction of target movement, and preferably extend substantially the length of area 2 . According to an embodiment of the present invention, FIG. 3 shows a radiation beam 10 reaching area 2 through an MLC aperture that extends parallel with and moves perpendicularly to the trajectory that defines region 2 . (Region 2 in FIG. 3 is the same as in FIGS. 1A , 1 B, 2 A and 2 B.) [0024] FIGS. 4A and 4B are similar to FIGS. 2A and 2B , showing the same target 4 movement at times t 1 , t 2 and t 3 ; however, they illustrate an optimized sliding window IMRT according to an embodiment of the present invention, wherein the beam motion and target motion are orthogonal. In FIG. 4A , as target 4 moves from top to bottom in region 2 , beam 10 moves across the region from left to right from time t 1 to t 3 . Thus, the movement of the beam (and hence the MLC slice or aperture) is orthogonal to the target trajectory. As a result, at all times throughout the delivery period at least some portion (e.g., 12 a , 12 b , 12 c ) of the target 4 is receiving radiation. Similarly, as shown in FIG. 4B , when the target 4 moves from bottom to top, sections 14 a , 14 b , 14 c receive radiation as aperture 10 moves across region 2 . Thus, regardless of the phase relationship between the target and the beam, i.e., where target 4 is at the beginning of the radiation delivery, beam 10 will deliver approximately the prescribed dose to the target. Moreover, the dose delivered to the entire region 2 is the same in both cases. [0025] FIG. 5 shows an exemplary MLC plane having a plurality of leaves 16 , arranged in opposing pairs, and an aperture 15 created by selected leaf movements, in well known fashion. Radiation passes through and is shaped by aperture 15 to create beam 10 . In IMRT, aperture 15 is moved continuously (sliding window) or periodically (point and shoot) across the face of the MLC in either of the directions indicated in FIG. 5 . As the aperture is moved its shape may be adjusted to control the fluence to different portions of the treatment volume, i.e., the combined leaf movements may be used, in known fashion, to vary the fluence delivered to the treatment area. An embodiment of the present invention uses leaf sequences wherein the beam through the MLC aperture is generally parallel to the motion of target 4 and substantially equal to the length of region 2 . As beam 10 moves, the configuration of aperture 15 , may be adjusted, thereby allowing additional control over the fluence delivered to the treatment area. [0026] FIG. 6A depicts the fluence delivered to a treatment field in the form of a topographical fluence map 20 , in accordance with an illustrative embodiment of the present invention. The lowest fluence represented in the map is in the generally annular region 18 a , and the fluence increases to a maximum fluence region 18 n . FIG. 6B shows the fluence received in the portion of the treatment area through the slice B-B of FIG. 6A . Slice B-B is aligned with the trajectory of movement. All of the points along slice B-B will receive a fluence that is between the lowest fluence 18 a and a middle fluence 18 c . Using the method of the present invention, the slices are aligned with the trajectory of the target's motion, thus even if a point in slice B-B were moving, it would not receive a higher fluence than the maximum for its slice, the middle fluence 18 c . Accordingly, the present technique has limited the range over which the delivered dose may vary. [0027] The MLC leaf movements of the present invention can be achieved with an algorithm similar to the one described in the co-pending, co-assigned application entitled “Leaf Sequencing Algorithm To Reduce Tongue And Groove Effects” (U.S. patent application Ser. No. ______), the disclosure of which is incorporated by reference. According to the current invention, the leaf sequence is optimized to produce the field of radiation delivery for a moving target that more closely matches the intended dose. To form MLC slices parallel to the target region's movement, the leaves may most easily be oriented to move perpendicularly to that movement, but other orientations are possible. The leaf motion need not be oriented in the same direction as the movement of the aperture, although such orientation may simplify planning. However, there may be competing treatment considerations that make it necessary or desirable orient the MLC such that the angle of leaf movement is not orthogonal to the trajectory. According to an aspect of the present invention, the angle between the elongate apertures formed in the MLC and the trajectory is minimized. [0028] The leaf movement may be perpendicular to the tumor movement (as shown in FIG. 5 ), allowing the leaves to modulate the fluence in all positions in one slice relatively quickly. Ideally, the orientation of the leaves is chosen based on the longest direction of the target field, such that they move perpendicularly to that direction as has been described. However, deciding on the orientation of the leaves is also influenced by the shape of the apertures that need to be formed in view of the shape of the tumor undergoing treatment. This is because some shapes present greater difficulties and can only be formed by a limited number of leaf arrangements. In some cases there will have to be a trade-off between the ideal orientation for the optimized leaf sequence based on the target movement and the physical constraints on the system for the leaves to form an aperture in the shape that is required. In such cases, the dose should be built up using the largest aperture possible that provides the precision needed. [0029] In another embodiment of the invention, the optimization is fine-tuned by controlling the time each movement slice is exposed to radiation through the aperture. For example, if each slice intersects with the open aperture for about the duration of one movement cycle, the dose distribution is closer to the planned average distribution. In a further embodiment, a variable dose rate could be used to better control the exposure time for groups of slices. While timing the dose in this way is effective in conjunction with the present invention, and timing or gating in general is useful in a variety of applications, timing alone is not sufficient to avoid the interplay effects in an un-optimized system. Due to the periodic nature of the target movement and the difficulties in determining the precise location of the target 4 within region 2 at any given time, it is not practical to attempt to avoid phase problems, such as the overlapping situation shown in FIG. 3B , by simply timing the dose. [0030] In a further embodiment of the invention, and as mentioned above, the trajectory of the target region may be curved. When the trajectory is not a simple line segment, but is curved or has some other shape, additional considerations must be taken into account in order to determine the proper orientation for the aperture and the related optimized leaf sequence. The best technique for handling a curved trajectory will depend on the exact shape and other aspects of the system, such as the physical constraints on leaf movement. In some cases, it may be sufficiently accurate and most efficient to simply map the trajectory to a predominant direction—a major axis of the trajectory curve, for example. In other cases, a rigid translation can be used to reduce the trajectories to a single direction, again, such as a predominant direction. This approach might be particularly useful for multiple, non-linear trajectories. Where the trajectory is more complex, it can be obtained from deformable image registration, in which imaging is used to find a best fit. There, features of the target region are matched in order to align the trajectory with a template image. With other complex trajectories, a point-specific movement model might be used to identify the trajectory, such as the use of boundary conditions to model the target region. Once the trajectory has been obtained, if necessary, the trajectory can be mapped or translated into a predominant direction as discussed above. [0031] Ideally, as shown in FIG. 7 , optimization of the sliding window IMRT system produces a fluence 6 that has the same value at all positions where it is possible for the tumor to be. Because target 4 only occupies a portion of region 2 at any one time, this ideal fluence may result in unnecessary irradiation of some portions of region 2 . Specifically, in addition to target 4 , region 2 may include healthy tissue which will be irradiated by the same dose as target 4 . While this is not the most desirable situation, in many situations it is more important to ensure an adequate and even dose to the target 4 than to avoid irradiating the surrounding tissue. In this regard, it should be noted that this unnecessary irradiation of portions of region 2 also occurs using the un-optimized system. For example, in FIG. 3A the entire region 2 is irradiated, although target 4 only occupies a portion of the total area. Thus, except for when target 4 is exposed to the aperture 8 at time t 2 , the remainder of the radiation delivery to region 2 is unnecessary. Accordingly, the present invention provides an improved method for delivering radiation to a moving target, but further improvements to reduce the unnecessary radiation delivered to regions in the trajectory of the target would be beneficial. [0032] The embodiments described above are illustrative of the present invention and are not intended to limit the scope of the invention to the particular embodiments described. Accordingly, while one or more embodiments of the invention have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit or essential characteristics thereof. Accordingly, the disclosures and descriptions herein are not intended to be limiting of the scope of the invention, which is set forth in the following claims.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This Continuation of Application claims the benefit of and priority to U.S. application Ser. No. 14/710,416 titled PEROXIDE GEL COMPOSITIONS filed May 12, 2015, which is in turn a Continuation Application of prior filed U.S. application Ser. No. 12/329,582 titled DENTAL TREATMENT COMPOSITIONS AND CONFORMABLE DENTAL TREATMENT TRAYS USING THE SAME filed Dec. 6, 2008, which is in turn a Continuation-in-part Application of prior filed U.S. Non-provisional application Ser. No. 11/307,463 filed Feb. 8, 2006. The content of each of the aforementioned applications in incorporated herein by reference in their entirety. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to the field of thickeners and more particularly relates to a thickener for the development of a gel for the storage and deliver of peroxide, particularly hydrogen peroxide, for bleaching and other purposes. BACKGROUND OF THE INVENTION [0003] Inorganic peroxide is usually defined as hydrogen peroxide and adducts thereof. Some examples are: hydrogen peroxide, carbamide peroxide, sodium percarbonate, sodium perborate. Peroxide is used in many different applications from an antiseptic for minor wounds to bleach for teeth, hair and laundry. Solutions of varying strengths of hydrogen peroxide are readily on the market, usually in a liquid form. [0004] For targeted bleaching applications, such as tooth whitening, it can be desirable to blend the peroxide into a gel by blending the peroxide with a thickener. Blending is accomplished by mixing the thickener with the peroxide, usually also with water or an appropriate organic solvent. However, due to the volatile oxidizing nature of peroxide (which imparts the substance's bleaching ability); there are very few thickeners that can withstand a peroxide environment. Most polymers will degrade quickly in a peroxide environment and will lose their thickening properties entirely due to the powerful oxidizing effects of peroxide. These gels will degrade into thin, water-type consistencies. It is rare to find a polymer that can withstand, for prolonged periods of time, the powerful effects of peroxide. [0005] Chemists have diluted hydrogen peroxide in order to tame its instability and raw oxidizing power. Liquid hydrogen peroxide is common and is by far the most aggressive oxidizer and the most unstable. Chemists have also produced adducts of hydrogen peroxide to stabilize hydrogen peroxide in the resultant compounds. The main adducts of hydrogen peroxide that are used for bleaching are: urea hydrogen peroxide (carbamide peroxide), sodium perborate, and sodium percarbonate. However, dilution of hydrogen peroxide by any means, while increasing stability, also reduces the bleaching efficacy of resultant gels. Carbamide peroxide contains about 36% hydrogen peroxide by weight. Therefore, a bleaching gel made with about 10% carbamide peroxide (which is an industry standard), yields only about 3% hydrogen peroxide. Sodium percarbonate has an even lower concentration of hydrogen peroxide. The use of these adducts then, generates an instant upper limit to the final concentration of hydrogen peroxide in a product. [0006] Dental whitening manufacturers have predominately been using carbamide peroxide. Carbamide peroxide is docile enough to be used with many polymers that would not work with hydrogen peroxide. The most used commercial thickener, CARBOPOL, is a good example of this. CARBOPOL is a good thickener for carbamide peroxide. However, CARBOPOL does not hold up to pure hydrogen peroxide for even short amounts of time. When CARBOPOL is used in a composition containing 30% hydrogen peroxide, the composition will begin to break down and form peroxide decomposition bubbles in about two weeks. Therefore what is needed is a polymer that is capable of withstanding hydrogen peroxide compositions for moderate amounts of time. [0007] The direct application of these manufactured gels and liquids to the teeth for the purpose of bleaching does have drawbacks. Direct delivery of these gels and liquids onto the teeth can be unsuccessful as they tend to run-off the teeth by the force of gravity. They also are subject to being wiped off quickly by the cheeks and gums. To make matters worse, the saliva is also there to quickly wash and dilute any treatment fluids off of the teeth. While gels may be more resistant to these drawbacks as compared to other liquids, they still have these inherent difficulties. [0008] In order to overcome the difficulties inherent in the direct application of fluidic treatment materials various inventions have been developed. One of the early inventions involved an insoluble barrier that would hold the treatment gels and liquids against the teeth and at the same time protect it against the tongue, cheek and saliva. This resulted in the invention of the plastic dental tray. The major drawback in the concept of a tray is that the variations in teeth anatomy make it very difficult to make and design a generic one-size-fits-all tray. Therefore some of the early trays were designed to fit onto the gums and mechanically pinch the gums in order to hold the tray onto the teeth. These mechanical trays were cumbersome and painful for patient use and became obsolete in favor of the custom tray. The custom tray involves creating an impression of the teeth, followed by casting a mold of said impression. Said mold is then covered with a pre-heated semi-molten plastic sheet with a vacuum in place in order to force the plastic to adapt to the casting's surface. Finally, the post-solidified tray is usually trimmed with scissors into a custom tray for a specific individual. The drawback to the custom tray is the amount of time and resource and effort needed to create one. The biggest drawback inherent in all trays of the prior art is their accompanying use of fluidic treatment gels and liquids. Once a tray is created it must be filled with a fluidic treatment gel or liquid and, most of the time, the patient must do this. [0009] Early dental treatment products were liquids. Liquids were most especially difficult to handle, as they tend to run out of the trays and were easily spilled while filling the trays. Liquids were abandoned as the product of choice in favor of higher viscosity fluidic gels. Gels provide more control over flow characteristics than liquids. A gel can obtain higher viscosities that limit the flow of treatment products thereby allowing the treatment product to remain in the tray better. A gel also adds the benefit of some adhesion between the tray and teeth aiding in holding the tray in place once fitted. The drawback inherent to these fluidic gels and liquids is that they are messy for both patient and practitioner. When these fluidic gels and liquids spill while filling the tray or express out of the tray while fitting and wearing the tray; they are a nuisance and a complaint of patients. These are the drawbacks of fluidic treatment products and trays: a. While filling trays, any spill is messy and a nuisance to clean up. b. When fitting the filled tray onto the teeth, the teeth must displace the treatment fluids and any excess gel or liquid will be forced out of the tray and into the mouth. In the case of gels this becomes especially messy, since it cannot be easily spit or rinsed out. The current procedure calls for a toothbrush to agitate the gel and with copious amounts of dilution water, the patient will eventually work away the excess gel. c. While wearing the trays, the upper teeth constantly come in contact with the lower teeth in a natural repetitive soft biting action. This natural biting action acts as a pump that when compressed will force more messy gel or liquid material out of the tray where it must be cleaned off or drowned in saliva. When the compression ends and the trays relax back into equilibrium it will either begin to empty out the tray and fill it with saliva (so the upper portion of the teeth are not treated) or they begin mixing and dilute the active ingredients. [0013] Another invention of the prior art that is used to deliver treatment gels and liquids is the dental strip. The dental strip is an insoluble flexible plastic strip onto which the treatment fluidic gels have been applied. Liquid treatment products obviously would not work well with strips, since they would just run-off the strip. The dental strip is then applied to the teeth. Current dental strips even incorporate in their design shallow pockets into the plastic strip in order to hold fluidic treatment gels. The lack of these shallow pockets would limit the amount of treatment gel available for actual treatment after fitting the strip in place, as most of the gel would be displaced from a smooth surface during fitting. The drawbacks of these prior art dental strips are again their reliance on gels for functionality. Gels suffer from many of the same problems as trays, in that while fitting and wearing the strip any excess gel that is displaced or pumped out ends up in the mouth as a constant mess. In some respects the strips are worse than the trays, since they are not tray shaped they must hold their shape against the teeth by either the adhesiveness of the gel or the rigidity of the backing material or they tend to unfold off the teeth during use. Strips that use gels also suffer from movement on the teeth during use. The gels act as a slimy lubricant between the teeth and strip, which allows the strip to annoyingly move around while it is being worn. Patients complain when they have to constantly adjust the strip back into place. One of the biggest complaints with strips that use gels is with patients with uneven teeth, the strip tends to favor the tooth that sticks out and fails to contact adjacent teeth creating a gap between the strip and teeth that allows saliva to enter, which dilutes and washes away the gel. [0014] Other disclosed inventions include more rigid or solidified treatment compositions that are set into a tray or onto a backing material. These solidified compositions can be sufficiently rigid as to maintain itself in a tray-like configuration absent their external supports. Others disclose a strip or a tray with a two-part treatment composition that is mixed and applied to the backing material just prior to use. These 2-part prior art compositions are incapable of being combined in a pre-mixed shelf stable treatment device. When combined, the resultant compound eventually sets to a rubber-like consistency and is placed against teeth; however, this is an unstable state. Over time, the compound decomposes into a dry powder and degraded peroxide. This is why this type of prior art system must be separated into 2 parts and mixed only upon patient use. These systems require the patient or clinician to make/mix the rubber-like substance first and then somehow load this same rubber-type consistency compound onto a whitening device prior to application to the patients teeth—this is too cumbersome. [0015] These more rigid treatment compositions are an improvement over gel or liquid compositions, since they resist flow they tend to stay on the backing strip or tray when fitting and wearing the implements. So they do not pump out of the tray or displace out of the dental strip when fitting. However, they do crack and break if flexed. The odd product is the dry or wet type patches that do not have a backing strip or tray. The drawback to patches is that they do not have a barrier between the back of the patch and the mouth; therefore they are again subject to the wiping effect of adjacent oral tissues and the washing and dilution effects of saliva. Another drawback is the lack of barrier means not only the active ingredient is treating the teeth but also treating all the oral tissues on the other side. Many of these active ingredients are irritating or harmful to soft tissue; the patch is not much of an improvement over gels and liquids that are placed in strips or trays. [0016] The drawback to more rigid treatment compositions placed in trays or dental strips is that they are limited to non-toxic, active ingredient stable, water-soluble thickeners of the prior art. Many of these thickeners have physical characteristics so that when they are dried from an aqueous state, they are not ideal for a tray or a dental strip. The ideal thickener would have these characteristics: a. Adhesion in aqueous environment: that when the surface of the more rigid composition becomes wetted it becomes sticky. Many thickeners do not have sufficient stickiness to overcome the forces exhibited while fitting and wearing a tray or strip to uneven teeth. The adhesion should be great enough to hold the backing strip or tray to all varieties of teeth whether straight or crooked. b. Hygroscopic: The water-soluble thickener should be able to resist drying to a powder over long periods of storage before use. Many thickeners tend to dry out even when sealed in their packages over time leaving condensation inside the package or may even just escape the packaging altogether. A hygroscopic thickener allows you to use and keep water in the formulation during storage because hygroscopic gels will retain an aqueous equilibrium of internal water and resist drying to a powder. This amount of internal water can be adjusted as it is directly proportional to the drying temperature; therefore, drying times and temperatures can be adjusted to adjust the visco-elasticity of the final product. Thickeners that dry out are limited to formulations that contain non-volatile solvents to keep them intact. The problem with these formulations is they tend to wet more slowly reducing short-term adhesion. Many thickeners will not even create a gel without water as one of the solvents. c. Compatible with organic solvents: The ideal thickener should be able to incorporate organic solvents to manipulate and adjust various properties. These water-soluble thickeners that can also incorporate organic solvents are adjustable in their elasticity, plasticity, solubility, tackiness and viscosity by the appropriate use of various organic solvents. A water-soluble thickener that does not incorporate organic solvents is left with only water as the modifier of choice. d. Elasticity: The ideal thickener would have sufficient elasticity, without splitting or cracking during storage or while fitting the implement. Some devices of the prior art are of a composition that has a rigidity so as to maintain itself in the shape of its container even when the external support is removed. These compositions have essentially dried out and are solid and brittle. Many rigid compositions of the prior art are dried solids adjacent a strip or tray. The backing strip and tray are usually flexible yet the dried composition is brittle and tends to crack when manipulating the implement. There is a drawback to dry and brittle compositions in that they need lots of water to become hydrated to a point where the active ingredients become “active”. These dry compositions will tend to draw the water out of the initial wetted layer, thus drying out the surface into a less mobile layer. Also many active ingredients are volatile and would simply evaporate when dried; others are only stable in the presence of water and would inactivate the product if it were dried out. Finally a dried composition tends to lose its adhesiveness and become loose from the backing strip or tray and falls out. [0021] What is needed is a thickener that demonstrates all of the above characteristics that can be conjoined to a film, backing strip, backing sheet or tray in order to more efficiently deliver the active ingredients to the teeth and gums. Poly(2-ethyl-2-oxazoline) is a water soluble thickener with ideal properties attuned to the creation of pre-mixed, shelf stable compositions that may take the form of gels, visco-elastic and gelatinous compositions, that are intended to release an active ingredient. These compositions can be matched to a backing material in various designs and shapes such as a tray or dental strip. [0022] The present invention represents a departure from the prior art in that the application of the present invention in peroxide gels allows for higher peroxide concentrations by providing a gel base that is surprisingly stable in a peroxide environment. The resultant gels may use pure hydrogen peroxide at concentrations where only adducts have been used in the prior art, thereby doubling or tripling the resultant concentration of hydrogen peroxide in the finished product while simultaneously providing comparable or superior gel stability. The present invention also presents the gels in a stable, gelatinous, visco-elastic form that is easily packaged and stored, and provides a delivery system for the same. When placed on a flexible backing, the gelatinous active component acts as a flexible adhesive that will adhere to a user's dental arch and have the thickness and elasticity to remain in place. The final product, then, is a conformable dental treatment tray that will shape itself to any particular irregularities of a user's dental arch. Therefore, it is truly customizable for the user, unlike prior art constructs. [0023] For purposes of this Application, the term “gelatinous” shall have the definition given first in the American Heritage Dictionary of the English Language, Fourth Edition, ©2006 by Houghton Mifflin Co.: “resembling gelatin, viscous.” A gelatinous compound shall be a visco-elastic compound having physical deformation properties between a solid and a fluid. A solid shall be defined as a substance that is sufficiently rigid so that it maintains its form indefinitely, independent of any structure or support. A fluid shall be defined as a substance that will conform and coalesce to the shape of a beaker into which multiple samples of the same substance are placed, within 10 minutes, with hand agitation of the container and/or hand mixing with an implement at 25° C. with an atmospheric pressure of 1 ATM. Therefore, a gelatinous compound, as the term is used in this Application, will have some degree of flex and deformation as required to fit inside a container, but will not coalesce so that a specific sample or portions thereof are still determinable. This is particularly evident if a number of discrete units of gelatinous material are placed in a container—they will bend as they contact the container but will not merge into one body. SUMMARY OF THE INVENTION [0024] In view of the foregoing disadvantages inherent in the known types of thickeners for peroxide gels, this invention provides an improved thickener. As such, the present invention's general purpose is to provide a new and improved thickener that is capable of maintaining a gel consistency for a peroxide gel while allowing for higher peroxide concentrations to increase efficacy. [0025] Chemical solutions and gels containing hydrogen peroxide are well known in the art. In principle, the solutions and gels are made by combining a peroxide, solvents and a thickening agent. Varying degrees of viscosity and strength are easily generated by altering the base components' proportions and identities. For the purpose of this application, the preferred embodiment will be described as a dental whitening gel, though many other applications may be easily conceived and should be deemed to be included in this Application and its claims. Such additional applications include bleaching products for hair or laundry, where viscosity may not be as important as with a dental gel, but the principles and invention described herein, namely higher viscosity and bleaching strength, are equally applicable. [0026] The novel thickening agent is Poly(2-ethyl-2-oxazoline). It is a polymer that swells upon absorption of liquids. Poly(2-ethyl-2-oxazoline) creates very viscous gels. There are many different molecular weights of Poly(2-ethyl-2-oxazoline) available commercially. These can be chosen to impart different physical properties to the gel for bleaching and other applications. [0027] Poly(2-ethyl-2-oxazoline) is surprisingly a polymer that is capable of excellent compatibility with peroxide and imparts excellent thick viscous properties to the gel. Experience has shown that a 30% hydrogen peroxide gel made with Poly(2-ethyl-2-oxazoline) stays a gel during six month's storage at room temperature. Poly(2-ethyl-2-oxazoline) is a superior polymer in an oxidizing peroxide environment to current thickening polymers like CARBOPOL, silica, PVP, and polyethylene glycols. [0028] One particular use of the combination of Poly(2-ethyl-2-oxazoline) and peroxide, and the focus of this application, is the creation of a formable dental treatment tray for the purpose of treating teeth. When peroxide is mixed with Poly(2-ethyl-2-oxazoline), with a solvent in the case of powdered peroxides, and the resulting combination is appropriately dried, the resultant product is a hygroscopic, gelatinous, visco-elastic substance that is less adhesive than a gel, is well packaged, relatively inert and behaves well in product production. When water is added to the surface of the substance, the substance regains the adhesiveness lost in the drying process and may be applied directly to a user's teeth in a manner that conforms to that individual user's dental arch. The gels may be applied to a tape-like backing, such as PARAFILM, dried, cut into appropriate shapes, like a strip, and packaged for a particularly effective bleaching tray to be used in clinical or home applications. [0029] Packaging of the product must resist moisture as the hygroscopic nature of the product will tend to absorb atmospheric moisture and alter its visco-elastic qualities. [0030] The more important features of the invention have thus been outlined in order that the more detailed description that follows may be better understood and in order that the present contribution to the art may better be appreciated. Additional features of the invention will be described hereinafter and will form the subject matter of the claims that follow. [0031] Many objects of this invention will appear from the following description and appended claims. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. [0032] As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0033] FIG. 1 is a perspective view of gel being placed on a backing to create a tray according to the present invention. [0034] FIG. 2 is a perspective view of the tray of FIG. 1 being dried. [0035] FIG. 3 is a perspective view of a finished tray. [0036] FIG. 4 is a perspective view of the tray of FIG. 3 , being hydrated. [0037] FIG. 5 is a perspective view of the tray of FIG. 4 , being folded prior to positioning. [0038] FIG. 6 is a perspective view of the tray of FIG. 2 being formed to a user's upper dental arch. DETAILED DESCRIPTION OF THE INVENTION [0039] The preferred embodiments of the peroxide gels used to create the deformable trays according to the precepts of this invention are herein described. It should be noted that the articles “a”, “an” and “the”, as used in this specification, include plural referents unless the content clearly dictates otherwise. [0040] Poly(2-ethyl-2-oxazoline) is commercially available in 50,000, 200,000 and 500,000 M.W. Varying viscosities and longevity of gels may be created based on the amount and weight of Poly(2-ethyl-2-oxazoline) used and the desired strength of peroxide. As a guide, dental gels are preferred to be a viscosity between 1000 and 200,000 centipoise. In such ranges, peroxide concentrations may reach up to 50% hydrogen peroxide using Poly(2-ethyl-2-oxazoline) as a thickener. In its preferred form, a 30% concentration may be obtained with a shelf life of six months at room temperature. The simplest preferred gel is obtained by mixing 50% strength hydrogen peroxide with 200,000 M.W. Poly(2-ethyl-2-oxazoline) in a ratio of 6:4. additional strengths of peroxide gels may be obtained by utilizing additional solvents and different molecular weights of Poly(2-ethyl-2-oxazoline). Some common solvents include: water, ethanol, polyethylene glycols, polypropylene glycols, glycerin, and propylene glycol. Any of these may be added for varying the consistency and properties of the gels created. However, each gel must be developed with the basic limitation that the strength of the peroxide in the gel makes the gel inherently more unstable. [0041] In the present invention, the resultant gels 15 are placed on preformed pieces of a backing 13 , such as PARAFILM (a polymeric wax mixture), as shown in FIG. 1 . The backing provides stability for the resultant substance and a surface with which the tray may be touched for manipulation. The gels 15 are then dried through conventional processes. Typical drying may be performed at temperatures of approximately 37° C. for 12 to 24 hours ( FIG. 2 ). Drying may also take place in any other suitable environment, including those of ambient air, room temperature, lower than room temperature, higher than room temperature, or vacuums. Times and temperatures may vary for individual gel composition. When dried, the gels form a bleaching compound that will conform to a user's dental arches and form a bleaching tray 10 without cracking or breaking ( FIG. 3 ). The resultant compound is visco-elastic, and gelatinous, having a flexibility and consistency similar to the popular confection known as gummi worms, and will deform when removed from the backing material. The resultant tray is initially planar; with a significant body of gelatinous whitening composition adhered to the backing. [0042] In use, FIGS. 4-6 , a user will take a tray 10 and wet it with water 20 . The gel will rehydrate and become more adhesive so that the tray will then be applied to the user's teeth (dental arch 30 ). The user will press and form the tray 10 around the dental arch 30 ( FIG. 6 ), conforming it to the individual shape of the arch 30 and, ideally covering at least one, if not both, sides of the arch 30 . The user may, if desired, pre-fold the tray ( FIG. 5 ) before applying it to the teeth. The tray 10 according to the present invention is therefore totally customizable and formable, creating a buccal wall 53 , a crease/bottom 56 and a lingual wall 59 . These walls and floor conform exactly to the user's dental arch 30 ( FIG. 6 ), mimicking the variations and individualities of a particular user's arch. Once treatment is completed, the user simply removes the tray. Additional water may be needed to complete removal due to the adhesiveness of the tray 10 . [0043] Due to the increased peroxide content in the whitening compound, time of treatment will be less than conventional prior art whitening methods. Treatment may be accomplished in three days, rather than over the course of a week. As always, a second round of treatment may be initiated, but it is recommended that a user wait at least one day between courses of treatment due to the increased potency of the product. Longer treatment times and courses may be utilized with lower concentration peroxide gels and may extend as long as a week of consecutive treatments. [0044] By way of example, the following formulations are supplied as examples of compositions for the gel according to the present invention. A true best mode will be dependent upon the desired attributes of the gels, and eventual trays, created. However these examples of possible gels all have the required consistency and bleaching power required by the present invention. It is, of course, to be understood that the following list is only for illustration and that any variation of these and other gels will fall within the purview of this invention. Accordingly, it is to be understood that those skilled in the art will be capable of formulating an infinite number of possible gels and, as such, this list should not in any way be deemed limiting of the invention. [0045] (Composition in % by weight) [0046] Formula #1 1. 11%—Carbamide Peroxide 2. 43%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 27.5%—Purified or distilled water 4. 16.7%—Ethanol 5. 1.0%—Poly acrylic acid 35% M.W. 100,000 6. 0.3%—Sucralose 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP [0055] Formula #2 1. 17%—Carbamide Peroxide 2. 40%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 25.5%—Purified or distilled water 4. 15.7%—Ethanol 5. 1.0%—Poly acrylic acid 35% M.W. 100,000 6. 0.3%—Sucralose 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP [0064] Formula #3 1. 23%—Carbamide Peroxide 2. 37%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 23.25%—Purified or distilled water 4. 14.7%—Ethanol 5. 1.0%—Poly acrylic acid 35% M.W. 100,000 6. 0.3%—Sucralose 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP 9. 0.25%—Sodium Fluoride USP [0074] Formula #4 1. 27%—Carbamide Peroxide 2. 33%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 25%—Purified or distilled water 4. 13.2%—Ethanol 5. 1.0%—Poly acrylic acid 35% M.W. 100,000 6. 0.3%—Sucralose 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP [0083] Formula #5 1. 17%—Carbamide Peroxide 2. 50%—Poly(2-ethyl-2-Oxazoline) M.W.200,000 3. 20.5%—Purified or distilled water 4. 10.7%—Ethanol 5. 1.0%—Citric acid 35% M.W. 100,000 6. 0.3%—Aspartame 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP [0092] Formula #6 1. 27%—Carbamide Peroxide 2. 33%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 25%—Purified or distilled water 4. 13.2%—Ethanol 5. 1.0%—Malic acid 35% M.W. 100,000 6. 0.3%—phenyl alanine 7. 0.4%—Banana Flavoring 8. 0.1%—Sodium Hydroxide USP [0101] Formula #7 1. 11%—Hydrogen Peroxide 2. 43%—Poly(2-ethyl-2-Oxazoline) M.W.500,000 3. 27.5%—Purified or distilled water 4. 16.7%—Ethanol 5. 1.0%—Poly acrylic acid 35% M.W. 100,000 6. 0.3%—Sucralose 7. 0.4%—Peppermint Oil USP 8. 0.1%—Potassium Hydroxide USP [0110] As can be seen, other ingredients include flavorings and sweeteners, solvents, plasticizers, and other elements for desired effect. It is, of course, readily conceived that other active ingredients may be added to the composition for more desired effects, with or without peroxide. Such active ingredients may include and are not limited to fluoride, desensitizers, anti-microbials, anti-fungals, re-mineralizers, surfactants, nutraceuticals, pharmaceuticals and other medicaments. While it is not as preferred as Poly(2-ethyl-2-Oxazoline), polyvinylpyrrolidone (“PVP”) may be used in this invention with good results. Again, proportions in formulas using PVP will vary according to desired characteristics and purposes. [0111] A specific list of possible additives includes, but is not limited to: [0112] Fluorides—sodium fluoride, potassium fluoride, Stannous fluoride, sodium monofluorophosphate and alkyl fluoroamines. [0113] Desensitizers—potassium citrate, glutaraldehyde, sodium citrate, potassium nitrate, sodium nitrate and Sodium and potassium salts of EDTA, and EDTA. [0114] Anti-microbials—chlorhexidine, chlorhexidine gluconate, benzalkonium chloride, thymol, sodium chlorite, potassium chlorite, triclosan, methyl paraben, propyl paraben, sodium benzoate, benzalkonium chloride, cetyl pyridinium chloride, zinc chloride. [0115] Anti-fungals: Ketoconazole, potassium permangante, terninafine HCL, zinc chloride [0116] Re-mineralizers—potassium sucrose phosphate, sodium sucrose phosphate, sodium phosphate mono basic, sodium phosphate dibasic, sodium phosphate tri-basic, alone or in combination with one or more of the following: calcium fluoride, calcium hydroxide, calcium hydroxy apatite, sodium fluoride, potassium fluoride, sodium monofluorophosphate. [0117] Surfactants—sodium lauryl sulfate, Polysorbates, Lauryl dimethyl amine oxide, Cetyltrimethylammonium bromide, Polyethoxylated alcohols, Polyoxyethylene sorbitan Octoxynol, N, N-dimethyldodecylamine-N-oxide, Hexadecyltrimethylammonium bromide, Polyoxyl 10 lauryl ether, Polyoxyl castor oil, Nonylphenol ethoxylate, Cyclodextrins, Lecithin, Methylbenzethonium chloride. [0118] Pharmaceuticals—Amoxicillin, amoxil, biaxin, cefzil, cipro, levaquin, minocycline, penicillin, tetracycline, trimox, zithromax, astringent alums [0119] Nutraceuticals—ascorbic acid, B-glucan, lutein, gallic acid, aloe vera, lactobacillus acidophilus, zinc, tocopherol, choline, Q-10, B-carotene, lycopene, sodium carbonate, glutathione. [0120] Sweeteners: sucrose, glucose, fructose, phenyl alanine, sucralose, sodium saccharin, xylitol. [0121] Flavors—peppermint oil, methyl salicylate, spearmint oil, cinnamon oil, artificial and natural fruit flavorings like banana flavoring, peach flavoring, and apple flavoring. [0122] Although the present invention has been described with reference to preferred embodiments, numerous modifications and variations can be made and still the result will come within the scope of the invention. Such modifications include increasing or decreasing viscosity and peroxide concentration for various purposes. No limitation with respect to the specific embodiments disclosed herein is intended or should be inferred.

1a

CROSS REFERENCE OF RELATED APPLICATION [0001] This is a non-provisional application that claims priority to U.S. provisional application, application No. 62/289,954, filed Feb. 2, 2016, the entire contents of each of which are expressly incorporated herein by reference. NOTICE OF COPYRIGHT [0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to any reproduction by anyone of the patent disclosure, as it appears in the United States Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND OF THE PRESENT INVENTION [0003] Field of Invention [0004] The present invention relates to a game ball, and more particularly to a game ball with non-slip layer covered around an outer surface of the game ball to provide improved handing and playable characteristics. [0005] Description of Related Arts [0006] Nowadays, game balls, such as football, baseball, and basketball, are very popular in the current market, wherein the game balls are made of different kinds of materials in order to satisfy with customers' need. On the other hand, the game balls, such as water-proof game balls, are customized-made to use in specific playing environment, such as beaches, parks, or playgrounds. [0007] A conventional clothes-made game ball is provided and very common in the current market. The clothes-made game ball is light in weight and cheap in cost, so people from all ages can play with this game ball, and especially for the child and the elder, they won't get hurt by hitting by the clothes-made game ball. However, the clothes-made game ball has the following disadvantage. The clothes-made game balls are not suitable to use in the wet environment. While the clothes-made game balls are played in the wet environment, the water is easily absorbed into a surface of the clothes-made game ball, so that the clothes-made game ball will become very heavy. In addition, since the water is retained in the surface of the clothes-made game balls, the surface of the clothes-made game balls will become very slippery, so it is hassle for the player to catch and throw the water-soaked game balls. Therefore, people will spend too much time to pick up the slippery clothes-made game ball. Furthermore, the surface of the clothes-made game ball is easy to damage during playing. For example, while the clothes-made game balls contact with the ground floor, the friction between the surface of the clothes-made game balls and the ground floor will cause scratches on the surface thereof, so after long-time frequently using, the clothes-made game balls are easily broken and damaged, and then people may frequently bought new game balls to replace the damaged game balls. [0008] Moreover, another improved leather-made game ball is also very popular in the market. The structure of the leather-made game ball is stronger than the clothes-made game ball, so the leather-made game balls cannot be easily damaged during playing. In addition, the surfaces of the leather-made game balls have better friction resistance than the clothes-made game ball, so the leather-made game ball won't be easily slip out during playing while the water contacts with the surface of the leather-made game ball. However, the leather-made game balls have the several disadvantages. The cost of the leather-made game ball is higher than the clothes-made game ball, so the price thereof is relatively expensive. In addition, due to the leather is harder than the clothes, specific machines are required for manufacturing the leather-made game ball. On the other hands, the structures of the leather-made game balls are harder than the clothes-made game balls. It is worth to mention that the leather has less flexibility than the clothes, and the bouncing forces of the leather-made game balls are less than that of the clothes-made game ball, so people usually get hurt by hitting from the leather-made game ball, and at the same time, people lose lots of fun when playing the game balls with less bouncing forces. SUMMARY OF THE PRESENT INVENTION [0009] The invention is advantageous in that it provides a game ball with non-slip layer covered around an outer surface of a ball surface of the game ball to provide improved handing and playable characteristics. [0010] Another advantage of the invention is to provide a game ball with non-slip layer comprising a plurality foam-like stretchable panels and marginal edges of the panels connected and sealed together to form a ball surface, wherein the non-slip layer can be selectively attach or detach on the outer surface of the game ball to provide better friction thereon. [0011] Another advantage of the invention is to provide a game ball with non-slip layer, wherein the non-slip layer can be a non-slip detachable bag which can be selectively cover on different portions of the water sport goods or water toys, such as pool noodles, kickboards, surfboards, water guns, etc. [0012] Another advantage of the invention is to provide a game ball with non-slip layer, wherein the non-slip layer can be attached on surfaces of water sport goods or water toys in order to increase the friction of the surfaces. [0013] Another advantage of the invention is to provide a game ball with non-slip layer, wherein the non-slip layer can be customized-made, so the non-slip layer can be designed as, a mesh, star-like or heart-like, non-slip layer. [0014] Additional advantages and features of the invention will become apparent from the description which follows, and may be realized by means of the instrumentalities and combinations particular point out in the appended claims. [0015] According to the present invention, the foregoing and other objects and advantages are attained by a game ball with non-slip layer comprising; [0016] a plurality of stretchable panels, and marginal edges of the panels connected and sealed together to form a ball surface; and [0017] a non-slip mesh layer attached on the ball surface to provide improved handing and playable characteristics. [0018] In accordance with another aspect of the invention, the present invention comprises a manufacturing method of a game ball with non-slip layer comprising steps of: [0019] 1. Preparing a plurality of stretchable panels having marginal edges; [0020] 2. Attaching non-slip layers on an outer surface of each of the stretchable panels; [0021] 3. Sealing each of the stretchable panels along the marginal edges in an edge-to-edge manner to form a ball surface; [0022] 4. Putting a bladder inside the ball surface to form a game ball with non-slip layer. [0023] Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings. [0024] These and other objectives, features, and advantages of the present invention will become apparent from the following detailed description, the accompanying drawings, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0025] FIG. 1 is a perspective view of a game ball with non-slip layer according to a preferred embodiment of the present invention. [0026] FIG. 2 is a perspective view of a plurality of stretchable panels of the game ball with non-slip layer according to the above preferred embodiment of the present invention. [0027] FIG. 3 is a sectional view of a non-slip layer according to the above preferred embodiment of the present invention, illustrating the non-slip layer is attached on an outer surface of a stretchable panel. [0028] FIG. 4 is an alternative mode of a non-slip layer bad according to the above preferred embodiment of the present invention. [0029] FIG. 5 is a manufacturing method of a game ball with non-slip layer according to the above preferred embodiment of the present invention. [0030] FIG. 6 is an alternative mode of a manufacturing method of a game ball with non-slip layer according to the above preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0031] The following description is disclosed to enable any person skilled in the art to make and use the present invention. Preferred embodiments are provided in the following description only as examples and modifications will be apparent to those skilled in the art. The general principles defined in the following description would be applied to other embodiments, alternatives, modifications, equivalents, and applications without departing from the spirit and scope of the present invention. [0032] Referring to FIG. 1 to FIG. 2B of the drawings, a game ball with non-slip layer according to a first preferred embodiment of the present invention is illustrated, wherein the game ball comprises a plurality of stretchable panels 10 , marginal edges 11 provided on edges of stretchable panels 10 sealed together to form a ball surface 100 , a non-slip layer 12 attached on the ball surface 100 to improve the friction of the ball surface 100 , and a bladder 13 received inside the ball surface 100 . [0033] Preferably, there are four pieces of stretchable panels 10 are sealed with each other, within each of the stretchable panels 10 comprises a pair of marginal edges 11 . The stretchable panels 10 comprise a first to fourth stretchable panels 10 A, 10 B, 10 C, and 10 D, wherein the structures of the four stretchable panels 10 are identical. The first stretchable panel 10 A comprises a pair of marginal edges 11 A, and the second stretchable panel 10 B comprises a pair of marginal edges 11 B, and the third stretchable panel 10 C comprises a pair of marginal edges 11 C, and the fourth stretchable panel 10 D comprises a pair of marginal edges 11 D. [0034] As shown in FIG. 2 , the non-slip layer 12 is attached on each of the stretchable panels 10 of the ball surface 100 by stitching, gluing, hot melting technology, etc., wherein the non-slip layer 12 can be made of durable and flexible materials in order to improve the hardness of the ball surface 100 of the game ball. Preferably, the non-slip layer 12 can be a mesh layer attached on the stretchable panels 10 of the game ball to provide better friction force of the ball surface 100 . Moreover, non-slip layer 12 with different color and patterns can be customized based on the customers' needs. For example, cartoon images or pictures can be printed on the non-slip layer 12 to not only increase the friction force of the ball surface 100 , but also improve aesthetic effects of the game ball. Furthermore, the mesh of the non-slip layer 12 can be designed as heart-like or star like meshes. [0035] Accordingly, one of the pair of the marginal edges 11 A of the first stretchable panel 10 A is sealed with one of the pair of the marginal edges 11 B of the second stretchable panels 10 B. And, the other of the pair of the marginal edges 11 A of the first stretchable panels 10 A is sealed with one of the pair of the marginal edges 11 D of the fourth stretchable panels 10 D, so as to connect the first stretchable panels with the second and fourth stretchable panels. In addition, the other of the pair of the marginal edges 11 B, 11 D of the second and fourth stretchable panels 10 B, 10 D are sealed with the pair of the marginal edges 11 C of the third stretchable panels 10 C respectively, so as to connect the third stretchable panel 10 C with the second and fourth stretchable panels 10 B, 10 D. On the other hand, the first to fourth stretchable panels 10 A, 10 B, 10 C, 10 D are sealed with each other to form the ball surface 100 . [0036] As shown in FIG. 1 , the ball surface 100 comprises an inflating hole 101 to inflate air into the bladder 13 . In addition, the bladder 13 comprises a inflation unit 131 arranged align with the inflating hole 101 to communicate with the ball surface 100 , so the air can be inflated into the bladder 13 through the inflating hole 101 and the inflation unit 131 . It is worth to mention that the inflation unit 131 is made of elastic and flexible material materials, and a diameter of the inflating unit 131 of the bladder 13 is slightly larger than a diameter of the inflatable hole 101 . Therefore, when the bladder 13 is received inside the ball surface 100 , the inflating unit 131 is deformed and passed through the inflatable hole 101 of the ball surface 100 , and after the inflating unit 131 is passed through the inflatable hole 101 , the inflating unit 131 reinstates to its original shape, and is locked on the inflatable hole 101 , so the bladder 13 can be remained at a fixed position without sliding inside the ball surface 100 . Therefore, the inflation unit 131 of the bladder 13 is not only used to inflate the bladder, but also used to affix the bladder 13 at a fixed position. [0037] Alternatively, as shown in FIG. 4 , an alternative mode of the non-slip layer 12 according to the above preferred embodiment of the present invention is illustrated, wherein a structure of the game ball in this alternative mode is the same, excluding a configuration of the non-slip layer 12 . In this alternative mode, the non-slip layer 12 is a non-slip layer bag 12 ′ having an bag opening 121 ′, and the game ball can be put inside the non-slip layer bag 12 through the bag opening 121 ′. On the other hand, the non-slip layer 12 ′ and the game ball are two separated items. Preferably, the non-slip layer 12 ′ is a non-slip detachable bag which can be selectively cover on the ball surface 100 of the game ball. Therefore, the player can use the game ball individual without non-slip layer 12 ′ in a normal playing environment, and after the non-slip layer 12 ′ is coved on the ball surface 100 ′ of the game ball, the game ball with non-slip layer 12 ′ can be used in wet and moist environment. It is worth mentioning that the non-slip layer bag 12 ′ is made of elastic materials, so when the non-slip layer bag 12 ′ is not in use the non-slip layer bag 12 ′ can be folded and stored in a compact size. And, when the game ball is putting inside the non-slip layer bag 12 ′, the non-slip layer bag 12 ′ is expanded to closely overlap on the outer surface of the ball surface 100 . [0038] A shape of the non-slip layer bag 12 ′ is shaped like the game ball. In order to deposit the game ball into the non-slip layer bag 12 ′, a diameter “w” of bag opening 121 ′ of the non-slip layer bag 12 ′ is changed while the game ball is depositing inside the non-slip layer bag 12 ′, wherein a maximum value of the diameter “w” of bag opening 121 ′ is slighting larger than a sectional radius “W” of the game ball. If the diameter “w” of the bag opening 121 ′ of the non-slip layer bag 12 ′ is much more larger than the diameter of the sectional radius “W” of the game ball, the non-slip layer bag 12 ′ is covered on the outer surface of the ball surface in an un-tightly state. Otherwise, the game ball cannot be received inside the non-slip layer bag 12 ′ if the diameter “w” of bag opening 121 ′ is smaller than the sectional radius “W” of the game ball. [0039] Accordingly, the non-slip detachable layer 12 can be attached on different portions of sport goods to improve the friction force thereof. For example, the non-slip detachable layer 12 ′ can be attached on handles of rackets in order to increase the friction force during the players are holding on the handles thereof. And, the non-slip detachable layer 12 can be attached on surfaces of the Frisbee or snowboards. Especially in the water sport goods or toys, such as noodle, handles of the water guns and water paddles, kickboards, surfboards and drive toys, the non-slip layer 12 can be applied thereon to provide better friction forces while the water sport goods are contacted with water during playing. [0040] Referring to FIG. 5 of the drawings, a manufacturing method of the game ball with non-slip layer according to a second preferred embodiment of the present invention is illustrated, wherein the manufacturing method comprising steps of: [0041] 1. Preparing a plurality of stretchable panels 10 having a plurality of marginal edges 11 ; [0042] 2. Attaching non-slip layer 12 on each of the stretchable panels 10 ; [0043] 3. Sealing each of the stretchable panels 10 together along the marginal edges 11 to form a ball surface 100 ; [0044] 4. Putting a bladder 13 inside the ball surface to form a game ball with non-slip layers 12 . [0045] In step 1, the number of the stretchable panels 10 is four, and each of the stretchable panels 10 comprises a pair of marginal edges 11 . [0046] Accordingly, the stretchable panels 10 comprise a first to fourth stretchable panels 10 A, 10 B, 10 C, and 10 D, wherein structures of the four stretchable panels are identical. The first stretchable panel 10 A comprises a pair of marginal edges 11 A, and the second stretchable panel 10 B comprises a pair of marginal edges 11 B, and the third stretchable panel 10 C comprises a pair of marginal edges 11 C, and the fourth stretchable panel 10 D comprises a pair of marginal edges 11 D. [0047] In step 2, the non-slip layer 12 is attached on each of the stretchable panels of the ball surface 100 by stitching, gluing, hot melting technology, etc., wherein the non-slip layer 12 can be made of durable materials in order to improve the life-span of the ball surface 100 of the game ball. [0048] In step 2, the non-slip layer 12 can be a mesh layer. Moreover, the non-slip layer with different color and patterns of 12 can be customized based on the customers' needs. For example, cartoon images or pictures can be attached on the non-slip layer 12 to not only increase the friction force of the ball surface 100 , but also improve aesthetic effects of the game ball. Furthermore, the mesh of the non-slip layer 12 can be designed as heart-like or star like meshes. [0049] In step 3, one of the pair of the marginal edges 11 A of the first stretchable panel 10 A is sealed with one of the pair of the marginal edges 11 B of the second stretchable panels 10 B. And, the other of the pair of the marginal edges 11 A of the first stretchable panels 10 A is sealed with one of the pair of the marginal edges 11 D of the fourth stretchable panels 10 D, so as to connect the first stretchable panels with the second and fourth stretchable panels. In addition, the other of the pair of the marginal edges 11 B, 11 D of the second and fourth stretchable panels 10 B, 10 D are sealed with the pair of the marginal edges 11 C of the third stretchable panels 10 C respectively, so as to connect the third stretchable panel 10 C with the second and fourth stretchable panels 10 B, 10 D. On the other hand, the first to fourth stretchable panels 10 A, 10 B, 10 C, 10 D are sealed with each other to form the ball surface 100 . [0050] In the step 4, the ball surface 100 comprises as inflatable hole 101 , and the bladder 13 comprises an inflating unit 131 , wherein the inflating unit 131 can be interlocked with inflatable hole 101 to connect the ball surface 100 and the bladder 13 . [0051] Referring to FIG. 6 of the drawings, a manufacturing method of a game ball with non-slip layer according to a third preferred embodiment of the present invention is illustrated, wherein the manufacturing method comprises the steps of: [0052] 1. Preparing a plurality of stretchable panels 10 having marginal edges 11 ; [0053] 2. Sealing each of the stretchable panels 10 together along the marginal edges 11 to form a ball surface 100 ; [0054] 3. Putting a bladder 13 inside the ball surface to form a game ball; and [0055] 4. Putting the game ball inside a non-slip layer bag 12 ′ through a bag opening 121 ′. [0056] In step 1, the number of the stretchable panels 10 is four, and each of the stretchable panels 10 comprises a pair of marginal edge 11 . [0057] Accordingly, the stretchable panels 10 comprise a first to fourth stretchable panels 10 A, 10 B, 10 C, and 10 D, wherein structures of the four stretchable panels are identical. The first stretchable panel 10 A comprises a pair of marginal edges 11 A, and the second stretchable panel 10 B comprises a pair of marginal edges 11 B, and the third stretchable panel 10 C comprises a pair of marginal edges 11 C, and the fourth stretchable panel 10 D comprises a pair of marginal edges 11 D. [0058] In step 2, one of the pair of the marginal edges of the first stretchable panel 10 A is sealed with one of the pair of the marginal edges 11 B of the second stretchable panels 10 B. And, the other of the pair of the marginal edges 11 A of the first stretchable panels 10 A is sealed with one of the pair of the marginal edges 11 D of the fourth stretchable panels 10 D, so as to connect the first stretchable panels with the second and fourth stretchable panels. In addition, the other of the pair of the marginal edges 11 B, 11 D of the second and fourth stretchable panels 10 B, 10 D are sealed with the pair of the marginal edges 11 C of the third stretchable panels 10 C respectively, so as to connect the third stretchable panel 10 C with the second and fourth stretchable panels 10 B, 10 D. On the other hand, the first to fourth stretchable panels 10 A, 10 B, 10 C, 10 D are sealed with each other to form the ball surface 100 . [0059] In the step 3, the ball surface 100 comprises as inflatable hole 101 , and the inflatable bag 13 comprises an inflating unit 131 , wherein the inflation unit 131 can be interlocked with inflatable hole 101 to connect the ball surface 100 and the inflatable bag 13 . And, the bladder 13 can be inflated through the inflatable hole 101 and the inflation unit 131 . [0060] In step 4, the non-slip layer bag 12 ′ and the game ball are two separated items. Preferably, the non-slip layer 12 ′ is a non-slip detachable bag which can be selectively cover on the ball surface 100 of the game ball. [0061] In the step 4, the non-slip layer bag 12 ′ is made of elastic materials and shaped like a game ball, so when the non-slip layer bag 12 ′ is not in use the non-slip layer bag 12 ′ can be folded and stored in a compact size. And, when the game ball is putting inside the non-slip layer bag 12 ′, the non-slip layer bag 12 ′ is expanded to closely overlap on the outer surface of the ball surface 100 . [0062] In order to deposit the game ball into the non-slip layer bag 12 ′, a diameter “w” of bag opening 121 ′ of the non-slip layer bag 12 ′ is changed while the game ball is depositing inside the non-slip layer bag 12 ′, wherein a maximum value of the diameter “w” of bag opening 121 ′ is slightly larger than a sectional radius “W” of the game ball. [0063] One skilled in the art will understand that the embodiment of the present invention as shown in the drawings and described above is exemplary only and not intended to be limiting. [0064] It will thus be seen that the objects of the present invention have been fully and effectively accomplished. The embodiments have been shown and described for the purposes of illustrating the functional and structural principles of the present invention and is subject to change without departure from such principles. Therefore, this invention includes all modifications encompassed within the spirit and scope of the following claims.

1a

[0001] The present invention relates to devices to exercise and strengthen the musculature of the body, mobilise the joints and train the nervous system for better balance and proprioception. BACKGROUND [0002] In conditioning the body for body weight, weight bearing exercise, it is often desirable and necessary to use certain exercise devices to support and carry part of the body weight. The exercise or stability ball is perhaps the most common device used in this capacity and many devices exist where a planer surface rolls bi-directionally in a planer motion within track; the pilates reformer, the SRF Board and the Total Gym and Gravity System are common examples. [0003] The limitation of an exercise ball is that while it rolls in any direction on a planer surface, it does so in an axial motion meaning that as the user reaches the end of range of a movement, they lose contact with the device. The limitation of devices running in tracks is that they are limited to two directions and one plane of motion and also limited to the length of the track or base. [0004] Some devices are known which allow for limited multidirectional movement over a supporting surface, but typically these are supported on four rolling elements such as castors. This configuration has a high propensity for a device so constructed to tip or flip in certain applications, especially when a supported limb of a user approaches the outer edge of the platform of the device. [0005] Other limiting features of these designs include; Handles or irregular padding on the outer rim or on the upper surface which direct and limit the manner and direction in which the exercises are applied. A generally non uniform upper supporting surface Limitations on the use of the entire working area of the upper supporting surface in this instance referring to inability of the user to significantly change the angle and point of contact of the supported limb and body part Support offered by the handles or padding generally directs the user towards short lever body weight exercises supporting the elbows and knees but less optimally the hand/s or foot/feet. [0010] The above product design features and limitations do not facilitate free movement or expression, do not support continuous changes of direction of every major joint through every angle and plane of movement and do not offer the stability to move in every direction while changing the contact point of the supported limb without flipping or tipping. [0011] It is an object of the present invention to address the above disadvantages, or at least provide a useful alternative. Notes [0000] 1. The above discussion of the prior art in the Background of the invention, is not an admission that any information discussed therein is citable prior art or part of the common general knowledge of persons skilled in the art in any country. BRIEF DESCRIPTION OF INVENTION [0013] Accordingly, in a first broad form of the invention, there is provided an exercise device for exercising the human body; said exercise device consisting of a unitary platform and at least five omnidirectional rolling elements attached at an underside of said unitary platform; said at least five rolling elements permitting omnidirectional movement of said device over a supporting surface. [0014] Preferably said device characterized in that each tipping axis of said device is no longer than 0.6D, where D is the maximum dimension which can be measured between opposing edges of said single platform. [0015] Preferably, each said tipping axis is defined as a line joining points of contact between adjoining ones of said at least five omnidirectional rolling elements and a supporting surface. [0016] Preferably, said at least five omnidirectional rolling elements form an equi-spaced array. [0017] Preferably, each of said omnidirectional rolling elements is located proximate a periphery of said platform. [0018] Preferably, an overhang area of said periphery beyond a said tipping axis is such that, in normal use, a force applied by a body weight of a user at said periphery, is unlikely to urge said device into a tilting motion about said tipping axis. [0019] Preferably, said at least five omnidirectional rolling elements comprise between six and eight omnidirectional rolling elements. [0020] Preferably, said platform is a circular platform; said platform having a substantially planar surface. [0021] Preferably, said platform is a circular platform; said platform having a concave central portion. [0022] Preferably, said circular platform is provided with a rim at the periphery of said platform; said rim assisting to urge a user's contact with said platform inboard of said rim. [0023] Preferably, said concave central portion is provided with a pattern of raised annular ridges; said annular ridges providing grip for greater retention of contact between said platform and a said body portion of a user. [0024] Preferably, said concave central portion is covered by a replaceable mat of resilient material; said resilient material including thermoplastic rubber or expanded EVA/PVS (closed cell) foam. [0025] Preferably, said omnidirectional rolling elements are swivelling castors. [0026] Preferably, said swivelling castors are low offset and low profile castors; swivel axes of said castors mounted adjacent said periphery. [0027] Preferably, said rim provides a covering for pintle bolts securing said castors to said platform. [0028] Preferably, wheels of said castors are of a non marking resilient material. [0029] In another broad form of the invention, there is provided an exercise device for exercising the human body; said exercise device including a platform and an equi-spaced array of at least five omnidirectional rolling elements supporting said platform; said at least five omnidirectional rolling elements permitting omnidirectional movement of said device over a supporting surface, characterized in that no angle, subtended at the centre of said array by a line between swivelling centres of adjoining ones of said omnidirectional rolling elements, is greater than 72 degrees. [0030] Preferably, a line joining points of contact of adjoining ones of said omnidirectional rolling elements defines a tipping axis of said device; the length of a said tipping axis being no greater than 0.6D, where D is the maximum dimension which can be measured between opposing edges of said platform. [0031] In yet a further broad form of the invention, there is provided a method of preventing tipping of an exercise device for exercising the human body; said exercise device comprising a circular platform mounted on an array of at least five omnidirectional rolling elements; said method including the steps of: (a) mounting said circular platform on at least five said omnidirectional rolling elements, (b) positioning said rolling elements proximate the periphery of said circular platform, and wherein lines between points of contact of adjoining ones of said omnidirectional rolling elements are not greater in length than 0.6D, where D is the diameter of said circular platform. [0035] In still another broad form of the invention, there is provided an exercise device for exercising the human body; said exercise device including a platform and an equi-spaced array of at least five omnidirectional rolling elements supporting said platform; said at least five omnidirectional rolling elements permitting omnidirectional movement of said device over a supporting surface, characterized in that said platform is polygonal in shape; sides of said polygon equalling said at least five rolling elements and wherein each of said rolling elements is located proximate a corner of said platform; each tipping axis of said device being substantially equal in length to a said side of said polygon. [0036] Preferably, said polygon is an octagon and wherein said at least five rolling elements comprise eight rolling elements. [0037] In a further broad form of the invention, there is provided an exercise device for exercising the human body; said exercise device including a platform and an equi-spaced array of at least five omnidirectional rolling elements supporting said platform; said at least five omnidirectional rolling elements permitting omnidirectional movement of said device over a supporting surface, characterized in that each of said rolling elements is mounted to an outrigger element extending from a periphery of said platform; the arrangement being such that each tipping axis of said device lies beyond said periphery. [0038] Preferably, said platform is circular. [0039] Preferably, said platform is octagonal; one outrigger elements extending from each corner of said octagon. BRIEF DESCRIPTION OF DRAWINGS [0040] Embodiments of the present invention will now be described with reference to the accompanying drawings wherein: [0041] FIG. 1 is a perspective view of a preferred embodiment of the exercise device according to the invention, [0042] FIG. 2 is a perspective of an alternative upper structure arrangement of the exercise device of FIG. 1 , [0043] FIG. 3 is an illustration of the geometric principles underlying the stability of the device of FIG. 1 when provided with a minimum of five omnidirectional rolling elements, [0044] FIG. 4 is a further illustration of the geometric principles when the device is provided with eight omnidirectional rolling elements, [0045] FIG. 5 is a perspective view of a second preferred embodiment of the invention, [0046] FIG. 6 is view from below of the exercise device of FIG. 5 , [0047] FIG. 7 is a perspective view of a third preferred embodiment of the invention, [0048] FIG. 8 is a perspective view of a further preferred embodiment of the invention showing a circular unitary platform, [0049] FIG. 9 is a perspective view of a further preferred embodiment of the invention showing a polygonal unitary platform, [0050] FIG. 10 is a top view of the embodiment of FIG. 8 , [0051] FIG. 11 is a top view of the embodiment of FIG. 9 , [0052] FIG. 12 is a view from below of the embodiment of FIGS. 9 and 11 , [0053] FIG. 13 is a view from below of the embodiment of FIGS. 8 and 10 , [0054] FIGS. 14 to 17 are views of a single device according to the invention in one example of use in which both feet are placed on the platform, [0055] FIGS. 18 and 19 are views of the device in use in which a single foot is placed on the platform, [0056] FIG. 20 is a view of the device in use in which the hands are placed on the platform, [0057] FIG. 21 is a view of the invention in use in which two devices are used simultaneously. [0058] FIGS. 22 and 23 show a further alternative embodiment of the device. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS First Preferred Embodiment [0059] With reference to FIG. 1 , the exercise device 10 of the present invention in a first preferred form, comprises a unitary platform 12 (that is, one single platform) at an underside of which are attached at least five omnidirectional rolling elements 14 . Preferably, platform 12 is circular as shown in FIG. 1 and may have a generally planar upper surface 22 . Preferably the device 10 is provided with eight omnidirectional rolling elements 14 in the form of castors 16 . Platform 12 may be fabricated from any suitable material such as for example, injection moulded polymer, laminated plywood or solid timber, and die-cast metal alloy. [0060] Omnidirectional rolling elements 14 are mounted as close as possible to the periphery 18 of platform 12 , and form an equi-spaced array. A feature of the exercise device of the invention is that its inherent stability is defined by the relationship of each of the tipping axes 20 of the device to the maximum dimension which may be measured between opposing edges of the platform. [0061] A tipping axis 20 is defined as the line joining the points of contact 24 with a supporting surface, of adjoining rolling elements. In the case of the minimum number of five rolling elements equally spaced in an array, the angle supported by a tipping axis at the centre of the array is 72 degrees. A limiting feature of the present invention includes that the angle subtended by a tipping axis of the device at the centre of the array of equally spaced rolling elements cannot be greater than 72 degrees. [0062] An object of the invention is to limit the propensity for tipping of the device to the point, where in normal use, the weight of a user's body, or portion thereof, placed anywhere on the device, is unlikely to cause tilting or tipping of the device. To this end the at least five omnidirectional rolling elements 14 of the device 10 are mounted as close to the periphery 26 of platform 12 as mechanical constraints permit. [0063] In the preferred embodiment shown in FIGS. 1 and 2 , the rolling elements 14 are swivelling castors 16 , the pintles 28 of which are located closely proximate the periphery 26 of platform 12 . Preferably, castors 16 are low offset castors, that is the distance between the vertical pintle (or swivelling) axis 30 of the castor and its horizontal wheel axis 32 is a minimum required for the castor to swivel according to the direction of motion applied to the vertical pintle axis. This ensures that the circle of rotation of the castor about its swivel axis 30 is kept to a minimum. This in turn maintains the footprint defined by the points of contact 24 of the castor wheels 34 with the supporting surface closely coextensive with the platform of the device, as can be seen in FIG. 3 . [0064] FIG. 3 shows the relevant geometric relationship between the castor wheel point of contact footprints 110 , the maximum length of a tipping axis 120 for a circular platform, and the minimum five rolling elements of the device 100 . It can be shown that for practical purposes the ratio of the tipping axis 120 to the maximum dimension of the platform 112 , in this case the diameter D, is approximately 0.6D. It is a further limiting feature of the present invention that the length of any tipping axis is not greater than 0.6D. [0065] FIG. 4 shows the equivalent geometry for the preferred array of eight omnidirectional rolling elements which clearly indicates that any number of rolling elements greater than five will have a tipping axis length shorter than 0.6D. It will also be understood from a comparison of FIGS. 3 and 4 that the commensurate overhang area 122 (and hence the propensity for tipping) decreases with the increasing number of rolling elements. [0066] Turning now again to FIGS. 1 and 2 , preferably, the castors 16 are low profile castors to keep the upper surface as low as possible. Castors 16 also preferably incorporate relatively wide profile wheels 34 , the outer rim of which at least is of a resilient non-marking material, such as polyurethane of 50 ShoreA hardness for example. The castor chassis may be of pressed metal, stainless steel or aluminium, or be a metal casting, or even of injection moulded plastic. [0067] FIG. 2 shows a further preferred upper surface in which the central portion is concave and provided with a number of raised annular rings or ridges 35 to provide a better grip for the limb or portion of a user's body resting on the device. The raised rings may be integral with the surface of the concave central portion 36 , or is preferably formed as a concave mat of resilient material such as a thermoplastic elastomer (TPE) of 30 to 60 ShoreA hardness, expanded EVA/PVC (closed cell) foam. It could also be formed of a self adhesive layer of high friction of coefficient material such as the “sandpaper” surface used in skateboards. In at least one preferred arrangement, the mat covering the central portion 36 is a replaceable item and may be provided in a number of selectable material and patterns. [0068] Raised outer peripheral rim 38 covering the attachment pintle bolts of the castors, assists to urge a user's contact with the device inboard of the rim. Second Preferred Embodiment [0069] With reference to FIGS. 5 and 6 , in this second preferred embodiment, the platform 112 is in the form of a polygon, preferably an eight-side regular polygon or octagon. In this arrangement the omnidirectional rolling elements 114 are located proximate each corner 119 of the platform 112 , as close to each corner 119 as the mechanical constraints of mounting the rolling elements will permit. [0070] It can be inferred from FIG. 6 that the maximum overhang 140 of the platform 112 beyond any tipping axis 120 is much reduced, and that the tipping axes are substantially equal to the length of the sides of the polygon. In the preferred use of castors as rolling elements, it is a function of the proximity of the mounting position of the castor swivel axis to the platform periphery, the offset distance of the castor wheel point of contact to the swivel axis and the disposition of the castor wheels at any given instant. Third Preferred Embodiment [0071] In a third preferred embodiment of the present invention, with reference to FIG. 7 , the device 210 again comprises a platform 212 which may be circular (as shown in FIG. 7 ) or polygonal, and which is supported by at least five omnidirectional rolling elements 216 . In this embodiment however the rolling elements 216 are mounted to outrigger elements 217 extending from the periphery of platform 212 . [0072] In the arrangement of FIG. 7 the outrigger elements 217 are equally spaced around the periphery of platform 212 . In the instance of a polygonal platform, an outrigger element is located at each corner of the platform. Preferably the omnidirectional rolling elements are castors having the same low profile and low offset as those described above. The length of each outrigger element 217 is such that each tipping axis 220 (as defined above) lies completely beyond the periphery 242 of platform. [0073] This arrangement provides that the device cannot be tipped about a tipping axis by any application of the body weight of a user at any point on platform 212 . Fourth Preferred Embodiment [0074] In a fourth preferred embodiment of the invention with reference to FIGS. 8 to 11 , the exercise device 200 is again comprised of a single piece, unitary construction, platform 210 , surmounting at least five, preferably eight, rolling elements 212 . Platform 210 may be circular as shown in FIG. 8 or in the form of a regular polygon as shown in FIG. 9 . [0075] Preferably, platform 210 has a slightly concave upper surface 214 , unobstructed by handles, strap attachment points or other projections or indentation. The platform 210 is of a size that allows two limbs, for example two hands or two feet of a user as can be seen in FIGS. 14 to 17 and FIG. 20 to be placed in any desired position on the surface 214 simultaneously. Moreover, the platform 210 preferably is large enough to allow a repositioning of one or both of the limbs supported on it as the device 200 is in rolling motion over a supporting surface. Preferably, the maximum dimension of the platform from a point on the periphery 216 to a diametrically opposite point, is not less than 34 cm. [0076] The unitary platform 210 may be formed from various materials and manufactured in various ways. These include wood, for example as moulded plywood, plastic formed through injection moulding or metal formed by pressing or die casting. [0077] The rolling elements 212 are preferably low-profile castors and are mounted with their swivel or pintel axes 218 as close to the periphery 216 of the platform 210 as mechanical constraints permit. [0078] With reference now to FIGS. 12 and 13 , at any time, a line between the contact points of two adjacent castor wheels 212 with a supporting surface, defines a tipping axis 220 of the device 200 , and the polygon defined by all the tipping axes 220 forms the “footprint” of the device on the supporting surface. [0079] It can be seen from FIGS. 12 and 13 that the disposition of the tipping axes 220 , and hence that of the footprint relative to the platform 210 , changes with the instantaneous direction of movement of the device when in use. It will also be appreciated that the greater the number, and therefore the closer the spacing of the rolling elements 212 at the periphery 216 , the closer the footprint and the platform become to being substantially coextensive. With the preferred number of eight equally spaced rolling elements 212 mounted with their swivel axes 218 in close proximity to the platform periphery 216 , the platform and the footprint are substantially coextensive, as can be seen particularly in the case of the polygonal platform in FIG. 12 . If the platform 200 is a regular polygon in shape, with the swivel axes 218 of the castors located sufficiently close to the corners 222 of the polygon as shown in FIG. 11 , at least some of the tipping axes 220 at any one time will be substantially coincident with the periphery 216 of the platform 210 when seen in plan view. [0080] In at least one preferred arrangement of the present embodiment, in which the platform is octagonal with each of the castors located in close proximity to the corners of the platform, at least one tipping axis lies beyond a side of the platform (when seen in plan view) for at least some of the time when the device is in motion 2 . This situation can be seen in FIG. 12 . [0081] As well, as also can be seen in each of FIGS. 10 to 13 , at least some portions of some of the rolling elements at the trailing edge of edges of the platform 210 , relative to the direction of motion, will project past the periphery 216 of the platform. [0082] It is a feature of the present preferred embodiment that, with eight rolling elements 212 in which the swivel axes 218 are mounted in close proximity to the periphery 216 , the length of any tipping axis 220 is not less than 0.35D, where D is the maximum length between any first point on the periphery of the platform and a second diametrically opposite point on the periphery. [0083] Similarly, with the swivel axis of the rolling elements in close proximity to the periphery, a seven rolling element device according to the invention will have a tipping axis of length not less than 0.4D, for a six rolling element device a tipping axis of length not less than 0.45D, and for a five rolling element device, a tipping axis length of not less than 0.53D. [0084] For each of these rolling element configurations, these minimum lengths of tipping axes provide the maximum stability possible for a platform with castor rolling elements, unless the rolling elements are mounted in the manner shown in FIG. 7 and described in the Third Preferred Embodiment above. Fifth Preferred Embodiment [0085] In a further alternative embodiment of the device 300 with reference to FIGS. 22 and 23 , the rolling elements may take the form of ball transfer units 316 . Again these units 316 are mounted as close to the periphery 326 as mechanical constraints permit to ensure maximum stability of the platform 312 , regardless of the placing of one or both limbs of a user. [0086] Ball transfer units 316 which comprise of a spherical rolling element 334 supported in a casing which allows the rolling element to rotate in any direction, have a fixed point of contact with a supporting surface relative to the platform. Thus the footprint of the device of the invention when fitted with this type of rolling element is constant, as can be seen in FIG. 23 . Depending on the size of the ball transfer units 316 employed and the proximity of their mounting to the periphery 326 of the platform 312 , the footprint defined by the tipping axes 320 of the device in this instance may be only slightly smaller than the platform itself. In Use [0087] In use, the exercise device of the first preferred embodiment of the present invention is almost incapable of being tilted about a tipping axis as defined above, by the loads placed on the device by a user. Moreover, the unobstructed upper surface provides the flexibility of supporting a limb or portion of the body in any orientation. The preferred use of low offset castors for the omnidirectional rolling elements provide for almost instantaneous response to changes of direction urged by movements of the user. [0088] By arranging the shape of the platform as a polygon with the rolling elements located proximate each corner, the region of possible overhang of the platform beyond a tipping axis, is reduced to a minimum, further decreasing the likelihood of the device being tipped. [0089] The arrangement of the third preferred embodiment completely precludes the tipping of the device about a tipping axis, by any application of body weight to the platform. [0090] The above describes only some embodiments of the present invention and modifications, obvious to those skilled in the art, can be made thereto without departing from the scope of the present invention.

1a

FIELD OF THE INVENTION This invention relates to a practical shoe lace arrangement to put on and remove shoes with a fastener to tighten the lace. BACKGROUND OF THE INVENTION: PRIOR ART. The quest for a fast, convenient, secure and reliable method to tie and un-tie shoe laces goes back too far to be asserted. The main nuisances with present lace attachments are in dealing with: multiple bowknots and the length of the lace, knots slipping, becoming un-tied, difficult to un-tie. opening the shoe wide enough to put it on and removing it, frayed laces, dirty laces, broken laces. With the present art the lace has to be soft and pliable so the users can tie a durable knot. Cotton is the material of choice to this end but cotton also frays, becomes dirty and breaks under wear. OBJECTS AND ADVANTAGES OF THE INVENTION While putting on and removing a pair of sports shoes today is easier than dealing with ski shoe laces when the first tension fasteners were introduced 30 years ago, today the buying public expect more convenience from their products. The popularity of the "moccasin" type of shoes for daily wear is proof, if one was needed, of the public reluctance to deal with shoe laces. It is also apparent that the line between sports shoes bought and worn for all sorts of leisure activities and shoes worn for going to an office, to Church, to visit friends; is less and less distinct. The object of the invention is to improve the concept of the tension fastener to fit the needs of most sports shoes on the assumption that if an improvement can tighten the shoe with few quick motions and offer comfort and security; it will make the shoe preferred in the market place. A case in point is the acceptance of VELCRO (Trade Mark) to provide a quick attachment, although it is doubtful that it delivers the kind of closure tension needed for most sports. The time to secure sports shoes with the proposed lace attachment is estimated at 5 to 10 seconds versus 30 to 60 seconds to secure the shoes with conventional laces. The time to untie the attachment for removing the shoe is estimated at 3 to 5 seconds, versus 15 seconds to several minutes for conventional laces. Conventional shoe lacing calls for using two hands and a support to hold the foot high enough to tie the knots comfortably. The invention eliminates these limitations. Based on the review of hundreds of patents, past inventors have only attempted to solve one or two of the many problems presented by this invention. To arrive at a compelling solution, the invention solves these problems with interdependent improvements, an approach that had not been found before. The advantages of the present invention are as follows: 1. The improvement permits the convenient, quick, un-restricted opening of the shoe. 2. The improvement eliminates bowknot, and the shoe can be opened and closed tight with two fingers. 3. The tension in the attachment is distributed on the entire lace. No pressure point is anticipated. 4. Attachments do not protrude significantly and are unlikely to cause injury. 5. Locking features insure that the attachment does not come loose during exercise. 6. The breadth of the attachment can accommodate any foot sizes and heights of in-steps. 7. The improvement is discreet and esthetically pleasing. It does not significantly modify the appearance of the product it improves. 8. The invention permits the use of a stronger lace that will give the shoe a clean and neat appearance. 9. The improvement is not expected to change manufacturing costs significantly. DESCRIPTION REFERENCES AND NUMERALS The locations of the lace attachments are numbered by pairs from pair 1 to pair 5 starting from the toes. On one side of the shoe frontal opening, the attachments are numbered 1a, 2a, 3a, 4a, 5a and so forth, and 1b, 2b, 3b, 4b, 5b and so forth, on the other side. See example in FIG. 2A. ______________________________________20. Lever with groove, ridge. 21. Shoe frontal opening22. Two holes protrusion 23. Protrusion peripheral groove24. Lace 25. Groove on lever26. Loop in lace 27. Stopper for lace end28. Crossing loop 29. Single hole attachment30. Pair of holes 31. Plate's supporting hinge32. Ridge on lever 33. Rotating bulge on hinge34. Gap underneath bulge 35. Hinge's movable part36. Hinge's stationery part 37. Raised end of lever38. Recess to grab lace 39. Lace exit notch40. Phantom lace path 41. Peripheral groove42. Transversal surface groove 43. Stationary bulge on hinge44. Lace locking stud 45. Under-cut facing hinge46. Groove recess for stud 47. Under-cut facing lever end48. Groove's cavity for stud 49. Annulus50. Lever, grooves, no ridge 51. Member holding annulus52. Overlapping loop 53. Lace holder54. Slack attachment 55. Knot to regulate slack56. Twin hole on lever 57. Lever with hole and ridge58. Aperture for stud 59. Locking ring for lever60. Locking ring support 61. Protrusion with one hole62. Endless loop 63. Half-ring hole attachment______________________________________ DESCRIPTION OF THE DRAWINGS Meaning of the words used: ANNULUS describes a rigid elongated ring attached to the lace to be engaged in a groove or a hole to perform a shoe closure. FASTENER indicates a tightening device. In the invention, the fastener has a hinged tension lever with either a hole or grooves to reduce the slack. The fastener establishes the tension in the lace when pulling on its lever. GROOVE ATTACHMENT refers to a situation where the lace can be removed from this attachment with the two ends of the lace immobilized. The groove can be mounted on a protrusion installed on the shoe upper or on a tension lever. HOLE ATTACHMENT refers to a situation where the lace can only be drawn out of the attachment after liberating the end of the lace. The hole can be through the shoe upper as an eyelet, or be a half ring on the edge of the frontal opening, or a hole in a protrusion, or a hole on a tension lever. In the present invention, the lace is not drawn out of a hole attachment in order to put on or take out the shoe. LIST OF DRAWINGS FIG. 1 and 1A. Lace arrangement and fastener for a low cut shoe in open position and closed position. FIG. 2 and 2A. Detail of the lace arrangement with protrusions having two holes and protrusions with peripheral groove. FIG. 3 and 3A. Detail of a fastener with tension lever having grooves and a ridge. FIG. 4. Detail of protrusion with two holes. FIG. 4A. Protrusion with two holes showing lace phantom path. FIG. 5. Protrusion with peripheral groove. FIG. 6. Protrusion with multiple surface grooves. FIG. 7. Front view of the fastener's hinge illustrating a rotating bulge and lace catching gap. FIG. 8. Front view of the fastener's hinge illustrating a stationary bulge and lace catching gap. FIG. 9. Lever with grooves and lace catching stud having a cut-out facing the hinge. FIG. 9A. Lever with groove and lace catching stud having a cut-out facing the end of the lever. FIG. 10 and 10A. Embodiment of the invention with annulus and tension lever having no ridge. FIG. 11 and 11A. Embodiment of the invention with a hole mounted on the tension lever and the lace passing through this hole. FIG. 12. Rotatable tension lever with hole for lace and embrasure for lace catching stud. The rotating bulge and lace catching gap are in the center of the hinge. FIG. 13. Stationery plate and hinge support with stud. center of the hinge. FIG. 14. Safety ring to hold tension lever. FIG. 15 and 15A. Embodiment of the invention with floating annulus. FIG. 16 and 16A. Engagement of the annulus on the tension lever with grooves having no ridge. FIG. 17 and 17A. Lace arrangement for high-cut shoe. This embodiment shows the lace in two circuits and two tension lever with ridge. DESCRIPTION OF THE INVENTION The invention is an arrangement of holes and grooves lace attachments that can be combined in over a hundred possible ways. A lace 24 goes through a hole attachment 22 and goes by a groove attachment 23 one or more times. When the lace crosses over a frontal shoe opening 21 for the purpose of closing the shoe, the lace goes from the hole attachment to the groove attachment or vice versa as the case may be. The two ends of the lace are found secured prior to wearing the shoes and can be either: (a) tied together as a one time operation or, (b) one end tied to the shoe upper and the other end attached to an annulus 49 or, (c) both ends tied to the shoe upper or, (d) an endless loop 62 or, (e) tied by the wearer. In all embodiments, two devices are added to the lace circuit: 1. One device is a slack reducing means which can be either: (a) A slack reducing attachment 54 placed further apart from the edge of the shoe frontal opening. (b) A protrusion with transversal horizontal grooves 42 on its surface. (c) A plurality of grooves on the tension lever. 2. The second device is a hinged fastener of the type shown in FIG. 3 and 3A with a tension lever 20 and a groove 25 or of the type shown in FIG. 12 with a hole 56 to engage the lace. But many other types of tension lever are possible. DESCRIPTION OF THE INVENTION TYPICAL EMBODIMENTS A typical embodiment is illustrated in FIG. 1, with the shoe open, and FIG. 1A with the shoe closed. On one side of shoe frontal opening 21 are protrusions with peripheral groove 23, and tension lever 20. On the opposite side of the shoe are the protrusions with holes 22. The lace arrangement with the shoe open and closed is detailed in FIG. 2 and 2A. In these 2 drawings, each end of the lace is secured to the shoe upper with a stopper 27 blocking the lace from entering a single hole attachment 29. The lace arrangement in FIG. 1 & lA utilizes protrusions with two holes FIG. 4. This auxiliary improvement pre-disposes the formation of a loop 26 to be wrapped around opposite protrusion with groove 23. For closing the shoe FIG. 2A, the lace is held by groove 25 of lever 20, FIG. 3 & 3A. Once lever 20 is closed, the tighten lace banks against a ridge 32 and, if elected in the construction of the fastener, is maintained against ridge 32 by passing in a gap 34 under a bulge 33. Another embodiment is shown in FIG. 10 and 10A where holes and grooves attachments now alternate in pairs. This time, a loop 28 crosses an opposite one as the lace leaves the hole to go to the groove. One end of the lace is attached by a connecting member 51 to an annulus 49. The permanent slack in the lace can be adjusted where the lace is tied to member 51. A tension lever 50 has grooves facing the shoe upon its closing. In this embodiment the tension lever does not need a ridge to hold the tension because of the annulus. In embodiment shown in FIG. 11 and 11A, the hole attachment is a half ring 63 and the lace is tied by a knot 55 to establish a permanent slack. The overlapping loops are between two hole attachments on the same side of the shoe frontal opening. A lace holder 53 maintains the lace as it goes to the back of the shoe. Endless loop arrangement 62 is shown in FIG. 15 and 15A. A single hole protrusion 61 above the shoe upper has hole parallel with the edge of the shoe upper. In embodiment shown in FIG. 17 and 17A, the lace is separated in two circuits with two fasteners. This arrangement for high cut shoes permits a different tension level around the ankle. DESCRIPTION OF THE INVENTION MAIN ELEMENTS TENSION FASTENER WITH RIDGE. FIG. 3 AND 3A In many embodiments the lace is engaged directly in one of the grooves of the tension lever. To prevent the lace under tension from pushing against the foot and unsnapping the fastener the lace banks against ridge 32. Ridge 32 extends along grooves 25 on both side of lever 20. This ridge is a substitute for the rigidity of the metallic annulus. PROTRUSION WITH TWO HOLES. FIG. 4 and 4A. The user's only motions for closing the shoe with the present invention are to grasp the lace as it leaves the hole attachment and position the lace in the grooves. To make this task easier, the hole attachment is designed to constrain the lace into making a loop by coming in and out of a pair of holes 30 above the shoe upper. The protrusion has a recess 38 making it easy to grasp the lace for positioning around the groove. A lace phantom path 40 inside two holes protrusion 22 is shown on FIG. 4A. Exit of lace by a notch 39 can be used to hold the end of the lace. PROTRUSION WITH PERIPHERAL GROVE. FIG. 5. The typical shoe hook is improved in this invention to prevent anything from being caught accidentally and causing injury. In FIG. 5, the lace is held by a shallow peripheral groove 41 with just enough width and depth for the lace. PROTRUSION WITH MULTIPLE TRANSVERSAL SURFACE GROVES. FIG. 6 Whenever a tension lever with a hole or a twin hole to hold the lace is used, there is a need for a device to regulate the slack in the lace. One of transversal surface groove 42 is used to regulate the slack and change tension in the lace circuit. TENSION LEVER WITH LACE CATCHER. FIG. 7 AND 8 FIG. 7 is a front view of a rotating lace catcher. Gap 34 under rotating bulge 33 extends at a end of hinge movable part 35. When the lever with the lace engaged in the groove is rotated, the bulge rotates with it and the lace is caught in gap 34 when the fastener closes. With the catcher, -he lace is maintained below the hinge's fulcrum and adds security against the lever snapping open under foot pressure. In FIG. 8, a stationary bulge 43 extends at a end of the hinge's stationary part 36. Here, the bulge does not rotate with the lever. When the lever rotates toward its close position, the elasticity in the lace causes it to pass over the bulge and take position in gap 34. HINGED TENSION LEVER WITH LOCKING MEANS FIG. 9 AND 9A One concern with the tension lever is to have it un-snap under strenuous foot activities such as tennis. Several types of locking means can be added to the fastener to prevent the tension lever from opening under tension. FIG. 9 shows a plate 31 supporting lever's hinge, extending to the length of the lever. On the plate is a number of nearly vertical studs 44, one stud for each corresponding groove on the lever. At the base of each stud is an under-cut 45 facing the hinge that catches the lace once the lever is closed. In the center of each groove 25 is a curved recess 46 perpendicular to the plane of the lever. Upon closure of the lever, stud 44 enters into recess 46 of the corresponding groove. The lace is caught by under-cut 45 of the stud. FIG. 9A shows a variation of the preceding locking means. An under-cut 47 in stud 44 faces the end of the lever. In the center of each groove is a cavity 48 on the vertical wall of the groove. When the lever is closed, stud 44 takes position inside cavity 48. The lace is then caught by under-cut 47. FIG. 14 shows an alternate lever lock being a ring 59 attached to a support 60 on the shoe upper. The ring can be tilted to catch and hold down a raised end of lever 37. TENSION LEVER WITH HOLE FIG. 12 AND 13. In this version of the tension lever, a twin hole 56 is mounted on a lever 57 and the lace is circuited in the twin holes where it slides freely. The lace goes in the center of the hinge where it passes over rotating bulge 33 to be caught in gap 34. Stud 44 on plate 31 enters into an aperture 58 upon closing of lever 57 and under-cut 47 catches the lace and holds the lever closed. Under tension, the lace banks against ridge 32. Lace tensioning with the lever is regulated by a slack reducing attachment 54 as in FIG. 11. TENSION LEVER WITH GROOVES AND FLOATING ANNULUS FIG. 16 AND 16A. Annulus 49 transfers the line of pull by the lace on lever 50, below the lever's hinge fulcrum. It prevents lace tension to: (a) overcome the hinge's dead center and (b) push the lever away causing the fastener to open. Connecting member 51 holds the floating annulus and the lace. The lace slides inside member 51 and the lace pressure is distributed on the entire lace. SLACK IN THE LACE TO OPERATE THE TENSION LEVER. The slack necessary and sufficient to install the lace in the grooves should be less than 2 inches. Beyond this, the slack is reduced by other means than the tension lever. Changing the slack in the lace can be done with a protrusion having multiple grooves as shown in FIG. 6; or slack reducing protrusion with groove 54 installed further away from the edge of shoe frontal opening as in FIG. 11. STOPPER FOR THE END LACE In many embodiments, the lace is secured to the shoe upper. One preferred way to immobilize the end of the lace is -o have the lace going in and out of small member 27 that itself cannot go through hole 29 as shown in FIG. 2. Having the lace traversing the hole in member 27, and after having made a sharp bend come back into the same hole, is sufficient from preventing the lace from slipping inside the hole. Notch 39 of protrusion shown in FIG. 4 can be used in the same manner to hold the end to the lace and so can a hole in connecting member 51 shown in FIG. 10. NATURE OF THE LACE The common shoelace requirements of flexibility with gripping properties to hold the knots is out of order. The preferred lace for most of the proposed embodiments has a slippery surface to slide easily in the holes and around the grooves. The sliding improves distribution of tension on the entire lace. The lace can now be made: (1) more resistant, (2) more durable, (3) less pliable and subject to fraying (4) less soft and subject to becoming dirty than the common shoe lace; by using more synthetic material in the lace composition. A lace less flaccid than ordinary shoe lace will maintain its general position and be easier to position around the grooves and disengaged from same. SHOE TONGUE The usual requirements for the tongue are linked to the space between the edges of the frontal openings. In conventional shoes, this space serves several functions: (a) To provide closure leeway for different in step heights, (b) To install the lace in cross patterns, (c) To cushion the foot against lace pressure, pressure which increases with the width of the frontal opening. Without holes into the shoe upper, as it is possible with many embodiments of the invention, the tongue can be sewn to one side of the shoe frontal opening. This would resolve the problem of tongue migration under strong foot motions. OPERATING THE INVENTION EMBODIMENT WHERE THE LACE DOES NOT CROSS ITS OWN PATH At rest, the opening of the shoe is completely un-restricted as shown in FIG. 1 and 2. Once the foot is in place the shoe frontal opening is closed FIG. 1A and 2A. On one side of the shoe frontal opening are holes 22 and on the other side of the opening are grooves 23. FIG. 2A shows the ends of the lace secured in attachments 1a and 6a to set the slack in the lace. Once the slack is set for the wearer there is no need to change it again. The lace goes in and out of protrusion with two holes in lace attachments 2a, 3a, 4a and 5a. Each time, the lace makes loop 26. Once the foot is in place, the shoe is closed; FIG. 1A and 2A. The lace is wrapped, possibly with one hand, around protrusions with groove 23 in attachments 2b, 3b, and 4b. Loop 26 is wide enough for the finger to grab inside it and carry it around groove 23. When pulling loop around 3b, the preceding loop is already in place around 2b. The need for slack in the lace remains nearly constant and is sufficient to go around each peripheral groove, one at a time. When the lace is engaged on all the grooves of the protrusions the last loop is engaged in one of the groove of the tension lever. The tension lever in FIG. 3 stands in an open position. Upon closing the lever in FIG. 3A the lace slides down against bulge 33 to take position in gap 34. EMBODIMENT WHERE HOLES AND GROOVES ALTERNATE IN PAIRS FIG. 10 and 10A. In this embodiment, holes 29 and grooves 23 alternate in pairs. Crossing loops 28 are disengaged from grooves 23 to open the shoe. Each end of the lace is tied to annulus 49 by connecting member 51. Member 51 is also used to regulate the slack in the lace. In this version of the tension lever, the grooves face the shoe upon closure. Starting from the middle of the lace between eyelets 1a and 1b, the even attachments are grooves and the odd attachments are holes. One half of the lace goes from 1a to 2b to 3a to 4b to 5a and to the annulus. The second half of the lace goes from 1b to 2a, 3b, 4a, to 5b and to the annulus. EMBODIMENT WHERE GROOVES ARE ON ONE SIDE OF THE SHOE OPENING. FIG. 11 and 11A. In this embodiment grooves 23 are on one side of the shoe opening and holes 63 on the other side. This disposition allows for the use of the common shoe lace. In 1b, 1a, 2a, 2b, 3a, 4a, 5a, 6a, 7a are holes and in 3b, 4b, 5b, 6b are grooves. Tension lever 57 with hole 56 and ridge 32 as shown in FIG. 12 and 13 is at the heel. The lace goes around part of the ankle increasing the security of the attachment to the foot. The lace makes an overlapping loop 52 as it crosses its path going up and down the shoe frontal opening. Permanent knot 55 between 1a and 1b is pre set to the proper slack for the desired tension. Afterwards, the lace is placed around the grooves and one snap of the tension lever establishes the final tension. To remove the shoe, the tension lever is opened releasing slack in the lace. The lace is then disengaged from the grooves while held in its general position by the holes. An alternative to having the wearer knot the ends of the lace between 1a and 1b is the looped lace. Slack in the looped lace can be manipulated with secondary groove attachment 54 or with attachments having multiple grooves as shown in FIG. 6. EMBODIMENT WITH FLOATING ANNULUS FIG. 15 and 15A. This embodiment is possible with the two previous arrangements. The two ends of the lace are either tied together or secured to the shoe upper. The hole attachments shown here are protrusions above the shoe upper with one hole 61. Lace holders 53 holds the lace around the ankle. The lace makes endless loop 62. The floating annulus channels the tension created by the lever on the entire lace. OTHER VARIATIONS IN THE EMBODIMENT Many variations of the preceding embodiments are possible. The specifications are the same: 1. The two ends of the lace are secured as follows: (a) tied together permanently with the proper slack. (b) One end tied to the shoe upper and the other end tied to a member holding an annulus. (c) Each tied to a member itself holding an annulus. (d) Both ends secured to the shoe upper. (e) Both ends tied at the factory or an endless loop. 2. The lace is engaged alternatively into the hole attachment and on the groove attachment and when the lace crosses over the shoe frontal opening, the lace goes from the groove to the hole or vice versa as the case may be. 3. The tension in the lace is established by a fastener. SUMMARY, RAMIFICATIONS AND SCOPE Accordingly, the reader will see that the lace arrangement with fastener of this invention can be used effectively to replace the ordinary lace for all kinds of shoes. The inserting of the foot in the shoe and its removal have been made simple. The opening and closing of the shoe that are separate and distinct operations have also been made simple. Comfort, adaptability, versatility, safety, reliability and durability are qualities apparently inherent with the invention. These qualities generally have an enormous market appeal. The appearance of the shoe is bound to be enhanced by these improvements. Although the preceding description contains many specificities, these should not be construed as limiting the scope of the invention but are only intended to show the versatility of the invention and the many ways the described elements can be fabricated and combined in hundreds of ways to satisfy different requirements. For example, a shoe for soccer may require a continuous strip of material for the holes and grooves attachment, on each edge of the shoe frontal opening, with no space between each attachment. The tension lever in the back of the shoe may have to be encased in plastic rubber. The descriptions only disclose some of the possibilities of the invention but the scope of the invention is to be determined by the claims and their legal equivalents rather than by the examples given.

1a

BACKGROUND OF THE INVENTION This invention deals with color cosmetic liquid products that are traditionally applied with a brush, sponge or foamed mitt utilized with a rod or stem. These products may include nail coatings, liquid eyeliner, lip-liner or other facial products. The invention is designed to serve multiple functions as a sealing mechanism and as a means to keep product from locating on the top of a bottle finish or on the continuous threads of the bottle opening. Existing cosmetic packages are subject to product migration onto surfaces where they can cause problems of inadvertent staining of ones clothes or other personal property. There is also the chance of product dry-out acting as an adhesive which binds the closure to the container, complicating subsequent use owing to the difficulty in cap removal. The function of the insert which is the subject of this invention, is to provide the means to maintain a product-free environment at the land seal and without, and at the same time, enhance the containment and sealing of the liquid product within the bottle. An additional advantage offered by this invention is the pre-assembly feature of the insert and the applicator brush or rod. Accordingly, the filler and assembler of the primary container which provides the packaging for the product need not place the insert and the applicator in their proper orientation via separate steps. A single placement of the pre-assembled components will accomplish the proper registration. In optional embodiments, the insert may be part of the bottle neck and may include inwardly projecting walls which act as a flow inhibitor. The lip of the container is also designed to be the smallest practical and to provide the minimum surface for the product which may be deposited thereon. This minimizes the amount of product which might reach the threads. The prior art includes U.S. Pat. No. 5,190,389 to Vasas which discloses a rod and applicator brush for applying cosmetics. The main feature of this patent concerns a wiper for removing excess product from the brush. U.S. Pat. No. 3,896,823 to Spatz discloses an applicator for coloring eyelashes which includes a wiper for removing excess mascara from the applicator member. Dahm U.S. Pat. No. 4,784,505 discloses a container with a stripper which prevents excess product from depositing on the applicator. Also of interest are U.S. Pat. No. 4,403,624 to Montgomery and U.S. Pat. No. 4,841,996 to Gueret. The prior art does not disclose the unique insert of this invention used in conjunction with a cosmetic container or bottle. SUMMARY OF THE INVENTION This invention relates to cosmetic containers and particularly to containers having a unique insert which serves multiple functions, namely sealing and preventing the product from locating on top of the container finish or the container threads. The insert is held in the neck of the bottle or container by friction and mechanical attachment to a recessed ring about the thread root of a continuous thread finish. The insert is molded from a polymer that repels the cosmetic product by means of molecular polarity. Typical of these plastics are the polyolefins, fluoroplastics, nylons, acetals, polyesters, epoxy resins and elastomeric polyesters. The insert design also physically relocates the aperture at the top of the container a distance above the threaded neck, making the continuous threads less susceptible to product coating or contamination. Additionally, the insert provides multiple seals which prevent leakage or loss of solvents from the container. More specifically, the container includes an insert which is preassembled to a brush by means of an undercut ring located beneath a brush flange and cooperating with an undercut recess in the neck of the container. The downwardly extending walls of the insert are held by friction in the container neck and the insert is anchored externally to the container by a ring which extends outwardly from the threaded container. The interaction between the external surface of the insert and the container's inner wall, together with the interlocking components at the finish exterior wall is more formidable than the preassembly lock between the insert and the brush. The insert is thus tightly locked in the neck of the container. The radial edge on the brush provides a means for wiping away excess product from the brush. Alternatively, the insert may not be preassembled to the brush and it can be separate from a bottle neck or part of a one-piece neck. Further, the lip of the bottle or container opening is reduced in surface area to limit the product which may be deposited thereon and thus prevent liquid from reaching the threads. Accordingly, it is an object of this invention to provide a new and improved insert for a container opening. Another object of this invention is to provide a new and improved insert for sealing a cosmetic container. A further object of this invention is to provide a new and improved sealed top for a cosmetic bottle having an elongated neck. A still further object of this invention is to provide a new and improved cosmetic container which includes a primary seal of a valve type where the cone of the brush plugs the bottle corkage and a secondary seal or land seal between the brush flange and the lip of the container. Another object of this invention is to provide a new and improved insert for a cosmetic container which is preassembled to a brush and which engages the container opening to maintain a product free environment at the land seal and without, while at the same time enhancing the containment and sealing of the liquid product within the container. A more specific object of this invention is to provide a plastic insert having a pre-assembled brush mounted thereto which fits into the neck of a container to effect a functional seal, said insert also having an undercut flange on the upper portion thereof which engages the threaded outer ring on the container for sealing purposes. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects and advantages of this invention may be more clearly seen when viewed in conjunction with the accompanying drawings wherein: FIG. 1 is an exploded cross-sectional view of the invention; FIGS. 2, 3 and 4 are enlarged cross-sectional views of the insert showing various embodiments thereof; FIGS. 2 a , 3 a and 4 a are respective cross-sectional views of the foregoing insert embodiments showing the entire bottle top assembly; FIGS. 5 a and 5 b depict an alternate embodiment of the invention wherein the features of the invention are embodied in a container design; FIG. 6 is an exploded perspective view of the invention; FIG. 7 is a cross-sectional view of the bottle of FIG. 6 which represents the prior art; FIG. 8 is a cross-sectional view of the invention showing the bottle and assembled insert of FIG. 6; FIG. 9 depicts the prior art with a coated brush being removed from the bottle of FIG. 7; FIG. 10 depicts a coated brush being removed from the bottle of FIG. 8; FIG. 11 shows the residue left on the rim of the bottle in FIG. 9; FIG. 12 shows the residue left on the rim of the bottle in FIG. 10; FIG. 13 shows the residue being squeezed away from the rim in FIG. 11 by the brush; and, FIG. 14 shows the residue being squeezed away from the insert rim in FIG. 12 by the brush. DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1 of the drawings, the invention comprises an insert 4 used to seal a container 1 normally containing liquid cosmetics such as nail enamel, liquid eyeliner or lip-liner. The insert 4 includes an upper flange 4 b extending outwardly from the upper portion of a hollow cylinder 10 . The flange 4 b also extends inwardly from the cylinder 10 with its elongated walls 4 d to an upwardly extending cylindrical portion having a narrow top edge 5 at the end thereof and having an undercut recess 4 c on its upper interior wall. The flange 4 b also includes an undercut recess 4 a on the outer lower surface thereof to connect to the container 1 . The cylinder 10 has an outwardly tapered edge 23 at the lower end thereof to facilitate entry into a container 1 . A brush 2 is pre-assembled to the insert 4 which saves considerable effort. Accordingly, the filler and assembler of the primary container which provides the packaging for the product need not place the insert 4 and the applicator 2 in their proper orientation via separate steps. A single placement of the pre-assembled components will accomplish proper orientation. The brush 2 includes a top gripping portion 11 , a circular liner or intermediate circular flange 2 b extending outwardly from the base of the top portion 11 and a downwardly tapered section or walls 12 leading to an undercut ring 2 d which engages the undercut recess 4 c in the insert 4 to secure the parts 2 and 4 together, that is, the brush 2 and insert 4 . A sealing ring (not shown) may be located between the liner 2 b and the flanges 4 b to act as a stopper in the container opening 31 . The brush 2 further includes a stem 2 a extending axially within the insert 4 and having a tufted applicator 2 c projecting outwardly from the end thereof into the container 1 . The stem 2 a and brush 2 c are an integral unit which may be pre-assembled and then the entire brush is pre-assembled to the insert 4 . Alternatively, the insert 4 may not be preassembled to the brush 2 and the insert 4 may also be separate from the bottle neck 13 or part of a one-piece neck. The container 1 includes an open neck portion 13 having an inner wall 1 a which is frictionally engaged by the outer wall 4 d of the insert 4 . The neck portion 13 comprises an outer surface having threads 1 t and an undercut ring 1 b at the upper edge thereof. The undercut ring 1 b engages the undercut portion 4 a in the insert flange 4 b to secure the insert 4 and brush 2 assembly to the container 1 by engagement with the ring 1 b . The lip surface 32 is designed to be as small as possible since this is the place where product tends to be deposited. The smaller the surface area, the less product will get on lip surface 32 . The main purpose is to prevent product from reaching the threads 1 t by a two level cascade design involving surfaces 32 and 33 . The surface 33 is sufficiently lower than 32 so that the brush 2 does not touch the surface 33 when being removed from and reinserted into container 1 . The container also includes a cap 15 having an interior recess 16 and outwardly sloped sides 18 extending downwardly from the top 17 . The recessed interior includes a lower portion having an enlarged recess 19 to accommodate the top 11 . The interior walls 20 include a ledge 21 which engages the liner 2 b and a threaded portion 22 which engages the exterior threads 1 t on the container neck 13 . FIGS. 2, 3 and 4 illustrate various embodiments of the invention while FIGS. 2 a , 3 a and 4 a are respectively enlarged cross-sectional views of the insert embodiment. FIGS. 2 and 2 a disclose a land seal 6 a and valve seal 7 a . The brush 2 and insert 4 assembly are attached in FIGS. 3 and 3 a to the container 1 by means of a cooperating male extension 8 at the top of the insert 4 , snapping it into undercuts 9 in the brush flange or liner 2 b . In FIGS. 3 and 3 a , there is a land seal 6 b and a radial valve seal with the projection 8 extending into recesses 24 . FIGS. 4 and 4 a illustrates an embodiment wherein there is a horizontal member 30 in the form of a dish at the top edge of the insert 4 . This provides a means for joining the insert 4 and the brush 2 before package assembly and a horizontal doctoring edge 11 to remove excess liquid product. There is also a land seal 6 c and a valve seal 7 c . A further embodiment is illustrated in FIGS. 5 a and 5 b wherein the bottles 1 are shaped at 40 a and 40 b to simulate the contours and functions of the inserts 4 . These designs provide an effective means for maintaining the clear separation of the land seal 33 from the continuous threads 34 . To summarize, the insert 4 and brush 2 may be snap fitted together. The undercut snap together feature of recess 4 c and liner 2 d is of lesser magnitude than the force between the insert 4 and the container 1 . Thus, the brush 2 separates from the insert 4 when the consumer uses the brush 2 . The primary function of the invention is to provide a dispensing surface 32 above the threads 1 t and located inwardly so that the liquid product such as nail enamel does not come in contact with the threads 1 t particularly when the brush is wiped to remove excess product. The invention has 2 seals, a primary valve type seal where the lower conical surface 5 plugs the container opening 31 and a secondary seal or land seal between the brush flange or liner 2 b and the lip 32 of the container. A purpose of the invention is to prevent the neck 13 of cosmetic containers 1 from becoming contaminated with cosmetic product from the container 1 . In theory, these ends can be attained by making the surface area of the top lip 32 as narrow as possible. In some instances, however, it may be necessary to have a thick lip 32 and design accommodations will have to be made. Another design criteria is to keep the top lip 32 and cap roof 12 from contact. The distance between the lip 32 and the cap inside wall 17 should also be as large as possible for best results. On the other hand, the lip 32 and wall 17 can be relatively close in particular designs. Referring now to FIG. 7 a , a clean neck 13 is achieved by keeping the top lip 32 narrow to carry less product which may be transferred to the neck 13 . A wider mouth opening is depicted in FIG. 7 b to permit the ready insertion of brushes 2 c back into the container 1 without scraping any product onto the top rim 32 . The container 1 is also solid on the inside of the land area. A narrow lip width is defined as a width which is narrower than the combined bottle neck 13 and wiper wall thickness. This automatically increases the mouth opening. On the other hand, if a large opening 31 is desired, the top rim 32 is simply extended. In another embodiment shown in FIG. 8 a , the plug 70 is extended outwardly and includes threads 71 on the outer surface 72 thereof. A larger opening results. Analyzing the drawback, the bottle neck 13 gets coated with product when the brush 2 c leaves a residue 73 on the lip 32 (see FIG. 8 b ). When the cap 15 is replaced, it compresses the residue 73 and spreads the product forward and to the sides (see FIG. 8 c ). A portion leaks onto the outside of the bottle neck 13 where it is sandwiched between the neck 13 and the cap 15 . The product is carried forward with the cap 15 . To solve the above problem, the rim width can be reduced so that only a small amount of residue is deposited thereon. The lip 32 is also kept away from the cap inside wall. More desirable, the cap 15 is not permitted to come into contact with the lip 32 so that contact is not made with the residue 73 . Ideally, the land surface 32 is kept distant from the cap wall 20 and away from the cap roof 17 . As shown in FIG. 9 a , a seal can be formed by friction rings 81 or by a regular land seal as shown in FIG. 9 b . For products which require a large spiral wound brush such as mascara or a large applicator such as lip gloss, a wide opening 31 is desirable in order to guide the brush/applicator back into the container 1 without scrapping any product off from the brush 2 onto the surface. FIG. 9 c illustrates a wide opening. The residue 73 left on the lip 32 will dry out and can be scraped off easily without contaminating the threads 1 c. The first key feature of this application is the reduction of the amount of product residue left on the surface of the rim by reducing the surface area for product contamination in a cosmetic container. Then the contamination area is separated from the clean surrounding area by elevating the contamination area upward and is protect by the larger diameter of the clean surrounding area so that the cap's inner surface will not be in contact with the residue. The insert or plug 4 is designed for the above purpose and not for the purpose of wiping the stem 2 a . To clarify the invention, FIG. 6 is an exploded perspective view of FIG. 1 showing the principal parts of the invention. A direct comparison with the prior art may be achieved by comparing the cross-sectional view of the conventional container or bottle 1 of FIG. 7 with applicant's bottle 1 in FIG. 8 . FIG. 9 illustrates a coated brush 2 being removed from the prior art bottle while FIG. 10 illustrates the coated brush 2 being withdrawn from the new bottle 1 with the insert or plug 4 . FIG. 11 shows the residue 73 left on the lip 32 of the bottle 1 p in FIG. 9 by the coated brush 2 while FIG. 12 shows the residue 74 left on the rim 75 of the insert 4 in FIG. 10 . FIG. 13 shows the residual, product being squeezed away from the rim area 32 to the inside and outside of the rim 32 . Note how the residue 73 flows down to the threads 1 t on the exterior of the bottle 1 p after repeated use. On the other hand, the small amount of residue 74 in FIG. 14 is squeezed away from the narrow insert rim 75 to the inside and outside surface of the elevated rim 75 in the new design. This lesser amount of residue 74 is a great advantage since the residue 74 which does flow on the outside of the rim 72 does not reach the threads 1 t . Instead, the outside flow is trapped on the flange 2 b away from the threads 1 t . The larger diameter of threads 1 t prevents the cap's inner surface from getting in contact with the residue. While the invention has been explained by a detailed description of certain specific embodiments, it is understood that various modifications and substitutions can be made in any of them within the scope of the appended claims which are intended also to include equivalents of such embodiments.

1a

This application is a continuation of application Ser. No. 920,567, filed Oct. 17, 1986, now abandoned. FIELD OF INVENTION This invention relates to the field of biochemistry and particularly to the enhancement of the biocompatibility of various surfaces. BACKGROUND OF THE INVENTION The implantation of such biomaterial articles as substitute blood vessels, synthetic and intraocular lenses, electrodes, catheters and the like in and onto the body is a rapidly developing area of medicine. A primary impediment to the long-term use of such biomaterial implantables as synthetic vascular grafts has been the lack of satisfactory graft surfaces. The uncoated surfaces of synthetic blood vessels made from plastics, for example, often stimulate rapid thrombogenic action. Various plasma proteins play a role in initiating platelet and fibrin deposition on plastic surfaces. These actions lead to vascular constriction to hinder blood flow, and the inflammatory reaction that follows can lead to the loss of function of the synthetic implantable. A "biomaterial" may be defined as a material that is substantially insoluble in body fluids and that is designed and constructed to be placed in or onto the body or to contact fluid of the body. Vascular grafts and contact lenses are examples of biomaterials. Ideally, a biomaterial will have the following characteristics: 1. It will not induce undesirable reactions in the body such as blood clottinq, tissue death, tumor formation, allergic reaction, foreign body reaction (rejection) or inflammatory reaction. 2. It will have the physical properties such as strength, elasticity, permeability and flexibility required to function as intended. 3. It can be purified, fabricated and sterilized easily. 4. It will substantially maintain its physical properties and function during the time that it remains implanted in or in contact with the body, whether it be an hour or a lifetime. As used herein, the solid surface of a biomaterial is characterized as "biocompatible" if it is capable of functioning or existing in contact with biological fluid and/or tissue of a living organism with a net beneficial effect on the living organism. Long term biocompatibility is desired for the purpose of reducing disturbance of the host organism. A number of approaches have been suggested to improve the biocompatibility of implantable items. One approach has been to modify the surface of a biomaterial to prevent undesirable protein adhesion by providing the biomaterial with a low polarity surface, a negatively charged surface or a surface coated with biological materials such as enzymes, endothelial cells and proteins. Solid surfaces have been coated with biochemical materials such as heparin, albumin and streptokinase to enhance thromboresistance. Albumin in particular has been physically adsorbed onto and electrostatically and covalently bound to polymer surfaces. Munro, et. al, U.S. Pat. No. 4,530,974 discloses a method of adsorbing albumin to a water-insoluble polymer such as polyurethane by covalently binding to the surface a nonionic hydrophobic aliphatic chain to which albumin will selectively bind. Nimni et al, U.S. Pat. No. 4,378,224 teaches a method of coating animal tissues, used to make prosthetic devices, through the formation of a three dimensional cross-linked matrix primarily composed of a calcification inhibitor. An example of an adverse reaction that is caused by the presence of a biomaterial is the deposition of protein on contact lenses. Often contact lens wearers develop an intolerance to their contact lenses with time and this intolerance may be linked to irritation and allergic responses to biochemicals (proteins, lipids, mucopolysaccharides, and others) which deposit onto the lenses while they are worn. Current cleansing and disinfection procedures remove some of these deposits, but these procedures often leave holes and crevices in the lenses which add to the eye irritation of the wearer and serve as foci for further biochemical deposition. Guire, U.S. Pat. No. 3,959,078, describes the use of reagents to covalently bind an enzyme to aminoethyl cellulose or alkylamine glass. See, also: Guire, Stepwise Thermophotochemical Cross-linking for Enzyme Stabilization and Immobilization; Enzyme Engineering 3:63-70 (1978) and Guire, Photochemical Immobilization of Enzymes and Other Biochemicals, Methods in Enzymology XLIV:280-288 (1976). These references describe a process of covalently binding an enzyme to substrates such as chemical derivatives of controlled-pore glass, cellulose, agarose and polyacrylamides by thermochemically coupling a linking reagent to the solid surface and photochemically coupling the enzyme to the linking reagent to provide a surface useful in the performance of in vitro diagnostic assays. SUMMARY OF THE INVENTION The invention relates to biomaterials that are provided with desired biocompatible surfaces A method for modifying the solid surface of a biomaterial employs molecules of a biocompatible agent and a chemical-linking moiety possessing a photochemically reactive group capable, upon activation, of covalently bonding to the solid surface and possessing a different reactive group that is capable, upon activation, of covalently bonding to separate molecules of the biocompatible agent. One of the groups is unresponsive to activation by a stimulus to which the other group is responsive. The method comprises applying stimulus to sequentially activate the groups to covalently bind the different reactive group of the linking moiety to the molecules of the biocompatible agent and to photochemically covalently bind the linking moiety to the solid surface with a sufficient population density to enable the molecules of the biocompatible agent to effectively shield the solid surface and to provide a biocompatible effective surface. A biocompatible "effective" surface is thus formed of a plurality of separate molecules of a biocompatible agent covalently linked, through a linking moiety, to the solid surface of a biomaterial to provide that surface with substantially the same biocompatible characteristics as are possessed by the biocompatible agent. The effective surface formed by the molecules of the biocompatible agent need not cover the entire surface of a biomaterial. It may cover the surface in spots. For example, spots along the surface of vascular grafts may be covered by a cell attachment factor such as fibronectin. The biocompatible effective surface formed at those spots then act as foci for attachment of cells to the modified surface. The different reactive group of the linking moiety desirably is a thermochemical group or a photochemical group that is unresponsive to the stimulus to which the first mentioned photochemically reactive group responds and to which molecules of the biocompatible agent will covalently bind. In another embodiment of the invention there is provided a device having a biocompatible effective surface formed of separate molecules of a biocompatible agent covalently linked by a chemical linking moiety residue to the solid surface of the device. The chemical linking moiety residue includes a residue of a photochemically reactive group covalently bonded to the solid surface, and, the residue of a different reactive group covalently bonded to molecules of the biocompatible agent, one of the reactive groups being unresponsive to a stimulus to which the other reactive group responds. The individual molecules of the biocompatible agent are attached through the linking moiety residue to the solid surface sufficiently proximate to one another as to cause said molecules to effectively shield the solid surface and to provide a biocompatible effective surface. The biocompatible agent is chosen to enhance the function of a particular device. For example, the function of contact lenses may be enhanced by attaching molecules of polyethylene glycol to the lens surfaces to diminish the deposition of proteins on these surfaces. As another example, a cell attachment factor such as fibronectin or laminin may be bonded to a device having a polyvinyl chloride surface to increase cell attachment to the device. This is desirable in the case of implantables such as catheters and substitute blood vessels. Yet another embodiment of the invention involves a method for modifying the solid surface of a biomaterial, the method employing molecules of a biocompatible agent joined to one another to form a biocompatible film, and a chemical linking moiety capable of linking the film to the solid surface of the biomaterial. The chemical linking moiety includes a photochemically reactive group capable upon activation of covalently bonding to the solid surface, and the residue of a reactive group covalently bonded to the film (e.g., to the residue of the biocompatible agent molecules making up the film). One of the reactive groups is unresponsive to a stimulus to which the other reactive group responds. The method comprises activating the photochemically reactive group with a stimulus to covalently bind the biocompatible molecules. By "joined" in this context, reference is made not only to covalent bonding of adjacent biocompatible agent molecules but also to interactions caused by such forces as hydrogen bonding, ionic bonding, bonding through Van der Waals forces, and the like. The biocompatible agent having molecules joined to one another to form a film may comprise molecules of one agent or it may comprise molecules of two or more agents such as heparin and albumin. DESCRIPTION OF THE PREFERRED EMBODIMENTS The solid surface that is rendered biocompatible in accordance with the invention desirably is of a synthetic or natural material that is insoluble in physiological fluids. The surface may be one or more surfaces of devices intended to function in contact with tissue and/or fluids of living organisms. The solid surface of the device may be any suitable metal such as polished titanium or stainless steel or a polymer such as polyurethane, polyvinylpyrrolidone, silicone elastomers, polyethylene, polytetrafluoroethylene, poly-(p-phenyleneterephthalamide), polyvinyl chloride, polypropylene, polyolefins, polyesters, polycarbonate, polyacrylates (including polymethacrylates); minerals or ceramics such as hydroxyapitite; human tissue such as bone, skin and teeth; organic materials such as wood, cellulose and compressed carbon; and other natural and synthetic materials such as glass, rubber, wood and the like. Examples of devices which may be provided with biocompatible surfaces in accordance with this invention include vascular graft tubing, dialysis tubing or membrane, blood oxygenator tubing or membrane, ultrafiltration membrane, intra-aortic balloon, blood bag, catheter, suture, soft or hard tissue prosthesis, synthetic prosthesis, artificial organs, and lenses for the eye such as contact and intraocular lenses. The solid surface is desirably thermochemically unreactive. "Thermochemically unreactive" means that the surface is free of any surface treatment designed to increase the ability of the surface to thermochemically react. Examples of thermochemically unreactive surfaces include polytetrafluroethylene, polyethylene, polypropylene, polyvinyl chloride, polyvinylpyrrolidone, silicone elastomers, stainless steel and titanium. Molecules of a biocompatible agent are attached to the surfaces of biomaterials to improve biocompatibility. The biocompatible agent may be a growth factor such as endothelial cell growth factor, epithial cell growth factor, osteoblast growth factor, fibroblast growth factor, platelet derived growth factor, neural growth factor, or angiogenin growth factor; an antimicrobial agent such as lysosyme or penicillin; an antithrombogenic agent such as heparin, albumin, streptokinase, tissue plasminogin activator (TPA) or urokinase; a thrombogenic agent such as collagen or a hydrophilic polymer such as polyethylene glycol (a synthetic polymer), chitosan or methyl cellulose, and other proteins, carbohydrates and fatty acids. The biocompatible agent may comprise molecules of one of the above listed agents or it may comprise molecules of two or more agents. For example, the biocompatible agent may comprise molecules of both albumin and heparin. In one embodiment the molecules of a biocompatible material are joined to one another to form a film that is attached to a solid surface by a linking moiety. The biocompatible agent desirably may be hyaluronic acid or albumin. A biocompatible device having a film attached may be an artificial hip joint coated with a film of hyaluronic acid. The chemical linking moiety preferably has the formula A--X--B in which A represents a photochemically reactive group capable in response to specific activation of bonding covalently to a solid surface; B represents a different reactive group capable desirably in response to specific activation to which group A is unresponsive, of forming a covalent bond to a biocompatible agent and X represents a relatively inert, noninterfering skeletal moiety joining groups "A", and "B", that is resistant to cleavage in aqueous physiological fluid. The physiological fluid referred to is such fluid with which X will come in contact. Thus, a device of the invention may have the ultimate structure: solid surface-A residue-X-B residue-molecules of biocompatible agent. X is preferably a C 1 -C 10 alkyl group such as polymethylene, a carbohydrate such as polymethylol, a polyoxyethylene, such as polyethylene glycol or a polypeptide such as polylysine. The reactive group B is a group that upon suitable activation covalently bonds to proteinaceous or other biocompatible agents. Such groups are typified by thermochemical groups and photochemical groups, as described and exemplified in Guire, U.S. Pat. No. 3,959,078, the teachings of which are incorporated herein by reference. The photochemically reactive groups (A) (the covalent bonding of which is activated by actinic radiation) may be typified by aryl, alkyl and acyl azides, oxazidines, isocyanates (nitrene generators), alkyl and 2-ketodiazo derivatives and diazirines (carbene generators), aromatic ketones (triplet oxygen qenerators), aromatic diazonium derivatives and numerous classes of carbonium ion and radical generators. Reference is made to Frederick J. Darfler and Andrew M. Tometsko, chapter 2 of Chemistry and Biochemistry of Amino Acids, Peptides and Proteins (Boris Weinstein, ed) vol. 5, Marcel Dekker, Inc. New York, 1978, for further description of photochemically reactive groups. Azidonitrophenyls, fluoroazido nitrobenzenes, and aromatic ketones form a preferred group due to their stability to chemical reaction conditions in the dark and their susceptibility to activation by light of wave lengths harmless to most biomaterials, to form short-lived reactive intermediates capable of forming covalent bonds in useful yield with most sites on the biomaterial. Nitrophenylazide derivatives (shown as including the --X-- group) appropriate for use as photochemically reactive groups for the most part can be derived from fluoro-2-nitro-4-azidobenzene, and include 4-azido-2-nitrophenyl(ANP)-4-amino-butyryl, ANP-6-aminocaproyl, ANP-11-aminoundecanoyl, ANP-glycyl, ANP-aminopropyl, ANP-mercaptoethylamino, ANP-diaminohexyl, ANP-diaminopropyl, and ANP-polyethylene qlycol. ANP-6-aminocaproyl, ANP-11-aminoundecanoyl, and ANP-polyethylene glycol are preferred. Aromatic ketones preferred for use as photochemically reactive groups include benzylbenzoyl and nitrobenzylbenzoyl. Thermochemical reactive groups (that are activated by heat energy) are typified by and include nitrophenylhalides, alkylamino, alkylcarboxyl, alkylthiol, alkylaldehyde, alkylmethylimidate, alkylisocyanate, alkylisothiocyanate and alkylhalide groups. Groups appropriate for use as thermochemically reactive groups include carboxyl groups, hydroxyl groups, primary amino groups, thiol groups, maleimides and halide groups. N-oxysuccinimide carboxylic esters of such groups as 6-amino hexanoic acid and amino undecanoic acid, alkylthiol groups such as mercaptosuccinic anhydride and beta-mercaptopropionic acid, homocysteinethiolactones, and polyetheylene qlycol derivatives are preferred. The devices of this invention have biocompatible solid surfaces that include molecules of a biocompatible agent and a chemical linking moiety residue. The chemical linking moiety residue possesses a residue of a photochemically reactive group bonded to the solid surface and possesses a residue of a different reactive group covalently bonded to the biocompatible agent. The residue of the photochemically reactive group is that portion of a photoreactive group (described above) represented by "A" in the general formula, that remains after a covalent bond has formed. When the photoreactive group is ANP and the solid substrate is polyethylene, the residue is a carbon-nitrogen bond. A nitrene formed when ANP is light-activated, reacts with a carbon of the polyethylene to form a covalent bond. When the photoreactive group is BBA and the solid substrate is polyethylene, the residue is a carbon-carbon bond. When BBA is stimulated by light, the carbon joining the two phenyl groups is activated to a triplet state causing a carbon-carbon bond to form between the polyetheylene and the BBA and to form an hydroxyl group. When the different reactive group ("B") is NOS the residue is the carboxyl carbon of that group bonded to an oxygen or nitrogen group of a biocompatible agent such as fibronectin. As enzymes, cell attachment factors and certain other substances that may be employed as biocompatible agents are somewhat sensitive to high temperatures, it is desired that the different reactive group on the linking moiety employed in the present invention be activated by (that is, undergo covalent bonding in response to) easily applied and nonharmful stimuli such as moderate heat (e.g., body temperature or below) and light. Reactive groups that are unresponsive to the stimulus to which the photochemically reactive group responds may be groups that react to changes in pH, or to the addition of another chemical species and the like. The chemical linking moieties desirably covalently bond to the surface in such population to enable the molecules of biocompatible agent moieties to shield the solid surface and to provide a biocompatible effective surface. The density of bound chemical moieties necessary to provide an effective surface varies with the particular biocompatible agent used. The invention may be better understood by reference to the following non-limiting examples. Table 1 is a list of abbreviations of terms used in the following descriptions. TABLE 1______________________________________LIST OF ABBREVIATIONSAbbreviation Full Name______________________________________EGF Endothelial growth factorPEG Polyethylene glycolPVC Polyvinyl chloridePE PolyethylenePP PolypropylenePTFE PolytetrafluoroethyleneFNAB FluoronitroazidobenzeneANP 4-azido-2-nitrophenylKOH Potassium hydroxideTLC Thin layer chromatographyNOS N-oxysuccinimideEAC(A) Epsilon amino caproic acidAUD(A) Amino undecanoic acidBBA Benzoyl benzoic acidDMSO Dimethyl sulfoxideDMF DimethylformamideEDC 1-ethyl-3-(3-dimethylamino- propyl) carbodimidePEG-1000 Polyethylene glycol molecular weight 1000PEG-4000 Polyethylene glycol molecular weight 4000PBS Phosphate buffered salineFN FibronectinCOL CollagennBBA Nitrobenzoylbenzoic acidHEPES N-2-hydroxyethylpiperazine- N'-2-ethane sulfonic acidHSA Human serum albuminHGG Human gamma globulinLYZ Lyzosymemmole millimoleml milliliterMW.sub.app Approximate molecular weightmg milligramM Molarpmole picamoleng nanogramug microgramID Inner diameter______________________________________ EXAMPLE 1 Endothelial Cell Attachment/Growth 1. Plastic Surfaces. Various cell factors were coupled to polymeric surfaces tested in vitro to determine the effect of these factors upon cell attachment and overgrowth. The polymeric surfaces included polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP) and polytetrafluoroethylene (PTFE) GORE--TEX (6 mm reinforced expanded PTFE, a trademarked product of W. L. Gore and Associates, Inc.). Commercial tubing tested included polyester (Dacron, D, 6 mm straight knitted dacron velour, a trademarked product of Dupont), silicone elastomer, (Silastic ®, S, 0.03 I.D., tubing, a trademarked product of Dow Corning) and polyurethane. Polystyrene plates were used as controls. 2. Preparation of the Chemical Linking Moiety. The chemical linking moiety used in these examples were the N-oxysuccinimide (NOS) esters of 4-azido-2-nitrophenyl epsilon amino caproic acid (ANP--EACA), 4-azido-2-nitro-phenyl amino undecanoic acid (ANP--AUDA) and benzoylbenzoic acid (BBA). ANP--EAC--NOS and ANP--AUD--NOS were prepared by the method described in P. Guire, D. Fliger and J. Hodgson, "Photochemical Coupling of Enzymes to Mammalian Cells", Pharmacological Research Communications, Vol. 9, pp --131-141 (1977), incorporated herein by reference Briefly, fluoro-2-nitro-4-azido benzene was reacted with either epsilon amino caproic acid or amino undecanoic acid to substitute the relatively poorly reactive fluoride with an amino alkyl carboxy group. The carboxy group was then esterified, by carbodiimide activation with N-hydroxy succinimide to yield the N-oxysuccinimide carboxylic ester. The NOS ester of benzoylbenzoic acid was prepared by esterifyinq the carboxy group by carbodiimide activation with N-hydroxy succinimide. When ANP--EAC--NOS or ANP--AUD--NOS is the chemical linking moiety used, the ANP group is the photochemically reactive group represented by the letter "A" in the A--X--B general formula discussed above. The NOS group is the different reactive group represented by the letter "B" in the formula. The EAC or AUD group acts as the spacer between the two reactive groups and is represented by the X in the general formula. When BBA--NOS is the chemical linking moiety, the benzoylbenzoic group is the photochemically reactive group represented by the "A" in the general formula and the NOS group is the different reactive group represented by the letter "B". The group represented by X is the carbon connecting the two reactive groups. 3. Covalent Bonding of Growth Factors to the Chemical Linking Moieties. The biocompatible agents fibronectin, laminin, collagen, endothelial growth factor, and human serum albumin were tested for their abilities to promote endothelial cell attachment and overgrowth on synthetic biomaterials. These agents were coupled to the N-oxysuccinimide (NOS) esters of 4-azido-2-nitrophenyl epsilon amino caproic acid (ANP--EACA), 4-azido-2-nitrophenyl-undecanoic amino acid (ANP--AUDA) or benzoylbenzoic acid (BBA) as follows. As used herein "photolabeled" refers to a biocompatible agent that has been coupled to a chemical linking moiety by the different reactive group and that has a photochemically reactive group. A. Covalent Binding of Fibronectin and Laminin to the Linking Moiety. Human fibronectin (University of Wisconsin Medical School) and mouse laminin (obtained from Bethesda Research Lab.) were separately dissolved at 1 mg/ml concentrations in 0.1 M borate, pH 9.0. A solution of ANP--EAC--NOS in dry dimethylformamide ("DMF"), ANP--AUD--NOS in dry DMF, or BBA--NOS in dry dioxane was slowly added to the fibronectin or laminin solution in equamolar amounts to the concentration of protein epsilon amino groups (lysine residues) by syringe drive at 4° C. in the dark over 16 hours. Then the mixture was stirred 4 hours in the cold. The fibronectin or laminin solution was centrifuged to remove insoluble material then applied to a Sephadex G-75 column to remove uncoupled photoreagent. The factions were monitored at 260 nm and 462 nm to assess the photogroup/protein ratios. B. Covalent Binding of EGF, Collagen, and HSA to Chemical Linking Moieties. Human placenta Type IV collagen (Sigma Pharmaceutical), endothelial growth factor (Sigma Pharmaceutical), and human serum albumin (Sigma Pharmaceutical) were separately dissolved at 2 mg/ml concentrations in 0.1 M borate, pH 9.0 solution of ANP--EAC--NOS in DMF, ANP--AUD--NOS in DMF or BBA--NOS in dioxane was slowly added to the solution containing the biocompatible agent in 5X molar amounts to the concentration of epsilon amino groups (lysine) residues by syringe drive at 4° C. in the dark over 16 hours. Then the solution was dialyzed against 4 1000 ml changes of phosphate buffered saline (PBS) and centrifuged to remove insoluble material. The product was analyzed at 260 nm, 280 nm and 462 nm to assess the photogroup/protein ratios. 4. Covalently Binding the Biocompatible Agents to Plastic Surfaces. Various sheets, tubes and flat pieces of polyethylene, chloride, polypropylene, polyurethane, Dacron® (velour), Silastic® (medical grade), and polytetrafluroethylene above were used. A 0.05 ml aliquot of solutions containing 0 to 500 ug/ml of photolabeled biocompatible agent was added to each 0.5 cm 2 section of plastic surface. The solution was allowed to adsorb onto each piece for 3 hours at room temperature in the dark. The excess liquid was removed and the biocompatible agents were covalently linked to the surfaces by photolysis for 12 hours at the appropriate wavelength (Tungsten "spotlite" for ANP and long wavelength UV for BBA). After photolysis, the specimens were washed with a 4 second stream of PBS to remove non-covalently linked molecules of photolabeled biocompatible agent. The pieces were then placed in tissue culture to assess the endothelial cell reaction to the cell factors as follows. 5. In Vitro Tests Performed with Modified Surfaces. A. Radio-labeled biocompatible agents. Radiolabeled [ 3 H] biocompatible agents were photolabeled as described above and photocoupled to plastic surfaces. The plastics surfaces were extensively washed with PBS, then dissolved in organic solvent, and counted by liquid scintillation spectrometry. Some representative results are given in the Table 2. TABLE 2__________________________________________________________________________Sample results of amounts of growth factorsphotocoupled to various materialsPhotolabeled Ng GrowthBiocompatible Solid Factor Ng Growth Factor % CouplingAgent Surface Applied/cm.sup.2 Photocoupled/cm.sup.2 Efficiency__________________________________________________________________________ANP-EAC-FN PVC 843.04 677.6 80.4% Polyurethane 843.04 823.04 97.6%BBA-FN PVC 3564.0 1091.2 30.62% Polyurethane 3564.0 2622.4 73.58%ANP-EAC-COL PVC 2675.2 374 14.0% Polyurethane 2675.2 2173.6 81.26%BBA-COL PVC 1105.2 197.56 17.9% Polyurethane 1105.2 920.3 83.3%__________________________________________________________________________ As these results show the photolabeled biocompatible agents covalently coupled to these surfaces. B. Attachment of Bovine Endothelial Cells to Modified Plastic Surfaces. Bovine endothelial cells were collected from fetal animals 8-24" in length. Cornea, aorta and umbilical endothelial cells were harvested aseptically. Cells were grown in a 5% CO 2 incubator at 37° C. in a known high glucose cell growth medium such as Dulbecco's modified Eagle's medium (described in R. Dulbecco and G. Freeman, Virology, Vol. 8:396 (1959) and J. D. Smith, G. Freeman, M. Vogt and R. Dulbecco, Virology, Vol. 12:185 196 (1960)) with 25 mmole HEPES buffer, 10% bovine calf serum, and 2.5 micrograms amphotericin B/ml (the "growth media"). Once the plates, tubes or sheets were prepared; cell cultures were prepared from primary cell lines. The cells were detached from the cell lines with a 0.25% solution of trypsin and resuspended in the growth media. Cells were then counted using a trypan blue (0.4%) solution and a hemocytometer. Various concentrations of cells were layered on the prepared materials. Cell attachment was monitored for various time periods from 5 minutes to 14 days. Attachments were determined by at least two methods. In one, sample materials were removed from culture media and washed 2 times with sterile saline. Cell stains were then applied and total cells on the surface were counted. A second method was to trypsinize the cells off the surface with a trypsin solution and count using the trypan blue method. Representive results of the attachment and outgrowth of endothelial cells on precoated polyvinyl chloride plastic pieces are reported in Table 3. The number of viable cells attached to each piece were determined by trypan blue staining procedures. TABLE 3__________________________________________________________________________Cell attachment determinations and outgrowthof endothelial cells on the treated polyvinylchloride surface.Biocompatibleagent andchemical-linking Ng growth 3-day cell 7-day cellmoiety factor/cm.sup.2 counts* counts 7-day outgrowth*__________________________________________________________________________ANP-EAC-FN 677.6 2610(2+-3+) 3539(2+-3+) 1.5-1.75 mm(2+)BBA-FN 1091.2 868(1+-2+) 14500(2+) 3.75-4.25 mm(2+-3+)ANP-EAC-COL 374.0 14500(3+-4+) 15833(2+-3+) 1.0-3.0 mm(3+)BBA-COL 197.6 5749(2+) 21500(3+) 2.5-4.0 mm(3+)Control PVC 0 7(2+) 1.5-2.0 mm(3+)__________________________________________________________________________ C. Attachment of Human Umbilical Endothelial Cells. Primary human endothelial cells were harvested from fresh (less than 4 days old) human umbilical cords. Cords were rinsed with 20 mls-cord buffer (0.144 M NaCl, 0.004 M KCl and 0.001 M PO 4 ) twice to remove blood and clots. Collagenase was pushed into the cord and left for 20 minutes at room temperature. Using 10 ml of warm cord buffer, the collengenase and detached cells were flushed into tubes. The suspension in the tubes were combined and centrifuged at 1500 rpm for 5-10 minutes. The supernatant was poured off and the cells resuspended in 10 ml of cord buffer. Following the second centrifugation, the cells were resuspended in cord buffer and plated into tissue culture disks. All cells were incubated in 37° C. incubator with 5% CO 2 . Cells were radiolabeled using 51 Cr in cord media without calf serum. Labeled cells were then used for cell attachment studies. Plates, sheets, and tubes of the plastics described above were prepared as recorded above. The cells were trypsinized and counted with the trypan blue method. Cells were allowed to adhere to the prepared plastic for three hours to seven days. Cells were rinsed off and the total number of any results attached cells were compared to the number of non-attached cells. Representative results appear in Table 3 above. D. Outgrowth Measurement using Endothelial Cells. The following techniques were used to monitor the outgrowth of cells from a point of origin as the cells grow to cover the surfaces of the plastics listed above modified as follows. Solutions of biocompatible agents containing from 0 to 500 micrograms of cell factors were coated onto surfaces from 1 to 6 cm long to establish a gradient. Cells were not detached from the tissue with trypsin or any proteinase. The tissue was placed on a point of origin at the low end of the gradient and marked. The tissue was allowed to sit for 15 minutes at room temperature. Growth media was added to give a moist coating over the plastic. All protocols were carried out using aseptic conditions. Plates were then incubated at 37° C. in a 5% CO 2 incubator. Outgrowth was measured daily for up to two weeks or until the length of plastic was completely covered. Outgrowth on the treated surfaces was compared to nontreated control surfaces as reported in Table 3 above. All materials were rinsed and stained for permanent scanning electron microscopy. These results demonstrated that the covalent attachment of the growth factors fibronectin (FN) and collagen (COL) to the plastic surface improved the biocompatibility of the plastic with bovine endothelial cells. The cells preferentially attached to the modified surfaces versus control surfaces as is indicated by the distance they grew out over the plastic surface. 6. In Vivo Studies. Two conditioned dogs were obtained for this study. Pieces of GORE--TEX (reinforced expanded polytetrafluroethylene, a trademarked product of W. L. Gore and Associates, Inc.) were precoated with FN, ANP--EAC--FN (adsorbed and photocoupled), ANP--EAC--FN (adsorbed only) and a PBS control. The testing was a blind study. The grafts were labeled by lettering; however, the surgical team did not know which grafts had modified surfaces and which were controls. Each dog received two 6 mm×5 cm pieces of GORE--TEX implanted in the left and right iliac artery. The grafts were left in the dogs for one month (30 days). The dogs were given the anti-inflammatory drugs Persontine and Aspirin to mimic human implant procedures. Both control grafts (PBS and FN) were patent and had sufficient caliber. The anastomatic lines were intact and the inner surfaces were smooth. Endothelialization was incomplete with the control grafts. There appeared to be no evidence of significant thrombosis. Both grafts to which ANP--EAC--FN was bound (photocoupled and adsorbed only) were free of thrombosis formation. Endothelialization was complete giving the inner surfaces of the grafts a smooth, shiny appearance. EXAMPLE 2 Modification of the Surfaces of Contact Lenses and Introcular Lens Implants The experiments described in this example involved preparations of hydrophilic polymers (a biocompatible agent) bound to a chemical linking moiety, photocoupling the moieties to contact lens surfaces, and measuring the in vitro protein deposition from artificial tear solutions onto these lenses in comparison to non-treated lenses. Experiments to study the compatibility of the biocompatible agents in vitro with corneal pieces and in vivo in rabbit eyes were conducted to assure that there were not toxic or irritant reactions to the resulting lenses. 1. Binding Biocompatible Agents to the Chemical Linking Moiety. A. Preparation of Photolabeled Polyethylene Glycols. Polyethylene glycols of molecular weights 1000 (PEG-1000) and 4000 (PEG-4000) were labeled with fluoronitroazidobenzene (FNAB) by modification of the phase transfer method of "Kimura, and S. Regen, Journal of Organic Chemistry 48; 195 (1983) the teachings of which are incorporated by reference herein. Briefly, the phase-transfer synthesis of 4-azido-2-nitrophenyl polyethylene glycol (ANP--PEG) involved the mixture of 60% aqueous potassium hydroxide ("KOH")/toluene with FNAB and PEG, followed by extraction and thin layer chromatographic (TLC) purification as described below. ANP--PEG--1000. ANP--PEG--1000 was prepared by adding 0.05 mmole PEG-1000 to 5 mls 60% KOH and 0.5 mmole FNAB to 10 ml toluene. This reaction mixture was rapidly stirred at room temperature for 16 hours. The product was isolated from the organic layer. TLC in 85/15/1/1 chloroform/methanol/H 2 O/acetic acid or ammonium hydroxide separated mono-and di-substituted derivatives of ANP--PEG--1000 from unlabeled PEG. The band corresponding to ANP--PEG--1000 (lower R f value) was extracted from silica gel with TLC solvent and azeotrophed to remove residual acid or base. The final product was soluble in water and resulted in the conversion of 30-40% of the pEG starting material to ANP PEG-OH product. ANP--PEG--4000. The ANP--PEG--4000 was prepared by the same procedure as that described above except that the reaction mixture was rapidly stirred at 50° C. to ensure all reagents remained in solution during the course of the reaction. The yield of ANP--PEG--4000--OH was 10%. B. Preparation of Photolabeled Jeffamines. Polyoxypropylenepolyamines and polyoxyethylenepolyamines (referred to as "Jeffamines", a trademark of Jefferson Chemical Co., Inc.) were photolabeled by coupling the N-oxysuccinimide ("NOS") esters of ANP-EACA, BBA and nBBA to the polymers. These NOS-derivatives were added in 0.5 X amounts to 1X Jeffamine in very dry (high purity) solvents (ANP--EAC--NOS in dry tetrahydrofuran, BBA--NOS in dry dioxane or dimethylformamide and nitro BBA--NOS in dry dioxane or dimethylformamide). After 16 hours of reaction at room temperature in the dark, the products were isolated by TLC in 85/15/1/1/ chloroform/methanol/H 2 O/acetic acid. Monosubstituted Jeffamine derivatives were extracted with the TLC solvent and azeotrophed with water to remove the residual acetic acid. The water-soluble products ANP--EAC--Jeffamine, BBA--Jeffamine, and nBBA--Jeffamine were isolated in 15%, 10% and 12% yields, respectively. C. Preparation of ANP-Hyaluronic Acid. The terminal sugar of human placental hyaluronic acid (MW app 100-130,000) was activated by the periodate procedure described in E. Junowicz and S. E. Charm, "The Derivatization of Oxidized Polysaccarides for Protein Immobilization and Affinity Chromatography," Biochimica et Biophysica Acta, Vol. 428: 157-165 (1976) and incorporated herein by reference. This procedure entailed adding sodium or potassium periodate to a solution of hyaluranic acid thus activating the terminal sugar. The hyaluronic acid was added to a 10 fold excess of Jeffamine and allowed to react 4 hours at room temperature. The linkages were stabilized by reduction with sodium cyanoborohydride, followed by exhaustive dialysis to remove most of the excess Jeffamine. A 10-fold molar excess of ANP--EAC--NOS in DMF was added to the Jeffamine-hyaluronate in 0.1 M carbonate, pH 9.0, by syringe drive. This addition required 16 hours and was conducted at room temperature in the dark. The excess ANP--EAC--NOS and ANP--EAC Jeffamine was removed by gel filtration chromatography. The integrity of the azide group, which is required for photocoupling of the moiety to the contact lens polymer backbone, was analyzed by infrared spectroscopy to detect the ANP group, a polyethylene glycol assay to detect the Jeffamine spacer, and a modified carbazole assay described in T. Bitter and H. Muir, Analytical Biochemistry Vol. 4: 330-334 (1962) and incorporated herein by reference to determine the uronic acid content of the derivative. The polyethylene glycol assay was developed using the Dragendorff reagent (tetraiodobismuthic acid-barium chloride). A 5-ml portion of stock reaqent (425-mg bismuth nitrate, 10-gm potassium iodide in acetic acid and water) was added to 10-ml 10% barium chloride in water and a background reading at 516+nm was noted. Then 0.1-ml of the sample was added and the contents mixed by inversion of the cuvette. A reading was taken at 516-nm after 1 minute of incubation. The values were compared to a standard curve. The carbazole assay was performed as follows. A 3.0 ml portion of sulfuric acid reagent (0.025 M sodium tetraborate-10 H 2 O in sulfuric acid) was cooled to -70° C. A 0.5 ml portion of sample was layered onto the acid and the mixture was stirred (30 min.) until it reached room temperature. The tubes were heated at 100° C. (10 min.), a 0.1 ml aliquot of carbazole reagent (0.125% carbazole in absolute ethanol) was added, the tube contents were mixed (5 min.), heated at 100° C. (15 min.), then cooled to room temperature in an ice bath. The samples were analyzed spectrophotometrically at 530 nm against a sulfuric acid reagent blank. The results were compared to a standard curve constructed with 4-40 μg/ml glucuronolactone standards. The assay was sensitive to detecting 20 pmole of hyaluronic acid. The fractions containing one ANP, one Jeffamine and one hyaluronate molecule were pooled and used as a biocompatible agent. D. Preparation of Photolabeled Hyaluronic Acid, Methyl Cellulose and Chondroitin Sulfate. ANP--EAC--Jeffamine, BBA--Jeffamine and nitro-BBA--Jeffamine were linked to the carboxyl groups of uronic acid residues of hyaluronic acid and chondroitin sulfate by a carbodiimide procedure as follows. A 5 molar excess of photolabeled Jeffamine and 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide with HCl was mixed with the polysaccharide polymer in water adjusted to pH 4.5 with 0.1N HCl. The mixture was allowed to react at room temperature in the dark for 24 hours. The product was purified by gel filtration chromatography then analyzed for photogroup and carbohydrate content as described above. E. Preparation of Photolabeled Collagen. Human placenta Type IV collagen (available from Sigma Pharmacueticals) was dissolved at a 1 mg/ml concentration in 0.1 M borate, pH 9.0. ANP--EAC--NOS in DMF, BBA--sulfa--NOS in dioxane or nitro BBA--NOS in dioxane was slowly added to the collagen solution in a 50x molar excess by syringe drive at 4° C. in the dark over 16 hours. After the addition was complete, the mixture was stirred 4 hours in the cold. The collagen product was dialyzed against 4 changes of PBS then centrifuged to remove insoluble material. The supernatant was measured spectrophotometrically at 260 nm, 280 nm and 462 nm to assess the photogroup/protein ratio. F. Preparation of Photolabeled Proteinases. ANP--EAC--NOS, BBA--NOS and nBBA--NOS photogroup dissolved in organic solvent at 25 mg/ml concentrations, were added in 50 molar excess to papain (papaya, MW 23,426) by syringe drive at 4° C. in the dark over 16 hours. After addition of the photogroup was completed, the mixture was stirred an additional 4 hours, then dialyzed in PDS to remove uncoupled photogroups. After dialysis, the product was centrifuged to remove insoluble material. The supernatant was measured spectrophotometrically at 260 nm, 280 nm, and 462 nm to estimate the photogroup/protein ratio. 2. Photocoupling Biocompatible Agents to Lens Surfaces. The photolabeled biocompatibles agents obtained above were added to the contact lens materials described in Table 4 at a concentration of 250-1000 pmole agent/contact lens. The solution was allowed to adsorb onto the contact lenses at room temperature in the dark for 3 hours. The photolabeled agents were then covalently linked to the plastic by photolysis for 12 hours at the appropriate wave length (450 nm for ANP and 320 nm for BBA and nBBA derivatives). After photolysis, the contact lenses were washed with 5×5 ml of normal saline (0.85% NaCl) to remove noncovalently linked groups. Radiolabeled groups may be coupled to the lens materials, and the lens pieces treated with tetrahydrofuran followed by DMSO to release the radiolabel from the solid surface. Scintillation fluor is then added and the amount of biocompatible agent/cm 2 determined by liquid scintillation spectroscopy. Representative results are shown in Table 4. TABLE 4__________________________________________________________________________Load Densities of Biocompatible Agents onVarious Contact Lens MaterialsBiocompatible Contact Lens CouplingAgent Material *pmole/cm.sup.2 ng/cm.sup.2 Efficiency__________________________________________________________________________ANP-1000 Polyvinyl chloride 19.96 19.96 22.86% Sofspin (polymacon) 33.45 33.45 12.95% Permaflex 33.97 33.97 12.90% Vistamarc 34.26 34.26 13.20% Lidofilcon 63.12 63.12 24.30% Silicone 33.97 33.97 4.80% **Polymacon Button 2408.60 2408.60 38.23%ANP-4000 Sofspin (polymacon) 27.06 108.24 10.50% Permaflex 42.86 171.44 16.50% Silicone 170.60 682.40 22.70% **Polymacon Buttons 1574.00 6296.00 25.00%nitro BBA- Polyvinyl Chloride 23.20 46.40 26.60%2000 Sofspin 13.14 26.28 5.10% Permaflex 8.21 16.42 3.20% Silicone 95.61 191.22 13.50% **Polymacon Buttons 3738.00 7476.00 56.45%BBA-2000 Silicone 113.20 226.40 15.60% **Polymacon Buttons 4035.10 8070.20 64.30%ANP-Hyal- Silicone 25.00 25.00 7.00%uronic acid **Polymacon Buttons 130.95 130.95 7.90%__________________________________________________________________________ *Values were averaged from replicates of 10 **Polymacon loads are based on total volume, cm.sup.3, rather than surfac area. Sofspin contacts are made of polymacon (polymethacrylate) with about 38.6 water and are a trademarked product of Bausch & Lomb, Inc. Permaflex contacts are made of polymethacrylate with about 74% water and are a trademarked product of Coopervision, Inc. Vistamarc contacts are made of polymethacrylate with about 58% water and are a trademarked product of Johnson & Johnson. Lidofilcon contacts are made of polymethacrylate with about 70% water and are a product of Bausch & Lomb, Inc. The values in Table 4 are expressed as pmole biocompatible agent per square centimeter surface area or ng/cm 2 . The coupling efficiencies were based upon addition of 260 pmole/cm 2 biocompatible agent/contact lens materials, 710 pmole/cm 2 biocompatible agent/ silicone, and 660 pmole/cm 3 biocompatible agent/cm 3 polymacon button. ANP-hyaluronate was added at 357 pmole/cm 2 silione and at 1655 pmole/cm 3 to polymacon button material. The ANP derivatives coupled at higher load densities than the nBBA--Jeff on the hydrogel contact lens materials. These results were reversed for the silicone compound. 3. In Vitro Protein Adsorption Studies. Artificial human tears were prepared according to the formula found in B. P. Gloor, "The Lacrimal Apparatus" in Adler's Physiology of the Eye: Clinical Applications (R. A. Moses, ed.), C. V. Mosby Co., St. Louis, MO (1981) the teachings of which are incorporated herein. As indicated in that reference the major proteins present in human tears are serum albumin (HSA), gamma globulin (HGG), and lysozyme (LYZ). The major sterols present in human tears are cholesterol and cholesterol esters. A. 3 H Proteins. The protein components were tritiated by reductive methylation with formaldehyde and tritiated sodium borohydride as described in N. Jentoft and D. C. Dearborn, Journal of Biochemistry, Vol. 254: 4359-4365 (1979) and incorporated herein by reference. Briefly, the biocompatible agent in 1 mg/ml concentration in 0.1 M HEPES, pH 7.4 was methylated by formaldehyde reacting with tritiated sodium borohydride and rocking at 22° C. for about 2 hours. The product was dialyzed against PBS in 0.01 M phosphate, 0.15 M sodium chloride, pH 7.4, and affinity purified on gelatin sepharose. Bound agent was eluted with 1 M sodium bromide 0.02 M sodium acetate, pH 5.0 then dialyzed against PBS, pH 7.4. B. Preparation of Artificial Tears. The radiolabeled proteins described above were used in preparation of artificial tears. One of the radio labeled proteins or the tritiated cholesterol was included in each tear mixture. The other components were not radiolabeled. The contact lens materials were incubated in the artificial tear solution for one week at 37° C. with gentle agitation. At the end of this time the lens materials were washed with 5×10 ml of 0.85% NaCl. The amount of protein adsorbed to the lens materials was then determined by liquid scintillation counting. In vitro protein deposition results are given in Table 5. Reduction in total protein deposition reached 85% in ANP-1000-OH modified Sofspin lenses. Individual biocompatible agents increased or stayed at the same levels as some of the control contact lens materials, but the overall protein amounts were reduced for all lens materials except ANP-1000-OH coated Polymacon buttons, ANP-4000-OH coated polymacon buttons and ANP-hyaluronate coated polymacon buttons. These poor results were all obtained with virgin polymacon materials which appears to react differently than polymacon contact lenses, such as Sofspin lenses. Overall, these in vitro protein deposition studies demonstrated significant to dramatic decreases in protein deposition from artificial tears on various contact lens materials during a one week period. TABLE 5__________________________________________________________________________In VitroProteins Adsorption from ArtificialTears: .sup.3 H Proteins* ug % ReductionBiocompat- Contact ugHSA/ % of ugHgg/ % of ugLys/ % of Total % of Totalible Agent Material cm.sup.2 control cm.sup.2 control cm.sup.2 control Protein control Protein__________________________________________________________________________Controls Polyvinyl .525 100. pp .524 .441 1.49 Chloride Sofspin 1.256 1.33 .576 3.162 (Polymacon) Permaflex .978 1.953 1.866 4.797 Vistamarc .553 .343 47.86 48.76 Lidofilcon 2.154 1.009 1.423 4.586 Silicone 1.121 .272 .264 1.657 **Polymacon 32.23 6.983 2.46 41.673 ButtonsANP-1000-OH Polyvinyl .298 56.8 .696 133 .0384 8.7 1.032 69.3 30.7 Chloride Sofspin .241 19.2 .191 14.4 .04 6.9 .472 14.93 85.07 Permaflex .582 59.5 1.351 69.2 1.693 90.73 3.626 75.6 24.4 Vistamarc .187 33.8 .378 110.2 39.19 81.88 39.76 81.5 18.5 Lidofilcon .640 29.7 .440 43.6 1.73 121.5 2.81 61.3 38.8 Silicone .103 9.2 1.016 373.5 .214 81.1 1.333 80.4 19.6 **Polymacon 36.00 111.0 5.44 77.9 2.47 100.0 43.91 105.4 (-5.4) ButtonsANP-4000 Polyvinyl .430 81.9 .356 67.9 .148 33.6 .934 62.7 37.3 Chloride Sofspin 1.16 92.4 .608 45.7 .297 51.6 2.065 65.3 34.7 Vistamarc .187 33.8 .686 200.0 43.24 90.3 44.11 90.5 9.5 Silicone 1.082 96.5 .242 88.9 .210 79.5 1.534 92.6 7.4 **Polymacon 37.62 116.7 4.172 59.7 1.863 75.7 43.655 104.7 (4.7) ButtonsnBBA-Jeff Polyvinyl .632 120.3 .576 109.9 .072 16.33 1.28 85.9 14.1 Chloride Sofspin .665 52.9 .859 64.5 .531 .922 2.055 64.9 35.1 Silicone .978 87.2 .061 22.4 .068 25.8 1.107 66.8 33.2 **Polymacon 26.35 81.76 .01 .14 .01 .41 26.37 63.28 36.72 ButtonsBBA-Jeff Polyvinyl .326 62.1 .454 86.6 .290 66.7 1.07 71.8 28.2 Chloride Silicone .921 82.15 .089 32.7 .149 56.4 1.159 69.9 30.1 **Polymacon 30.61 94.9 3.695 52.9 .01 .40 34.32 82.34 17.66 ButtonsANP-Jeff Polyvinyl .486 92.6 .456 87.0 .192 43.5 1.134 76.1 23.9 Chloride Silicone .904 80.6 .231 83.7 .257 97.6 1.392 84.01 15.99 **Polymacon 35.48 110.1 5.62 80.5 1.94 78.86 43.04 103.3 (3.3) Buttons__________________________________________________________________________ *The values are calculated from 10 replicates **Polymacon buttons are based on volume rather then surface area cm.sup.3 ***Values in parentheses indicate an increase in protein adsorption The results of the in vitro cholesterol deposition studies are given in Table 6. The amount of cholesterol deposition after 7 days of incubation in artificial tears was reduced by as much as 83% on polyvinyl chloride. All contact lens types exhibited reduction of cholesterol deposition except the polymacon button pieces. Again, these materials react differently than the contact lenses made of the same polymer. TABLE 6__________________________________________________________________________Cholesterol Adsorption from Artificial Tears:.sup.3 H Cholesterol *ugBiocompatible Cholesterol/ % of %Agent Contact Material cm.sup.2 Control Reduction__________________________________________________________________________Controls Polyvinyl Chloride .096 100 72.9 Sofspin .091 100 Permaflex .196 100 Vistamarc .032 100 Lidofilcon .053 100 Silicone .103 100 Polymacon Button .215 100ANP-1000 Polyvinyl Chloride .026 27.1 72.9 Sofspin .075 82.4 17.6 Permaflex .134 68.4 31.6 Vistamarc .028 87.5 12.5 Lidofilcon .046 86.8 13.21 Silicone .086 83.5 16.5 Polymacon Button .245 113.9 **(13.9)ANP-4000 Polyvinyl Chloride .0166 17.3 82.7 Sofspin .101 110.9 (10.9) Permaflex .134 68.4 31.6 Vistamarc .023 71.9 28.1 Silicone .104 100.9 (0.9) Polymacon Button .248 115.3 (15.3)nBBA-Jeff Polyvinyl Chloride .038 39.6 60.4 Sofspin .138 151.6 (51.6) Permaflex .164 83.7 16.33 Silicone .072 69.9 30.1 Polymacon Button .148 68.8 31.2BBA-Jeff Polyvinyl Chloride .0214 22.3 77.7 Silicone .107 103.8 (3.8) Polymacon Button .230 106.9 (6.9)ANP-Jeff Polyvinyl Chloride .028 29.2 70.2ANP- Silicone .224 217.5 (117.5)Hyaluronate Polymacon Button .238 110.6 (10.6)__________________________________________________________________________ *Values were the averages of ten replicates. **Values in parentheses indicate increase in cholesterol adsorption. C. Amino Acid Analysis. Control and surface modified lenses were incubated in the artificial tear solution for one week at 37° C. with gentle agitation. The lenses were washed with 5 10 ml washes of 0.85% NaCl, then hydrolyzed with 6N HCl and the hydrolysates subjected to standard amino acid analyses on an amino acid analyzer. Total amino acid content of control and surface modified lenses were compared to each other. Reduction in total amino acid content indicated a reduction in protein absorption. The total amino acid analyses of the acid hydrolyzed contact lenses are given in Table 8. These results are expressed as total amino acids in nmole/ml. These results again indicated that the ANP-1000-OH, ANP-4000-OH and nBBA--Jeff modifications of Sofspin polymacon lenses reduced the deposition of proteins on the lenses after 7 days of incubation in artificial human tears. TABLE 7______________________________________Total Amino Acid Analyses from ArtificialTear Deposits on Contact Lenses Total Amino AcidsContact Biocompatible nmol/lensMaterial Agent no NH.sub.3 % Reduction______________________________________Sofspin ANP-1000 62.75 59.7 ANP-4000 136.272 12.4 nBBA-Jeff 105.381 32.3 Control 155.616 --Permalens ANP-1000 168.714 32.5 ANP-4000 210.207 15.9 nBBA-Jeff 181.302 27.5 Control 249.939 --______________________________________ 4. In Vitro Toxicity Testing. The biocompatible lens materials described above were tested for irritant or toxicity responses. Control and biocompatible lenses were prepared under sterile conditions with final washing procedures conducted in a laminar flow hood. The lenses were placed in a solution of a known high glucose cell medium such as Dulbecco's Modified Essential Medium, with 10% fetal calf serum, and 5% glutamine (to which antibiotic and anti-fungal agents had been added). Pieces of viable 3-5 month fetal bovine corneas were placed on top of the lenses. The epithelial surface of the cornea was placed in contact with the lens surface in some studies, and the endothelial cell surface was placed directly on the lens surface in other studies. The systems were placed in culture at 7-10% CO 2 and 37° C. for 1-2 week periods. At various intervals after initiation of culture the viabilities of the epithelial and/or endothelial cells were assessed by staining procedures. 5. In Vitro Assay for Stability of Covalent Bond. The stability of the covalent attachment was assessed by subjecting the surface-modified polymacon (polymethacrylate) to enzymatic cleaner (papain), thermal disinfection and chemical disinfection (buffered acqueous solution containing sodium chloride, sodiumborate and boric acid.) These results are given in Table 8. TABLE 8______________________________________Stability of Covalent Linkage to CleaningDisinfection ProceduresBiocompatibleAgent Treatment pmole/cm3 % Remaining______________________________________ANP-1000 No treatment 831 100 Enzymatic cleaner 862 100 Boiling 761 91.6 Chemical cleaner 721 86.8ANP-4000 No treatment 1574 100 Enzymatic cleaner 2012 100 Boiling 2092 100 Chemical cleaner 1564 99.4nBBA-2000 No treatment 1732 100 Enzymatic cleaner 1785 100 Boiling 1795 100 Chemical cleaner 1129 65.2BBA-2000 No treatment 1651 100 Enzymatic cleaner 1996 100 Boiling 1619 98.1 Chemical cleaner 1409 85.3ANP- No treatment 300 100Hyaluronate Enzymatic cleaner 317 100 Boiling 340 100 Chemical Cleaner 307 100______________________________________ *Values are the averages of 10 replicates The covalent linkages remained 100% stable to enzymatic cleaning and thermal disinfection. There was some loss of biocompatible agent with the chemical disinfection procedures except for the ANP-hyaluronate. 6. In Vivo Assessment of Biocompatibility. Preliminary in vivo biocompatibility testing was conducted in rabbit model systems. A population of at least 24 animals was used in each study. Scleral lenses designed to fit rabbit eyes were used in these studies. The rabbits wore lenses according to the following schedule: ______________________________________ 6 rabbits No lens left eye, control lens right eye 6 rabbits Control lens left eye; physically treated lens (same physical treatment as surface modified lenses but not coated with biocompatible agent) right eye12 rabbits Control lens left eye; surface- modified lens right eye.______________________________________ The rabbits were anesthetized with Ketamine/Xylazine prior to placing the lenses in the rabbit eyes. A methyl cellulose/normal saline wetting solution was applied hourly to maintain adequate eye and lens lubrication. The contacts were worn 8 hours/day. After chosen periods of lens wear the rabbits were analyzed by slit lamp and fluorescein dye methods. The degree of eye irritation was graded by the McDonald Shadduck scale as described in T. O. McDonald and J. A. Shadduck, "Eye Irritation," in Advances in Modern Toxicology, Vol. 4, pp. 162-166 (1977) incorporated herein by reference. The McDonald Shadduck procedure allows the investigator to grade conjuctival congestion, conjuctival swelling, conjunctival discharge, aqueous flare, iris involvement and corneal cloudiness and other characters on a scale of 0-4, with 0 being normal and +4 the most complete involvement. The results of the in vivo rabbit studies are given in Table 9. The McDonald-Shadduck scores for the rabbits are represented in the table. Mann-Whitney U tests were performed on these results and indicated that there were no statistical differences between the surface-modified and control lenses (p <0.05). Therefore, these tests indicate that in this 4 day study in rabbits, no detectable differences in conjunctival congestion, conjunctival swelling, conjuctival discharge, aqueous flare, iris involvement, corneal cloudiness, pannus vascularization, norepithelial damage of the surface modified lenses was detected as compared to control lenses. The irritation which was demonstrated in the control and the modified lenses appeared to be associated with the rabbits development of tolerance to contact lenses. TABLE 9______________________________________Average McDonald-Shadduck ScoresFor In Vivo Rabbit Study Day 1 Day 2 Day 3 Day 4______________________________________Control Lens 0.53 0.78 0.19 0.33Surface 0.58 0.65 0.17 0.21Modified Lens______________________________________ EXAMPLE 3 Coupling of Albumin, Heparin and Urokinase to Polyurethane Tubing 1. Preparation of Photolabeled Albumin. Serum albumin (canine) was dissolved in 0.1 M borate buffer at pH 9.0. A volume of 4 azido 2 nitrophenyl 6-aminocaproyl-N-oxysuccinimide (ANP--EAC--NOS) solution at 25 mg/ml in DMF to provide a 10 fold molar excess of ANP--EAC--NOS over albumin was added to the albumin with stirring at room temperature in the dark over about 12 hours using a syringe drive. The solution was then dialyzed in the dark against three one liter volumes of phosphate buffered saline (PBS). After dialysis, the solution was centrifuged to remove insoluble material. The absorance at 470 nm of a 1/100 dilution was measured spectrophotometrically to estimate the ANP/albumin ratio. 2. Photocoupling of Albumin to Polyurethane Tubing. Polyurethane tubing was dipped into dioxane for thirty seconds after which it was immediately rinsed with deionized water. The etched tubing was immersed in a solution of photoreactive albumin for at least two hours at room temperature in the dark with mixing. The tubing was then air dried for at least ten minutes in the dark, then exposed to high intensity visible light for at least one hour. The immersion in photoreactive albumin, drying and photolyzing was repeated twice, the last time the dipping was left overnight. The tubing was then washed in 1.0 N NaCl for one hour at room temperature. The NaCl solution was changed at least once during the one hour. 3. Coupling of Heparin to Albumin on Polyurethane Tubing. The albumin-polyurethane tubing was immersed in 5.0 ml. of deionized water. 200 mg of 1-ethyl-3-(3-dimethylaminopropyl) carbodimide (EDC) was dissolved in the water, then the pH was adjusted to 4.0 with 1N HCl. One ml of water containing 30 mg of heparin was added to the EDC solution. The pH was again adjusted to 4.0 with 1N HCl. The solution containing the immersed polyurethane tubing was mixed for two hours at room temperature after which another 200 mg of EDC was added. The reaction was then allowed to continue overnight at room temperature. The tubing was then rinsed in PBS to remove uncoupled heparin and reaction biproducts. 4. Coupling of Urokinase to Albumin on Polyurethane Tubing. Polyurethane tubing having serum albumin immobilized thereon was immersed in 1.25% glutaraldehyde in 0.1 M phosphate buffer, pH 7.0 for 15-18 hours at room temperature. The tubing was then washed in deionized water for 30 minutes, the water being changed at least once during that time. The polyurethane-albumin-glutaraldehyde was then immersed in a solution of urokinase (8.3 units/ml, 2-3 mg/ml) in 0.1 M borate of pH 9.0 and mixed overnight at 4° C. The tubing was then rinsed for four hours in PBS after which it was assayed for urokinase activity. Two polymers were used as the solid surface, polyurethane and polyhema. The modified surfaces yielded 1-10 mg heparin/cm 2 an 0.6-1.3 mg urokinase/cm 2 . EXAMPLE 4 Coupling of a Film to a Solid Surface Formation of a Coating Film and its Covalent Attachment to a Surface. Preparation of ANP hyaluronic acid. Photolabeled derivatives of hyaluronic acid (ANP--EAC--Jeffamine, BBA--Jeffamine and nitro-BBA--Jeffamine) were prepared as previously described. Films are formed from the photoreactive coating material and placed on surfaces of contact lenses (by dipping and drying) in the dark. Covalent attachment to the biomaterial surface and strengthening of the film by intermolecular cross-linking may be accomplished through illumination. In another example, an artificial hip joint is soaked in ANP--EAC--Jeffamine-hyaluronic acid (0.1:1 mg/ml) for three hours in the dark. The joint is then removed from solution and allowed to dry forming a thin film of coating material on the artificial joint. The film is then covalently attached to the joint by illumination at 400 to 450 nm for 8 hrs. at 4° C. The joint is then rinsed in physiological saline to remove uncoupled ANP--EAC--Jeffamine-hyaluronate. The hyaluronic acid bound to the bone reduces friction and reduces wearing of the bone in the joint area. 100 mg of bovine serum albumin is dissolved in 2 ml of 0.1 M borate buffer pH 9. 14 mg of ANP-AUD-NOS is dissolved in 50 ul of dimethylformamide (DMF). The ANP-AUD-NOS solution is added to the BSA solution slowly over 15 hrs at room temperature in the dark with good stirring. After an additional 3 to 4 hours of stirring the solution is dialyzed against 0.1 M borate buffer at pH 9 in the dark over 24 hrs. with at least 4 changes of 2 liters each of buffer. The dialyzed ANP-BSA is pipetted onto paraffin films in 100 ul aliquots and dried in the dark. After the films have dried they are overlaid with 100 ug aliquots of 1.25% glutaraldehyde and borate buffer pH 9 and incubated for one hour at room temperature in the dark. The films are then washed by slowly dropping water onto them while still on the paraffin films and allowing the water to run off. After one hour of such washing, the films are redried and then carefully lifted off the paraffin film and transferred to a plastic surface (e.g., polyurethane). On the plastic surface the films are again wetted with water containing 20% dioxane, then redried in the dark. The films on the plastic surfaces are then exposed to high intensity visible light for four hours at 4° C. to bind the film to the surface with a fan blowing across the surface to prevent excessive heating of the surface. While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention is related to an improved snowboard. 2. Description of Background and Relevant Information A snowboard is device for gliding over snow on which both feet of the user are separated from one another along the board and are fixed along a substantially transverse or inclined orientation with respect to the longitudinal axis of the board. U.S. Pat. No. 3,900,204 is the first disclosure to teach the most suitable positioning of the bindings for the practice of this sport. In the practice of this discipline, the rocking forces generated at turns are translated by a combination of substantial bending and torsional forces between the feet of the snow boarder. Consequently, this portion of the board is a zone subject to deliberately forceful stresses which the snowboarder must be able to master under all circumstances. However, it has been measured, especially at very fast speeds, that this portion of the board is subject to localized vibrational phenomena appearing at frequencies greater than 10 Hertz, and most of these are caused by small jolts and the unevenness of the terrain, and have nothing to do with the deliberate deformations caused by the snowboarder himself when he executes turns. These vibrational phenomena disturb the performance of the board, which thus become difficult to handle. Thus, there is a need for shock-absorption between the feet of the snowboarder, while simultaneously retaining a certain flexibility in bending and torsion that is necessary to handle the board in a turn. The main objective is therefore to dampen the adverse vibrations without adding static stiffness in the central zone. The document FR-A-2 665 081 is related to a snowboard having a symmetrical construction with a shock-absorption device located, in all cases, at the front of the board in an asymmetrical manner so as to provide a shock-absorption that is preponderant on the "back-side". In a known manner, this is a plate having a high modulus that stresses a layer of visco-elastic material connected to the board. However, it has been noted that in the current manner of snowboarding, the front and rear zones are used to make figures by taking support on these zones and taking advantage of their elasticity in order to bound or jump. One especially famous figure style, known as "Ollie" consists of taking support on the rear of the board with one's entire weight and then of taking advantage of the spring effect to surge forward. As such, it is important not to diminish the elasticity in these zones with a shock-absorption device. In addition, the device according to this document adds too much stiffness to the zone where it is located due to the fact that the elongate facing is adhered along the entire surface of the board. Thus, one cannot equip the central portion of the snow board with such a device without affecting its flexibility, and therefore the ease of handling of the board. The document FR 2 729 086 is related to a snowboard equipped with a shock-absorption device formed of visco-elastic strips that are stressed by a material having a high elasticity modulus and as such, this disclosure has the same disadvantages as the solution of the document FR-A-2 665 081. SUMMARY OF THE INVENTION Thus, it is an object of the instant invention to provide a satisfactory solution to the above-cited problems related to the shock-absorption of a snowboard. In order to accomplish this, the invention is related to a snowboard comprising two binding mounting zones, spaced longitudinally along the surface of the board, a central portion located between the mounting zones, end portions located on either side of the mounting ones, and at least one of the end portions ending in a raised edge. In addition, the board comprises a shock-absorption device connected to the board in the central portion, equipped with at least one elongate element for transmitting the bending and/or torsion stresses of the central portion, the element having at least two opposing end portions connected to the board, and between such end portions, a central portion that is free in translation without any connection with the board; at least one of the end portions being in contact with a shock-absorption mechanism that dissipates the energy resulting from the translational, and possibly rotational displacements of the end portion during the bending and/or torsional deformations of the central portion of the board by shearing or friction. A board equipped with such a device retains its properties of flexibility during bending and torsion at the center, and this promotes ease of handling while taking turns; its ends also retain their responsiveness for the execution of figures and jumps provides a satisfactory response in terms of dampening the vibrations in the zones where a shock-absorption is necessary to handle the board, even at high speeds and over bumpy terrain. According to an advantageous characteristic of the invention, the shock-absorption device is constituted by two elongate transmission elements that are oriented substantially along the longitudinal direction of the board and that are spaced laterally from one another and located on either side of the longitudinal median axis. This favors the absorption of vibrations during combined bending and torsional deformations, with a preponderance towards bending due to the longitudinal orientation of the transmission elements. According to a variation, the shock-absorption device is constituted by an elongate element in the shape of a cross comprising a central portion that is without any connection with the board, and starting from the central portion, four end portions form the opposing arms in pairs. In this case, it is preferable that the elongate element be oriented along the board in such a away that each portion extends along a preferred direction, forming an orientation angle of approximately 45 degrees with respect to the longitudinal direction of the board. In this case, preference is given to the dissipation of energy caused during the maximum torsional deformations mainly due to the vibrations, without creating any stiffness in the central portion of the board. BRIEF DESCRIPTION OF THE DRAWINGS Other characteristics and advantages of the invention will become apparent from the description that follows with reference to the annexed drawings which are provided only as non-limiting examples thereof, wherein: FIG. 1 is a top view of a snowboard equipped with binding elements; FIG. 2 is a partial side view of a shock-absorption device; FIG. 3 is a top view of the element of FIG. 2; FIG. 4 is a sectional view taken along line IV--IV of FIG. 3; FIG. 5 is a sectional view taken along line V--V of FIG. 4; FIG. 6 shows a side view of a board according to the invention, on which a snowboarder is mounted in the resting position; FIG. 6a is a detailed sectional view like that of FIG. 4 but in the configuration of FIG. 6; FIG. 7 illustrates a pure bending deformation of the board; FIG. 7a is a sectional view that is similar to FIG. 6a in the configuration of the deformation of FIG. 7; FIG. 8 is a view similar to the view of FIG. 1 according to a variation of the invention; FIG. 9 is a side, partially sectional view of the device according to FIG. 8; FIG. 10 is a top view of a detail of the device according to another variation; FIG. 11 is a sectional view taken along line XI--XI of FIG. 10; FIG. 12 is a sectional view taken along line III-XII of FIG. 10; FIG. 13 is a top view of a board according to another variation of the invention; FIG. 14 is an enlarged view of a detail of FIG. 13; FIG. 15 is a sectional view taken along line XV--XV of FIG. 13; FIG. 16 is a sectional view taken along line XVI--XVI of FIG. 13; FIG. 17 is a sectional view taken along line XVII--XVII of FIG. 13; FIG. 18 is a top view of a board according to another variation of the invention; FIG. 19 shows a detail of FIG. 18; and FIG. 20 is a sectional view of the view of FIG. 19. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to FIG. 1, the drawing illustrates a snowboard 1 for snowboarders who keep their left foot at the back, or in a "goofy" position, and comprises two mounting zones, viz., a rear zone 10 where the rear binding 20 is located, and a front zone 11 where the front binding 21 is located. Between the two zones 10, 11 that have been illustrated schematically in a circular fashion due to the possibility of the angular displacement of the bindings, is located a central portion 2. Towards the rear of the rear zone is the rear end portion 3 that end in a raised edge 30. Similarly, the front end 4 is located beyond the front zone and it ends in a raised edge 40. The board as illustrated represents a non-limiting example, and it would be possible to envision a single raised edge at the front, for example. According to the invention, the central portion 2 comprises a shock-absorption device 5 that is connected to the board and comprises two separate elongate elements 50, 51 for transmitting the bending and torsional stresses. The two elongate transmission elements 50, 51 are oriented substantially along the longitudinal direction of the board and are spaced laterally from one another and located on either side of the longitudinal median axis I-I'. These elements each have a first end portion 500, 510 and a second end portion 501, 511 that are connected to the board. Between the end portions of each element is located a central portion 502, 512 that has the special characteristic of having no connection with the board, and of thus being free, especially in translation, during the deformation of the central portion of the board during bending and/or torsion. The end portions 500, 510, 501, 511 are all connected to the board via flexible shock-absorption devices 600, 610, 601, 611 that will be described in detail below. The device thus adds much less stiffness compared to a shock-absorption element that is connected along its entire length via a flexible means, as is the case in the prior art cited previously. The arrangement of the two elements 50, 51 that are laterally spaced from one another and, preferably in the vicinity of each edge of the board, has the advantage of being able to handle both the pure bending deformations, i.e., maximum in the orientation along the axis I-I' as well as the torsional deformations, oriented in an inclined manner with respect to the axis I-I' (maximum at ±45 degrees with respect to I-I'). The details of element 50 equipping the board are illustrated in FIGS. 2 through 5. The other element 51 has an identical design and the following description applies equally to such element 51. Similarly, only one of the halves of element 50 has been represented and described in the following description and it is to be understood that the element has been designed symmetrically with respect to the vertical and transverse plane P passing through the center of such element. The elongate element 50 thus comprises a central portion 502 which is not connected to the upper surface of the board by any type of connection arrangement such as adhesive, for example. In other words, this portion is free in longitudinal translation, but it also has a certain capacity for vertical displacement with respect to the surface of the board depending on the bending and torsional stresses that are applied onto the central portion of the board. The elongate element is extended at the end by an end portion 500 that is connected to the board via a flexible connection mechanism 600. The connection is thus ensured by layers of flexible material, preferably a visco-elastic material 600a, 600b. This flexible shock-absorption mechanism 600 allows a translational displacement of the end 500a of the end portion 500. A protection and guiding device 7 covers the end of the portion that is free in translation and is fixedly connected to the board. This protection and guiding device 7 is a casing through which an opening 70 is provided for the passage of the end of the free portion and leads to a housing 71. The housing contains a or quantity of visco-elastic material surrounding the end of the free portion, thus forming an upper layer 600b adhered on top of housing 71 and on top of the end, and a lower layer 600a adhered on top of the board and beneath the end. Under no circumstances can the end 500a come into abutment against the base 710 of the housing of the casing under normal conditions of use. During the displacement of the end 500a in the housing 71, the layers of visco-elastic material 600a, 600b are stressed together during shearing and dissipate the energy transmitted by the elongate element. Preferably, the visco-elastic material is an elastomer whose Shore Hardness A is comprised between 5 and 85, whose elasticity modulus is comprised between 1 and 150 MPA and whose shock-absorption coefficient is comprised between 0.1 and 2.5. Some of these materials are preferred over others, such as mastics, due to their self-adhesive properties that do not necessitate the use of adhesives. Generally, these mastics have shock-absorption coefficients and moduli that vary substantially depending on the temperature. In order to identify those that can be used, we consider that they must have a modulus comprised between 1 and 20 MPA and a shock-absorption coefficient comprised between 0.1 and 2.2 for a useful temperature range comprised between -20 and +20 degrees. The use of other synthetic rubbers or elastomers is not excluded. However, it will generally be necessary to stick these layers via an appropriate adhesive. FIGS. 6, 6a, 7, 7a schematically represent the functioning of the shock-absorption device. FIG. 6 shows the board in a state of rest, and FIG. 7, when it is being bent. During bending, the central portion becomes deformed, for example, along the direction F of FIG. 7; this causes a longitudinal displacement relative to the end portions 500, 501 with respect to the surface of the board; and especially within the casings 7. This displacement leads to the shearing of the layers of visco-elastic material 600a, 600b and thus shock-absorption due to the energy dissipated in the material. The free bending of the board, especially its central portion, is hardly influenced by the fact that the elongate element is "floatably" mounted and is not rigidly connected to any spot to the board, and that the central portion especially is capable of being displaced with respect to the surface of the board. FIGS. 8 and 9 illustrate a variation of the invention wherein the shock-absorption device 5 is constituted of an elongate element in the shape of a cross 52 comprising a central portion 520 without any direct connection with the board and starting from the central portion, four end portions 521a, 521b, 521c and 521d form arms that are aligned and opposed in pairs. As regards these end portions, they are connected to the board via flexible shock-absorption mechanisms 600, 601, 610, 611. The elongate element 52 is oriented along the board in such a way that each end portion extends along a preferred direction (A--A; B--B) forming an orientation angle Θ of approximately 45 degrees with respect to the longitudinal direction I-I' of the board. In this configuration, torsional shock-absorption is favored. Preferably, the central portion 520 is located at a point that is equidistant from the two mounting zones 10, 11. FIG. 9 shows the shock-absorption element whose construction principle is based on the previous embodiment. The ends of each end portion is engaged in the protection and guiding devices or casing 7, that number four in all. Inside, the construction is identical to that of FIG. 4. According to a different embodiment illustrated in FIGS. 10 through 12, the protection and guiding device 7 is a stirrup that includes a shim 72 upon which a guiding element 73 is affixed; a guiding housing 71 through which the end 501a of the free portion 501 is adapted to be displaced in translation; a layer of visco-elastic material 602 is provided at the contact between the shim 72 and the end. In this case, provision has been made for just one layer of flexible material for the purpose of simplification. The purpose of the shim is to maintain the elongate element in the form of a facing at a distance d from the surface of the board in order to avoid any friction along the element with the board. The main function of the guiding element 73 is to ensure the translational guidance of the elongate element during the displacement of the free portion 501, and also to avoid the adhesive link between the end of the element and the visco-elastic layer 602, or the link between the layer 602 and the shim 72 from getting ripped off. In some cases it would be possible to envision eliminating the guiding element 73 whilst still remaining within the scope of the invention. Regardless of the embodiment, the elongate element for transmitting the bending and/or torsional stresses can be provided in the form of blands, profiles, rings, rods or plastic tubes, whether reinforced or otherwise. In order to ensure a good transmission of the forces, the element must be constituted of a material having a high modulus, selected from among metals and composite resin, fiber glass, carbon, acrylic, polyester based materials and a mixture of such fibers, as well as from among certain high modulus plastics. In the context of FIG. 1, the device comprises two separate elements that extend longitudinally along the board. It would also fall within the scope of the invention to provide a shock-absorption device constituted of a single element 50. In this case, the element can be located in a laterally offset manner with respect to the axis I-I', or even be located in an aligned manner along the longitudinal axis I-I'. In the latter case, only the shock-absorption of the longitudinal bending of the board is taken into account. FIGS. 13 through 17 illustrate another possible variation of the invention. In this case, the shock-absorption device comprises two elongate elements 50,51 constituted of rods that have been spaced laterally with respect to one another and located on either side of the median axis I-I'. In this embodiment, the end portions 500, 510 of the two rods 50, 51 are fixedly connected to the board via a fixed connection device that maintains a firm grip on the ends and does not allow for the possibility of any translational or rotational movement. In addition to this connecting arrangement, each rod is extended by an opposite end portion 501, 511 connected to the board via a flexible connecting arrangement 600 that comprises a casing 7 which is rigidly affixed to the board. As is shown in FIG. 14, the casing comprises openings 70a, 70b in order to enable the introduction of the ends of the free portions 510, 511, both in translation and also in rotation. A recess 71 is provided within casing 71 in order to allow a free displacement of each rod in translation. The volume is totally or partially filled with a block of visco-elastic material 603. Each end having a substantially cylindrical section, is thus surrounded by the material. In order to facilitate the assembly of the shock-absorbing device, while at the same time ensuring the constant spacing of the rods, the fixed connection device, located across from it, is presented in the form of a second housing 8 connected to the board by any means such as welding, screwing, adhesive etc. The fixed portions of the rods are themselves affixed in the casing 7 by means of an adhesive layer 80, for example. A protective sheath 9 surrounds the rods between the fixed connection arrangement 8 and the shock-absorbing casing 7. The advantage of this embodiment lies in the fact that it efficiently absorbs both the bending deformations as well as the torsional deformations by virtue of the freedom of movement that is conferred on the end portions 510, 511 both in translation, as well as in rotation. It is not essential that the rods be assembled in parallel, and they can also have different lengths in order to provide asymmetrical shock-absorption, for example. The rods can also have a non-circular section, such as a flattened, substantially semi-circular or oval shape, for example. They can have a filled or hollow section as well. The embodiment of FIGS. 13 through 17 represents a simplified and more economical example of the invention, wherein the flexible shock-absorption arrangement is present only at one of the two ends of each rod, whereas the other end is rigidly affixed to the board. It is to be understood that one could envision providing an identical shock-absorption arrangement at each end of each rod, as was the case in the previous embodiments. In the possible variations of the invention, it could be envisioned that the flexible shock-absorption mechanisms 600, 601, 610, 611 of the embodiments described and illustrated be replaced by a friction shock-absorption arrangement that comprises a friction layer having a friction surface that is covered with a material having a high friction coefficient. In this case, the friction layer can be directly or indirectly connected to the board and it can brake the translational, and possibly the rotational displacements of the end portion 501, 510, 511, 521a, 521b, 521c, 521d. The friction layer has to be guided in translation and/or rotation via a protection and guiding device of the type as described in the above cited embodiments. In another possible embodiment, the friction layer can be connected to the end portion and its friction surface remains in contact either with the upper surface of the board, or with one of the surfaces of the protection and guiding device. However, for a more efficient functioning of the shock-absorption device over time, the use of a flexible shock-absorption device, working in shearing is preferable. Indeed, the friction means is subject to quicker wear and tear. The shock-absorption conditions can also vary depending on the conditions. For example, if the snow is wet, water can penetrate inside and get interspersed between the friction surface of the layer and the surface that is subject to the friction (ski or casing) and thus affect the shock-absorption. With reference to FIGS. 18 through 20 that show another variation of the invention, the central portion 2 of the snowboard represented comprises a shock-absorption device 5 connected to the board. The device 5 comprises four elongate elements 50a, 50b, 51a, 51b that are grouped together in pairs. Each elongate element is oriented in an inclined manner with respect to the longitudinal direction of the axis I-I'. Preferably, the inclination α of each element with respect to I-I' is close to 45°. Each of the elements has a first end portion 500a, 500b, 510a, 510b that is connected to the board via a fixed connection, such as via screws that extend through the element and become anchored into the body of the board. The screws can be replaced by any other equivalent means, such as adhesive, vibration welding, or other means. The fixed portions are extended by the central portions 502a, 502b, 512a, 512b that have the special characteristic of not being linked to the board, and of thus being free in translation during the torsional deformation of the central portion. Finally, the elements end in second end portions 501a, 501b, 511a, 511b that are connected in pairs via a flexible shock-absorption arrangement 600, 601. In fact, the end portions 501a, 501b are connected to each other by a shock-absorption arrangement 60, and more specifically by means of a layer made of a flexible material 600. The same applies to the end portions 511a, 511b that are connected via shock-absorption arrangement 61 by means of a layer made of a flexible material 601. During the displacement of the ends during the torsional stresses of the central portion, the layers 600, 601, that are preferably layers made of a visco-elastic material, are stressed by shearing and dissipate the energy transmitted by the elongate elements. For the correct functioning of the device, it is necessary that each of the end portions 501a, 501b, 511a, 511b be guided in translation by a protection and guiding device 7, present in the form of a casing through which openings 70a, 70b, 70c, 70d are provided for the passage of the second end portions. It should be noted that in this specific embodiment, the end portions 501a, 501b, 511a, 511b are not directly linked to the surface of the board by flexible shock-absorption means, but on the contrary, they are free to become displaced with respect to the board, especially during the bending stresses of the central portion. Such an embodiment thus provides shock-absorption and stability during torsional deformations and retains flexibility and responsiveness during bending deformations. The invention is not limited to the embodiments that have been expressly described therein, and includes the different variations and generalizations that fall within the scope of the following claims. The instant application is based upon the French priority patent application No. 96.10698 filed on Aug. 29, 1996, the disclosure of which is hereby expressly incorporated by reference thereto, and the priority of which is hereby claimed under 35 USC 119.

1a

BACKGROUND OF THE INVENTION This is a continuation-in-part of our co-pending application Ser. No. 839,960, filed Oct. 6, 1977. This invention relates to new and useful radiation screening preparations and to methods of protecting the human skin against the harmful effects of sunlight. The skin responds differently to the different wavelengths of electromagnetic radiation. In sunlight, visible and infrared radiation (3900 A. to 14,000 A.) produce a transient reddening of the skin. The well known tanning effect of the sun is a result of exposure to near ultraviolet radiation between 3200 A. and 3900 A. which is pigmetogenic. The ultraviolet radiation of between 2900 A. and 3200 A. will induce erythema which may be severe in fair-skinned individuals. It is the object of sunscreen agents to prevent erythema of the skin by ultraviolet rays having a wavelength between 2900 A. and 3200 A. Conventional sun-screen agents are classified according to how they accomplish this object. One group of conventional sunscreen powders protects the skin by forming a reflective barrier thereon. Examples of such agents are kaolin, talc and pigments such as zinc oxide, magnesium carbonate, aluminum hydroxide and the like. Most common pigments also exhibit some absorption of ultraviolet light. The use of such powders and/or pigments has been rather limited because of the difficulty in applying them to the entire body and their unattractiveness when used over large areas. A second major group of sunscreens or light screens protects the skin by absorption of wavelengths in the erythemal range, i.e. between about 2900 A. and 3900 A. The comparative effectiveness of such substances as aids in tanning is at least partially dependent on degree of adsorption of tanning wavelengths in addition to adsorption of wavelengths in the erythemal range. Many such agents are known, as will be further explained hereinafter. It has been noted by Andrew P. Warin in British Journal of Dermatology (1978), Vol. 98, p. 474, "Ultra-Violet Erythemas in Man", that the formation of prostaglandins are a cause of the inflammatory action in humans resulting from the sun's erythema producing rays. Therefore, in order to prevent the sun from causing erythemas in man it is necessary to either block the sun's rays or to inhibit the formation of prostaglandins. It has been surprisingly found in accordance with the present invention that certain anti-inflammatory compounds possess the additional ability to not only protect the human skin against potentially harmful ultraviolet rays of sunlight or artificial light in the total spectrum but to inhibit the formation of prostaglandins. The combination of useful properties permits the compounds of the present invention to be applied not only to obtain relief from existing sun-produced erythemas but to further act as a sunscreen and prevent additional erythemas from occurring. BRIEF DESCRIPTION OF THE INVENTION The present invention pertains to sunscreening and erythema-treating preparations containing as an active ingredient a compound of the formula: ##STR1## where: R is hydrogen or alkyl; R 1 , R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , R 8 , R 9 , and R 10 may be the same or different and are hydrogen, alkyl, cyano, nitro, amino, haloloweralkoxy, haloloweralkyl, halo, loweralkoxy, acyl, acyloxy, thio, acylthio, loweralkylthio, loweralkylsulfinyl, loweralkylsulfonyl; hydroxy, carboxy, and carbalkoxy; R 3 and R 8 may also be cycloalkyl, cycloalkenyl, aryl and heteroloweralkylidenyl. DETAILED DESCRIPTION OF THE INVENTION The sunscreen preparations provided in accordance with the present invention contain as the essential active ingredient a compound of the formula: ##STR2## where: R is hydrogen or alkyl; R 1 , R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , R 8 , R 9 and R 10 may be the same or different and are hydrogen, alkyl, cyano, nitro, amino, haloloweralkoxy, haloloweralkyl, halo, loweralkoxy, acyl, acyloxy, thio, acylthio, loweralkylthio, loweralkylsulfinyl, loweralkylsulfonyl; hydroxy, carboxy, and carbalkoxy; R 3 and R 8 may also be cycloalkyl, cycloalkeny, aryl and heteroloweralkylidenyl. The more preferred compounds for a method of topically treating inflammation embrace those compounds of the Formula II: ##STR3## where: R 1 , R 2 , R 4 , R 5 , R 6 , R 7 , R 9 and R 10 are hydrogen, alkyl, alkoxy, halo, haloloweralkyl, hydroxy, carboxy, carbalkoxy, and alkylsulfonyl. R 3 and R 8 are hydrogen, alkyl, alkoxy, carboxy, carbalkoxy, halo, cyano, alkylsulfonyl, alkylsulfinyl, haloloweralkyl, phenyl, and cyclohexyl. In the descriptive portions of this invention, the following definitions apply: "alkyl" refers to a loweralkyl hydrocarbon group containing from 1 to about 7 carbon atoms which may be straight chained or branched; "alkenyl" refers to an unsaturated or partially unsaturated hydrocarbon group containing from 2 to about 7 carbon atoms which may be straight chained or branched; "cycloalkyl" refers to a hydrocarbon ring having up to about 7 carbon atoms; "cycloalkenyl" refers to a partially unsaturated hydrocarbon ring having up to about 7 carbon atoms; "aryl" refers to any benzenoid aromatic group but preferably phenyl; "acyl" refers to any organic radical derived from an organic acid by the removal of its hydroxyl group such as formyl, acetyl, propionyl, 3-carboxy-2-propenoyl, camphoryl, benzoyl, toluoyl or heteroyl such as pyridinoyl, piperidonyl, thenoyl, etc. The compounds of this invention may be prepared by the following general procedures. Condensation of an aniline derivative with benzaldehyde derivatives or phenyl ketones along the procedures as described by Gillman and Blatt, Organic Synthesis, Coll. Vol. I, 2nd Ed., N.Y., John Wiley and Sons, pages 80-81 will result in the desired product. The following reaction equation illustrates this synthesis: ##STR4## where R, R 1 , R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , R 8 , R 9 and R 10 are as described above. An alternate method for the production of certain compounds of Formula I involves the distillation of a product from a heated mixture of an aryl aldehyde or ketone and an aniline derivative at an elevated temperature and under a reduced pressure. A still further method of preparing certain compounds of Formula I would be by condensation of a hindered aryl aldehyde or ketone and an aniline derivative by the azeotropic removal of water. Appropriately desired end products having various substituents can be prepared at various stages of synthesis using suitable reactions in order to convert one group to another. Thus, for example, using conventional methods, a halogen group can be converted under Rosenmund Von Braun conditions to the nitrile compound. A nitro can be reduced to an amino which can be alkylated to the dialkylamino substituent. An hydroxy compound can be prepared by demethylation of a methoxy substituent. A Sandmeyer type reaction can be carried out on an amino compound to introduce a chloro, bromo, xanthate, hydroxyl or alkoxyl group. The xanthate can then lead to the mercapto by hydrolysis, this in turn can be alkylated to an alkylthio group which can be oxidized to alkylsulfinyl and alkylsulfonyl groups. A thiocyanato group may be removed by catalytic hydrogenation. Among the suitable compounds which may be utilized in connection with the sunscreen and prostaglandin-inhibiting compositions of the present invention include: N-benzylideneaniline N-(hydroxybenzylidene)aniline N-(carboxybenzylidene)aniline N-(carbomethoxybenzylidene)toluidine N-carboethoxybenylidene-m-toluidine N-benzylidene-p-toluidine N-(o-hydroxybenzylidene)-m-toluidine N-(o-hydroxybenzylidene)-p-toluidine N-(o-hydroxybenzylidene)-m-α,α,α-trifluorotoluidine N-(o-hydroxybenzylidene)-o-α,α,α-trifluorotoluidine N-(benzylidene-o-ethylaniline N-benzylidene-o-hydroxyaniline N-benzylidene-m-hydroxyaniline N-benzylidene-p-hydroxyaniline N-(o-hydroxybenzylidene)-o-hydroxyaniline N-(m-hydroxybenzylidene)-o-hydroxyaniline N-(p-hydroxybenzylidene)-o-hydroxyaniline N-(o-hydroxybenzylidene)-m-hydroxyaniline N-(m-hydroxybenzylidene)-m-hydroxyaniline N-(p-hydroxybenzylidene)-m-hydroxyaniline N-(o-hydroxybenzylidene)-p-hydroxyaniline N-(m-hydroxybenzylidene)-p-hydroxyaniline N-(p-hydroxybenzylidene)-p-hydroxyaniline N-(2,3-dihydroxybenzylidene)-o-hydroxyaniline N-(2,4-dihydroxybenzylidene)-o-hydroxyaniline N-(2,5-dihydroxybenzylidene)-o-hydroxyaniline N-(2,6-dihydroxybenzylidene)-o-hydroxyaniline N-(3,4-dihydroxybenzylidene)-o-hydroxyaniline N-(3,5-dihydroxybenzylidene)-o-hydroxyaniline N-(2,3,4-trihydroxybenzylidene)-o-hydroxyaniline N-(2,4,6-trihydroxybenzylidene)-m-hydroxyaniline N-(3,4,5-trihydroxybenzylidene)-m-hydroxyaniline N-(2,3-dihydroxybenzylidene)-p-hydroxyaniline N-(2,4-dihydroxybenzylidene)-p-hydroxyaniline N-(2,5-dihydroxybenzylidene)-p-hydroxyaniline N-(2,6-dihydroxybenzylidene)-p-hydroxyaniline N-(3,4-dihydroxybenzylidene)-p-hydroxyaniline N-(3,5-dihydroxybenzylidene)-p-hydroxyaniline N-(2,3,4-trihydroxybenzylidene)-p-hydroxyaniline N-(2,4,6-trihydroxybenzylidene)-p-hydroxyaniline N-(p-morpholinobenzylidene)aniline N-(p-phenylbenzylidene)aniline o-chlorobenzylideneaniline m-chlorobenzylideneaniline p-chlorobenzylideneaniline N-benzylidene-o-chloroaniline N-benzylidene-m-chloroaniline N-benzylidene-p-chloroaniline N-benzylidene-2,3-dichloroaniline N-benzylidene-2,4-dichloroaniline N-benzylidene-2,5-dichloroaniline N-benzylidene-2,6-dichloroaniline N-benzylidene-3,4-dichloroaniline N-benzylidene-3,5-dichloroaniline N-benzylidene-2,3,4-trichloroaniline N-benzylidene-2,4,6-trichloroaniline N-(o-chlorobenzylidene)-o-chloroaniline N-(m-chlorobenzylidene)-o-chloroaniline N-(p-chlorobenzylidene)-4-toluidine N-(p-chlorobenzylidene)-o-chloroaniline N-(o-chlorobenzylidene)-m-chloroaniline N-(m-chlorobenzylidene)-m-chloroaniline N-(p-chlorobenzylidene)-m-chloroaniline N-(o-chlorobenzylidene)-p-chloroaniline N-(m-chlorobenzylidene)-p-chloroaniline N-(p-chlorobenzylidene)-p-chloroaniline N-(o-chlorobenzylidene)-o-fluoroaniline N-(m-chlorobenzylidene)-o-fluoroaniline N-(p-chlorobenzylidene)-o-fluoroaniline N-(o-chlorobenzylidene)-m-fluoroaniline N-(m-chlorobenzylidene)-m-fluoroaniline N-(p-chlorobenzylidene)-m-fluoroaniline N-(o-chlorobenzylidene)-p-fluoroaniline N-(m-chlorobenzylidene)-p-fluoroaniline N-(p-chlorobenzylidene)-p-fluoroaniline N-(2,3-dichlorobenzylidene)-o-chloroaniline N-(2,4-dichlorobenzylidene)-o-chloroaniline N-(2,5-dichlorobenzylidene)-o-chloroaniline N-(2,6-dichlorobenzylidene)-o-chloroaniline N-(3,4-dichlorobenzylidene)-o-chloroaniline N-(3,5-dichlorobenzylidene)-o-chloroaniline N-(2,3,4-trichlorobenzylidene)-o-chloroaniline N-(2,4,6-trichlorobenzylidene)-o-chloroaniline N-(2,3-dichlorobenzylidene)-m-chloroaniline N-(2,4-dichlorobenzylidene)-m-chloroaniline N-(2,5-dichlorobenzylidene)-m-chloroaniline N-(2,6-dichlorobenzylidene)-m-chloroaniline N-(3,4-dichlorobenzylidene)-m-chloroaniline N-(3,5-dichlorobenzylidene)-m-chloroaniline N-(2,3,4-trichlorobenzylidene)-m-chloroaniline N-(2,4,6-trichlorobenzylidene)-m-chloroaniline N-(2,3-dichlorobenzylidene)-p-chloroaniline N-(2,4-dichlorobenzylidene)-p-chloroaniline N-(2,5-dichlorobenzylidene)-p-chloroaniline N-(2,6-dichlorobenzylidene)-p-chloroaniline N-(3,4-dichlorobenzylidene)-p-chloroaniline N-(3,5-dichlorobenzylidene)-p-chloroaniline N-(2,3,4-trichlorobenzylidene)-p-chloroaniline N-(2,4,6-trichlorobenzylidene)-p-chloroaniline o-fluorobenzylideneaniline m-fluorobenzylideneaniline p-fluorobenzylideneaniline N-benzylidene-o-fluoroaniline N-benzylidene-m-fluoroaniline N-benzylidene-p-fluoroaniline N-benzylidene-2,3-difluoroaniline N-benzylidene-2,4-difluoroaniline N-benzylidene-2,5-difluoroaniline N-benzylidene-2,6-difluoroaniline N-benzylidene-3,4-difluoroaniline N-benzylidene-3,5-difluoroaniline N-(o-chlorobenzylidene)-p-trifluoromethylaniline N-benzylidene-2,3,4-trifluoroaniline N-benzylidene-2,4,6-trifluoroaniline N-(o-fluorobenzylidene)-o-fluoroaniline N-(m-fluorobenzylidene)-o-fluoroaniline N-(p-fluorobenzylidene)-o-fluoroaniline N-(o-fluorobenzylidene)-m-fluoroaniline N-(m-fluorobenzylidene)-m-fluoroaniline N-(p-fluorobenzylidene)-m-fluoroaniline N-(o-fluorobenzylidene)-m-fluoroaniline N-(m-fluorobenzylidene)-m-fluoroaniline N-(p-fluorobenzylidene)-m-fluoroaniline N-(2,3-difluorobenzylidene)-o-fluoroaniline N-(2,4-difluorobenzylidene)-o-fluoroaniline N-(2,5-difluorobenzylidene)-o-fluoroaniline N-(2,6-difluorobenzylidene)-o-fluoroaniline N-(3,4-difluorobenzylidene)-o-fluoroaniline N-(3,5-difluorobenzylidene)-o-fluoroaniline N-(2,3,4-trifluorobenzylidene)-o-fluoroaniline N-(2,4,6-trifluorobenzylidene)-o-fluoroaniline N-(2,3-difluorobenzylidene)-m-fluoroaniline N-(2,4-difluorobenzylidene)-m-fluoroaniline N-(2,5-difluorobenzylidene)-m-fluoroaniline N-(2,6-difluorobenzylidene)-m-fluoroaniline N-(3,4-difluorobenzylidene)-m-fluoroaniline N-(3,5-difluorobenzylidene)-m-fluoroaniline N-(2,3,4-trifluorobenzylidene)-m-fluoroaniline N-(2,4,6-trifluorobenzylidene)-m-fluoroaniline N-(2,3-difluorobenzylidene)-p-fluoroaniline N-(2,4-difluorobenzylidene)-p-fluoroaniline N-(2,5-difluorobenzylidene)-p-fluoroaniline N-(2,6-difluorobenzylidene)-p-fluoroaniline N-(o-chlorobenzylidene)-p-bromoaniline N-(2,4-dichlorobenzylidene)-p-bromoaniline N-benzylidene-2-methyl-3-chloroaniline N-benzylidene-2-methyl-4-chloroaniline N-benzylidene-2-methyl-3-fluoroaniline N-benzylidene-2-methyl-4-fluoroaniline N-(o-chlorobenzylidene)-2-methyl-3-chloroaniline N-(o-chlorobenzylidene)-2-methyl-4-chloroaniline N-(o-chlorobenzylidene)-2-methyl-5-chloroaniline N-(m-chlorobenzylidene)-2-methyl-3-chloroaniline N-(m-chlorobenzylidene)-2-methyl-4-chloroaniline N-(p-chlorobenzylidene)-2-methyl-3-chloroaniline N-(p-chlorobenzylidene)-2-methyl-4-chloroaniline N-(p-chlorobenzylidene)-2-methyl-5-chloroaniline N-(m-fluorobenzylidene)-2,4-dichloroaniline N-(o-fluorobenzylidene)-2,4-dichloroaniline N-(p-fluorobenzylidene)-2,4-dichloroaniline N-(o-fluorobenzylidene)-2-methyl-3-chloroaniline N-(o-chlorobenzylidene)-2-methyl-3-chloroaniline N-(o-hydroxybenzylidene)-2-methyl-3-chloroaniline N-(o-methylbenzylidene)-2-methyl-3-chloroaniline N-(o-ethylbenzylidene)-2-methyl-3-chloroaniline N-(o-chlorobenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(o-chlorobenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(o-chlorobenzylidene)-2-trifluoromethyl-3-fluoroaniline N-(p-chlorobenzylidene)-2-trifluoromethyl-3-fluoroaniline N-(p-bromobenzylidene)-2-trifluoromethyl-3-fluoroaniline N-(p-bromobenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(p-fluorobenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(p-phenylbenzylidene)-p-toluidine N-(p-phenylbenzylidene)-p-bromoaniline N-(p-phenylbenzylidene)-2-methyl-4-chloroaniline N-(p-phenylbenzylidene)-2-methyl-4-fluoroaniline N-(p-phenylbenzylidene)-2-chloro-4-bromoaniline N-(3-chlor-4-cyclohexylbenzylidene)-4-fluoroaniline N-(3-chloro-4-cyclohexylbenzylidene)-4-bromoaniline N-(o-hydroxybenzylidene)-o-chloroaniline N-(o-hydroxybenzylidene)-m-chloroaniline N-(o-hydroxybenzylidene)-p-chloroaniline N-(o-hydroxybenzylidene)-o-fluoroaniline N-(o-hydroxybenzylidene)-m-fluoroaniline N-(o-hydroxybenzylidene)-p-fluoroaniline N-(o-hydroxybenzylidene)-2-methyl-3-chloroaniline N-(o-hydroxybenzylidene)-2-methyl-4-chloroaniline N-(o-hydroxybenzylidene)-2,3-dimethylaniline N-(o-hydroxybenzylidene)-2,4-dimethylaniline N-(o-hydroxybenzylidene)-o-toluidine N-(o-hydroxybenzylidene)-m-toluidine N-(o-hydroxybenzylidene)-p-toluidine N-(benzylidene)-2,4-dibromoaniline N-(m-fluorobenzylidene)-2,4-dibromoaniline N-(m-fluorobenzylidene)-2-methyl-4-iodoaniline N-(o-fluorobenzylidene)-2,4-dibromoaniline N-(o-fluorobenzylidene)-2-methyl-4-iodoaniline N-(m-fluorobenzylidene)-2,4-dibromoaniline N-(m-fluorobenzylidene)-2-methyl-4-iodoaniline N-(m-fluorobenzylidene)-3-trifluoromethyl-4-chloroaniline N-(o-fluorobenzylidene)-3-trifluoromethyl-4-chloroaniline N-(p-fluorobenzylidene)-3-trifluoromethyl-4-chloroaniline N-(acyloxybenzylidene)aniline N-(carboxybenzylidene)-m-toluidine N-(carbomethoxybenzylidene)-m-toluidine N-(benzylidene-carboxyaniline N-benzylidene-carbomethoxyaniline N-benzylidene-methylthioaniline N-benzylidene-methylsulfonylaniline N-benzylidene-methylsulfinylaniline N-benzylidene-acetylthioaniline N-(carboxylbenzylidene)hydroxyaniline N-(carboxylbenzylidene)chloroaniline N-(carboxylbenzylidene)fluoroaniline N-(methylsulfonylbenzylidene)hydroxyaniline N-(methylsulfonylbenzylidene)chloroaniline N-(acetyloxybenzylidene)hydroxyaniline N-(carbomethoxybenzylidene)chloroaniline N-(hydroxybenzylidene)carboxyaniline N-(chlorobenzylidene)carboxyaniline N-(dihydroxybenzylidene)carboxyaniline N-(dichlorobenzylidene)carboxyaniline N-(difluorobenzylidene)carboxyaniline N-(dihydroxybenzylidene)methylsulfonylaniline N-(dichlorobenzylidene)methylsulfonylaniline N-(difluorobenzylidene)methylsulfonylaniline N-(2,3,4-trihydroxybenzylidene)carboxyaniline N-(3,5-dichlorobenzylidene)-p-carbomethoxyaniline N-(4-carbomethoxybenzyliene)-dichloroaniline N-(2,4,6-trichlorobenzylidene)carboxyaniline N-(3,4,5-trifluorobenzylidene)carboxyaniline N-(p-morpholinobenzylidene)carboxyaniline N-(p-phenylbenzylidene)carboxyaniline N-(methylsulfonylbenzylidene)chloroaniline N-(carboxybenzylidene)chloroaniline N-(p-carboxybenzylidene)-4-toluidine N-(p-chlorobenzylidene)-2-[(5-methyl-4-imidozolyl)methyl mercapto]aniline N-(2,3-dichlorobenzylidene)carboxyaniline N-(2,4-dichlorobenzylidene)acetyloxyaniline N-(2,5-dichlorobenzylidene)methylsulfonylaniline N-(p-cyanobenzylidene)-3,5-dichloroaniline N-(p-nitrobenzylidene)-3,5-dichloroaniline N-(p-carbomethoxybenzylidene)-3,5-dichloroaniline N-(p-methylsulfonylbenzylidene)-3,5-dichloroaniline N-(p-chlorobenzyldiene)-2-carboethoxy-4-fluoroaniline N-(p-carbomethoxybenzylidene)-4-methylaniline N-(2,3,4-trichlorobenzylidene)-p-carboxyaniline N-(2,4,6-trichlorobenzylidene)-p-carboxyaniline N-(o-carboxybenzylidene)-p-trifluoromethylaniline N-(halo-4-cyclohexylbenzylidene)-4-haloaniline N-(3-chloro-4-cyclohexylbenzylidene)-4-fluoroaniline N-(3-chloro-4-cyclohexylbenzylidene)-4-bromoaniline N-(2,3-difluorobenzylidene)carboxyaniline N-(2,4-difluorobenzylidene)carboxyaniline N-(2,5-difluorobenzylidene)carboxyaniline N-(2,6-difluorobenzylidene)carboxyaniline N-(3,4-difluorobenzylidene)carboxyaniline N-(3,5-difluorobenzylidene)carboxyaniline N-(2,3,4-trifluorobenzylidene)carboxyaniline N-(2,4,6-trifluorobenzylidene)methylsulfonylaniline N-(2,3-difluorobenzylidene)methylsulfonylaniline N-(2,4-difluorobenzylidene)acetyloxyaniline N-(2,5-difluorobenzylidene)acetyloxyaniline N-(2,6-difluorobenzylidene)acetyloxyaniline N-(2,3,4-trifluorobenzylidene)carboxyaniline N-(2,4,6-trifluorobenzylidene)carboxyaniline N-benzylidene-2-methyl-3-carboxyaniline N-benzylidene-2-methyl-4-carboxyaniline N-benzylidene-2-methyl-3-acetyloxyaniline N-benzylidene-2-methyl-4-acetyloxyaniline N-(chlorobenzylidene)-2-methyl-3-carboxyaniline N-(chlorobenzylidene)-2-methyl-4-carboxyaniline N-(chlorobenzylidene)-2-methyl-5-carboxyaniline N-(chlorobenzylidene)-2-methyl-3-chloroaniline N-(chlorobenzylidene)-2-methyl-4-acetyloxyaniline N-(p-carboxybenzylidene)-2-methyl-3-chloroaniline N-(p-carboxybenzylidene)-2-methyl-4-chloroaniline N-(p-carboxybenzylidene)-2-methyl-5-chloroaniline N-(m-carboxybenzylidene)-2,4-dichloroaniline N-(carboxybenzylidene)-2,4-dichloroaniline N-(methylsulfonylbenzylidene)-2,4-dichloroaniline N-(carboxybenzylidene)-2-methyl-3-chloroaniline N-(methylsulfonylbenzylidene)-2-methyl-3-chloroaniline N-(hydroxybenzylidene)-2-carboxy-3-chloroaniline N-(methylbenzylidene)-2-carboxy-3-chloroaniline N-(ethylbenzylidene)-2-methylsulfonyl-3-chloroaniline N-(p-carboxybenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(p-carboxybenzylidene)-2-trifluoromethyl-3-fluoroaniline N-(p-acetyloxybenzylidene)-2-trifluoromethyl-4-fluoroaniline N-(p-phenylbenzylidene)-2-methyl-4-carboxyaniline N-(p-phenylbenzylidene)-2-methyl-4-acetyloxyaniline N-(p-phenylbenzylidene)-2-chloro-4-carboxyaniline N-(3-chloro-4-cyclohexylbenzylidene)-4-carboxyaniline N-(o-carboxybenzylidene)-2,3-dimethylaniline N-(o-carboxybenzylidene)-2,4-dimethylaniline N-(o-methylsulfonylbenzylidene)-o-toluidine N-(o-acetyloxybenzylidene)-m-toluidine N-(o-methylsulfinylbenzylidene)-p-toluidine N-(fluorobenzylidene)-3-trifluoromethyl-4-carboxyaniline N-(fluorobenzylidene)-3-trifluoromethyl-4-acetyloxyaniline N-(fluorobenzylidene)-3-trifluoromethyl-4-methylsulfonylaniline These active materials are applied to the skin in combination with a compatible carrier material which may be aqueous, alcoholic, fatty or a combination of these. Carrier materials as contemplated herein include those materials generally utilized as a base for sunscreen preparations such as, for example, creams, milks, ointments, gels, oils, lotions, aerosol sprays or the like. Such carrier materials, in order to be suitable, must be selected on a basis of their dermatological acceptability and compatibility with the specific active ingredient of the present invention which is utilized. Preferred among carrier formulations for the sunscreen agents of the present invention are creams, milk, ointments, lotions and aerosols. Examples of suitable carrier materials for the formulation of the sunscreen compositions of the invention include the paraffins, waxes, vegetable or animal oils and fats such as, for example, olive oil, sesame oil, peanut oil and the like, wool fat, spermaceti, esters of fatty acids such as stearic, palmitic and oleic as well as the acids themselves, glycerides of said acids, ethyl, isopropyl, cetyl, stearyl and palmityl alcohols, emulsifying agents of all common types, e.g., nonionic, anionic or cationic suitable for the preparation of both water-in-oil and oil-in-water emulsions, thickeners such as, for example, the commercially available cellulose ethers, trajacanth, alginic acid or salts thereof and the like. A particularly preferred emulsifying agent is polyoxyethylene stearyl ether having a molecular weight of about 700 and commercially available under the trademark Brij J by Atlas Powder Co., Wilmington, Delaware. Additional additives which may be incorporated into the sunscreen preparations of the invention are preservatives, buffers, pH regulators to adjust the pH thereof to slightly acidic, perfumes, physiologically compatible dyestuffs and the like. Other agents which have medicinal or therapeutic value may also be incorported in the compositions of the invention. Where the preparations of the invention are in the form of aerosol sprays or foams, suitable conventional propellants, i.e. polyhalogenated hydrocarbons are also included therein. It is contemplated that where the compositions of the invention are in aerosol form, the propellant will comprise about 10% by weight of said compositions. The concentration of the active sunscreen ingredient in dermatologically acceptable carrier preparations such as contemplated herein is between about 1% and about 30% by weight and preferably between about 2% and about 5% by weight. Wherein the sunscreen preparations of the invention contain mixtures of more than one of the active ingredients, such active ingredients may be combined in any proportions. It is preferred, however, to combine two or more of such ingredients in approximately equimolar concentrations. Compositions in accordance with this invention afford excellent protection from the erythemal rays of the sun. Additionally, they are effective in preventing and treating painful sunburn. These compositions may be applied freely to the skin. As with any conventional skin treatment preparation, such amounts vary with the exposure conditions, the sensitivity and the pigmentation of the skin of the user, and the like. Therefore, the effective amount of the preparations of the invention may be chosen within the discretion of the user. The following examples serve further to illustrate the invention, but are not intended to define or to limit the scope of the invention, which is defined in the appended claims. EXAMPLE 1 A sunscreen lotion in milk form, having the following composition: ______________________________________Hydrogenated, ethoxylated(10 mol) lanolin 2.0 g.Triglyceride of fatty acidof coconut oil 7.0 g.Cetylalcohol 0.6 g.Stearylalcohol 0.6 g.Paraffin oil (light weight) 5.0 g.N-(o-chlorobenzylidene)-3-chloro-2-methylaniline 2.5 g.Stearic acid 3.0 g.Demineralized water 74.0 g.Triethanolamine 0.8 g.Perfume 0.5 g.Carboxyvinylpolymer 2.0 g.Conservation agent 2.0 g.______________________________________ was manufactured as follows: A mixture of 2.0 g. hydrogenated, ethoxylated (10 mol) lanolin, 7.0 g. triglyceride of fatty acid of coconut oil, 0.6 g. cetylalcohol, 0.6 g. stearyl alcohol, 5.0 g. paraffin oil, 2.5 g. N-(o-chlorobenzylidene)-3-chloro-2-methylaniline and 3.0 g. of stearic acid was melted at 70° C. After addition of 2.0 g. carboxyvinylpolymer in 74.0 g. demineralized water were added at 70° C. with stirring to the resulting suspension. The mixture was stirred for 15 minutes and then cooled. 0.8 g. of triethanolamine and 0.5 g. of perfume were added at 60° C. and 45° C., respectively. The resulting mixture was stirred until cold and a white milk, which was stable at 3,000 rpm for 1 hour, was obtained. Other lotions identical to that described immediately above are prepared by replacing the N-(o-chlorobenzylidene-3-chloro-2-methylaniline with any of the active compounds previously mentioned. EXAMPLE 2 A sunscreen product, composed of: ______________________________________Triglyceride of fatty acidof coconut oil 56.3 g.Cetylalcohol 2.6 g.Stearylalcohol 10.6 g.Paraffin oil (light weight) 8.0 g.N-benzylidene-p-toluidine 5.0 g.Demineralized water 12.2 g.Triethanolamine 0.8 g.Perfume 0.5 g.Carboxyvinylpolymer 2.0 g.Conservation agent 2.0 g.______________________________________ was manufactured as follows: A mixture of 56.3 g. triglyceride of fatty acid of coconut oil, 2.6 g. cetylalcohol, 10.6 g. stearyl alcohol, 5.0 g. paraffin oil and 5.0 g. N-benzylidene-p-toluidine was mixed at 70° C. 12.0 g. carboxyvinylpolymer in 12.2 g. demineralized water were added at 70° C. with stirring to the resulting suspension. The mixture was stirred for 15 minutes and then cooled. 0.8 g. of triethanolamine and 0.5 g. of perfume were added at 60° C. and 45° C., respectively. The resulting mixture was stirred until cold and a lotion, which was stable at 3,000 rpm for 1 hour, was obtained. Other preparations identical to that described immediately above are prepared by replacing the N-benzylidene-p-toluidine with any one of the aforementioned active compounds. EXAMPLE 3 An ointment was prepared by first mixing 5.0 g. of p-carboxybenzylidene-2-chloroaniline in a hot mixture of 57.5 g. of distilled water. 11.5 g. of propylene glycol and 1 ml. of concentrated ammonia solution. The resulting mixture was heated to 75° C. and added with stirring to a hot (75° C.) mixture of 17.0 g. of glycerine, 4.0 g. of a polyoxyethylene stearyl ether having a molecular weight of about 700. Lactic acid was added while the emulsion was still hot in order to adjust to a pH approximating that of the skin, i.e. about 5.5. After cooling, the resulting cream was further worked utilizing a three-roller frame and filled into tubes. The product had excellent properties in protecting the human skin against ultraviolet and visible light rays when spread out over selected areas of the body. EXAMPLE 4 An ointment was prepared by first mixing 7.0 g. N-(4-carbomethoxybenzylidene)-3,5-dichloroaniline in a hot mixture of 53.93 g. of distilled water, 14 g. of propylene glycol and 1 ml. of concentrated ammonia solution. The resulting mixture was heated to 75° C. and added with stirring to a hot (75° C.) mixture of 17.0 g. of isopropyl myristate, 4.0 g. of glycerine and 4.0 g. of a polyoxyethylene stearyl ether, molecular weight about 700. Lactic acid was then added to the hot emulsion to adjust the pH thereof to approximate the pH of the skin, i.e. about 5.5. After cooling, the resulting cream was further worked using a three-roller frame and filled into tubes. EXAMPLE 5 An ointment was formed by first mixing 4.0 g. N-(4-nitrobenzylidene)-3,5-dichloroaniline in a hot mixture of 60.3 g. of distilled water, 11.5 g. of propylene glycol and 10.1 g. of sodium hydroxide. The resulting solution was heated to 75° C. and added with stirring to a hot (75° C.) mixture of 15.0 g. isopropyl palmitate, 5.0 g. of glyceryl trioleate and 3.0 g. of polyoxyethylene stearyl ether. Lactic acid was added to the hot emulsion to adjust the pH thereof to about 5.5. After cooling, the resulting cream was further worked using a three-roller frame and filled into tubes. It had excellent sunscreen properties when applied to the human skin. EXAMPLE 6 An ointment was formed as above by first mixing 7.0 g. N-(4-methylsulfonylbenzylidene)-3,5-dichloroaniline in a hot mixture of 60.83 g. of distilled water, 11.5 g. of propylene glycol and 0.1 g. of sodium hydroxide. The resulting solution was heated to 75° C. and added with stirring to a hot (75° C.) mixture of 13.0 g. polyol diester of capric acid, 5.0 g. of isopropyl myristate and 5.0 g. of polyoxyethylene stearyl ether. Lactic acid was added to the hot emulsion to adjust the pH thereof to about 5.5. After cooling, the resulting cream was further worked using a three-roller frame and filled into tubes. The product had excellent properties when used as a sunscreen. EXAMPLE 7 A prostaglandin-inhibiting composition having the following composition: ______________________________________Hydrogenated, ethoxylate(10 mol.) lanolin 1.8 g.Triglyceride of fattyacid of coconut 7.0 g.Cetylalcohol 0.6 g.Stearylalcohol 0.6 g.Paraffin oil (lightweight) 5.0 g.N-(p-carboxylbenzylidene)-3-chloro-2-methylaniline 0.75 g.Stearic acid 3.0 g.Demineralized water 72.2 g.Triethanolamine 0.8 g.Perfume 0.5 g.Carboxyvinylpolymer 2.0 g.Conservation agent 2.0 g.______________________________________ was manufactured as follows: A mixture of 1.8 g. hydrogenated, ethoxylated (10 mol.) lanolin, 7.0 g. triglyceride of fatty acid of coconut, 0.6 g. cetylalcohol, 0.6 g. stearyl alcohol, 5.0 g. paraffin oil, 0.05 g. hydrocortisone and 3.0 g. of stearic acid was blended at 70° C. After addition of 0.75 g. N-(p-carboxylbenzylidene)-3-chloro-2-methylaniline, 2.0 g. carboxyvinylpolymer in 72.2 g. demineralized water were added at 70° C. with stirring to the resulting suspension. The mixture was stirred for 15 minutes and then cooled. 0.8 g. of triethanolamine and 0.5 g. of perfume were added at 60° C. and 45° C., respectively. The resulting mixture was stirred until cold and a white milk, which was stable at 3,000 rpm for one hour was obtained. Viscosity: 6000 Cp (Brockfield, Spindel, 5, 10 rpm). EXAMPLE 8 A prostaglandin-inhibiting composition was prepared as follows: 0.5 g. of N-4-chlorobenzylidene)-4-chloro-2-methyl-aniline and 0.20 g. N-(4-hydroxybenzylidene)-2-methyl-3-chloroaniline are predispersed in 30.0 g. of propylene glycol. The mixture is then homogenized into 97.4 g. of finished cream, ointment or lotion following a modification of any one of the procedures described in F. W. Martin et al, "Remington's Pharmaceutical Sciences", 14th Ed., Mack Publishing Co., Easton, Pennsylvania (1965).

1a

BACKGROUND OF THE INVENTION [0001] We have known for many years that humankind needs to consume dietary fiber when feeding. Due to its different affinity for water, dietery fiber is divided into soluble and insoluble. Insoluble fiber is mainly made up of cellulose and lignin, while hydrosoluble fiber is made up of B-glucans, pectin and other types of mucilage or gum that bond many times their weight in water. Inadequate consumption of insoluble dietary fiber may cause severe digestive disorders, and that includes colon cancer, constipation, diverticulosis, colitis and associated problems. On the other hand, soluble dietary fiber has been associated with a decrease in diabetes, hypercholesterolemia, hyperlipidemia, and cardiovascular disease symptoms. For the purpose of this invention, nopal is the pad or cladodes of the edible plants of the Cactacea family, Subfamily Opuntiodeae, all species of cacti plants known in Mexico as nopal or nopales. [0002] Nopal is one of the few foodstuffs containing high quantities of both types of dietary fiber and consequently it is an excellent product to help prevent all previously described disorders. Its soluble dietary fiber content is outstanding, which has positive health effects on diabetics, and people with high cholesterol, and those prone to cardiovascular diseases. These chronic degenerative diseases are responsible for most deaths occurring today in the modern World. [0003] Vegetables and whole grains are a natural source of dietary fiber. The nopal “produce” variety is a product used since ancient times; its consumption as a dehydrated product, although known for many years, has not had a considerable development nor has it been used in composite food product manufacturing. In truth, its main use has been as a nutrition supplement in capsules. [0004] On the other hand, the Occidental world diet is high in consumption of refined flours, mainly from corn, wheat and other. These cereals are prepared as bread, corn chips, tortillas, carckers, low dietary fiber products, etc. [0005] The nopal's pad dehydration process has been known for many years. It may be sun dried or dehydrated by artificial processing. Grinding the dehydrated nopal produces a fine powder of flour. The means or methods to obtain flour, be it by sun drying or by artificial means, and the method for milling, are out of the scope of the present invention, nopal flour is considered a raw material. [0006] The dietary fiber content of the resulting mix improves when mixing nopal flour with cereal flours, and when mixed in the appropriate amounts novelty foodstuffs will be obtained, as they will not be “the same” as those currently consumed, they will have the typical greenish color, depending on the amount added, and will be nutritionally very different. [0007] The idea of mixing cereal flours with nopal flour, or nopal juice, even if simple, has not been used to manufacture cookies, tostadas, fritters, tortilla chips, wheat tortillas, bread and many other products. [0008] The scope of the present invention encompasses many more lines of products, as well as mixing liquefied nopal with other juices; for example orange, however; substitution of required water has not been sought when manufacturing the aforementioned products, with liquefied nopal. This is achieved as follows: the nopal is cleaned off spines, cut in chunks and processed in a blender or hammer mill, until it is much liquefied or in paste form. Before and/or after cleaning spines form the nopal, disinfect in a water-based solution containing 200-300 ppm chlorine and/or other disinfectant (See annex A, examples 1,3,4 and 5). This invention aims to substitute water with liquefied nopal in the manufacture of several products and/or adding dehydrated nopal flour and/or other dehydrated vegetables, replacing a portion of legumes and/or oilseed and/or cereal flours or their secondary products or their total substitution of said flours with nopal flour. [0009] By using the present invention, the nopal is used as base vegetable, when considering its diverse nutritional properties, which does not limit the invention to this single vegetable. DESCRIPTION OF THE INVENTION [0010] The present invention refers to the elaboration of diverse nutritional products that use nopal flour and/or liquefied nopal mixed with cereal flour, grains, legumes and/or oil seeds, either refined and/or whole; in order to obtain diverse foodstuffs with a different color and nutritional profile to that obtained if nopal and/or liquefied nopal was not used. [0011] In the same manner, the present invention refers to the elaboration of a snack based on cut nopal processed by using a potato chip cutter, and dehydrated. BEST METHOD FOR THE PREFERRED EMBODIMENT [0012] The manner in which foodstuffs will be prepared using nopal flour or liquified nopal will depend on the product sought for manufacture. [0013] In general, the following products may be manufactured with nopal flour and/or liquefied nopal, mixed with other cereal flours: [0000] 1. Fermented bread products with a different color and nutritional profile from those currently obtained. [0000] 2. Leavened bakery products, fermented with industrial yeast or baking powders, or chemical leavening agents, with a different color and nutritional profile from those currently obtained. [0000] 3. Long and/or short pasta, with a different color and nutritional profile from those currently obtained. [0000] 4. Nixtamalized, fried and/or non fried bakery and/or snack products with a different color and nutritional profile from those currently obtained. [0000] 5. Refined and/or whole-wheat flour tortillas, which may or may not contain chemical agents with a different color and nutritional content from regular flour tortillas. [0014] 6. Mixes or compound flours from flour products, from cereals, legumes and other grains; refined and/or whole with nopal flour or flour form other vegetables elaborated to be sold, and that adding one or more missing ingredients, may be used to elaborate any of the aforementioned products. [0015] 7. Products for breading meats, vegetables and other foodstuffs, either using nopal flour and/or other vegetable flours, mixed with commercial breading/batter formulas and/or bakery products enriched with nopal flour as those aforementioned as an integral portion of the formula. Additionally, liquefied nopal may be used alone or combined with batters as a binder. [0016] Similar to the aforementioned new applications, by means of this invention a new way to consume dehydrated nopal may be found: [0000] 8. To elaborate a snack based on dehydrated nopal, spiced or not, obtaining a novelty product, said snack having very different and superior nutritional properties compared snacks currently consumed. EXAMPLE 1 [0017] To elaborate fermented bakery products with a different color and nutritional profile. [0018] Mixes containing 10%, 20% and 30% nopal flour with moisture content of 8% and particle size less than U.S. 60 with commercial bakery wheat flour preferably classified as bakers or hard. Yeast leavened bread was elaborated using the AACC (American Association of Cereal Chemists) official micro baking procedure (2002). Basic formulation is shown in Table 1. TABLE 1 Formulations used for pan bread production with nopal flour using direct micro baking method. Nopal flour (gr.) 0 10 20 30 Wheat flour (gr.) 100 90 80 70 Salt (gr.) 1.5 1.5 1.5 1.5 Sugar(gr.) 6 6 6 6 Dry yeast (gr.) 2 2 2 2 Vegetable shortening 3.5 3.5 3.5 3.5 Vital Gluten (gr.) 0 0 0 1.5 Water (gr.) 63 62 62.5 62.5 Nopal flour (gr.) 0 10 20 30 Malt (gr.) 0.1 0.1 0.1 0.1 [0019] Water was used in this instance; however, it may be substituted by liquefied nopal. The ingredients where weighed, mixed and kneaded in a laboratory micro-mixer until the desired dough texture was achieved (fully developed gluten). The resulting dough was divided in two equal portions of the same weight in order to obtain data from loaves produced with 100 gr. of flour; the dough was allowed to ferment for an hour in a fermentation cabinet regulated or calibrated to 29° C. and 85.95% relative humidity. Portions were sheeted using a roller sheeter calibrated to 3/16 inch to eliminate carbon dioxide generated during fermentation and to create multiple micro spaces within the dough that later become the typical internal crumb texture. The dough was placed again in the fermentation cabinet for 25 minutes and was sheeted the same way; finally, the dough was placed for 13 more minutes in the fermentation cabinet in preparation for its final sheeting and molding. The fermented dough was sheeted in this instance thru a pair of rollers with 5/16 inch clearance and the resulting strip was manually rolled to make a cylinder, which was placed in pregreased baking pans. The pans, with their dough cylinders were placed in the fermentation cabinet for 37 minutes; once final fermentation ended, the height was measured and they were immediately placed in a pre-heated oven at. 210° C., baking time was exactly 20 minutes; the resulting loaves were immediately removed from the pan and characterized, the height on the midway of the loaves, loaf weight, and loaf volume determined by displacement of rapeseed, apparent density (weight/volume) and subjectively the internal texture of the breadcrumb. TABLE 2 Effect from adding different concentrations of nopal flour to the estimated bread properties by direct bakery process. Height Dough Loaf differ- height height ence Weight Volume Density Treatment (cm) (cm) (cm) (gr.) (cm3) (gr./cm. 3) Control A 6.9 9.1 2.2 153.2 655 0.233 B 6.9 8.7 1.9 152.3 650 0.234 10% A 7.2 7.3 0.1 154.1 553 0.278 Nopal B 7.2 7.7 0.5 154.2 595 0.259 20% A 6 6.2 0.2 161.1 <400 >0.4 Nopal B 6 6.1 0.1 161.2 <400 >0.4 30% A 5 5.3 0.3 163.3 <400 >0.4 Nopal B 4.6 5.0 0.4 163.1 <400 >0.4 [0020] Results clearly indicate that it was feasible to produce pan bread using different amounts of nopal flour. However, adding nopal significantly decreased volume and height of the loaf consequently increasing apparent density (Table 2); Addition of nopal flour produced breads with a greenish color and a pleasant flavor; addition of 30% nopal flour increased total dietary fiber from 2% to 8.09% and decreased caloric density from 274 kcal/100 g to 240 kcal/100 g. Consumption of 100 gr. of bread containing 30% nopal flour provided approximately 27% of the daily dietary fiber requirement considering 30 g/day as requirement (Table 3). [0021] This example clearly demonstrates that it is feasible to use nopal flour in partial substitution of wheat flour and that similar results may be expected from other yeast leavened bakery products like French bread, baguettes, pita bread, or inclusive saltine crackers or wafers. Adding nopal did not affect yeast activity. To counteract the diluting impact of nopal in gluten, and negative on bread volume, formulations may be enriched with Vital Gluten. TABLE 3 Nutritional content effect from adding different concentrations of nopal flour on bread and its relation to nutritional requirements on a 2000 kcal/day diet % of the % of the % of the % of the requirement requirement requirement requirement with an with an with an with an Bread Bread Bread intake of an intake of intake of intake of 100% w/10% w/20% w/30% Daily intake of 100 g bread 100 g bread 100 g bread bread nopal nopal nopal require- 100 g bread w/10 nopal w/20 nopal w/30 nopal 100 g flour flour flour ment consumption flour flour flour Moisture y (%) 34.8 35.2 34 35 — — — — — Energy (Kcal) 274 262 255 240 2000 13.7 13.1 12.75 12 Dietary fiber (gr.) 2 4.02 6.15 8.09 30 6.6 13.4 20.5 26.96 Calcium (mg) 32 195.6 364 522 1000 3.2 19.56 38.4 52.252.2 Potassium (mg) 111 361.8 620 561 2000 5.5 18.09 31 43.05 EXAMPLE 2 [0022] In order to manufacture chemically leavened bakery products with a different color and nutritional profile to the one currently held on these types of products. [0023] In order to demostrate this, oat cookies were elaborated with nopal. The following ingredients were mixed in the quantities specified below: [0024] 180 gr. of Wheat flour [0025] 190 gr. of Oats [0026] 185 gr. of Sugar [0027] 120 gr. eggs (two hen eggs) [0028] 180 gr. of butter [0029] 4 gr. Double Acting baking powder [0030] 3 gr. of salt [0031] 90 gr. of nopal flour [0032] All ingredients were perfectly mixed with a blender. To add other/stronger flavors, additional cinnamon, raisins, coconut, pecan, almonds, etc., according to personnel taste; once all ingredients had been mixed, the dough was sheeted and cut; the resulting portions were placed on a previously greased baking sheet, which in turn was placed in an oven at 170° C. during 15 minutes. It was feasible to make oat cookies enriched with nopal, using the regular preparation procedure for this type of cookies, adding nopal flour had significant effect on the cookie color and flavor, when adding this amount of nopal flour the content of dietary fiber was increased 5% approximately. TABLE 4 Effect of adding 9.4% nopal flour vs. not adding in cookies of % of the Req. with % of the Req. with 100 g of oat 100 g of oats an intake of 100 g an intake of 100 g cookies w/nopal Daily requirement oat cookies oat cookies w/nopal Moisture (%) 17.1 16.9 — — — Calories (kcal) 468 2000 23.4 21.6 Dietary fiber (g) 2.5 5.03 30 8.3 16.7 Calcium (mg) 79.4 306 1000 7.94 30.6 Potassium (mg) −140 495 2000 7 24.75 [0033] Addition of nopal flour decreased caloric density of the cookies and significantly increased the content of dietary fiber, calcium and potassium. (Table 4). These cookies may help maintain gastrointestinal health, and provide over 24% of daily requirements of calcium and potassium, these minerals are generally deficient in the human diet, calcium helps to prevent osteoporosis and potassium prevents hypertension. [0034] By this example, it is clearly demonstrated that it is feasible to manufacture bakery products leavened with chemical or baking powder agents as muffins, hot cakes, biscuits, etc., by partial substitution of wheat flour by nopal flour. EXAMPLE 3 [0035] For fabrication of long and/or short pasta, with a different color and-nutritional profile from those currently available in these type of products. [0000] Weigh the following: [0036] +200 grams of Semolina (88.2%) [0037] +27 grams of nopal flour (11.8%) [0038] +90 grams of Water [0039] The ingredients were perfectly mixed in a laboratory pasta mixer-extruder, it was left mixing for 6 minutes and proceeded to extrude thru a macaroni die; half the macaroni were dried to produce dehydrated pasta, and the other half was cooked in excess water. [0040] Macaroni was cooked in boiling water for 4 minutes; their color, texture, and flavor were pleasant and characteristic, the difference was in color, as nopal flour made the pasta acquire a greenish tint. The nutritional profile of the macaroni with nopal: is different from the commercial, dietary fiber increased from 2.7% to approximately 5.85%. Consumption of 100 g of dehydrated pasta with nopal provides 19.8% of the requirement of dietary fiber (Table 5). [0041] Weight 170 g of Semolina, 57 g of nopal flour (73% or/and 25% respectively) and were both mixed with 90 g of water in a commercial pasta mixer-extruder. It was mixed for 6 minutes until the proper dough for extrusion was formed. After that extrusion began, macaroni sixe was uniformly maintained to prevent differences in the drying and cooking times. Macaroni were cut to average 4 cm in lenght; the resulting macaroni were cooked for 4 minutes in boiling water, its color, flavor, and texture were characteristic. However, macaroni tended to break apart easily, and therefore to loose their form or structure, in both cases water may be substituted for liquefied nopal. [0042] Dietary fiber content in the first case increased to almost 6% of the weight of the macaroni; in the second case, the increase wass over 10% (Table 5). [0043] Calcium supply when consuming 100 g of macaroni with 11.8% nopal flour is slightly higher than 50% of the daily requirement for this nutrient. [0044] With this example, it is demonstrated that it is feasible to produce fresh and dehydrated pasta enriched with nopal flour; therefore, this example is not limiting and covers all types of pasta (composite pastas, microwave fast cooking, instant soups, etc.) *TABLE 5 Effect from adding two levels of nopal flour in the nutrient content of 100 g macaroni, and its relation to daily requirements of several nutrients on a 2000 kcal/day diet 100 g 100 g % of the Req. % of the Req. regular regular % of the Req. Supplied when Supplied when macaroni macaroni Supplied when consuming 100 consuming 100 100 g with with 25% consuming 100 g of macaroni g of macaroni regular 11.8% of of nopal Require- g of regular with 11.8% of with 25% of macaroni nopal flour flour ment macaroni nopal flour nopal flour Moisture (%) 12 12.1 11 — — — — Energy (kcal) 364 353 341 2000 18.2 17.65 17.05 Dietary fiber (gr) 2.7 5.85 10.7 30 9 19.5 35.5 Calcium (mg) 252 525 830 1000 25.2 52.5 83 Potassium (mg) 107 508 1085 2000 5.35 28.4 54 EXAMPLE 4 [0045] For fabrication of nixtamalized products, fried and non-fried, with a different color and nutritional profile as to what is available in these types of products. [0046] A typical way, but not unique, of preparing these types of products is to weigh: 850 g of commercial nixtamalized corn flour Weigh 150 g of nopal flour (15%) 1000 ml of warm water (38° C.) was added and knead until obtaining a consistent dough (approximately 5 minutes), water may be substituted with nopal juice and/or liquefied nopal, or mix 150 g of nopal flour with 1.85 kg nixtamalized dough obtained using the traditional or industrial process. A tortilla machine was used to make several tortilla disk that were baked for approximately 1 minute at 280° C. in a typical three-tier gas fired oven. The resulting tortilla may be packaged to supply table tortillas or may be used as raw material for making tostadas and/or fritters; for the first step it is recommended to fine-mill the nixtamal or use fine nixtamalized flour, for appetizer fabrication it is recommended to use coarse dough or flour. Nopal flour and/or any other vegetable content may vary from 1% up to 99.5% depending on the concentration and product being sought. To obtain additional data on nopal flour impact on nixtamalized products, tortillas containing a higher concentration of nopal flour (25%) were elaborated. Weigh 750 g of commercial nixtamalized corn flour. Weigh 250 g of nopal flour 25%. 1000 ml of warm water (38° C.) was added and kenad until obtaining consistent dough (approximately 5 minutes). The tortillas were elaborated using the same tortilla machine used previously. [0058] In both cases, nopal-containing tortillas were the characteristic greenish color, higher nopal content produces tortillas with a darker color. [0059] To convert the tortillas into tortilla chips and/or tostadas, they were deep-fat fried in edible oil for 1 minute at 175°, if desired, salt and/or seasonings may be added right after frying. *TABLE 6 Effect from adding two different levels of nopal flour in the elaboration of tortillas and fritters 100 g of 100 g of % of the Req. % of the Req. regular regular Supplied when Supplied when tortilla tortilla % of the Req. consuming 100 consuming 100 with 15% with 25% Supplied when g of tortilla with g of tortilla with 100 g of regular of nopal of nopal Require- consuming 100 15% of nopal 25% of nopal tortilla flour flour ment g of tortilla flour flour Moisture (%) 46 47.5 48.1 — — — — Energy (kcal) 222 185 181 2000 11.1 9.25 9.05 Dietary fiber (g) 4.99 6.8 8.16 30 16.6 22.6 27.2 Calcium (mg) 168 342 344 1000 16.8 34.2 34.4 Potassium (mg) 148 439 643 2000 7.4 22 32 [0060] Addition of nopal flour significantly decreased the product's caloric density and increased dietary levels of dietary fiber, Calcium & Potassium. These may be channeled to the diet product market that has higher nutritional attributes than the commercial product. This example clearly demonstrates that nopal may be a partial substitute for nixtamalized corn, dough or nixtamalized flour, this example demonstrates that it is feasible to produce other nixtamalized products like tostadas, fritos, tamales, atoles (gruel), etc. EXAMPLE 5 [0061] To elaborate wheat flour tortillas, refined and/or whole, that may or may not contain chemical leavening agents with a color and nutritional content different from those found currently in flour tortillas; a typical way, but not unique, of preparing these types of products is: [0062] Weighed the following ingredients: All purpose Wheat flour 180 gr. Nopal flour 20 gr. Vegetable shortening or animal fat 20 gr. Baking powder 3 gr. Salt 3 gr. Emulsifier 0.4 gr. Powdered milk 1 gr. Lecithin 0.5 gr. [0071] 100 ml of warm water (35-40° C.) was added and all listed ingredients were kneaded until obtaining a well developed gluten and smooth dough consistency; liquefied nopal may be used instead of water (see examples 1,3,4,5 in Annex). “We proceeded to cut the dough in 35 gr. portions that were immediately hand rolled forming balls and left to rest at ambient temp during 10 minutes, a controlled environment chamber may be used regulated to 28-30° C. and 85% relative humidity; the dough balls were hot pressed forming disks, which were baked during 45 seconds in a three tier gas fired oven regulated to 220° C.; The resulting tortillas were cooled and packed in polyethylene bags. The resulting tortillas may be consumed as such, or, as part of another product. To obtain sweet flour tortillas using the previous mix, sugar and other types of sweeteners may be added. Content of nopal flour or any other vegetable may be between 1% and 99%. [0076] In the previous example, dietary fiber content was increased to over 4.5% when consuming 100 g of this product, representing 15.7% of the daily requirement, Calcium and Potassium were significantly increased also, (Table 7). TABLE 7 Effect from adding 10% nopal flour to flour tortilla elaboration. % of the req. % of the req. supplied when Flour tortilla supplied when consuming 100 g of Regular flour w/10% of Require- consuming 100 g of regular flour tortilla tortilla 100 g nopal flour ment regular flour tortilla w/10% of nopal flour Moisture (%) 38% 39% — — — Energy (kcal) 313 299 2000 15.65 14.95 Dietary fiber (g) 3.4 4.7 30 11.3 15.7 Calcium (mg) 15 184 1000 1.5 18.4 Potassium (mg) 163 386 2000 8.15 19.3 [0077] With this example, it is demonstrated that it is also feasible to produce refined and/or whole-wheat flour tortillas “enriched with nopal flour”, as well as fried products like salad baskets and chimichangas (deep fried burritos). [0078] Annex To Examples 1,2,3,4, & 5 [0079] If water is substituted by liquefied nopal, in examples 1 to 5, it is recommended to exercise good hygiene practices. A typical way of elaboration is presented next. [0080] 1. Select nopal pads in perfect shape and of good quality. [0081] 2. Disinfect with chlorine water (200 ppm chlorine), if chlorine water is not available, use any other desinfectant, bactericide, viricide or similar in the water, at the recommended dosage. Pads may be left in the specified solution during the required time (from 10 minutes to 1 hour) or enough amount of the solution may be flushed over the pads. [0082] 3. Clean spines off nopal, may be done manually or mechanically, or both ways. [0083] 4. Once pads are free of spines, it is convenient to disinfect again obtaining a cleaner product. [0084] 5. Once pads have been cleaned of spines and disinfected, proceed to liquefy in a blender until they are completely liquefied. The resulting liquid my be strained of filtered or used directly as a water substitute. [0085] Step 3, cleaning of spines may be eliminated if you are sure the blender will destroy spines and/or liquefied nopal will be filtered or strained. [0086] For the purposes of this invention, nopal that has been disinfected and cleaned of spines is considered as raw material. The ways and procedures used to accomplish the aforementioned, are outside the scope of the present invention. In the same manner, the juice and/or other liquefied vegetables are considered raw material, regardless of the procedure performed to obtain them. [0087] Similarly, nopal flour and/or from other vegetables is considered raw material, regardless of the process used to elaborate it. [0088] In addition to the foregoing, in all examples described in the present invention, the following may be included as ingredients; flavorings, gums, colorants, preservatives, etc. EXAMPLE 6 [0089] To elaborate flour product mixes from cereals, leguminous and grains in general, refined and/or whole that are elaborated to be sold, and that adding one or more missing ingredients, they may be used to elaborate any of the aforementioned products. [0090] This example refers to elaboration of products that are mixtures of vegetable and/or nopal powders with cereal and/or legumes and/or oilseed flours. These mixtures may be marketed so that once the missing ingredient or ingredients are added; novelty products may be elaborated that are equivalent to the current ones, but with a different color and nutritional profile. [0091] To exemplify: [0092] a. If it is required to elaborate any nixtamalized product that contains nopal flour and/or other vegetable flours, a mixture will be prepared containing nixtamalized corn flour and nopal and/or vegetable flour, and packed for use; afterwards. Whoever has acquired this mix, at home or his/her business, will add water and/or liquefied nopal to elaborate tortillas, tostadas, etc. The invention consists of using nopal flour and/or other vegetable flous in the nixtamalized flour mix. [0093] b. If required to elaborate wheat flour tortillas with nopal and/or any other vegetable flour, wheat flour is mixed with nopal flour and/or other vegetable(s) & other ingredients such as baking powder, powdered milk, emulsifiers, shortening, etc. being able to pack this mix. [0094] Afterwards, whoever has acquired this mix, will add water and/or liquefied nopal, and any other ingredients like flavorings, preservatives, etc., will knead and proceed to elaborate flour tortillas with nopal flour and/or other vegetable flours. The present invention consists of the addition of nopal flour and/or other vegetable flours in the flour mixture; in addition, substitution, if desired, of water by liquefied nopal. [0095] c. If required to fabricate leavened bakery products, with chemical leavening agents or baking powders, all dry-powdered ingredients will be mixed with the refined and/or whole cereal flours, sugar, cinnamon, seasonings, etc., with nopal flour and/or other vegetable flours, for later packin and/or marketing, shortening and/or similar products may also be added, to this mix water and/or liquefied nopal will be added, lard, margarine, butter, etc., if the necessary amounts was not previously added, in the proper amounts to fabricate the desired products. The present invention consists of the inclusion of nopal flour and/or other vegetables flours and/or later addition of liquefied nopal together with/or instead of water. [0096] d. If required to fabricate long and/or short pasta, semolina is mixed with nopal flour and/or other vegetables flours or condiments in the desired amounts. This mixture may be packaged; water and/or liquefied nopal would be added later for dough texture and extrusion and cutting to desired size and drying during the necessary time; the present invention consists of the inclusion of nopal flour and/or other vegetable flours or condiments in the solids mixture and/or substitution of water by liquefied nopal. [0097] e. To elaborate fermented bakery products with a different color & nutritional profile. For elaboration of these products, all ingredients should be mixed based on powders or flours, as: nopal flour and/or from other vegetables, wheat flour, salt, sugar, dry yeast, malt, Vital Gluten, and if required some other ingredient, condiments and/or preservatives, including lard, are mixed and packaged for later use. To this mixture water and/or liquefied nopal and lard will be added later, if required, in the amounts required for the elaboration of the desired products proceeding to sheeting and baking. The present invention consists of the inclusion of the mixture of nopal flour and/or of other vegetables with the other solid ingredients and/or water substitution with liquefied nopal. EXAMPLE 7 [0098] To elaborate a product for “breading” with nopal flour, and/or a mixture of nopal flour with spices, and/or ground toasted bread, and/or saltine cookies, and/or ground Habanera cookies, and/or wheat flour, and/or raw or nixtamalized corn flour, either elaborated with refined and/or whole flours. In addition to using liquefied nopal alone or combined with wheat flours and/or other cereals supplemented with battered eggs, milk gums, emulsifiers and modified starch as adherent agent, similarly ground toasted bread may be used, that has been elaborated in the manner described in example 1, that is to say, in both cases with nopal flour and/or liquefied nopal, and/or other vegetable flours and/or juice or liquefied vegetables. [0099] Fried chicken was elaborated using a commercial breading formula from which 30% of its weight was substituted by nopal flour; Chicken thighs were first submerged in a batter elaborated from wheat flour, beaten eggs, milk, and water and later breading by simple contact of the portion “wetted” in the batter with the breading mix. Products were fried at 175° C. during 4 minutes a commercial fryer containing canola vegetable oil. The breading that had 30% nopal flour increased aherence and changed color towards a darker greenish shade that became darker after the frying process, flavor changed slightly also but was pleasant for consumers. [0100] In the same way, the formulation may be entirely substituted with nopal flour obtaining a “breading” with higher adhesion power, darker and pleasant flavor; this product with 100% nopal flour breading and/or other vegetable flours, may be used by consumers that desire to increase their dietary fiber, Calcium & Potassium intake. TABLE 8 Effect from adding two different levels of nopal flour in two commercial breading products, and a ground dry bread containing 30% of nopal flour, and 100% nopal flour product, and their relation with the nutritional requirements for several nutrients on a 2000 kcal/day diet. 100 g 100 g 100 g 100 g bread 100 g tradi- bread 100 g tradi- 100 g contain- granulated tional 100 g contain- granulated tional commer- 100 g ing 30% corn ground commer- 100 g ing 30% corn ground cial tradi- dry flakes bread cial tradi- dry flakes bread granulated tional nopal w/20% w/20% 100 g granulated tional nopal w/20% w/20% 100 g corn ground (sample nopal nopal nopal Require- corn ground (sample nopal nopal nopal flakes bread 1) flour flour flour ment flakes bread 1) flour flour flour Moisture 10 11 12 9.6 10.4 8 — — — — — — — (%) Energy 370 306 325 350.8 300 274 2000 18.5 15.3 16.25 17.5 15 13.7 (kcal) Dietary 2.5 0.6 10.95 6.8 7.36 34.4 30 8.3 2 36.5 29.3 24.5 114 fiber (g) Calcium (mg) 213 200 707 683 673 2505 1000 213 20 70.7 68.3 67.3 256.5 Potassiu 105 112 1165 888 894 4020 2000 5 5.6 58.25 44.4 44.7 201 (mg) [0101] Similar to previous examples, adding nopal lowered caloric density and significantly increased dietary fiber, Calcium & Potassium levels; these results demostrate that it is feasible to substitute different levels on the formulations for shakes and/or breading, and to manufacture meats, seafood, and produce with a different nutritional profile to breaded products containing regular formulations. A 100% substitution of bread by nopal flour is worth mentioning. Dietary fiber, Calcium & Potassium supply to daily requirement is over 100%. In addition, caloric content decreased remarkably. EXAMPLE 8 [0102] Elaborate a snack based on dehydrated nopal, maybe spiced or not. Obtaining a totally innovative product, with superior nutritional value in comparison to those currently consumed. Commercial French fries are regularly cut using a produce cutter, obtaining very thin slices and later fried and lastly salted and/or seasoned. [0103] This invention consists in processing nopal in a similar way to commercial potato offerings, that is to say, sut in a produce processor in very thin slices, to be consumed as a snack, being elaborated using dehydrated nopal, preferably using the following procedure: [0104] 1) Select whole, good quality nopal pads, [0105] 2) Disinfect with chlorinated water (200 ppm of chlorine) or using another bactericide at the proper concentration. [0106] 3) Clean spines off nopal. This may be done by hand, mechanically, or both. [0107] 4) Cut the nopal pads. The desired and searched form is that of a thin nopal sliver of variable thickness of less than 1 mm, or up to 3 mm or more. The searched form is similar to that of fried potato snacks currently consumed. This operation may be performed with raw or cooked nopal in boiling water during 5 minutes or longer. [0108] 5) As nopal's external cuticle is the thinnest part on this cut, the inside becomes exposed, which is the one containing the moist and sticky mucilage, thus its possible to add a solid seasoning like ground hot chilly peppers, ground garlic, ground onion, etc. Similarly, a liquid seasoning may be added like salt dissolved in water, citric acid dissolved in water, the amounts of each of these, to provide the taste of preference of the target market. [0109] 6) With or without seasonings, cut nopal is dehydrated in trays thru a dehydrator tunnel, or using any dehydration method, for example lyophilization, microwave oven drying, vacuum drying and/or a combination of these. [0110] 7) In order to preserve the most color and flavor, temperature should never exceed 80 degrees centigrade. It is recommended to use the highest possible air speed, to shorten dehydration time, which may vary from 1 to 16 hours, being air speed and its temperature the most important variables, the foregoing in case dehydration takes place in a dehydration tunnel or similar. To improve color, flavor, texture and rehydration ability of dehydrated nopal and/or other dehydrated vegetables, it is recommended to use newer sophisticated dehydration methods, as lyophilization, conventional vacuum drying, and microwave drying with and without vacuum. [0111] 8) Nopal may be bagged directly when dry, it, this operation may be performed by hand, mechanically or electronically. To prevent texture loss, it is recommendable to pack the hygroscopic product in aluminized sealed bags, or highdensity polypropylene, or any material that may offer a good barrier against air humidity. [0112] 9) If no seasoning was added in step 4, and this is desired, it is recommended to apply a water solution with gum Arabic (@10%), or water/maltodextrins (@10%), or any other adherent in order to wet the nopal chips; when moist, seasoning may be applied in a way to improve adhesion to the finished product. Drying may be achieved using the same tunnel dehydrator or any of the previously described methods. [0113] 10 Once dehydration is finished, bagging will proceed, according to number 8, previously described. [0114] Dietary fiber content of this product is approximately 34.4%. TABLE 9 Typical commercial fried potatoes assay comparison with a low calorie snack. % of daily % of daily 100 gr. requirement requirement 100 g dehy- with 100 with 100 fried drated Require- g fried gr. dry potatoes nopal ment potatoes nopal Mois- 1.4 8 — — — ture (%) Energy 558 274 2000 27.9 13.7 (kcal) Dietary 3.6 34.4 30 12 114.7 fiber (g) Calcium 24 2555 1000 2.4 256.5 (mg) Potassi- 1008 4020 2000 50.4 201 um (mg) [0115] Difference between these two products is significantly notorious, given that calorie content of fried potatoes is over twice as much. Content of dietary fiber, Calcium & Potassium is significantly extremely different. With this we prove, that this invention substitutes, in a very advantageous manner conventional fried potatoes that may, in most cases, over 30% oil. [0116] The previous description is offered as an example to demonstrate the preferred method of procedure preparation, however, it is not our intention to limit the scope of this invention to what has been described, but to reserve any procedure that following the principles herewith, produces the same industrial results.

1a

BACKGROUND [0001] The present application relates to the following applications, all of which are filed concurrently herewith, assigned to the same assignee, and are hereby incorporated by reference. Attorney Title Docket No. Inventor(s) Materials, Devices, and Methods for P22656.00 Hai H. Trieu Treating Multiple Spinal Regions 31132.378 Including The Interbody Region Materials, Devices, and Methods for P22615.00 Hai H. Trieu Treating Multiple Spinal Regions 31132.377 Including The Anterior Region Materials, Devices, and Methods for P22681.00 Hai H. Trieu Treating Multiple Spinal Regions 31132.379 Including Vertebral Body and Endplate Regions Use Of A Posterior Dynamic P22397.00 Aure Bruneau et al. Stabilization System With An 31132.420 Interdiscal Device [0002] Disease, degradation, and trauma of the spine can lead to various conditions that require treatment to maintain, stabilize, or reconstruct the vertebral column. As the standard of care in spine treatment begins to move from arthrodesis to arthroplasty, preserving motion and limiting further degradation in a spinal joint or in a series of spinal joints becomes increasingly more complex. To date, standard treatments of the vertebral column have not adequately addressed the need for multiple devices, systems, and procedures to treat joint degradation. Likewise, current techniques do not adequately address the impact that a single treatment or arthroplasty system may have on the adjacent bone, soft tissue, or joint behavior. SUMMARY [0003] The present disclosure describes materials, devices, and methods for treating multiple spinal regions including the posterior and spinous process regions. In one embodiment, a method of treating a spinal condition includes attaching an interspinous device between spinous processes of a pair of vertebrae and attaching an anterior system between the pair of adjacent vertebrae to prevent hyperkyphosis. [0004] In some embodiments, the interspinous device may include a flexible interspinous process portion, a flexible ligament for extending around at least one of the spinous processes, or a rigid interspinous process portion. [0005] In some embodiments, the anterior system may include a rigid bone fixation plate or a flexible plate. [0006] In another embodiment, a method of treating a spinal condition includes inserting an interbody device into a disc space between a pair of vertebrae and attaching a interspinous device between spinous processes of a pair of vertebrae to prevent hyperlordosis. [0007] In some embodiments, the interbody device may be a motion preserving disc or a fusion device. [0008] In another embodiment, a method of treating a spinal condition includes inserting an interbody device into a disc space between a pair of vertebrae, attaching a interspinous device between spinous processes of a pair of vertebrae to prevent hyperlordosis, and attaching an anterior device to anterior faces of the pair of vertebrae. [0009] In some embodiments, the anterior device includes a graft material, a woven textile material, an annulus repair device, or PEEK. [0010] In another embodiment, a method of treating a spinal condition includes attaching a motion preserving device between a pair of bone anchors, attaching each of the bone anchors to a posterior bone portion of a respective pair of vertebrae, and inserting an interspinous device between a pair of spinous processes of the pair of vertebrae. [0011] In another embodiment, a method of treating a spinal condition includes inserting an interbody device into a disc space between a pair of vertebrae and attaching a interspinous device between spinous processes of a pair of vertebrae to prevent hyperlordosis. The method further includes attaching bone anchors to posterior bone portions of the pair of vertebrae and extending a posterior device between the bone anchors. [0012] In another embodiment, a method of treating a spinal condition includes inserting an interbody device into a disc space between a pair of vertebrae and attaching a interspinous device between spinous processes of a pair of vertebrae to prevent hyperlordosis. The method further includes attaching bone anchors to posterior bone portions of the pair of vertebrae, extending a posterior device between the bone anchors, and attaching an anterior system to anterior bone portions of the pair of vertebrae. [0013] In another embodiment, a method of treating a spinal condition includes implanting an interbody treatment system between a pair of vertebrae and extending a posterior motion preservation system between posterior bone segments of the pair of vertebrae to prevent compression of posterior nerves. [0014] Additional embodiments are included in the attached drawings and the description provided below. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a sagittal view of a section of a vertebral column. [0016] FIG. 2 is a superior view of a vertebral body depicted in FIG. 1 . [0017] FIGS. 3-9 are sagittal views of a section of a vertebral column having multiple region treatments. DETAILED DESCRIPTION [0018] The present disclosure relates generally to vertebral reconstructive devices, and more particularly, to systems and procedures for treating multiple spinal conditions. For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments, or examples, illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. [0019] Referring first to FIGS. 1 and 2 , the reference numeral 10 refers to a vertebral joint section or a motion segment of a vertebral column. The joint section 10 may be considered as having several regions extending from anterior to posterior. These regions include an anterior region 12 , an anterior column region 14 , a posterior region 16 , and a spinous process region 18 . The anterior column region 14 may be further considered to have several regions extending longitudinally along the vertebral column. These regions include a vertebral body region 20 , an endplate region 22 , and an interbody or disc space region 24 . [0020] Disc degeneration may lead to disc collapse or loss of disc height, resulting in pain or neurodeficit. Similarly, degeneration of the facet joints may lead to pain or neurodeficit. When treating one degenerated area of the vertebral joint, the impact of the treatment on the surrounding regions should be considered. For example, inappropriate restoration of disc height to only a posterior portion of the interbody space may result in hyperkyphosis with loss of height in the anterior interbody area and placement of the anterior annulus in compression. Likewise, in appropriate restoration of disc height to only an anterior portion of the interbody space may result in hyperlordosis with loss of posterior disc height and compression of the posterior annulus and facet joints. [0021] Treatment, stabilization, and/or reconstruction of the vertebral joint section 10 may be diagnosed and carried out in a systematic manner depending upon the conditions and material or systems available for treatment. To achieve an improved clinical outcome and a stable result, multiple regions of the vertebral column may be treated. [0000] Anterior [0022] Anterior or anterolateral systems and devices for treating anterior region 12 may include synthetic or natural tissue based prostheses for replacing or supplementing the anterior longitudinal ligament (ALL). Alternatively, anterior or anterolateral systems may include anterior bone fixation plates for the cervical, thoracic, or lumbar vertebral regions. Such plates may include those offered by or developed by Medtronic, Inc. of Minneapolis, Minn. under brand names such as the ATLANTIS plate, PREMIER plate, ZEPHIR plate, MYSTIC plate, PYRAMID plate, or DYNALOK CLASSIC plate, CD HORIZON ECLIPSE. In still another alternative, anterior or anterolateral systems may be made of flexible materials such as woven or braided textile based devices, elastomer-based devices, or polymeric composite-based devices that connect with two or more vertebrae. In still another alternative, the anterior or anterolateral systems may include annulus repair or replacement devices for the anterior portion of the annulus. Some anterior systems may be bioresorbable or partially resorbable. [0023] The anterior or anterolateral devices may connected to two or more vertebral bodies or vertebral endplates through the use of any connection mechanism such as bone screws, staples, sutures, or adhesives. The anterior or anterolateral systems may be loaded in compression or tension depending upon the patient's indication or the performance of other implanted systems or treatments. For example, an anterior plate may be installed in tension to counteract disc or facet degeneration in more posterior regions of the vertebral joint. [0024] The anterior or anterolateral systems may be formed from a rigid material or configuration such as a titanium or stainless steel plate. Alternatively, systems may be formed of less rigid or more flexible materials such as polyaryletherketone (PAEK)-based materials, which includes polyetheretherketone (PEEK), polyetherketoneketone (PEKK), PEEK-carbon composite, polyetherimide, polyimide, polysulfone, polyethylene, polyester, polylactide, copolymers of poly L-lactide and poly D-lactide, polyorthoester, tyrosine polycarbonate, polypolyurethane, silicone, polyolefin rubber, etc. The systems may be formed of inelastic material, such as braided tethers or woven fabric of polyester or polyethylene, or of elastic material, such as rubber banding or plates, sheets, rods, or tubing made of silicone or polyurethane. [0000] Interbody [0025] The disc space may require treatment due to disc collapse or loss of disc height due to degeneration, disease, or trauma. Disc space or intervertebral body devices and systems for treating region 24 may include rigid fusion devices such as those offered by or developed by Medtronic, Inc. of Minneapolis, Minn. under brand names such as INTERFIX cage, INTERFIX RP cage, LT cage, CORNERSTONE spacer, TELAMON spacer, MDII and MDIII threaded bone dowels, PRECISION GRAFT and PERIMETER ring spacers, etc. Alternatively, interbody devices may include prosthetic motion preserving discs such as those offered by or developed by Medtronic, Inc. under brand names such as MAVERICK, BRYAN, PRESTIGE, or PRESTIGE LP. Single articulating surface motion preserving discs may be disclosed more fully in U.S. Pat. Nos. 6,740,118; 6,113,637; or 6,540,785 which are incorporated by reference herein. Double articulating surface motion preserving discs may be disclosed more fully in U.S. Pat. Nos. 5,674,296; 6,156,067; or 5,865,846 which are incorporated by reference herein. In still another alternative, motion preserving interbody devices may extend posteriorly from the interbody space and include features for providing posterior motion. These types of bridged systems may be disclosed in U.S. Pub. Pat. App. Nos. 2005/0171610; 2005/0171609; 2005/0171608; 2005/0154467; 2005/0154466; 2005/0154465; 2005/0154464; 2005/0154461 which are incorporated by reference herein. In still another alternative, a spherical, ellipsoidal or similarly shaped disc replacement device may be installed in the interbody space. Such devices may include the SATELLITE system offered by or developed by Medtronic, Inc. This type of device may be described in detail, for example, in U.S. Pat. No. 6,478,822 which is incorporated by reference herein. In still another alternative, a disc replacement device may be an elastically deformable device comprising a resilient or an elastomeric material such as silicone, polyurethane, polyolefin rubber or a resilient polymer, and/or may comprise a mechanical spring component. [0026] Alternatively, interbody motion preserving devices may include nucleus replacement implants that work in conjunction with all or portions of the natural annulus. Such nucleus replacement implants may include those offered by or developed by Medtronic, Inc under a brand name such as NAUTILUS or offered by or developed by Raymedica, Inc. of Minneapolis, Minn. under brand names such as PDN-SOLO® and PDN-SOLO XL™. These types of nucleus replacement implants may be described in detail in, for example, U.S. Pat. Nos. 6,620,196 and 5,674,295 which are incorporated by reference herein. Injectable nucleus replacement material including a polymer based system such as DASCOR™ by Disc Dynamics of Eden Prairie, Minn. or a protein polymer system such as NuCore™ Injectable Nucleus by Spine Wave, Inc. of Shelton, Conn. may be alternatives for preserving interbody motion. Other acceptable alternative injectable or insertable disc augmentation biomaterials may be natural or synthetic and may include injectable and in situ curable polyurethane or an in situ curable poly vinyl alcohol compound. Injectable silicone or collagen may also be used to restore disc height and/or preserve joint motion. Injected collagen may be autogenic, allogenic, or synthetic and may be crosslinkable. Injectable materials may be used alone or together with an inflatable container implanted within the interbody space. [0027] The interbody systems may be loaded in compression or tension depending upon the patient's indication or the performance of other implanted systems or treatments. These interbody systems may provide a desired level of intervertebral disc space distraction the depending upon the patient's indication. For example, an interbody device or system may be sized or filled to balance posterior interspinous distraction provided by an interspinous device. [0000] Posterior [0028] Posterior region systems for treating region 16 may extend along the posterior or posterolateral side of the vertebral column and may span one or more vertebral joints. Posterior systems may be used with intact anatomy or in situations in which one or more facet, the spinous process, or even the entire lamina have been resected. Examples of posterior region systems may include rigid fixation systems such as hook, rod, and screw systems which are offered by or developed by Medtronic, Inc. of Minneapolis, Minn. under brands such as CD HORIZON, CD HORIZON SEXTANT, CD HORIZON M8, CD HORIZON LEGACY, CD HORIZON ANTARES, COLORADO 2, EQUATION, VERTEX, TSRH, and TSRH-3D. Semi-rigid or flexible systems may also be used and may include systems offered by or developed by Medtronic, Inc. under brand names such as FLEXTANT or AGILE or offered by or developed by Zimmer, Inc. of Warsaw, Ind. such as the Dynesys® Dynamic Stabilization System. These types of flexible systems may be disclosed, for example, in U.S. Pat. Pub. Nos. 2005/0171540 and 2005/0131405. These particular systems may replace or supplement natural facet joints and may attach to the posterior features of adjacent vertebrae using bone screws. Additional systems may include Archus Othopedics, Inc.'s TOTAL FACET ARTHROPLASTY SYSTEM (TFAS™) or similar devices performing facet functions [0029] Alternatively, dampener systems such as those described in U.S. Pat. Nos. 5,375,823; 5,540,688; 5,480,401 or U.S. Pat. App. Pub. Nos. 2003/0055427 and 2004/0116927, each of which is incorporated by reference herein. Additionally, rod and screw systems that use flexible PEEK rods may be chosen. In another alternative, posterior systems may be made of flexible materials such as woven or braided textile based devices that connect with two or more vertebrae. These flexible materials may be formed of natural graft material or synthetic alternatives. In still another embodiment, the posterior region systems may include annulus repair or replacement devices for the posterior portion of the annulus. [0030] The posterior region systems and devices may connected to two or more vertebral bodies or vertebral endplates through the use of any connection mechanism such as bone screws, staples, sutures, or adhesives. The systems and devices may be loaded in compression or tension depending upon the patient's indication or the performance of other implanted systems or treatments. For example, a flexible device attached to adjacent vertebrae with bone screws may be installed in tension to balance disc degeneration or subsidence of an interbody prosthesis. [0031] The posterior region systems may be formed from rigid materials such as a titanium or stainless steel. Alternatively, systems may be formed of less rigid or more flexible materials such as polyaryletherketone (PAEK)-based materials, which includes polyetheretherketone (PEEK), polyetherketoneketone (PEKK), PEEK-carbon composite, etc., polyetherimide, polyimide, polysulfone, polyethylene, polyester, polylactide, copolymers of poly L-lactide and poly D-lactide, polyorthoester, tyronsine polycarbonate, polypolyurethane, silicone, etc. The systems may be formed of inelastic material, such as braided tethers or woven fabric of polyester or polyethylene, or of elastic material, such as rubber banding or plates, sheets, rods, or tubing made of silicone or polyurethane. The systems may be formed of composite material including one or more materials listed above. [0000] Spinous Process [0032] Spinous process systems for treating region 18 may extend between adjacent spinous processes and/or extend around or through adjacent spinous processes. As one example, spinous process systems may include rigid interspinous process systems such as the Spire Plate system offered by or developed by Medtronic, Inc. of Minneapolis, Minn. or the X-Stop system offered by or developed by St. Francis Medical Technologies of Alameda, Calif. Such systems may be disclosed in U.S. Published App. No. 2003/0216736 or in U.S. Pat. Nos. 5,836,948; 5,860,977; or 5,876,404 which are incorporated by reference herein. Spinous process systems may also include semi-rigid spacer systems having flexible interspinous process sections and flexible ligaments or tethers for attaching around or through spinous processes. Such devices may include the DIAM system offered by or developed by Medtronic, Inc. or the Wallis system offered by or developed by Abbott Laboratories of Abbott Park, Ill. Semi-rigid spacer systems may be disclosed in greater detail in U.S. Pat. Nos. 6,626,944 and 6,761,720 which are incorporated by reference herein. Alternatively, semi-rigid spacer systems may have rigid interspinous process sections formed of materials such as titanium but incorporating flexible ligament or tethering devices that permit a limited amount of flexion-extension motion at the vertebral joint. [0033] In still another alternative, spinous process systems may include artificial ligaments for connecting two or more spinous processes. In another alternative, interspinous process systems may be made of flexible materials such as woven or braided textile based tethers that connect with two or more vertebrae. Elastic or rubber-like materials may also be used in the interspinous process region. Depending upon the system chosen, the spinous process systems may be installed through open surgical procedures, minimally invasive procedures, injection, or other methods known in the art. These systems and devices may be loaded in compression or tension depending upon the patient's indication or the performance of other implanted systems or treatments. [0000] Vertebral Body [0034] Vertebral bodies may become damaged due to compressive trauma fractures or osteoporosis. The vertebral body region 20 may be treated to strengthen diseased or traumatized bone, reinforce bone adjacent to prosthetic implants, or repair bone loss caused by implantation or revision of prosthetic systems. One or more vertebral bodies may be treated with injectable or implantable biocompatible materials that can be placed into cancellous or cortical bone. The material may be allowed to solidify to provide structural support and reinforcement. Examples of suitable biocompatible materials may include bone cements such as those made from polymethylmethacrylate (PMMA), calcium phosphate, hyrdroxyapatite-tricalcium phosphate (HA-TCP) compounds, bioactive glasses, polymerizable matrix comprising a bisphenol-A dimethacrylate, or CORTOSS™ by Orthovita of Malvern, Pa. (generically referred to as a thermoset cortical bone void filler). Calcium sulfate bone void fillers and other filling materials or combinations of filling materials may also be used. Bone void fillers or bone cements may be treated with biological additives such as demineralized bone matrix, collagen, gelatin, polysaccharide, hyaluronic acid, keratin, albumin, fibrin, cells and/or growth factors. Additionally or alternatively, bone void fillers or bone cements may be mixed with inorganic particles such as hydroxyapatite, fluorapatite, oxyapatite, wollastonite, anorthite, calcium fluoride, agrellite, devitrite, canasite, phlogopite, monetite, brushite, octocalcium phosphate, whitlockite, tetracalcium phosphate, cordierite, berlinite or mixtures thereof. [0035] Other osteoinductive, osteoconductive, or carrier materials that may be injected, extruded, inserted, or deposited into vertebral bone include collagen, fibrin, albumin, karatin, silk, elastin, demineralized bone matrix, or particulate bone. Various bone growth promoting biologic materials may also be used including mysenchymal stem cells, hormones, growth factors such as transforming growth factor beta (TGFb) proteins, bone morphogenic proteins (including BMP and BMP2), or platelet derived growth factors. Examples of such materials that can be injected into vertebral bodies are disclosed in U.S. Pub. No. 2005/0267577, which is hereby incorporated by reference. [0036] The above mentioned bone fillers may be used alone such as in vertebroplasty procedures that inject bone cement directly into the interstitial spaces in cancellous bone. Alternatively, the above mentioned bone fillers and treatments may be used with void creation devices such as balloon expansion systems offered by or developed by Kyphon, Inc. of Glendale, Calif. examples of such systems are disclosed in U.S. Pub. Nos. 2004/0102774 and 20040133280 and U.S. Pat. Nos. 4,969,888 and 5,108,404, all of which are incorporated by reference herein. Other void creation systems that utilize expandable cages or displacement systems may also be used for vertebral body repair. Such systems may be disclosed in U.S. Published Pat. App. No. 2004/0153064 and 2005/0182417 and are incorporated by reference herein. In still another alternative, vertebral body replacement devices or corpectomy devices may be used to replace an entire vertebrae or series of vertebrae. Such corpectomy systems may be of the type disclosed, for example, in U.S. Pat. Nos. 5,702,453; 5,776,197; 5,5776,198; or 6,344,057 which are incorporated by reference herein. [0000] Endplate [0037] Endplates may become fractured, damaged, or collapsed as a result of degeneration, disease, or trauma. Even relatively healthy endplates may need reinforcement due to procedures that affect surrounding regions. The endplate region 22 of vertebral body 20 may be replaced, reinforced or otherwise treated to strengthen the area in preparation for further procedures or to repair damage caused by interbody procedures such as disc replacement surgery. Endplate supplementation systems may use rigid or flexible devices such as metal plates with spikes or other attachment mechanisms to anchor the plates to existing bony tissue. Alternatively, vertebral endplates may be treated with injectable or implantable biocompatible materials that can be placed into cancellous or cortical bone. The material may be allowed to solidify to provide structural support and reinforcement. Examples of suitable biocompatible materials may include bone cements such as those made from polymethylmethacrylate (PMMA), calcium phosphate, hyrdroxyapatite-tricalcium phosphate (HA-TCP) compounds, bioactive glasses, polymerizable matrix comprises a bisphenol-A dimethacrylate, or thermoset cortical bone void filler. Calcium sulfate bone void fillers and other filling materials or combinations of filling materials may also be used. These implant materials may be treated with biological additives such as demineralized bone matrix, collagen, gelatin, polysaccharide, hyaluronic acid, keratin, albumin, fibrin, cells and/or growth factors. Additionally or alternatively, the implant materials may be mixed with inorganic particles such as hydroxyapatite, fluorapatite, oxyapatite, Wollastonite, anorthite, calcium fluoride, agrellite, devitrite, canasite, phlogopite, monetite, brushite, octocalcium phosphate, Whitlockite, tetracalcium phosphate, cordierite, Berlinite or mixtures thereof. [0038] Other osteoinductive or osteoconductive materials that may be injected into vertebral endplates include collagen, fibrin, albumin, karatin, silk, elastin, demineralized bone matrix, or particulate bone. Various bone growth promoting biologic materials may also be used including mysenchymal stem cells, hormones, growth factors such as transforming growth factor beta (TGFb) proteins, bone morphogenic proteins (including BMP and BMP2), or platelet derived growth factors. Additional materials that can be injected into vertebral bodies are disclosed in U.S. Pub. No. 2005/0267577, which is hereby incorporated by reference. [0000] Treating Multiple Areas [0039] Treatment, stabilization, and/or reconstruction of the vertebral column may be diagnosed and carried out in a systematic manner depending upon the conditions and material or systems available for treatment. To achieve an improved clinical outcome and a stable result, multiple regions of the vertebral column may be treated. [0040] An objective for treating multiple areas may include one or more of the following benefits: more immediate and adequate stabilization, more accurate anatomical correction, accelerated healing and/or improved clinical outcomes due to mutual reinforcements between the treated areas. The treated regions and employed devices can vary depending upon clinical objectives such as elimination or reduction of motion, restoration or increase of motion, elimination or reduction of intervertebral collapse, restoration or maintenance of disc height, elimination or reduction of hyperlordosis, restoration or increase of lordosis, elimination or reduction of hyperkyphosis, restoration or increase of kyphosis, correction of scoliosis, improvement of spinal alignment in the sagital and/or coronal plane, restoration or increase of vertebral/endplate strength, restoration or increase of vertebral/endplate density, acceleration of intervertebral fusion, and achieving differential stiffness or motion at different regions. [0000] Spinous Process/Posterior [0041] In one example, a spinous process system and a posterior system, chosen from the systems described above, may be combined As shown in FIG. 3 , a multiple region system 100 may include an interspinous process system 102 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 100 may also include a posterior motion system 104 such as a Dynesys® Dynamic Stabilization System offered by or developed by Zimmer, Inc. It is understood that the combination of treatment methods and devices described in FIG. 3 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process and posterior regions. [0042] Other examples include, but are not limited to, the following combinations: 1) the ADGILE posterior system and an elastic tension band connecting spinous processes, 2) an elastic posterior tension band and the X-STOP interspinous system, 3) a PEEK rod posterior system and a resorbable tether connecting the spinous processes, 4) the Total Facet Replacement System by Archus Orthopedics, Inc. for the posterior and the DIAM interspinous device and 5) a PEEK rod posterior system and an elastic tension band connecting spinous processes. [0000] Spinous Process/Anterior [0043] In one example, a spinous process system and an anterior system chosen from the systems described above, may be combined. As shown in FIG. 4 , a multiple region system 110 may include an interspinous process system 132 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 110 may also include an anterior system 114 which may be a bioresorbable anterior plate attached to the anterior faces of adjacent vertebral bodies with bone screws. It is understood that the combination of treatment methods and devices described in FIG. 4 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process and anterior regions. [0044] Other examples include, but are not limited to, the following combinations: 1) the DIAM interspinous spacer and an elastic anterior tension band, 2) the WALLIS interspinous system and a flexible woven anterior plate, 3) The X-STOP interspinous system and a resorbable polylactide-based anterior plate, 4) an elastic interspinous tension band and a flexible anterior band, and 5) an interspinous tether and an anterior PEEK plate. [0000] Spinous Process/Interbody [0045] In one example, a spinous process system and an intervertebral body system may be combined. As shown in FIG. 5 , a multiple region system 120 may include an interspinous process system 122 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 120 may also include an intervertebral body augmentation material 124 which may be, for example, an injectable material such as PVA, polyurethane, or collagen. It is understood that the combination of treatment methods and devices described in FIG. 5 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process and interbody regions. [0046] Other examples include, but are not limited to, the following combinations: 1) the NAUTILUS nucleus implant and an elastic interspinous tension band, 2) the BRYAN disc prosthesis and an interspinous braided tether, 3) the SATELLITE nucleus implant and the WALLIS interspinous system, 4) the MAVERICK disc prosthesis and a semi-elastic interspinous tension band, and 5) injectable/in situ curable biomaterials in the disc space and the DIAM interspinous device. [0000] Spinous Process/Interbody/Anterior [0047] In one example, a spinous process system, an intervertebral body system, and an anterior system, chosen from the systems described above, may be combined As shown in FIG. 6 , a multiple region system 130 may include an interspinous process system 132 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 130 may also include an intervertebral body material 134 which may be, for example, an injectable material such as polyvinyl alcohol (PVA) hydrogel, polyurethane, collagen, demineralized bone matrix, gelatin, polysaccharide, hyaluronic acid, keratin, albumin, silk, elastin, fibrin polymethylmethacrylate (PMMA), calcium phosphate, hyrdroxyapatite-tricalcium phosphate (HA-TCP) compounds, bioactive glasses, polymerizable matrix comprises a bisphenol-A dimethacrylate, or CORTOSS™ by Orthovita of Malvern, Pa. (generically referred to as a thermoset cortical bone void filler) or their combinations. [0048] The system 130 may also include an anterior system 136 which may be a flexible plate connected to anterior surfaces of adjacent vertebrae with bone screws to provide support to the anterior disc annulus. [0049] Other examples include, but are not limited to, the following combinations: 1) the DIAM interspinous spacer, RayMedica's PDN disc nucleus implant and an elastic anterior tension band, 2) an elastic interspinous tension band, the MAVERICK disc prosthesis and a flexible woven anterior plate, 3) the X-STOP interspinous system, injectable collagen for interevertebral disc space and a resorbable polylactide-based anterior plate, 4) an interspinous braided tether, the NAUTILUS disc nucleus implant and a flexible anterior band, and 5) the WALLIS interspinous system, LT cages for intervertebral space and anterior PEEK plate. [0050] It is understood that the combination of treatment methods and devices described in FIG. 6 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process, interbody, and anterior regions. [0000] Spinous Process/Posterior/Interbody [0051] In one example, a spinous process system, an intervertebral body system, and a posterior system, chosen from the systems described above, may be combined As shown in FIG. 7 , a multiple region system 140 may include an interspinous process system 142 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 140 may also include a posterior motion system 144 such as a Dynesys® Dynamic Stabilization System offered by or developed by Zimmer, Inc. The system 140 may also include an intervertebral body system 146 which may be a NAUTILUS nucleus implant offered by or developed by Medtronic, Inc. [0052] Other examples include, but are not limited to, the following combinations: 1) the ADGILE posterior system, RayMedica's PDN disc nucleus implant and an elastic interspinous tension band, 2) an elastic posterior tension band, the MAVERICK disc prosthesis and a flexible braided interspinous tether, 3) a PEEK rod posterior system, an injectable polymethylmethacrylate bone cement for interevertebral disc space and a resorbable interspinous spacer, 4) the Total Facet Replacement System by Archus Orthopedics, Inc. for the posterior, the NAUTILUS disc nucleus implant and a semi-elastic interspinous tension band, and 5) a PEEK posterior rod system, LT cages for intervertebral space and the WALLIS interspinous system. [0053] It is understood that the combination of treatment methods and devices described in FIG. 7 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process, interbody, and posterior regions. [0000] Spinous Process/Posterior/Interbody/Anterior [0054] In one example, a spinous process system, an intervertebral body system, an anterior system, and a posterior system, chosen from the systems described above, may be combined As shown in FIG. 8 , a multiple region system 150 may include an interspinous process system 152 having a flexible interspinous portion and flexible lugs extending from the interspinous portion and along the adjacent spinous processes. Exemplary systems may include the DIAM interspinous process system offered by or developed by Medtronic, Inc. The system 150 may also include a posterior motion system 154 such as a Dynesys® Dynamic Stabilization System offered by or developed by Zimmer, Inc. The system 150 may also include an intervertebral body system 156 which may be a NAUTILUS nucleus implant offered by or developed by Medtronic, Inc. The system 150 may also include an anterior system 158 which may be flexible woven fabric plate with bone screws that secure to the vertebrae adjacent the interbody region. [0055] Other examples include but are not limited to the following combinations: 1) an interspinous braided tether, the ADGILE posterior system, RayMedica's PDN disc nucleus implant and an elastic anterior tension band, 2) the DIAM interspinous device, an elastic posterior tension band, the MAVERICK disc prosthesis and a flexible woven anterior plate, 3) an elastic interspinous tension band, a PEEK rod posterior system, injectable collagen for interevertebral disc space and a resorbable polylactide-based anterior plate, 4) the DIAM interspinous device, the Total Facet Replacement System by Archus Orthopedics, Inc. for the posterior, the NAUTILUS disc nucleus implant and a flexible anterior band, and 5) the X-STOP interspinous system, a PEEK posterior rod system, LT cages for intervertebral space and anterior PEEK plate. [0056] It is understood that the combination of treatment methods and devices described in FIG. 8 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the spinous process, interbody, anterior, and posterior regions. [0000] Posterior/Interbody [0057] In one example, a posterior system and an intervertebral body system, chosen from the systems described above, may be combined. As shown in FIG. 9 , a multiple region system 110 may include a posterior system 112 such as a Dynesys® Dynamic Stabilization System offered by or developed by Zimmer, Inc. The system may further include a nucleus replacement device 114 such as a NAUTILUS device offered by or developed by Medtronic, Inc. [0058] Other examples include but are not limited to the following combinations: 1) an elastic posterior tension band and the NAUTILUS nucleus implant, 2) a flexible posterior cervical rod system and the BRYAN disc prosthesis, 3) the ADGILE posterior system and the SATELLITE nucleus implant, 4) the Total Facet Replacement System by Archus Orthopedics, Inc. for the posterior and the MAVERICK disc prosthesis, 5) a flexible posterior lumbar rod system and injectable collagen-based materials for lumbar discs, 6) the ADGILE posterior system and injectable polyvinyl alcohol hydrogel for lumbar discs, and 7) the PEEK posterior rod system and injectable polymethyl-methacrylate bone cement for intervertebral disc space. [0059] Still other examples include but are not limited to the following combinations: 1) the ADGILE posterior system and RayMedica's PDN disc nucleus implant, 2) an elastic posterior tension band and the MAVERICK disc prosthesis, 3) a PEEK rod posterior system and injectable polymethylmethacrylate bone cement for interevertebral disc space, 4) the Total Facet Replacement System by Archus Orthopedics, Inc. for the posterior and the NAUTILUS disc nucleus implant, and 5) a PEEK posterior rod system and LT cages for intervertebral space. [0060] It is understood that the combination of treatment methods and devices described in FIG. 9 is merely exemplary and that other materials and systems may be chosen to achieve a desired result involving the posterior and intervertebral body regions. [0061] Although only a few exemplary embodiments have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this disclosure. Accordingly, all such modifications and alternative are intended to be included within the scope of the invention as defined in the following claims. Those skilled in the art should also realize that such modifications and equivalent constructions or methods do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure. It is understood that all spatial references, such as “horizontal,” “vertical,” “top,” “upper,” “lower,” “bottom,” “left,” “right,” “anterior,” “posterior,” “superior,” “inferior,” “upper,” and “lower” are for illustrative purposes only and can be varied within the scope of the disclosure. In the claims, means-plus-function clauses are intended to cover the elements described herein as performing the recited function and not only structural equivalents, but also equivalent elements.

1a

BACKGROUND OF THE INVENTION [0001] This invention relates to a setting for a jewelry item, and more particularly, to a prong setting for accommodating different size jewelry stones. [0002] In the jewelry trade, prong settings are used to hold and retain diamonds and other types of precious or semi-precious stones. Presently, prong settings are fixed in position with respect to the jewerly item, and therefore different bezel sizes (openings) are required for different size stones. Prong settings usually come in ¼ carat (4 m/m), ⅜ carat (4½ m/m), one-half carat—⅝ carat—¾ carat—1 carat—all the way up to about 2 carats. For each size, there is a ½ m/m increase. Moreover, even with the ½ m/m separation, the stone that is used often does not fit appropriately. [0003] The problem with the prior art prong settings is that it is necessary to have a different size setting for each ring or other jewelry item in order to cover the various range of stone sizes. Moreover, even having different size settings is less than desirable, since some stones may not fit appropriately within the prong setting. Moreover, prior art prong settings are less than adequate in terms of strength in holding a stone in position therewithin. Even though a conventional bezel setting overcomes this disadvantage and has added strength for holding the stone in position within the setting, such a setting is less than desirable from an aesthetic point of view. In a conventional bezel setting, a substantial portion of the retained stone is partially or completely hidden from view. [0004] Accordingly, it is desirable to provide a prong type setting for a ring or other jewelry item which overcomes the above disadvantages and enables the easy retention of various size jewelry stones. SUMMARY OF THE INVENTION [0005] Generally speaking, in accordance with the invention, a prong setting for a ring or other jewelry item is provided. The prong setting is mounted along the jewelry item and includes a first prong element and a facing second prong element for defining an opening therebetween in which a jewelry stone is received. In one embodiment, the prong elements are movable with respect to one another in order to be able to selectively adjust the distance between the prong elements, and thus the size of the opening. As a result, the prong setting can accommodate jewelry stones of varying size. [0006] Preferably, the prong elements of the setting are movable with respect to one another by being pivotally attached along the jewelry item. In particular, each prong element has a depending flexible pin element coupled to the jewelry item. Each pin element is received in a hole formed in the jewelry unit and can flex in both a forward and back direction. As a result, each prong element is adjustable in both a forward and back direction so that the setting is capable of receiving different size jewelry stones. [0007] After the prong elements for any given jewelry item have been moved or positioned as directed, each prong element, including its corresponding depending pin element, is soldered and/or bonded in position. [0008] In a preferred design, the prong elements include a top lip or wire portion used to engage the jewelry stone. The lip or wire portion of the design is specially sized and shaped to enhance the strength of the setting in holding the stone in position therewithin. [0009] Accordingly, it is an object of the invention to provide an improved prong setting for a jewelry item. [0010] Still another object of the invention is to provide a prong setting for a jewelry item which can accommodate various size jewelry stones. [0011] Still a further object of the invention is to provide a prong setting for a jewelry item in which the bezel elements thereof may be adjusted in position therealong. [0012] Yet another object of the invention is to provide a prong setting for a jewelry item in which a jewelry stone fits correctly therewithin. [0013] A further object of the invention is to provide a setting for a jewelry item which has greater strength in retaining a stone. [0014] Another object of the invention is to provide a setting for a jewelry item which enables better viewing of the retained stone. [0015] Still other objects and advantages of the invention will in part be obvious and will in part be apparent from the following description. [0016] The invention accordingly comprises the features, elements and parts as described in the following description, and the scope of the invention will be indicated in the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0017] For a fuller understanding of the invention, reference is made to the following description taken in connection with the accompanying drawings, in which: [0018] [0018]FIG. 1 is an exploded perspective view showing the various component parts of a ring assembly incorporating the inventive bezel setting; [0019] [0019]FIG. 2 is a perspective view of the inventive bezel setting mounted to a ring and retaining a jewelry stone therewithin. [0020] [0020]FIG. 3 is a cross-sectional view taken along line 3 - 3 of FIG. 2; [0021] [0021]FIG. 4 is a cross-sectional view taken along line 4 - 4 of FIG. 3; [0022] [0022]FIG. 5 is a cross-sectional view taken along line 5 - 5 of FIG. 3; [0023] [0023]FIG. 6 is side elevational view in partial cross-section showing the bezel elements of the inventive bezel setting being outwardly adjusted in position in accommodate a larger size stone; [0024] [0024]FIG. 7 is a side elevational view in partial cross-section showing the bezel elements of the inventive bezel setting being adjusted inwardly in order to accommodate a smaller size stone; [0025] [0025]FIG. 8 is an enlarged cross-sectional view showing a portion of the inventive bezel setting once soldering has taken place; [0026] [0026]FIG. 9 is a side elevational view showing the inventive bezel setting retaining a jewelry stone and permanently fixed to the ring; [0027] [0027]FIG. 10 is an exploded perspective view showing the component parts of a ring assembly incorporating the inventive prong setting; [0028] [0028]FIG. 11 is a perspective view of the inventive prong setting mounted to a ring and retaining a jewelry stone therewithin; [0029] [0029]FIG. 12 is a cross-sectional view showing the inventive prong setting mounted to the ring; [0030] [0030]FIG. 13 is an exploded perspective view showing the component parts of a ring assembly incorporating an alternate embodiment of the inventive prong setting; [0031] [0031]FIG. 14 is a side elevational view of the alternative embodiment of the inventive prong setting mounted to the ring; and [0032] [0032]FIG. 15 is a top plan view of the alternative embodiment of the inventive prong setting mounted to the ring. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0033] Referring first to FIGS. 1 - 5 , a ring assembly generally indicated at 11 and which utilizes the inventive setting 18 is described. Ring assembly 11 consists of a ring or shank 13 made from a precious metal such as gold, silver or platinum, defined by an outer surface 17 , an inner surface 15 and a pair of sidewalls 14 , as is well known in the art. Ring 13 is formed with a cut-out 19 in outer surface 17 in which setting 18 of the invention is received. Cut-out 19 formed in ring 13 is defined by a pair of sloped end walls 16 which lead to a separating protrusion 20 , as shown in FIG. 1. Each of end walls 16 is formed with a radially inwardly extending hole 29 that is used for mounting bezel setting 18 within cut-out 19 of ring 13 , as described below. [0034] Setting 18 is defined by two facing bezel elements 21 also made from a precious metal. Each bezel element 21 includes an inwardly curved member 25 (see FIG. 4) formed with a slot 26 that is sized to slidably pivot along outside surface 17 of ring 13 . Curved member 25 increases in radial dimension in an upward direction and is formed with an annular running tubular lip 27 . Lip 27 includes an underlying annular groove 28 in which the girdle of a stone mounted in bezel setting 18 is matingly received. Curved member 25 of each of bezel elements 21 leads to a lower axially running supporting bridge element 22 from which a depending pin 23 projects. Depending pin 23 of each of bezel elements 21 is designed for reception within holes 29 formed in cut-out 19 of ring 13 , as best shown in FIGS. 2 and 3. [0035] As is well known in the art, a jewelry stone, such as a round diamond, is generally indicated at 31 and includes a table portion 33 , a girdle 35 below which is a tapered portion leading to a cutlet 37 . Stone 31 is mounted within bezel elements 21 of bezel setting 18 (see FIGS. 2 and 3) such that girdle 35 is matingly received within grooves 28 of bezel elements 21 , as discussed above, and cutlet 37 is disposed above bridge element 22 . [0036] In order for setting 18 to accommodate varying size jewelry stones, pins 23 , which are made from metal, of bezel elements 21 are selectively flexible in is both forward and back directions (see FIGS. 6 and 7), such that each bezel element 21 is capable of slidably moving along ring 13 in corresponding forward and back directions. This is in part achievable since each bezel element 21 has a cut-out 26 which is shaped and sized to slidably fit over outside wall 17 of ring 13 at a location adjacent to where cut-out 19 is formed in ring 13 . Accordingly, as shown in FIGS. 6 and 7, a larger size stone 33 A, having a table portion 31 A, girdle 35 A and cutlet 37 A, as well as a smaller size stone 31 B, having a table portion 33 B, a girdle 35 B and a cutlet 37 B, can be engagingly accommodated within inventive bezel setting 18 . [0037] As shown in FIGS. 8 and 9, once each of bezel elements 21 of setting 18 are slidably adjusted in position for accommodating a selected size jewelry stone, both curved member 25 and pin 23 are soldered or bonded in some other manner along end walls 16 of cut-out 19 formed in ring 13 by means of solder or bonding agent 38 . A finished ring product, as shown in FIG. 9, is then achieved. [0038] In accordance with the invention, each setting element is capable of being selectively moved back and forth to accommodate different size jewelry stones. Thus, a selected stone may be laid into the bezel setting in order to obtain a more desired fit than in conventional bezel settings. The advantage is that a buyer can see the jewelry stone in the setting as if it were set permanently therewithin, helping the buyer to envision what the jewelry item will look like when delivered to the buyer in permanent condition. In contrast, prior art bezel settings were not capable of having the stone fit correctly therein, and oftentimes the stone tends to float on top or go too low in the setting, which is less than desirable. [0039] Referring now to FIGS. 10 - 12 , a prong setting is shown substituted for a bezel setting and is defined by two facing bezel elements 121 made from a precious metal. Each bezel element 121 includes a pair of upwardly depending prongs 125 separated by a slot 126 that is sized to slidably pivot along outside surface 17 of ring 13 . Prongs 125 are each formed with a lip or wire portion 127 at the top end thereof. Lip or wire portion 127 of each prong 125 includes an underlying annular groove 128 in which girdle 35 of stone 31 mounted in the prong setting is matingly received. Prongs 125 of each of bezel elements 121 leads to a lower axially running supporting bridge element 122 from which a depending pin 123 projects. Depending pin 123 of each of bezel elements 121 is designed for reception within holes 29 formed in cut-out 19 of ring 13 , as best shown in FIG. 11. As with the first embodiment of the invention, pins 123 of prong elements 121 are selectively flexible in both forward and back directions such that bezel elements 121 are capable of slidably moving along ring 13 in corresponding forward and back directions. [0040] Referring now to FIGS. 13 - 15 , an alternative embodiment of a ring assembly which utilizes the inventive prong setting is generally indicated at 211 . Ring assembly 211 consists of a ring or shank 213 made from a precious metal such as gold, silver or platinum, and defined by an outer surface 217 , an inner surface 215 and a pair of side walls 214 , as is well known in the art. Ring 213 is formed with a cut-out portion 219 in which setting 218 of the invention is received. [0041] Setting 218 includes a bottom 223 from which four upwardly depending, angularly directed and equally spaced prongs 225 extend. Each prong 225 is formed with a lip or wire portion 227 at the top end thereof. Lip or wire portion 227 of each prong 225 includes an underlying groove 228 in which girdle 35 of stone 31 mounted in prong setting 218 is matingly received. Each of lip or wire portions 227 has a substantially cylindrical configuration defining an arcuate length A (see FIG. 15) which extends from between about 18° and 27°. Significantly, the sum of the arcuate lengths of each of lip or wire portions 127 of prongs 225 is between about 20% and 30% of the circumference defined by girdle 35 of stone 31 . This feature is found in both the embodiment of FIG. 13 and 15 , as well as the embodiment of FIGS. 10 - 12 . [0042] In the specific example shown in FIGS. 3 - 5 , setting 218 consists of four prongs 225 having four corresponding lip or wire portions 227 , as described above. Each wire portion 227 , which is disposed at a substantially equal angular distances from the two adjacent wire portions 227 , has an angular length A. The length A of each wire portion 227 is from between about 20% and 30% of one-quarter of the circumference defined by girdle 235 —in other words, each wire portion 227 has an arcuate extent of 18° to 27°. This ensures sufficient contact between each of lip or wire portions 227 to girdle 35 , maintaining a more secure engagement of stone 31 within setting 218 . Preferably, each lip or wire portion 227 has an arcuate length of from between about 1½ and 2½ millimeters, with a width or thickness of B (see FIG. 14) of between about ¾ and 1¼ millimeters. [0043] As can be appreciated from viewing the embodiment of FIGS. 13 - 15 , as well as the embodiment previously discussed of FIGS. 10 - 12 , lip or wire portion 227 of each of prongs 225 bulges outwardly in a direction away from stone 31 . Significantly, lip or wire portion 227 bulges outwardly past the outside wall of each of prongs 225 in an amount between about 10% and 25% as compared to the width or thickness of each of prongs 225 . This feature provides further reinforcement to the setting 218 , enhancing its holding strength with respect to stone 31 . [0044] As can be appreciated from viewing FIGS. 11 - 12 and 14 - 15 , the inventive prong setting design, while providing enhanced strength in holding a stone within the setting, still enables a substantial portion of the stone, whether viewed from the side, top or at an angle, to be visible. This is advantageous as compared to a bezel-type setting, as, by way of example, described in the embodiment of FIGS. 1 - 9 . [0045] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained, and since certain changes may be made in the invention described herein without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense. [0046] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention described herein, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

1a

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS [0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. [0002] The present application claims priority benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/061,132 filed Oct. 7, 2014, titled Regional Oximetry-EEG Sensor. The above-cited provisional patent application is hereby incorporated in its entirety by reference herein. FIELD OF THE DISCLOSURE [0003] The present disclosure relates to physiological sensors. More specifically, the present disclosure relates to configurations for modular physiological sensors. BACKGROUND [0004] Pulse oximetry is a widely accepted noninvasive procedure for measuring the oxygen saturation level of arterial blood, an indicator of a person's oxygen supply. A typical pulse oximetry system utilizes an optical sensor attached to a fingertip to measure the relative volume of oxygenated hemoglobin in pulsatile arterial blood flowing within the fingertip. Oxygen saturation (SpO2), pulse rate and a plethysmograph waveform, which is a visualization of pulsatile blood flow over time, are displayed on a monitor accordingly. [0005] Conventional pulse oximetry assumes that arterial blood is the only pulsatile blood flow in the measurement site. During patient motion, venous blood also moves, which causes errors in conventional pulse oximetry. Advanced pulse oximetry processes the venous blood signal so as to report true arterial oxygen saturation and pulse rate under conditions of patient movement. Advanced pulse oximetry also functions under conditions of low perfusion (small signal amplitude), intense ambient light (artificial or sunlight) and electrosurgical instrument interference, which are scenarios where conventional pulse oximetry tends to fail. [0006] Advanced pulse oximetry is described in at least U.S. Pat. Nos. 6,770,028; 6,658,276; 6,157,850; 6,002,952; 5,769,785 and 5,758,644, which are assigned to Masimo Corporation (“Masimo”) of Irvine, Calif. and are incorporated in their entireties by reference herein. Corresponding low noise optical sensors are disclosed in at least U.S. Pat. Nos. 6,985,764; 6,813,511; 6,792,300; 6,256,523; 6,088,607; 5,782,757 and 5,638,818, which are also assigned to Masimo and are also incorporated in their entireties by reference herein. Advanced pulse oximetry systems including Masimo SET® low noise optical sensors and read through motion pulse oximetry monitors for measuring SpO2, pulse rate (PR) and perfusion index (PI) are available from Masimo. Optical sensors include any of Masimo LNOP®, LNCS®, SofTouch™ and Blue™ adhesive or reusable sensors. Pulse oximetry monitors include any of Masimo Rad 8®, Rad 5®, Rad®-5v or SatShare® monitors. [0007] Advanced blood parameter measurement systems are described in at least U.S. Pat. No. 7,647,083, filed Mar. 1, 2006, titled Multiple Wavelength Sensor Equalization; U.S. Pat. No. 7,729,733, filed Mar. 1, 2006, titled Configurable Physiological Measurement System; U.S. Pat. Pub. No. 2006/0211925, filed Mar. 1, 2006, titled Physiological Parameter Confidence Measure and U.S. Pat. Pub. No. 2006/0238358, filed Mar. 1, 2006, titled Noninvasive Multi-Parameter Patient Monitor, all assigned to Cercacor Laboratories, Inc., Irvine, Calif. (Cercacor) and all incorporated in their entireties by reference herein. Advanced blood parameter measurement systems include Masimo Rainbow® SET, which provides measurements in addition to SpO2, such as total hemoglobin (SpHb™), oxygen content (SpOC™), methemoglobin (SpMet®), carboxyhemoglobin (SpCO®) and PVI®. Advanced blood parameter sensors include Masimo Rainbow® adhesive, ReSposable™ and reusable sensors. Advanced blood parameter monitors include Masimo Radical-7™, Rad-87™ and Rad-57™ monitors, all available from Masimo. Such advanced pulse oximeters, low noise sensors and advanced blood parameter systems have gained rapid acceptance in a wide variety of medical applications, including surgical wards, intensive care and neonatal units, general wards, home care, physical training, and virtually all types of monitoring scenarios. SUMMARY [0008] The present disclosure relates to modular physiological sensors. In some situations in the clinical environment, it is necessary to use multiple physiological sensors in the same general measurement site of a patient. For example, the forehead, arm, hand, ear, and noes are all common areas where multiple physiological sensors may be used at the same time. The present disclosure provides for modular physiological sensors that are physically and/or electrically configured to share the measurement site for the comfort of the patient and to ensure proper operation of the sensors without interference from other sensors. The modular aspect is realized by providing outer housing shapes that generally conform to other physiological sensors; mounting areas for attachment of one sensor to another sensor; providing release liners on the overlapping sensor attachment areas; and/or providing notches, tabs or other mechanical features that provide for the proper placement and interaction of the sensors. [0009] For example, regional oximetry (rO2), also referred to as tissue oximetry and cerebral oximetry, enables the continuous assessment of tissue oxygenation beneath a regional oximetry optical sensor. Regional oximetry helps clinicians detect regional hypoxemia that pulse oximetry alone can miss. In addition, the pulse oximetry capability in regional oximetry sensors can automate a differential analysis of regional to central oxygen saturation. Regional oximetry monitoring is as simple as applying regional oximetry sensors to any of various body sites including the forehead, forearms, chest, upper thigh, upper calf or calf, to name a few. Up to four sensors are connected to a conventional patient monitor via one or two regional oximetry pods. The pods advantageously drive the sensor optics, receive the detected optical signals, perform signal processing on the detected signals to derive regional oximetry parameters and communicate those parameters to a conventional patient monitor through, for example, standard USB ports. Although much of the present disclosure is explained by way of example with respect to EEG and rO2 sensors, it is to be understood that the modular configurations of the sensors can be applied to other types of physiological sensors and are not limited to EEG and rO2 sensors. [0010] In some embodiments, an EEG sensor is advantageously shaped and marked on either side of a connector stem so as to allow regional oximetry (rO2) sensors to be placed in close proximity to the EEG sensor and so as to guide the proper placement of one or more rO2 sensors compactly next to the EEG sensor. The proper placement assistance and joint operation of the sensors provides for improved patient comfort and improved monitoring by ensuring the sensors do not interfere with each other. In some embodiments, the body shape of the EEG sensor is designed to the egg-shaped contours of the rO2 sensor heads. Further, markings on EEG contours correspond to notches on the rO2 sensor heads. These notches allow the rO2 sensor heads to conform to the curvature of a person's forehead. This integrated rO2-EEG sensor combination allows for measuring cerebral regional oximetry in conjunction with EEG parameters, such as depth of consciousness. The EEG sensor is applied first, as the EEG sensor electrodes have particular placement criteria. The EEG sensor markings, as described above, guide placement of the rO2 sensors, as these too require a particular placement for cerebral regional oximetry measurements. The EEG sensor skin-side is advantageously colored black so as to prevent the EEG sensor from reflecting the rO2 sensor-emitted light into the sensor detectors, which would degrade rO2 sensor performance. [0011] In some embodiments, the rO2 sensors connect with a single rO2 pod and cable and the EEG sensor connects with a separate EEG pod and cable. In various other embodiments, a combination rO2-EEG sensor pod houses a single rO2 analog/digital signal processing board and a single EEG signal processing board and the rO2-EEG sensors each connect to the single rO2-EEG sensor pod. [0012] One aspect of a brain analysis sensor is an EEG sensor having a stem, a left branch and a right branch. The left branch and the right branch extend generally perpendicularly from the stem so as to form a branch intersection. A plurality of right and left active electrodes are disposed along the left branch and the right branch. A ground electrode and reference electrode are disposed proximate the branch intersection. A mounting zone is disposed proximate the branch intersection for removable attachment of at least one regional oximetry (rO2) sensor. [0013] In various embodiments, the mounting zone accommodates a regional oximetry sensor head having light emitting and light detecting elements. The mounting zone is marked with a curved line generally indicating a shape of the regional oximetry sensor head. The mounting zone comprises a release layer so that the regional oximetry sensor head removably attaches to the mounting zone. The regional oximetry sensor head has notches that accommodate a curved surface and the mounting zone has notch markings that generally align with the sensor head notches so as to aid regional oximetry sensor placement. The mounting zone is configured to removably attach two regional oximetry sensor heads. A first regional oximetry sensor head is mounted proximate a EEG sensor left branch and a second regional oximetry sensor head is mounted proximate a EEG sensor right branch. [0014] Another aspect of a brain analysis sensor is a sensor method comprising mounting an EEG sensor on a forehead tissue site, mounting a first regional oximetry sensor on the forehead tissue site so as to at least partially overlap a first portion of the EEG sensor and mounting a second regional oximetry sensor on the forehead tissue site so as to at least partially overlap a second portion of the EEG sensor. [0015] In various embodiments, the first portion and the second portion of the EEG sensor are marked for placement of the first and second regional oximetry sensors. A release liner is disposed on the first portion and the second portion for aiding removal of the regional oximetry sensors. The shape of the marked portions conform to shape of the regional oximetry sensors. The marked portions also designate the location of notches on head portions of the regional oximetry sensors. [0016] A further aspect of a brain analysis sensor is an electrical sensor means for passively measuring an EEG signal, an optical sensor means for detecting an oxygen saturation and a placement means for at least partial overlapping the electrical sensor means and the optical sensor means on a tissue site. In an embodiment, the placement means comprises a marking means for designating the partial overlapping. In an embodiment, the marking means comprises at least a partial duplication of the optical sensor means shape on the electrical sensor means. [0017] Regional oximetry sensors and pods are disclosed in U.S. patent application Ser. No. 14/507,620, titled Regional Oximetry Sensor, filed Oct. 6, 2014 by Masimo Corporation, Irvine, Calif. and incorporated in its entirety by reference herein. An EEG sensor and monitor are disclosed in U.S. patent application Ser. No. 14/470,819, titled Depth of Consciousness Monitor, filed Aug. 27, 2014 by Masimo Corporation, Irvine, Calif. and incorporated in its entirety by reference herein. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 is a perspective view of a brain analysis system having an advantageous modular brain analysis sensor applied to a forehead site and in communications with a physiological monitor for generating simultaneous electroencephalogram (EEG) and left and right forehead regional oximetry (rO2) parameter values and waveforms; [0019] FIGS. 2-3 are perspective views, respectively, of a regional oximetry (rO2) sensor and cable assembly and an EEG sensor and cable assembly; [0020] FIGS. 4A-B are an exploded plan view ( FIG. 4A ) and a detailed plan view ( FIG. 4B ), respectively, of a modular brain analysis sensor having an advantageous keyed mounting zone (shaded) for precise, overlaid placement of dual rO2 sensors on an rO2-configured EEG sensor; [0021] FIGS. 5A-E are top, perspective, bottom, side and exploded perspective views, respectively, of an rO2-configured EEG sensor; and [0022] FIGS. 6A-E are top, side, bottom and exploded top perspective views, respectively, of a rO2 sensor and an enlarged perspective view of rO2 sensor optical elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0023] FIG. 1 illustrates a brain analysis system 100 having an advantageous modular brain analysis sensor 400 applied to a forehead tissue site in communications with a physiological monitor 101 for measuring and generating simultaneous electroencephalogram (EEG) and left and right forehead regional oximetry (rO2) parameter values and waveforms. The modular brain analysis sensor 400 can be advantageously assembled and placed within a limited-area forehead site. Also, the rO2 components 600 and EEG component 500 can be advantageously purchased, stocked and used separately and individually, saving hospital and medical care center costs over other, more specialized brain analysis sensors not having separately useable regional oximetry and EEG sensor functions. The same cost savings is realized by modular designs for any and all types of physiological monitoring sensors. [0024] As shown in FIG. 1 , the brain analysis sensor 400 has an EEG sensor ( FIGS. 4-5 ) that co-mounts dual regional oximetry (rO2) sensors. Each of these sensor functions are in communications with a physiological monitor 101 having a main display 120 and a (removable) handheld monitor 130 having a handheld display 132 . The main display 120 provides EEG waveforms and parameter values 122 in addition to forehead left 124 and forehead right 125 regional oximeter waveforms and parameters. The handheld display 132 provides a 3-D man graphic displaying green, yellow and red organ symbols (brain, lung and kidneys) corresponding to EEG and/or rO2 parameter values. Similar displays can be provided for other physiological parameters as well. [0025] Also shown in FIG. 1 , a modular brain analysis sensor 400 advantageously has dual rO2 sensors 600 that overlap right- and left-side portions of a specially-configured and marked (rO2-configured) EEG sensor 500 so as to compactly fit these modular sensors 500 , 600 within a limited-space forehead site, as described in detail with respect to FIGS. 2-4 , below. An rO2-configured EEG sensor 500 is described in detail with respect to FIGS. 5A-E , below. An regional oximetry sensor 600 is described in detail with respect to FIGS. 6A-E , below. [0026] Further shown in FIG. 1 , in an EEG screen portion 122 , the physiological monitor 101 display 120 shows 4 simultaneous EEG channels along with a patient state index (PSI) readout versus time so as to enable continuous assessment of both sides of the brain, such as for improved anesthetic management. In addition, forehead left 124 and forehead right 125 regional oximetry waveforms and readouts enable monitoring of brain tissue oxygen saturation and detect regional hypoxemia. [0027] FIGS. 2-3 illustrate, respectively, a regional oximetry (rO2) sensor and cable assembly and an EEG sensor and cable assembly. As shown in FIG. 2 , the regional oximetry (rO2) cable assembly 200 interconnects dual rO2 sensors 600 to a physiological monitor 101 ( FIG. 1 ). The rO2 cable assembly has dual sensor connectors at a sensor end, a monitor connector (MOC9) at a monitor end and a rO2 pod mounted between and in communications with the sensor connectors and the monitor connector. Also shown in FIG. 2 , the rO2 pod has regional oximetry analog and digital boards. The analog board communicates with one or more of the regional oximetry sensors 600 . The digital board enables the pod to perform the sensor communications and signal processing functions of a conventional patient monitor. This allows pod-derived regional oximetry parameters to be displayed on a variety of monitors ranging from simple display devices to complex multiple parameter patient monitoring systems. [0028] As shown in FIG. 3 , the EEG cable assembly 300 interconnects an EEG sensor 500 to a physiological monitor 101 ( FIG. 1 ). The EEG cable assembly 300 has an EEG connector at a sensor end, a monitor connector (MOC9) at a monitor end and a EEG pod mounted between and in communications with the sensor connectors and the monitor connector. [0029] FIGS. 4A-B illustrate a modular brain analysis sensor 400 having advantageous keyed mounting zones 501 (shaded) for precise, overlaid placement of dual rO2 sensors on an EEG sensor. In particular, the EEG sensor 500 has two mounting zones 501 , one on either side of the interconnected between the EEG electrodes and the EEG sensor connector. Each mounting zone accommodates one of two rO2 sensors (see FIG. 1 and FIG. 4A ). Further, each mounting zone 501 ( FIG. 4B ) is shaped and printed to conform to a top and side portion of an rO2 sensor head 610 ( FIGS. 6A-D ). Further, each mounting zone has printed notches 502 , 504 corresponding to actual notches in the rO2 sensor heads 610 ( FIG. 6A ) that accommodate curved tissue site surfaces. These printed notches 502 , 504 further aid in the alignment of rO2 sensors to the mounting zones 501 . [0030] FIGS. 5A-E further illustrate an rO2 configured EEG sensor 500 having a generally “T” shape with six electrodes including two right electrodes R 1 , R 2 ; two left electrodes L 1 , L 2 ; a ground electrode CB and a reference electrode CT. As shown in FIG. 5A , the R 1 , R 2 , L 1 , L 2 and CB electrodes are disposed across the horizontal top of the “T.” The reference electrode CT is disposed on the vertical middle of the “T.” The advantageous mounting zone 501 ( FIG. 4B ) is disposed on either side of the vertical middle of the “T” proximate the horizontal top of the “T.” [0031] As shown in FIG. 5E , the EEG sensor 500 has multiple layers including a release liner 510 that allows an attached rO2 sensor 600 ( FIG. 1 ) to be removed and repositioned; artwork 520 including rO2 sensor positioning lines 502 ( FIG. 4B ); a polyester substrate 530 ; silver pads 540 (electrodes); silver ink traces 550 ; a dielectric layer 560 that isolates and protects the traces 550 and a foam pad 570 that contacts a user's skin. The EEG sensor connector includes a top shell 582 and a bottom shell 584 . An information element 585 mechanically and electrically connects to the trace layer 550 . [0032] FIGS. 6A-E further illustrate a rO2 sensor and its optical elements having a sensor head 610 , a stem 620 and a connector 630 . The sensor head 610 houses an emitter 682 , a near-field detector 684 and a far-field detector 688 within a layered tape having a top side ( FIG. 6A ) and an adhesive bottom side ( FIG. 6C ) disposed on a release liner. The release liner is removed so as to adhere the bottom side to a skin surface. The emitter 682 and detectors 684 , 688 have lens that protrude from the bottom side ( FIG. 6E ) advantageously providing a robust optics-skin interface. The top side has printed emitter/detector indicators so as to aid precise sensor placement on a patient site. A connector 630 terminates the interconnect 620 at the connector contacts 632 . [0033] Also shown in FIG. 6D , a sensor head assembly 610 has a face tape 612 , a flex circuit 622 , a stem tape 620 , a base tape 624 , a connector top 634 and a connector base 636 . The face tape 612 and base tape 622 encase the flex circuit 622 and corresponding emitter and detectors 682 - 688 . [0034] A modular physiological sensor has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of this disclosure and the claims herein. One of ordinary skill in art will appreciate many variations and modifications. It should be understood specifically that the present mounting zones, tabs, relative shapes and modular configuration can be applied to other physiological sensors including, for example, ear, nose, hand, harm, and/or chest sensors or any other types of physiological sensors where the sensors are configured to jointly measure the same measurement site of a patient.

1a

CROSS REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of U.S. application Ser. No. 60/302,870, filed Jul. 3, 2001, and entitled Perorally Insertable/Removable Anti-Reflux Valve, which is hereby incorporated by reference in its entirety. BACKGROUND OF INVENTION This invention relates to a device and non-invasive surgical method for treating gastroesophageal reflux disease. More specifically, it relates to an anti-reflux valve prosthesis and associated instrumentation for its peroral placement and in situ fixing at the gastroesophageal junction, to prevent the reflux of gastric contents into the esophagus. The invention further relates to the instrumentation and methodology for peroral removal of such a prosthesis. Gastroesophageal reflux disease (GERD) is the commonest cause of dyspepsia, affecting some 30% of the United States adult population intermittently and some 10% on a continuous and troublesome basis. Gastroesophageal reflux disease produces heartburn, abdominal pain and regurgitation of acid-containing gastric contents into the esophagus and pharynx. It may also lead to alteration of the lining of the esophagus (Barrett's Esophagus), which may in turn lead to esophageal cancer. Current methods of treating GERD include powerful antacid medication therapies and surgical interventions. Medication therapy with powerful antacids is directed at treating the symptoms of GERD, and is necessarily not curative. Furthermore, medication-based therapies are not always fully effective, as reflux is not prevented and the esophagus may continue to be exposed to gastric content. Surgical intervention typically involves either open surgery (performed through the abdomen or the chest) or laparoscopic surgery (performed through one or more incision access ports inserted through the abdominal wall), and the re-sectioning of tissue or the implanting of a prosthetic device. Although surgical interventions can be curative, these treatments are seriously invasive and have the attendant risk of such procedures. Despite the risk, the field has been motivated to provide solutions to the GERD problem, which has resulted in the development of a number of surgically implantable anti-reflux valve prosthetic devices. Prior anti-reflux valve prostheses are essentially one-way valves implanted at the gastroesophageal junction using open or laparoscopic surgery. The implanted prosthesis allows normal swallowing to take place in an orthograde manner while preventing the reflux of gastric contents from the stomach into the esophagus. Examples of surgically implanted esophageal anti-reflux valve prostheses include the devices of: Godin (U.S. Pat. No. 5,314,473) which discloses a one-way, antivalve comprising a flattened tubular part associated with an annular fixing element; and Reich (U.S. Pat. No. 4,846,836) which discloses a bi-directional valve and housing for similar purposes. These devices were developed to be inserted into the gastroesophageal junction via open or laparoscopic surgery and fixed there. The purpose was to permit the unidirectional passage of ingested materials into the stomach while preventing the reflux of gastric content of the stomach into the esophagus. Typically, these devices require suturing or other means to fix them to the tissue of the esophagus. Generally, all of these prior devices and methods require surgical invasion of a body cavity and breach of the body membrane in some fashion (e.g., open surgery or laparoscopy) in order to accomplish their utility. Invasive surgical interventions are too frequently complicated by problems such as stricture formation, “gas bloat,” or recurrent symptoms of reflux disease. Additionally, the results obtained by gross surgical treatment can be technique-dependent and vary significantly from surgeon to surgeon. More recently, perorally implantable valve prostheses were disclosed for fixation in the esophageal lumen near the gastroesophageal junction in patent applications by one of the present co-inventors, Dr. Thomas V. Taylor, U.S. Ser. No. 08/987,693, filed Dec. 9, 1997, U.S. Pat. No. 6,254,642; U.S. Ser. No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. 6,544,291; and U.S. Ser. No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. 6,544,291; each of which is hereby incorporated herein by reference in its entirety. SUMMARY OF INVENTION The present invention relates to an anti-reflux valve prosthesis system for treating gastroesophageal reflux disease (GERD) in a patient, which does not require open or laparoscopic surgery to implant. The present invention provides for perorally inserting a removable sutureless anti-reflux valve prosthesis down the lumen of the esophagus, to the gastroesophageal junction, where it is fixed in place. The advantage of this system is that peroral insertion of such a valve eliminates the need for either open formal laparotomy, thoracotomy or a laparoscopic approach using multiple access ports. In the event it is later desired to remove or replace the prosthesis, the valve can be removed using a peroral extraction tool, again generally without the need for laparotomy, thoracotomy, laparoscopy, or any other surgically invasive technique. In one aspect, the present invention provides an anti-reflux valve prosthesis. The prosthesis has an annular fixation element for fixing the prosthesis in an esophagus, and a one-way valve depending from the annular fixation element for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. The valve includes a semipermeable membrane that is essentially liquid impermeable, but gas permeable to allow retrograde permeation of gas through the valve. The prosthesis can be configured to be perorally installed or perorally removable. The one-way valve of the prosthesis can be a sleeve valve. The prosthesis can be made of a biologically inert material, including but not limited to, a fluorinated polymer. The prosthesis is configured to be implanted in the esophagus of a patient with gastroesophageal reflux disease (GERD), preferably when that patient's esophagus is cancer free. In another aspect, the present invention provides another embodiment of an anti-reflux valve prosthesis that has an annular fixation element for fixing the prosthesis in the esophagus and a sleeve valve depending from the annular fixation element for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. The sleeve valve has a plurality of magnets secured at a distal end thereof to facilitate closure of the valve. Additionally, the prosthesis may contain a gas permeable membrane to allow retrograde permeation of gas therethrough, where the membrane is preferably liquid impermeable. In still another aspect, the present invention provides an anti-reflux valve prosthesis for peroral implantation in the esophagus. The prosthesis in this embodiment includes an annular body and a valve depending from the annular body for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. A plurality of substantially rigid spikes are spaced along a circumference of the annular body adjacent one end thereof, preferably the proximal end. The valve depending from the annular body can be a sleeve valve which may include a plurality of magnets secured at a distal end to facilitate closure of the valve. The prosthesis may also include a gas permeable, and preferably liquid impermeable, membrane to allow retrograde permeation of gas therethrough. Each spike has a tip at a free end thereof and a base at the other end attached to the annular body. A dog is formed on each spike between the base and the tip. Each spike is outwardly bendable at the base between a retracted generally longitudinal alignment for insertion and a radially outwardly deployed alignment for fixation. Preferably, the spikes can include a chamfer at the base to facilitate the bending. A keeper is positioned on an exterior surface of the annular body for receiving the dogs and locking the respective spike in the deployed alignment. The annular body of the prosthesis can be threaded to allow engagement with a tool to perorally insert and/or remove the prosthesis from the esophagus. The prosthesis is configured to be implanted in the esophagus of a patient with gastroesophageal reflux disease (GERD), preferably when that patient's esophagus is cancer free. In a further aspect, the present invention provides a tool for implanting the perorally implantable prosthesis. In this embodiment, the annular body is internally threaded and the spikes are attached to a proximal end of the annular body. The tool includes inner and outer tubes, a nipple secured to a distal end of the inner tube for releasably coupling the annular body, and a handle secured adjacent to a proximal end of the inner tube for manipulation of the tool. The inner tube and the outer tube are configured for advancement of the outer tube by rotating the outer tube with respect to the inner tube. A headpiece is secured to a distal end of the outer tube for bending the spikes outwardly into the deployed alignment by advancement of the headpiece into abutment with the nipple. A handle is preferably secured adjacent to a proximal end of the outer tube to facilitate rotation of the outer tube with respect to the first tube. Optionally, a plurality of transverse passages are formed in the headpiece in fluid communication with an annular space defined by an inner diameter of the headpiece, an outer diameter of the inner tube and annular seals on each end thereof. If present, the annular space is in turn in fluid communication with a vacuum source via a transverse bore in a wall of the inner tube and a central longitudinal passage through the inner tube, for drawing a lumen of the esophagus inwardly to facilitate penetration of the spikes. Optionally, a fiber optic cable is disposed within a central longitudinal passage of the inner tube for viewing the esophagus. In still another aspect of the invention, there is provided a method of using a tool to perorally implant an anti-reflux prosthesis in an esophagus. The method includes: (a) mounting the anti-reflux valve prosthesis onto a headpiece of the tool; (b) positioning the anti-reflux valve prosthesis in the esophagus; (c) deploying a plurality of radial spikes of the prosthesis; (d) pulling a vacuum across a longitudinal passage of the tool; and (e) drawing a lumen of the esophagus inwardly to facilitate impaction of the spikes. Optionally the headpiece of the tool can be configured to be removable and replaced with a crown. The crown would be configured to assist in the peroral removal of the prosthesis from the esophagus. In still another aspect of the invention, there is provided a tool to perorally implant an anti-reflux prosthesis in an esophagus. The tool includes: (a) a means for mounting the anti reflux valve prosthesis onto a headpiece of the tool; (b) a means for positioning the anti-reflux valve prosthesis in the esophagus; (c) a means for deploying a plurality of radial spikes of the prosthesis; (d) a means for pulling a vacuum across a longitudinal passage of the tool; and (e) a means for drawing a lumen of the esophagus inwardly to facilitate impaction of the spikes. In still another aspect of the invention, there is provided a method of using a tool for implanting the anti-reflux valve prosthesis. The method includes: (a) perorally inserting and positioning the anti-reflux valve prosthesis into the esophagus; (b) deploying a plurality of spikes, the spikes depending radially from the anti-reflux prosthesis; and (c) impaling the esophagus upon the spikes to hold the prosthesis in place. Optionally, the method can include using a vacuum to assist in impaling the esophagus upon the spikes. Furthermore, another aspect of the invention provides for a tool to implant an anti-reflex prosthesis. The tool includes: (a) a means for perorally inserting and positioning the anti-reflux valve prosthesis into the esophagus; (b) a means for deploying a plurality of spikes, the spikes depending radially from the anti-reflux prosthesis; and (c) a means for penetrating the esophagus with the spikes to hold the prosthesis in place. In still another aspect of the invention, there is provided a method of using a tool for implanting an anti-reflux valve prosthesis. The method includes: (a) releasably engaging a nipple of the tool with an annular body of the prosthesis, the prosthesis having a plurality of retractable embedment spikes; (b) perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction; (c) extending the spikes fully outwardly into a deployed alignment for engagement with a lumen of the esophagus; (d) uncoupling the nipple from the prosthesis; and (e) withdrawing the tool from the esophagus. Furthermore, the method can optionally include actuating a vacuum source to draw the wall of the lumen inwardly and facilitate engagement of the spikes. In still another aspect of the invention, there is provided a tool for implanting an anti-reflux valve prosthesis. The tool includes: (a) a means for releasably engaging a nipple of the tool with an annular body of the prosthesis, the prosthesis having a plurality of retractable embedment spikes; (b) a means for perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction; (c) a means for extending the spikes fully outwardly into a deployed alignment for engagement with a lumen of the esophagus; (d) a means for uncoupling the nipple from the prosthesis; and (e) a means for withdrawing the tool from the esophagus. A further aspect is the provision of a tool for extracting the anti-reflux prosthesis wherein the prosthesis includes an annular body and extended radial spikes therefrom. The tool includes an inner tube and an outer tubes, with the tubes being generally concentrically aligned, an nipple secured to a distal end of the inner tube, the nipple configured to be releasably coupled with the annular body, and a crown secured to a distal end of the outer tube, the crown having a plurality of tangentially projecting shoes to receive and retract the extended radial spikes. Optionally, the outer tube of the tool can be configured to be advanced or retracted as the outer tube is rotated with respect to the inner tube. The tool can also comprise a handle secured to a proximal end of the inner tube for manipulation thereof. The tool can also include a second handle secured adjacent to a proximal end of the outer tube to facilitate movement of the outer tube with respect to the inner tube. The tool can optionally include a fiber optic cable disposed within a central longitudinal passage of the inner tube for viewing the esophagus. The tool can optionally include an overtube having a shield of enlarged diameter at a distal end thereof, wherein the overtube is slidable over the outer tube to receive the plurality of spikes to facilitate removal of the prosthesis from the esophagus. The shield may optionally be tapered from a larger diameter at a distal end to a smaller diameter at a proximal end. The crown may optionally be configured to be removable and replaced with a headpiece that is configured to assist in reinstalling the prosthesis into the esophagus. A further aspect of the invention involves a method for using a tool to extract an anti-reflux valve prosthesis from an esophagus. The method includes: (a) perorally inserting the tool into the esophagus, wherein the tool comprises a nipple and a crown; (b) engaging the nipple into an annular body of the prosthesis, wherein the prosthesis includes a plurality of extended embedment spikes; (c) advancing the crown with respect to the nipple, the crown configured to retract the embedment spikes; and (e) removing the tool and engaged prosthesis from the esophagus. Optionally, the method can include advancing a shield over the spikes to place the spikes into a retracted position. A further aspect of the invention involves a tool to extract an anti-reflux valve prosthesis from an esophagus. The tool includes: (a) a means for perorally inserting the tool into the esophagus, wherein the tool comprises a nipple and a crown; (b) a means for engaging the nipple into an annular body of the prosthesis, wherein the prosthesis includes a plurality of extended embedment spikes; (c) a means for advancing the crown with respect to the nipple, the crown configured to retract the embedment spikes; and (e) a means for removing the tool and prosthesis from the esophagus. Optionally, the tool can include means for advancing a shield over the spikes to place the spikes into a retracted position. An alternate embodiment of the invention is an anti-reflux valve prosthesis for peroral implantation in the esophagus, comprising an annular body preferably made of a biologically inert polymer, a valve depending from the annular body for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents, and a plurality of substantially rigid spikes spaced along a circumference of the annular body adjacent one end thereof and extending radially outwardly from the annular body. Each spike has a tip at a free end thereof and a base at the other end attached to the annular body. Each spike is temporarily inwardly bendable for implantation and has memory to return to the radially outwardly extending position. Another aspect of the invention is the provision of a tool for implanting the anti-reflux valve prosthesis of this alternative embodiment wherein the annular body is internally threaded and the spikes are attached to a proximal end of the annular body. The tool includes an inner tube, a nipple secured to a distal end of the inner tube for releasably threadably coupling the annular body, and a handle secured adjacent to a proximal end of the inner tube for manipulation thereof. An overtube is slidable along and receives the inner tube. A handle is secured to a proximal end of the overtube for manipulation. A shield is attached to a distal end of the overtube. The shield is longitudinally movable between a first position for receiving the fixation spikes in the inwardly bent configuration during peroral insertion into the esophagus, a second position for releasing the fixation spikes, and a third position for facilitating return of the fixation spikes to the memory position. Another aspect of the invention is a method of using the tool just described for implanting the anti-reflux valve prosthesis. The method comprises: (a) threadably engaging the nipple in the annular body; (b) bending the spikes inwardly and positioning the shield in the first position over the spikes; (c) perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction; (d) while holding the valve prosthesis in place, moving the shield into the second position to release the spikes to return to the memory position; (e) optionally moving the shield into the third position to facilitate return of the spikes into the memory position to facilitate engagement of the spikes in a wall of the esophagus; (f) rotating the inner tube with respect to the annular body to uncouple the nipple; and (g) withdrawing the tool from the esophagus. A further aspect of the invention is a tool for extracting the anti-reflux valve prosthesis of the alternate embodiment wherein the annular body is internally threaded and the spikes are attached to a proximal end of the annular body. The tool includes inner and outer concentric tubes, a nipple secured to a distal end of the inner tube for threadably coupled the annular body, and a handle secured adjacent to a proximal end of the inner tube for manipulation thereof. The inner tube and the outer tube are in threaded interengagement for advancement of the outer tube by rotating the outer tube with respect to the inner tube. A crown is secured to a distal end of the outer tube and has a plurality of tangentially projecting shoes disposed on a distal end of respective longitudinal arms spaced along a circumference of the crown in correspondence with the spikes for bending the fixation spikes inwardly. An overtube has a shield of enlarged diameter at a distal end. The overtube is slidable over the outer tube to receive the plurality of inwardly bent spikes within the shield to inhibit laceration of the esophagus during movement of the prosthesis. A still further aspect of the invention is a method of using the tool just described for extracting the anti-reflux valve prosthesis. The method includes: (a) perorally inserting the tool into the esophagus and threadably engaging the nipple in the annular body of the prosthesis; (b) while holding the inner tube in place, rotating the outer tube with respect to the inner tube to advance the crown with respect to the nipple, engage the spikes with the shoes and bend the fixation spikes radially inwardly; (c) advancing the overtube to position the shield over the inwardly bent spikes; and (d) withdrawing the tool and the prosthesis from the esophagus. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a side sectional view of a preferred embodiment of the antivalve prosthesis according to the present invention. FIG. 2 is a top plan view of the prosthesis of FIG. 1 showing the fixation spikes in a deployed configuration. FIG. 3 is a side sectional view of the annular body used in the prosthesis of FIG. 2 showing the fixation spikes in a longitudinal, pre-deployment configuration. FIG. 4 is a top view of the annular body of FIG. 3 . FIG. 5 is an enlarged sectional view of the upper end of the annular body showing a preferred embodiment of the outer edge profile. FIG. 6 is a side view, partly in section and partly cut away, of an insertion tool according to the present invention for peroral implantation of the anti-reflux valve prosthesis of FIGS. 1–5 . FIG. 7 is a side view, partly in section and partly cut away, of an extraction tool according to the present invention for peroral removal of the anti-reflux valve prosthesis of FIGS. 1–5 . FIG. 8 is a simplified schematic of the crown of the extraction tool of FIG. 7 showing the extraction foot detail. FIG. 9 is an exploded side view, partly in section and partly cut away, of an insertion tool-prosthesis assembly in preparation for implantation of the anti-reflux valve prosthesis of FIGS. 1–5 with the tool of FIG. 6 . FIG. 10 is a side view, partly in section and partly cut away, of the distal end of the insertion tool-prosthesis assembly of FIG. 9 showing implantation of the prosthesis in the esophageal lumen following deployment of the fixation spikes and application of the vacuum source prior to disengagement of the tool from the prosthesis. FIG. 11 is a side view, partly in section and partly cut away, of the distal end of the extraction tool of FIGS. 7–8 threaded into the prosthesis of FIGS. 1–5 implanted in a patient's esophagus in preparation for foot release extraction according to one embodiment of the present invention. FIG. 12 is a side view, partly in section and partly cut away, of the distal end of the extraction tool-prosthesis assembly of FIG. 11 in a patient's esophagus with the overtube shield positioned in preparation for foot release extraction according to one embodiment of the present invention. FIG. 13 is a side view, partly in section and partly cut away, of the distal end of the extraction tool-prosthesis assembly of FIG. 12 with the overtube shield advanced in position over the fixation spikes following the foot release extraction step and the assembly being removed from the patient's esophagus according to one embodiment of the present invention. FIG. 14 is a side view of an alternate embodiment of an antisleeve valve having embedded magnets for use with the annular body of FIGS. 3–5 . FIG. 15 is an end sectional view of the valve of FIG. 14 . FIG. 16 is a top view of the valve of FIGS. 14–15 . FIGS. 17A and 17B are side sectional and top plan views, respectively, of an alternate embodiment of the annular body used in the anti-reflux valve prosthesis of the invention wherein the spikes are secured in a deployed configuration for implantation in the lumen of the esophagus. FIG. 18 is a side view, partly in section and partly cut away, of an assembly of a valve prosthesis made with the annular body of FIGS. 17A and 17B coupled to the distal end of an insertion tool in preparation for peroral insertion. FIG. 19 is a side view, partly in section and partly cut away, of the assembly of FIG. 18 following peroral placement of the prosthesis near the gastroesophageal junction and retraction of the overtube to deploy the fixation spikes. FIG. 20 is a side view, partly in section and partly cut away, of an assembly of the valve prosthesis in FIGS. 17–19 coupled to the distal end of a peroral extraction tool in preparation for removal. FIG. 21 is a side view, partly in section and partly cut away, of an assembly of FIG. 20 following retraction of the fixation spikes within the overtube shield in preparation for peroral removal from the esophagus. DETAILED DESCRIPTION As exemplified by the figures wherein like numerals refer to like parts, the present invention provides a peroral prosthesis system for treatment of gastroesophageal reflux disease (GERD) in a patient comprising an anti-reflux valve prosthesis, a peroral implantation tool for perorally inserting and positioning the valve prosthesis at the distal end of the lumen of the esophagus and implanting or fixing the valve prosthesis to the lumen wall, and a peroral extraction tool for removing the prosthesis. Referring to FIGS. 1–2 , in a preferred embodiment, the present invention provides a valve prosthesis 10 comprising a valve 12 , preferably of the sleeve type, depending from an annular body 14 . The sleeve valve 12 is made of a tubular membrane such as a tube of silicone, latex, polyester, or preferably GORE-TEX or TEADIT fluoropolymer, and has an upper end having a circular cross-section for mounting to the annular body 14 via rings 16 , which can be made of a suitably inert material such as stainless steel or heat-shrink TEFLON tubing. The lower end of the sleeve valve 12 is preferably flat to facilitate closure upon exertion of pressure from the gastric contents, thereby preventing reflux or retrograde passage of gastric contents through the valve 12 under normal conditions. In a preferred embodiment, the sleeve is a semipermeable membrane that is essentially impervious to liquid but allows gas permeation to facilitate relief and ease discomfort from gas bloat, e.g. GORE-TEX film. If desired, the sleeve valve 10 can be designed to evert when excessive gastric pressures are present, as in regurgitation. The annular body 14 is made from a biologically inert material such as TEFLON, fluorinated ethylene-propylene copolymer (FEP) or polytetrafluoroethylene (PTFE), or the like, and serves as a mounting ring for the sleeve valve 12 , carrying an array of fixation spikes 18 , preferably at an upper or proximal end thereof. The main portion of the body 14 can have a pair of grooves 20 formed in the exterior surface near the distal or lower end to facilitate retention of the rings 16 and form a seal between the valve 12 and the body 14 . A shoulder 21 is formed in the exterior surface near the proximal end of the main body to serve as a keeper to lock the spikes 18 in position for fixation, as discussed in more detail below. The main portion of the annular body 14 can be internally threaded, for example, with special acme right hand threads 22 that are relatively large with a high pitch and rounded or contoured bottoms to facilitate threaded engagement for implantation and extraction, and also to inhibit the retention and accumulation of swallowed material as it passes through. For example, the threads 22 are formed in one preferred embodiment with the dimensions given for medium size threads (7 threads per inch) for rolled threads for screw shells of electric sockets and lamp bases, American Standard, in the Machinist's Handbook. The inside diameter of the annular body 14 should be large enough so as to facilitate the orthograde passage of food and liquids through the esophagus, e.g. about 25 mm. The outside diameter of the annular body 14 , especially at the shoulder 21 , should be sufficiently large to seat firmly in the esophagus with some slight stretching of the lumen wall to facilitate the formation of a fluid-tight seal therewith. The spikes 18 are evenly spaced along the circumference of the annular body 14 as best seen in FIGS. 2–4 . Each spike 18 has a pointed or sharpened tip 24 and a flexible or hinged base 26 secured to the main portion of the annular body 14 . The spikes 18 are preferably integrally formed with the main portion of the body 14 , but can have a smaller thickness than the wall of the main body. For example, 1/16″ thick spikes may be utilized with a main body thickness of 3/32″. To facilitate bending of the spikes 18 , a notch 28 can be provided at the base 26 , preferably leaving sufficient thickness so that the spike 18 is biased upwardly to facilitate the extraction process. A downwardly sloped arm 30 disposed between the tip 24 and base 26 extends radially outwardly from each fixation spike 18 and functions as a dog to lock the spike 18 into place for fixation in the lumen wall. The arm 30 and the shoulder 21 are complementarily dimensioned and positioned so that a lower surface of the arm 30 is securely retained against inwardly tapered shelf 32 formed in the shoulder 21 . The proximal surface of the shoulder 21 is preferably at a right angle to an axis of the body 14 to help position the spikes 18 at a corresponding right angle. The distal surface of the shoulder 21 can be sloped to generally correspond approximately to the angle of the arm 30 . With reference to FIG. 6 , there is illustrated a tool 100 that can be used to insert or implant the prosthesis 10 . The tool 100 has an inner tube 102 received within an outer tube 104 . The tubes 102 and 104 can be rigid or flexible, as desired, preferably made of autoclavable and/or sterilizable materials or combinations of materials such as stainless steel, polypropylene or the like. The inner tube 102 is provided with a nipple 106 at the distal end and a manipulating handle 108 at the proximal end. The nipple 106 is threaded on an exterior surface to threadably engage the prosthesis 10 (See FIG. 9 ) in preparation for peroral insertion. The nipple 106 preferably has an elongated distal end 110 of reduced outside diameter to facilitate engagement with the prosthesis 10 , and a proximal end 112 of slightly enlarged outside diameter to slightly bias the fixation spikes 18 outwardly upon engagement of the prosthesis 10 . If desired, the inner tube 102 is provided with a central passage 113 for equipping an optics package 114 including a light source and a fiber optic cable and/or a conventional endoscope. The outer tube 104 is provided with a proximal handle 116 and a distal headpiece 118 . The outer tube is threadedly connected to the inner tube 102 at threaded section 120 , which preferably has left-handed or opposite-direction standard threads. The headpiece 118 has a relatively enlarged outside diameter 122 so as to bend the fixation spikes 18 outwardly as the outer tube is advanced along the inner tube 102 by counterclockwise rotation of the outer tube 104 while the inner tube 102 is held stationary. The left-handed threads ensure that the rotation of the outer tube 104 does not tend to turn the prosthesis 10 . The headpiece can have a recess 124 formed in a distal end surface to shoulder the proximal end 112 and ensure that the fixation spikes are fully deployed and locked in place. If desired, the tool 100 can be provided with a passageway to apply vacuum adjacent the prosthesis to draw the lumen wall inwardly and facilitate penetration of the spikes 18 . The headpiece 118 is provided with a plurality of transverse passages 126 in communication with an annulus defined by the inside diameter of the headpiece 118 , the outside diameter of the inner tube 102 , and opposing O-ring seals 128 on either side thereof. A transverse bore 130 is formed in the inner tube 102 in fluid communication between the annulus and the central passageway 113 . A vacuum hose 132 connects the proximal end of the central passageway 113 to a conventional vacuum source. With reference to FIG. 7 , there is illustrated a tool 200 that can be used to remove or extract the prosthesis 10 . This can be desirable if the prosthesis 10 is not functioning properly for the patient, e.g. if the lumen stretches and fails to seal against the prosthesis 10 , the valve 12 leaks, the prosthesis 10 irritates the patient, or the like. The tool 200 has an inner tube 202 received within an outer tube 204 , which in turn can be received within an overtube 205 . The tubes 202 , 204 and 205 can be rigid or flexible, as desired, preferably made of autoclavable and/or sterilizable materials or combinations of materials such as stainless steel, polypropylene or the like. The inner tube 202 is provided with a nipple 206 at the distal end and a manipulating handle 208 at the proximal end. The nipple 206 is threaded on an exterior surface to threadably engage the prosthesis 10 in preparation for extraction. The nipple 206 preferably has an elongated guide member 210 of reduced outside diameter at a distal end to facilitate engagement with the prosthesis 10 , and a proximal end 212 of slightly enlarged outside diameter for shouldering upon threaded engagement of the prosthesis 10 . If desired, the inner tube 202 can be provided with a central passage for equipping an optics package including a light source and a fiber optic cable and/or a conventional endoscope, as in the insertion tool 100 (see FIG. 6 ). The outer tube 204 is provided with a proximal handle 216 and a distal crown 218 . The outer tube 204 is threadedly connected to the inner tube 202 at threaded section 220 , which preferably has left-handed or opposite-direction standard threads. As best seen in FIG. 8 , the crown 218 has a plurality of evenly spaced longitudinal arms 222 , each carrying a tangential extraction shoe 224 along a circle in the proximal surface of the shoulder 21 of the prosthesis 10 , in one-to-one correspondence between the spikes 18 and the shoes 224 . The shoes 224 are designed with a thickness increasing from a forward point to the respective arm 222 , such that, upon advancement of the outer tube 204 by counterclockwise rotation, they catch between a respective spike 18 and the shoulder 21 , and upon further counterclockwise rotation, they force the spikes 18 upwardly and disengage the arms 30 from the shelves 32 , unlocking the spikes 18 . The overtube 205 is slideabe over the outer tube 204 , and is provided with a proximal handle 226 and a distal shield 228 . The shield 228 has a frustoconical section 230 flared outwardly from a small diameter adjacent the overtube 205 to a maximum diameter adjacent to a relatively short cylindrical section 232 at a free distal end thereof. The diameter of the cylindrical section 232 is larger than the diameter of the crown 218 , but less than the diameter of the deployed spikes 18 to house the spikes 18 during retraction of the prosthesis 10 from the esophagus. To use the insertion tool 100 to implant the prosthesis 10 , the prosthesis 10 is threaded onto the nipple 106 of the insertion tool 100 as shown in FIG. 10 , shouldering the prosthesis 10 against the enlarged diameter 112 and pushing the spikes 18 slightly outwardly. The outer tube 104 at this time is in a retracted position, with the headpiece 118 spaced from the spikes 18 . If desired, the headpiece 118 (see FIG. 20 ) can be advanced along the inner tube 102 until the distal end just touches the tips 24 (see FIG. 9 ) of the spikes 18 to ensure that further advancement of the headpiece 118 will push the spikes outwardly. Then the assembly is inserted through the mouth and into the esophagus E to position the prosthesis 10 at the desired location of implantation, e.g. at the gastroesophageal junction. Holding the inner tube 102 and the prosthesis 10 in place, the headpiece 118 is advanced by rotating the outer tube 104 counterclockwise to push the spikes 18 outwardly until the enlarged diameter 112 shoulders into the recess 124 and the arms 30 are locked into place in cooperation with the shoulders 21 . If desired, the vacuum source can be connected and actuated for a brief period to draw in the lumen of the esophagus and facilitate penetration of the spikes 18 , which preferably perforate the esophagus E. The inner tube 102 is then rotated counterclockwise to release the threaded engagement with the prosthesis 10 and the tool 100 is retracted, leaving the prosthesis 10 in place. As seen in FIG. 11 , to remove the prosthesis 10 previously implanted in the esophagus, the distal end of the tool 200 is inserted through the mouth and down the esophagus E until it contacts the prosthesis 10 . The nipple 206 is threaded into the prosthesis 10 by rotating the inner tube 202 clockwise with the handle 208 , and then by turning the outer tube 204 counterclockwise, the crown 218 is shouldered up against the spikes 18 . The overtube 205 can then be advanced to position the shield 228 near the spikes 18 , as shown in FIG. 12 . This stretches the esophageal lumen outwardly to help retract the spikes 18 . Further rotation of the outer tube 204 engages the extraction feet 224 between the base of the spikes 18 and the proximal surface of the shoulder 30 , and dislodges the arms 30 to unlock the spikes 18 . The spikes 18 are biased or have some memory to return inwardly toward a longitudinal orientation, but if desired, the tool 200 can be advanced in the esophagus E to facilitate release of the spikes 18 . The overtube shield 228 is then advanced over the prosthesis 10 to hold the spikes 18 and minimize interference or catching on the lumen wall, as illustrated in FIG. 13 . The tool 200 is then retracted, removing the prosthesis 10 from the esophagus. FIGS. 14–16 illustrate an alternate embodiment of a sleeve valve 300 that uses magnets 302 embedded within the tubing material near the distal end thereof. The valve 300 is in all respects otherwise similar to the valve 12 illustrated in the prosthesis 10 of FIG. 1 . The magnets 302 are paired with opposite poles in an opposing magnet 302 ″ in the opposing side of the valve 300 to facilitate closure, yet the magnetic force is not so strong as to inhibit opening of the valve for orthograde passage of food and liquids. The magnets 302 also serve to facilitate detection by x-ray or other radiographic imaging techniques. FIGS. 17A , 17 B, and 18 – 21 illustrate an alternate embodiment wherein the annular body 400 is formed with fixation spikes 402 that are in an outwardly radiating configuration with memory for positioning the spikes 402 in a deployed configuration, ready for implantation in the lumen of the esophagus. The annular body 400 can be formed, for example, by injection molding or transfer molding the fluorinated polymer in the shape of a blank having a tubular section and a disk portion that extends radially outwardly from one end of the tubular section. The fixation spikes 402 , internal threads 404 and external sleeve valve 406 (see FIGS. 18–20 ) retention grooves 408 , are then formed by milling or machining the blank. The fixation spikes 402 have some flexibility so that they can be bent slightly to facilitate insertion and removal, but also have memory to return to the outwardly radiating configuration to facilitate implantation once the prosthesis is properly positioned in the esophagus for implantation. It is not necessary for the fixation spikes 402 to have immediate memory, and can, if necessary, take several minutes to return to the memory position (radial deployment), or if desired, can be assisted into the memory position by mechanical and/or slight heating to body temperature. As best seen in FIG. 18 , to implant the prosthesis 410 , it is threaded onto the nipple 414 on the distal end of implantation tool 416 , which is generally similar to the implantation tool 100 of FIG. 6 . The implantation tool 416 has an overtube 418 , which is longitudinally slideable over an outer tube 420 . A shield 422 of enlarged diameter is secured to the distal end of the overtube 418 . To prepare the assembly for peroral implantation, the fixation spikes 402 are bent upwardly toward the proximal end, and the overtube 418 and shield 422 are moved forwardly so that the spikes 402 are received within the shield 422 . The distal end of the assembly is then inserted perorally to position the prosthesis 410 near the esophageal junction or other location at which it is desired to be fixed, while retaining the spikes 402 within the shield 422 so as to avoid laceration by the spikes 402 . Once placed in the desired location within the esophagus, the overtube 418 and shield 422 are retracted to release the spikes 402 (See FIG. 19 ). The spikes 402 have memory to return to the outwardly disposed configuration and pierce the lumen wall to fix the prosthesis 410 in place. If desired, the spikes 402 can be mechanically assisted by a sliding the shield 422 forward and pushing against the proximal surfaces of the spikes 402 . The tool 416 can also include modifications for applying a vacuum to the esophagus to facilitate impaction of the fixation spikes 402 into the wall of the esophagus, as in the embodiment of FIGS. 9–10 , or rapidly retracting the shield 422 to the position shown in FIG. 19 can also induce an impaction-facilitating localized vacuum. In addition, slightly retracting the prosthesis 410 with the implantation tool 416 after the tips of the fixation spikes have caught on the lumen wall can also serve to facilitate impaction. The implantation tool 416 is then disconnected by rotating the inner tube 424 to unthread the nipple 414 from the prosthesis 410 , and withdrawn from the esophagus to leave the prosthesis 410 fixed in place to inhibit reflux. In the event that it is desired to remove the prosthesis 410 , the extraction tool 426 of FIGS. 20–21 , which is generally similar to the extraction tool 200 of FIGS. 7–8 , is inserted perorally and the nipple 428 on the distal end thereof is threaded into the annular body 400 until it shoulders as shown in FIG. 20 . The outer tube 430 is then advanced by means of opposite-direction threads 432 so that the extraction shoes 224 on the distal end of the crown 218 (see FIG. 8 ) engage below the fixation spikes 402 , and continued rotation of the outer tube 430 bends the spikes 402 upwardly or toward the proximal end of the tool 426 until they can be received within the shield 434 carried on the distal end of the overtube 436 , which is slideable over the outer tube 430 into position as shown in FIG. 21 . Removal of the spikes 402 is facilitated by the localized expansion of the lumen by the shield 434 , and also by advancing the prosthesis 410 slightly with the tool 426 . Additionally, air or another inert gas can be injected into the esophagus, or a balloon (not shown) could be inflated around or just below the prosthesis 410 . While the above description contains many specifics, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of preferred embodiments thereof. Many other variations are possible, which would be obvious to one skilled in the art. Accordingly, the scope of the invention should be determined by the scope of the appended claims and their equivalents, and not just the illustrative embodiments.

1a

TECHNICAL FIELD [0001] The present invention relates generally to neckties, and more particularly, to reversible neckties which can be worn with either of two sides facing outward from the wearer, including a necktie in which the one side facing outward has two different patterns. BACKGROUND [0002] The most commonly used fibers for the manufacturing of neckties are silk, polyester, wool and wool blends, acetate, rayon, nylon, cotton, linen, and ramie. Neckties made from silk represent about 40 percent of the market. Raw silk is primarily imported from China and, to a far lesser extent, Brazil. Domestic weavers of tie fabrics buy their silk yarn in its natural state and have it finished and dyed by specialists. Technological advances have made possible the use of microfiber polyesters, which produce a rich, soft fabric resembling silk and which can be combined with natural or other artificial fibers to produce a wide range of effects. [0003] The design of neckties is an interactive process between weavers and tie manufacturers. Because small quantities in any given pattern and color are produced, and because fabrics can be so complex, tie fabric weaving is seen as an art form by many in the industry. [0004] The main components of a necktie are the outer fabric, or shell, the interlining (both cut on the bias), and the facing or tipping, which is stitched together by a resilient slip-stitch so that the finished tie can “give∞ while being tied and recover from constant knotting. The quality of the materials and construction determines if a tie will drape properly and hold its shape without wrinkling. [0005] A well-cut lining is the essence of a good necktie. This interlining determines not only the shape of the tie but also how well it will wear. Therefore, it must be properly coordinated in blend, nap, and weight to the shell fabric. Lightweight outer material may require heavier interlining, while heavier outer fabrics need lighter interlining to give the necessary hand, drape, and recovery. Most interlining manufacturers use a marking system to identify the weight and content of their cloths, usually colored stripes, with one stripe being the lightest and six stripes being the heaviest. [0006] It is also known in the art to have a reversible necktie having two sides or faces, each face being suitable for facing outward from the wearer. The materials used in the two sides of the necktie may be of different colors or different types of fabric or can have different imprinted patterns. Both sides are most commonly joined by together as by stitching and the necktie is everted to produce the reversible tie. As a result of this type of construction, some type of stitching is visible along the length of the necktie. This produces an unattractive appearance for the tie and therefore, there is a need for a method of fabricating a reversible necktie in which no visible line of stitching is present in the peripheral seam of the completed necktie. [0007] In addition, there is also a need to provide a more fashionable necktie that includes two different sections providing two different appearances that can be visible when wearing the necktie. SUMMARY [0008] A reversible necktie according to one embodiment includes first and second fabric pieces that have matching necktie shapes. Each of the fabric pieces has a finished face side, a wide end, longitudinal edges and a narrow end. The fabric pieces are superimposed in mating relationship with the finished sides facing outward, wherein each of the first and second fabric pieces is formed of a first section that has a first appearance and a second section that has a second appearance that is visually different from the first appearance. The first and second sections are joined together along a seam. The first section of first fabric piece overlies the second section of the second fabric piece and the second section of the first fabric piece overlies the first section of the first fabric piece. [0009] A method of manufacturing a reversible necktie includes the steps of: (a) providing a first fabric piece having a necktie shape and having a finished face side that has a first appearance, a wide end and a narrow end; (b) providing a second fabric piece having a necktie shape and having a finished face side that has a second appearance, a wide end and a narrow end; (c) superimposing the first fabric piece on the second fabric with the wide ends being at one end and the narrow ends at the other end and the finished face sides facing one another; (d) forming an interlining layer having a necktie shape having a wide end and a narrow end and a layer of second material that has a necktie shape and includes a wide end and narrow end, the layer of second material having dimensions greater than dimensions of the interlining layer; (e) superimposing the interlining layer on the layer of second material such that both wide ends are near one another and attaching the interlining layer to the layer of second material to form a first layered structure; (f) superimposing the first layered structure on the superimposed first and second fabric pieces with the layer of second material being in contact with and overlying the first fabric piece; (g) attaching the layer of second material to the superimposed first and second fabric pieces such that the interlining layer remains free and unattached to the first and second fabric pieces to form a second layered structure; and (h) everting the second layered structure so that the first and second finished sides face outward. [0010] In one embodiment, each of the first and second fabric pieces is formed of a first section that has a first appearance and a second section that has a second appearance that is visually different from the first appearance. The first and second sections are joined together along a seam and the first section of first fabric piece overlies the second section of the second fabric piece and the second section of the first fabric piece overlies the first section of the first fabric piece both in the first layered structure and the second layered structure. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0011] FIG. 1A is a front elevation view of a first side of a necktie according to one exemplary embodiment; [0012] FIG. 1B is a rear elevation view of a second side of the necktie of FIG. 1A ; [0013] FIG. 2A is a front elevation view of a first side of a necktie according to another exemplary embodiment; [0014] FIG. 2B is a rear elevation view of a second side of the necktie of FIG. 2A ; [0015] FIG. 3 is front elevation view of two pieces that form an interlining that is part of the necktie of FIGS. 1A and 1B , wherein the two interlining pieces are joined together; [0016] FIG. 4 is front elevation view of two pieces that form a thin layer that is part of the necktie of FIGS. 1A and 1B , wherein the two thin layer pieces are joined together; [0017] FIG. 5 is a front elevation view of the interlining laid over and attached to the thin layer; [0018] FIG. 6 is a front elevation view of first and second fabric pieces joined together to form a first side of the necktie of FIGS. 1A and 1B ; [0019] FIG. 7 is a front elevation view of first and second fabric pieces joined together to form a second side of the necktie of FIGS. 1A and 1B ; [0020] FIG. 8 is an exploded perspective view the attached structure of FIG. 5 laid over the fabric piece of the first side of the necktie which is itself laid over the fabric piece of the second side of the necktie; [0021] FIG. 9 is a perspective view of the layers of FIG. 8 with the attached structure of FIG. 5 attached to the fabric pieces defining the first and second sides of the necktie; [0022] FIG. 10 is a front elevation view of first and second fabric pieces joined together to form a first side of the necktie of FIGS. 2A and 2B ; [0023] FIG. 11 is a front elevation view of first and second fabric pieces joined together to form a second side of the necktie of FIGS. 2A and 2B ; [0024] FIG. 12 is an exploded perspective view the attached structure of FIG. 5 laid over a second fabric piece of the first side of the necktie which is itself laid over a fourth fabric piece of the second side of the necktie; [0025] FIG. 13 is an exploded perspective view the attached structure of FIG. 5 laid over a first fabric piece of the first side of the necktie which is itself laid over a third fabric piece of the second side of the necktie; and [0026] FIG. 14 is a perspective view of the layers of FIG. 12 with the attached structure of FIG. 5 attached to the fabric pieces defining the first and second sides of the necktie. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0027] Referring first to FIGS. 1A and 1B , a necktie 100 according to one embodiment is illustrated. The necktie 100 is generally in the form of a long strip of material that has a first pointed end 102 that is worn near the wearer's belt or waist line and an opposite second pointed end 104 that is narrower than the first pointed end 102 . Between the first and second pointed ends 102 , 104 is a narrow neck band 106 . The necktie 100 has a first side 110 and a second side 120 connected opposite the first side 110 . Sides 110 , 120 are preferably symmetric in that they have the same contours and dimensions. [0028] In accordance with the first embodiment of the present invention, the materials used in the first side 110 and the second side 120 of the necktie 100 can be of different colors or different types of fabric or can have different imprinted patterns. In other words, the first side 110 has a different appearance from the second side 120 , with either the first side 110 or the second side 120 being wearable facing outward from the wearer. In the illustrated embodiment, the first side 110 has a first appearance, such as stars or polka dots, and the second side 120 has a second appearance, such as a stripped pattern. [0029] The colors of the first and second sides 110 , 120 can be complementary in that the colors can be the same or similar colors or they can be different but complementary colors. Alternatively, the colors of the first side 110 can be in contrast to the colors of the second side 120 . This provides the wearer with two tie options that are visually much different, such as one side being a bright red color and pattern and the opposite side being a blue color and pattern. [0030] In the first embodiment, the first side 110 has the same pattern from the first pointed end 102 to the second pointed end 104 and similarly, the second side 120 has the same pattern from the first pointed end 102 to the second pointed end 104 . [0031] The necktie 100 is worn like any other conventional tie and in particular and as is commonly done, the necktie 100 is worn as a four-in-hand necktie. When the necktie 100 is tied around the neck of a wearer, the necktie 100 is positioned around the neck and is tied so that either the first or second sides 110 , 120 face outwardly from the wearer. As is know, when the necktie 100 is tied around the wearer's neck, a first section that contains the second pointed end 103 lies underneath a second section that contains the first pointed in such a manner that both outer surfaces of the two sections are the same and product the same visual appearance. In the event that the underling fist section becomes displaced from its position under the second section, the outer appearance of the necktie 100 is still satisfactory since the visible surfaces of the necktie 100 is the same. [0032] Referring first to FIGS. 2A and 2B , a necktie 200 according to one embodiment is illustrated. The necktie 200 is generally in the form of a long strip of material that has a first pointed end 202 that is worn near the wearer's belt or waist line and an opposite second pointed end 204 that is narrower than the first pointed end 202 . Between the first and second pointed ends 202 , 204 is a narrow neck band 206 . The necktie 200 has a first side 210 and a second side 220 connected opposite the first side 210 . Sides 210 , 220 are preferably symmetric in that they have the same contours and dimensions. [0033] In accordance with the second embodiment of the present invention, the materials used in the first side 210 and the second side 220 of the necktie 200 can be of different colors or different types of fabric or can have different imprinted patterns. In other words, the first side 210 has a different appearance from the second side 220 , with either the first side 210 or the second side 220 being wearable facing outward from the wearer. In the illustrated embodiment, a main display region of the first side 210 has a first appearance, such as polka dots or stars, and a main display region the second side 220 has a second appearance, such as a stripped pattern. [0034] The colors of the first and second sides 210 , 220 can be complementary in that the colors can be the same or similar colors or they can be different but complementary colors. Alternatively, the colors of the first side 210 can be in contrast to the colors of the second side 220 . This provides the wearer with two tie options that are visually much different, such as one side being a bright red color and pattern and the opposite side being a blue color and pattern. [0035] Unlike, the first embodiment, in the second embodiment, the first side 210 does not have the same pattern from the first pointed end 202 to the second pointed end 204 and similarly, the second side 220 does not has the same pattern from the first pointed end 202 to the second pointed end 204 . [0036] According to the second embodiment, the first side 210 has two distinct sections that contain two different patterns and similarly, the second side 220 has two distinct sections that contain two different patterns. For example, the first side 210 includes an end section that includes the first pointed end 202 and a tail section that includes the second pointed end 204 with a line that divides the two sections being formed in the narrow neck band 206 . [0037] The line can be a diagonal line relative to the longitudinal edges of the tie 200 or it can a straight line perpendicular to the longitudinal edges. [0038] The necktie 200 is worn like any other conventional tie and in particular and as is commonly done, the necktie 200 is worn as a four-in-hand necktie. When the necktie 100 is tied around the neck of a wearer, the necktie 200 is positioned around the neck and is tied so that either the end section of the first or second side 110 , 120 faces outwardly from the wearer. As is know, when the necktie 100 is tied around the wearer's neck, the tail section that contains the second pointed end 204 lies underneath the end section that contains the first pointed end 202 ; however and in contrast to the first embodiment in FIGS. 1A and 1B , the visible outer surface of the tail section that underlies the end section does not have the same pattern as the visible outer surface of the end section. In other words and when viewed by another, the tail section under the end section provides a different visual appearance than the outwardly visible end section. [0039] The manufacture of the necktie 100 according to the first embodiment is described with reference to FIGS. 3-9 . An interlining 130 is provided and includes two sections, namely, a first section 140 (which can also be referred to as a tie tail portion) and a second section 150 (which can also be referred to as an end portion of the tie). As with conventional neckties, the interlining 130 is cut in the shape of the necktie 100 itself. As shown in FIG. 3 , the first section 140 includes a first end 142 that is defined by a cut line (e.g., diagonal line) and an opposite second end 144 in the form of a pointed end. The second section 150 includes a first end 152 that is defined by a cut line (e.g., a diagonal line) and a second end 154 in the form of a pointed end. [0040] As shown in FIG. 3 , the first and second sections 140 , 150 are joined together by arranging the first ends 142 , 152 adjacent (abutting) one another so that the pointed ends 144 , 154 define the two ends of the elongated interlining structure. When positioning the two first ends 142 , 152 , the ends are fitted that the diagonal ends compliment each other and the width of the interlining 130 is uniform in this region as shown in FIG. 3 . The manner of attaching the first ends 142 , 152 can be any number of conventional techniques, including stitching or tacking, the two sections 140 , 150 together. [0041] It will also be appreciated that instead of being formed in two different sections, the interlining 130 can be formed of a single structure that can be cut from a piece of material that forms the interlining 130 . [0042] The interlining 130 is formed of traditional necktie interlining materials. [0043] The next step is to prepare a thin, flexible layer 160 that similar to the interlining 130 has a shape of the necktie 100 as illustrated in FIG. 4 . The layer 160 has greater dimensions (length and width) relative to the interlining 130 . Similar to the interlining 130 , the layer 160 can be formed of two sections, namely, a first section 162 (which can also be referred to as a tie tail portion) and a second section 167 (which can also be referred to as an end portion of the tie). The layer 160 is cut in the shape of the necktie 100 itself. As shown in FIG. 4 , the first section 162 includes a first end 164 that is defined by a cut line (e.g., diagonal line) and an opposite second end 166 in the form of a pointed end. The second section 167 includes a first end 168 that is defined by a cut line (e.g., a diagonal line) and a second end 169 in the form of a pointed end. [0044] As shown in FIG. 4 , the first and second sections 162 , 167 are joined together by arranging the first ends 164 , 168 adjacent (abutting) one another so that the pointed ends 166 , 169 define the two ends of the elongated interlining structure. When positioning the two first ends 164 , 168 , the ends are fitted that the diagonal ends compliment each other and the width of the layer 160 is uniform in this region as shown in FIG. 4 . The manner of attaching the first ends 164 , 168 can be any number of conventional techniques, including stitching the two sections 162 , 167 together. [0045] The layer 160 can be formed of any number of different materials so long as the layer 160 is a thin layer. For example, the layer 160 can be formed of a paper material or it can be formed of a synthetic material, such as a thin plastic mesh, both of which can easily be cut. [0046] Now referring to FIG. 5 in which the interlining 130 is disposed and laid over the layer 160 such that the pointed end 144 is proximate and aligned with the pointed end 166 and the pointed end 154 is proximate and aligned with the pointed end 169 . As shown in FIG. 5 , the greater dimensions of the layer 160 compared to the interlining 130 causes an outer peripheral strip section 161 to be formed around the peripheral edge of the interlining 130 . The interlining 130 is then attached to the layer 160 using traditional techniques, including using stitching or the like (indicated at 163 ). [0047] As shown in FIGS. 6-7 , the next step is to form two tie swatches that ultimately form the first and second sides 110 , 120 , respectively. More specifically, a first swatch 170 has a shape similar to the completed necktie 100 as illustrated in FIG. 6 . The first swatch 170 represents and defines the first side 110 of the necktie 100 . Similar to the other components, the first swatch 170 can be formed of two sections, namely, a first section 172 (which can also be referred to as a tie tail portion) and a second section 174 (which can also be referred to as an end portion of the tie). The first swatch 170 is cut in the shape of the necktie 100 itself. As shown in FIG. 6 , the first section 172 includes a first end 173 that is defined by a cut line (e.g., diagonal line) and an opposite second end 175 in the form of a pointed end. The second section 174 includes a first end 176 that is defined by a cut line (e.g., a diagonal line) and a second end 178 in the form of a pointed end. The first swatch 170 has an inner side or surface and an opposite outer side or surface 179 that represents the first side 110 of the necktie 100 . [0048] More specifically, a second swatch 180 has a shape similar to the completed necktie 100 as illustrated in FIG. 7 . The second swatch 180 represents and defines the second side 120 of the necktie 100 . Similar to the other components, the second swatch 180 can be formed of two sections, namely, a first section 182 (which can also be referred to as a tie tail portion) and a second section 184 (which can also be referred to as an end portion of the tie). The second swatch 180 is cut in the shape of the necktie 100 itself. As shown in FIG. 7 , the first section 182 includes a first end 183 that is defined by a cut line (e.g., diagonal line) and an opposite second end 185 in the form of a pointed end. The second section 184 includes a first end 186 that is defined by a cut line (e.g., a diagonal line) and a second end 188 in the form of a pointed end. The second swatch 180 has an inner side or surface and an opposite outer side or surface 189 that represents the second side 120 of the necktie 100 . [0049] As shown in FIG. 6 , the first and second sections 172 , 174 are joined together by arranging the first ends 173 , 176 adjacent (abutting) one another so that the pointed ends 175 , 178 define the two ends of the elongated interlining structure. When positioning the two first ends 173 , 176 , the ends are fitted that the diagonal ends complement each other and the width of the first swatch 170 is uniform in this region as shown in FIG. 6 . The manner of attaching the first ends 173 , 176 can be any number of conventional techniques, including stitching (sewing) the two sections 172 , 174 together. Similarly, the second swatch 180 is attached in the same manner the first swatch 170 is attached as shown in FIG. 7 . In particular, the first and second sections 182 , 184 are joined together by arranging the first ends 183 , 186 adjacent (abutting) one another so that the pointed ends 185 , 188 define the two ends of the elongated interlining structure. When positioning the two first ends 183 , 186 , the ends are fitted that the diagonal ends complement each other and the width of the second swatch 180 is uniform in this region as shown in FIG. 7 . The manner of attaching the first ends 183 , 186 can be any number of conventional techniques, including stitching (sewing) the two sections 182 , 184 together. [0050] As shown in FIG. 8 , the first and second swatches 170 , 180 are laid over one another so that outer surfaces (faces) 179 , 189 thereof face another, with the inner surfaces 171 , 181 facing outward and away from one another. In aligning the swatches 170 , 180 , the pointed ends 175 , 185 lie over one another and the pointed ends 178 , 188 lie over one another. It will be appreciated that while FIG. 8 shows the second swatch lying over the first swatch, the opposite arrangement is equally possible and yields the same result. [0051] As shown in FIGS. 8 and 9 , next the attached layer 160 and interlining 130 structure is laid over the combined first and second swatches 170 , 180 to form a layered structure defined by the two swatches 170 , 180 , layer 160 and interlining 130 . The layer 160 is laid over and in contact with the inner surface 181 of the second swatch 180 , with the pointed end 166 overlying the pointed end 185 and the pointed end 169 overlying the pointed end 188 . The interlining 130 represents one outer layer of the layered structure. [0052] The layer 160 is then attached to the first and second swatches 170 , 180 as shown in FIG. 9 by attaching the outer peripheral strip section 161 to the layered swatches 170 , 180 . For example, the outer peripheral strip section 161 is stitched (sewn) to the layered first and second swatches 170 , 180 . The stitching, generally indicated at 181 , is positioned close to but not in contact with the interlining 130 and therefore, the interlining is not directly stitched to the swatches 170 , 180 . This space that is left between the interlining 130 and the stitching ensure that the interlining 130 is not sewn and therefore, the entire layered structure of FIG. 9 can be everted (flipped over) as discussed below. It will be understood that the attached structure formed by the interlining 130 and thin layer 160 can equally be attached to the inner surface 171 of the first swatch which is arranged such that its outer surface 179 faces the outer surface 189 of the second swatch. [0053] The eversion of the necktie 100 completes the fabrication process. The wider pointed ends 178 , 188 , of the swatches 170 . 180 can be urged into the internal space or cavity formed between the two swatches 170 , 180 and by means of an everting tool, such as a rod having a blunt end. The everting process continues and is completed when the necktie 100 is fully everted resulting in necktie 100 that is free of any side seams. Instead, the stitch lines are located inside the necktie 100 resulting in a visually pleasing article where the outer surfaces 179 , 189 face outwardly on the two respective sides. [0054] FIG. 1A shows the first side 110 of the necktie 100 after it has been everted and FIG. 1B shows the second side 120 after the necktie 100 has been everted. [0055] The manufacture of the necktie 200 according to the second embodiment is described with reference to FIGS. 10-14 . The interlining 130 is provided and includes two sections, namely, the first section 140 (which can also be referred to as a tie tail portion) and a second section 150 (which can also be referred to as an end portion of the tie). As with conventional neckties, the interlining 130 is cut in the shape of the necktie 100 itself and it includes the same structure as shown in FIG. 3 and therefore, will not be described in detail again. [0056] The next step is to prepare the thin, flexible layer 160 that similar to the interlining 130 has a shape of the necktie 100 as illustrated in FIG. 4 . Once again, the layer 160 has already been described with reference to FIG. 4 and therefore will not be described in great detail again. [0057] Now referring to FIG. 5 in which the interlining 130 is disposed and laid over the layer 160 such that the pointed end 144 is proximate and aligned with the pointed end 166 and the pointed end 154 is proximate and aligned with the pointed end 169 . The interlining 130 is then attached to the layer 160 using traditional techniques, including using stitching 163 or the like. [0058] As shown in FIGS. 10-11 , the next step is to form two tie swatches that ultimately form the first and second sides 210 , 220 , respectively. More specifically, the first swatch 170 is formed of two sections, namely, a first section 172 (which can also be referred to as a tie tail portion) and a second section 174 (which can also be referred to as an end portion of the tie). The first swatch 170 is cut in the shape of the necktie 100 itself. As shown in FIG. 20 , the first section 172 includes a first end 173 that is defined by a cut line (e.g., diagonal line) and an opposite second end 175 in the form of a pointed end. The second section 174 includes a first end 176 that is defined by a cut line (e.g., a diagonal line) and a second end 178 in the form of a pointed end. The first swatch 170 has an inner side or surface 171 and an opposite outer side or surface 179 that represents the first side 110 of the necktie 100 . [0059] More specifically and as shown in FIGS. 10-11 , the second swatch 180 is formed of two sections, namely, a first section 182 (which can also be referred to as a tie tail portion) and a second section 184 (which can also be referred to as an end portion of the tie). The second swatch 180 is cut in the shape of the necktie 100 itself. As shown in FIG. 20 , the first section 182 includes a first end 183 that is defined by a cut line (e.g., diagonal line) and an opposite second end 185 in the form of a pointed end. The second section 184 includes a first end 186 that is defined by a cut line (e.g., a diagonal line) and a second end 188 in the form of a pointed end. The second swatch 180 has an inner side or surface 181 and an opposite outer side or surface 189 that represents the second side 120 of the necktie 100 . [0060] Unlike the first embodiment, both sections of the swatch 170 do not form one complete side of the necktie 200 and similarly, both sections of the swatch 180 do not form one complete side of the necktie 200 . In contrast, the first section 172 of the first swatch 170 is joined to the second section 184 as shown in FIG. 11 by arranging the first ends 173 , 186 adjacent (abutting) one another so that the pointed ends 175 , 188 define the two ends of the elongated interlining structure. The manner of attaching the first ends 173 , 186 can be any number of conventional techniques, including stitching (sewing) the two sections 172 , 184 together. [0061] Similarly, the first and second sections 182 , 174 are joined together by arranging the first ends 183 , 176 adjacent (abutting) one another so that the pointed ends 185 , 178 define the two ends of the elongated interlining structure as shown in FIG. 10 . When positioning the two first ends 183 , 176 , the ends are fitted that the diagonal ends complement each other. The manner of attaching the first ends 183 , 176 can be any number of conventional techniques, including stitching (sewing) the two sections 182 , 174 together. [0062] The result is that each of the first and second sides 210 , 220 is defined by a combination of two different swatches so that each side is not uniform along its entire length. In particular, the first side 210 is defined by the first section 172 of the first swatch 170 and the second section 184 of the second swatch 180 and the second side 220 is defined by the first section 182 of the second swatch 180 and the second section 174 of the first swatch 170 . [0063] As shown in FIG. 12 , the combined first section 172 and second section 184 is laid over the combined first section 182 and second section 174 so that the outer surfaces 189 , 179 (faces) thereof face another, with the inner surfaces 181 , 171 facing outward and away from one another. In aligning the these combined swatches, the pointed ends 175 , 185 lie over one another and the pointed ends 178 , 188 lie over one another. [0064] As shown in FIGS. 12-13 , next the attached layer 160 and interlining 130 is laid over the attached first section 172 and second section 184 and the attached first section 182 and second section 174 to form a layered structure defined by the sections of the two swatches 170 , 180 , the layer 160 and the interlining 130 . The layer 160 is laid over and in contact with the inner surface ( 171 , 181 , respectively) of the joined first section 172 and second section 184 , with the pointed end 166 overlying the pointed end 175 and the pointed end 169 overlying the pointed end 188 . The interlining 130 represents one outer layer of the layered structure. [0065] The layer 160 is then attached to the layered first section 172 and second section 184 and the attached first section 182 and second section 174 as shown in FIGS. 12-14 by attaching the outer peripheral strip section 161 to the layered swatches using stitches 181 . For example, the outer peripheral strip section 161 is stitched (sewn) to the layered first and second swatches. The stitching 181 is positioned close to but not in contact with the interlining 130 and therefore, the interlining is not directly stitched to the parts of the swatches 170 , 180 . This space that is left between the interlining 130 and the stitching ensure that the interlining 130 is not sewn and therefore, the entire layered structure of FIG. 14 can be everted (flipped over) as discussed below. [0066] The eversion of the necktie 200 completes the fabrication process as described above. [0067] FIG. 2A shows the first side 210 of the necktie 200 and FIG. 2B shows the second side 220 . [0068] It will be appreciated that the necktie 200 offers a much different appearance and provides a much different fashion statement in that when the necktie 200 is tied in a typical four in hand knot, the outermost tie section with the wider pointed end has a first appearance on the surface facing outward which is visible to people and the underling tail portion of the necktie that is narrow and includes the narrower pointed end has a second appearance on its surface that faces outward and is visible to people. Thus, two different patterns will be visible when the underlying tail portion becomes misplaced from the outermost tie section. Depending upon the contrast and the differences in the patterns and colors, etc., the two different sections can either be in slight contrast or in significant contrast with one another. For example, the overlying portion can be a bright green pattern and the underlying portion can be a yellow pattern. Similarly, the patterns themselves can be much different and provide contrast with one another. [0069] It will be appreciated by persons skilled in the art that the present invention is not limited to the embodiments described thus far with reference to the accompanying drawings; rather the present invention is limited only by the following claims.

1a

FIELD OF THE INVENTION [0001] The present invention regards compositions for prevention and/or treatment of renal disorders in mammals. More specifically, the present invention concerns the use of compositions for prevention and/or treatment of renal disorders comprising natural and non-natural amino acids preferably in an elderly subject. BACKGROUND [0002] Although human kidneys age better than other fundamental organs, such as the heart and brain, their decline in structure and function increases the susceptibility of healthy subjects as well as those with chronic disease to drugs and electrolyte abnormalities during stressful conditions. Chronic kidney diseases (CKD) and their progression to end-stage renal disease (ESRD) are considerable social and economic problems in all industrialized countries. [0003] Each year in Italy, more than 18,000 patients are diagnosed as having CKD, and about a half million Italians have serum creatinine levels higher than 1.5 mg/dL. The incidence of CKD is strictly linked to age. A French epidemiological study indicated that the CKD incidence in patients over 75 years was almost 7 times that in patients aged 20-39 years and more the twice that in patients aged 40-59 years. Therefore, interventions that may prevent the development of CKD in middle age and the progression of CKD to ESRD are very important for public health. [0004] Restricting protein in the diet of pregnant mice results in reduced numbers of nephrons in newborn animals greater than 30%. Low (LPD) or very low (VLPD) protein diets have been widely used, first for treating uremia and then to prevent the progression of CKD, but recently, a meta-analysis of existing data concluded that there is no evidence that LPD or VLPD diets have any effect in reducing the progression of kidney disease in diabetic nephropathy, and very often some degree of dangerous protein malnutrition occurs in these patients. SUMMARY OF THE INVENTION [0005] The present invention has the aim of providing new compositions for a prophylactic and therapeutic treatment, preferably but not exclusively intended for elderly subjects, of renal disorders. [0006] According to the invention, the above object is achieved thanks to the subject matter recalled specifically in the ensuing claims, which are understood as forming an integral part of this disclosure. [0007] In an embodiment, the composition described herein is particularly useful in the prophylactic and therapeutic treatment of renal disorders, and comprises a mixture of amino acids in free form suitable for use over a long period of time. [0008] The inventor found, in fact, that the combination of some free amino acids is surprisingly efficient at preventing and/or treating renal diseases, like for example chronic kidney disease or renal failure in mammals. In a preferred application, such mixture improves renal filtration, particularly in elderly subjects. [0009] Therefore, the present invention regards compositions based on amino acids for preventing and/or treating renal diseases in mammals having—as main active ingredients—the branched chain amino acid leucine in combination with at least one of, and preferably both, the branched chain amino acids isoleucine and valine. In a particular embodiment, the present invention concerns compositions comprising—as main active ingredients—the branched chain amino acids leucine, isoleucine and valine in combination with at least one of, and preferably both, threonine and lysine. [0010] An advantage linked to the use of the compositions described herein lies in the high tolerability of the composition, which can be administered chronically. In a preferred embodiment, the administration may occur over a period of time sufficiently long to allow at least partial recovery of renal function. [0011] A substantial advantage of the compositions subject of the invention is represented by the simple use of the same for the treated patients. The compositions are preferably produced, with or without excipients, according to known production, in formulations suitable for oral administration. In a preferred embodiment, the compositions described herein have a pH in aqueous solution comprised between 6.5 and 8.5, with or without excipients suitable for preparing tablets, capsules, powders, etcetera, through which a pharmacological performance suitable for oral administration is intended to be obtained. Also amino acids compositions produced, still according to per se known production techniques, for other types of administration shall be deemed comprised in the scope of the invention. [0012] An advantage linked to the use of the composition described herein lies in the fact that the use of amino acids in free form allows producing such compositions at a comparatively extremely low cost with respect to proteins and growth factors synthesis, through per se known production processes and widely used in the field of preparing compositions based on free amino acids. The field of application of the invention may however also be extended to amino acids obtained through genetic engineering or any other artificial method. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The invention will now be described, by way of example only, with reference to the enclosed figures of drawing, wherein: [0014] FIG. 1 . A) Density of glomeruli (Nglo/mm 2 ) and B) ratio between glomerular area and total area (Aglo/Atot) in the 3 experimental groups. *P<0.05 versus young; ° P<0.05 versus M-aged, Student-Newman-Keuls test. [0015] FIG. 2 . VEGF immunohistochemistry (counterstained with hematoxylin). The M-aged animals expressed much less VEGF than young animals. After EAA supplementation, the VEGF immunostaining increased inside the glomerulus and inside the cells of Bowman's capsule. Scale bar, 100 μm. [0016] FIG. 3 . eNOS immunohistochemistry (counterstained with hematoxylin). Young animals strongly expressed eNOS inside the tubular cells, whereas the expression decreased strongly in the M-aged animals. EAA supplementation restored the immunostaining in the tubular compartment to a level similar to that in the young group. Immunostaining was absent or very faint inside the glomeruli. Scale bar, 100 μm. [0017] FIG. 4 . iNOS immunohistochemistry (counterstained with hematoxylin). Young and EAA-fed M-aged animals showed intense iNOS expression only in some cells of distal tubules (star). The M-aged animals fed a standard diet showed intense immunostaining inside glomeruli and in the tubular compartment. Scale bar, 100 μm. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0018] In the following description, numerous specific details are given to provide a thorough understanding of embodiments. The embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the embodiments. [0019] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. [0020] The headings provided herein are for convenience only and do not interpret the scope or meaning of the embodiments. [0021] The compositions according to the invention (in the following referred as AA-compositions) comprise—as main active ingredients—the branched amino acid leucine in combination with at least one of, and preferably both, the branched amino acids isoleucine and valine. The preferred molar ratios of isoleucine and valine, with respect to one mole of leucine, are as follows: isoleucine: from 0.2 to 0.7, preferably from 0.4 to 0.6; valine: from 0.2 to 0.8, preferably from 0.4 to 0.7. [0024] The inventor ascertained that the activity of the mixtures grew after adding at least one of, and preferably both, the amino acids threonine and lysine to the branched chain amino acids. More in detail, the preferred molar ratios of these amino acids, with respect to one mole of leucine, are as follows: threonine: from 0.15 to 0.50, preferably from 0.2 to 0.45; lysine: from 0.15 to 0.60, preferably from 0.3 to 0.55. [0027] In particular, currently, the studies carried out by the inventor have demonstrated that the more efficient compositions are those in which, considering the sum of leucine, isoleucine and valine equal to 1, in the abovementioned stoichiometric ratio, then the sum of threonine and lysine is comprised between 0.10 and 0.50 (i.e. 1:0.10-0.50), still according to the molar weight, preferably between 0.25 and 0.45 (i.e. 1:0.25-0.45). [0028] Studies carried out by the inventor have further shown that such compositions are more active in presence of further one or more essential amino acids selected from histidine, phenylalanine, methionine and tryptophan. Considering the sum of leucine, isoleucine, valine, threonine and lysine equan1 to 1, then the overall amount of the further essential amino acids may vary between 0.02 to 0.25 (i.e. 1:0.02-0.25), preferably from 0.05 to 0.15 (i.e. 1:0.05-0.15), still intended as the molar ratio. [0029] The sum of the amount of threonine and lysine, still on the basis of the molecular weight, is preferably lower with respect to the sum of the single amounts of branched amino acids used, but greater with respect to the sum of the amount of the further essential amino acids used in the mixture. Furthermore, still preferably and on a molecular weight basis: the amount of lysine is lower with respect to single amounts of the branched amino acids, but greater with respect to the single amounts of each of the further essential amino acids used in the mixtures (and hence even greater than the sum of the single amounts of such further essential amino acids, not considering threonine thereamong); the amount of threonine is lower with respect to the single amounts of lysine and of the branched amino acids, but greater with respect to the single amounts of the further essential amino acids used in the mixtures, and much more preferably greater than the sum of the single amounts of the further essential amino acids. [0032] In case methionine is used, the activity of the mixtures may be further enhanced by also providing for the insertion of the non-essential amino acid cystine (and/or cysteine) into the composition, in an amount of moles at least equivalent to that of methionine, and preferably comprised between 150 and 350% of methionine. [0033] Alongside the abovementioned amino acids the AA-compositions described herein may also comprise the non-essential amino acid tyrosine, whose ideal amount shall be comprised between 15 and 50%, preferably between 20 and 35%, of the amount of phenylalanine in moles. [0034] Though the AA-compositions may possibly comprise other amino acids with respect to the ones described above, the overall amount of said other amino acids shall not exceed 20% of the total of the active ingredients, and/or not exceed 10% per each single said other amino acid (still in molar weight). Furthermore, in particular, when preparing the AA-compositions according to the invention, the amino acids serine, proline, glycine, alanine, glutamic acid and, above all, arginine, are preferably avoided, given that they can be counterproductive or even harmful in some concentrations or stoichiometric ratios with the said formulation. [0035] The amino acids used in the experimentation that led to the identification of the indicated ratios are those of the levogyrous type, corresponding to those present in nature and which are thus to be considered the preferred active form. However, the inventor ascertained that also the racemic form may perform the same activity, though in a lower manner proportional to the d-form percentage. Also the active derivatives of the indicated amino acids, in particular the salts thereof, shall obviously be deemed falling within the scope of the present invention. [0036] Further specifications, in terms of amounts and ratios among the various amino acids provided for by the compositions for prevention and/or treatment of renal diseases are contained in the attached claims, which form an integral part of the technical teaching provided herein in relation to the invention. [0037] Though expressed on the basis of molecular weight (i.e. in moles), the ratios indicated are applicable, in general terms, also in case of calculation according to the weight in grams of the various amino acids indicated (however bearing in mind that the amount of lysine, expressed in grams, may then be greater with respect to the single amounts of isoleucine and valine). [0038] In the aged kidney, progressive glomerulosclerosis, and reduced glomerular filtration rate, all occur concomitantly with the loss of functioning nephrons, so that elderly kidneys are more susceptible to failure when other insults are superimposed. [0039] The main findings of the instant description in the kidney after prolonged AA-composition intake in M-aged animals were 1) very scarce fibrosis limited to the interstitium and glomeruli; 2) increases in glomerular perfusion markers such as eNOS and VEGF and 3) recovery and/or maintenance of renal function also in elderly subjects. [0040] To better understand the renal effects of dietary AA-composition intake in middle-aged rats the present inventor assessed changes in the glomerular, and tubular compartments with a combined morphological/morphometric, histochemical, and immunohistochemical approach. [0041] The present inventor demonstrated in the instant description that in M-aged rats chronic AA-composition supplementation prevents the onset of morphological changes during the early stages of senescence. In particular, by using high-resolution morphometry on semi-thin sections reduced glomerular tufts was detected in the M-aged group that were restored after AA-composition supplementation to the form in younger rats. [0042] In conclusion, the present data show that prolonged administration of a AA-composition have beneficial effects on kidney metabolism of M-aged rats, mainly retarding the typical alterations seen in senescence. AA-composition supplementation in the diet is a new strategy for maintaining a healthy renal status to prevent renal disorders and improve the quality of life. [0043] Materials and Methods [0044] Animals. [0045] The experimental protocol was approved and conducted in accordance with the Italian Ministry of Health and complied with the The National Animal Protection Guidelines . Seventeen male Wistar rats were used: 5 young (2-month-old) animals, and 12 middle-aged (M-aged; 18-month-old) animals. [0046] The animals were caged separately. M-aged animals were divided into 2 groups: control group (M-aged, n=6) and AA-composition treated group (M-aged+AA, n=6). The animals were placed in a quiet room with the temperature and humidity controlled. A 12/12-h light/dark cycle was maintained (lights on from 7 a.m. to 7 p.m.). The rats were fed a standard diet ad libitum (18.8% protein content; Dottori Piccioni, Gessate, Milan, Italy) with water ad libitum (control M-aged and young groups) or a diet supplemented with AA-composition in the form of a solution (M-aged+AA group) that provided 1.5 g/kg per day of AA-compositions in the drinking water for 90 days. The concentration of the AA-composition in the drinking water was adjusted to the average daily water consumption of the rats (about 25 mL) and mimicked the recommended daily dose for humans (1). The composition of AA-composition used in the present experiments is shown in Table 1. The body weight and water or AA-composition consumption of each animal were monitored daily. [0047] At the end of the treatments, the animals were killed under deep ether anesthesia. The kidneys were quickly removed and placed in an ice-cold saline solution. The samples used for histochemical analysis were carefully mounted in Tissue-tek® OCT (Sakura Finetek Europe, the Netherlands) embedding medium before they were frozen in liquid nitrogen and stored at −80° C. [0048] AA-Composition. [0049] The composition of AA-composition used in the present experiments is shown in Table 1. [0000] TABLE 1 Molecular % on Amino acid weight* g/100 g % on Tot. group L-Leucine 131.17 31.2500 31.25% 50.00% L-Isoleucine 131.17 15.6250 15.63% 25.00% L-Valine 117.15 15.6250 15.63% 25.00% Branched group 62.5000 62.50% 100.00% L-Lysine 146.19 16.2500 16.25% 65.00% L-Threonine 119.12 8.7500 8.75% 35.00% Lysine + threonine group 25.0000 25.00% 100.00% L-Histidine 155.16 3.7500 3.75% 46.88% L-Phenylalanine 165.19 2.5000 2.50% 31.25% L-Methionine 149.21 1.2500 1.25% 15.63% L-Tryptophan 204.23 0.5000 0.50% 6.25% Further essentials group 8.0000 8.00% 100.00% L-Tyrosine 181.19 0.7500 0.75% L-Cystine 240.30 3.7500 3.75% Total composition 100.0000 100.00% *from “Amino Acid, Nucleic Acids & Related Compounds - Specification/General Tests”, 8 th Edition, Kyowa Haklco Kogyo Co., Ltd. [0050] In the following table, the amounts of AA-composition in grams according to Table 1 are expressed according to the molecular weight, i.e. in moles. [0000] TABLE 2 Molecular Amino acid weight Mol % on Tot. % on group L-Leucine 131.17 0.23824 31.97% 48.55% L-Isoleucine 131.17 0.11912 15.98% 24.27% L-Valine 117.15 0.13338 17.90% 27.18% Branched group 0.49074 65.85% 100.00% L-Lysine 146.19 0.11116 14.92% 60.21% L-Threonine 119.12 0.07346 9.86% 39.79% Lysine + threonine group 0.18461 24.77% 100.00% L-Histidine 155.16 0.02417 3.24% 48.21% L-Phenylalanine 165.19 0.01513 2.03% 30.19% L-Methionine 149.21 0.00838 1.12% 16.71% L-Tryptophan 204.23 0.00245 0.33% 4.88% Further essentials group 0.05013 6.73% 100.00% L-Tyrosine 181.19 0.00414 0.56% L-Cystine 240.30 0.01561 2.09% Total composition 0.74522 100.00% [0051] As observable from Table 1, the weight ratios between leucine, isoleucine and valine are preferably equivalent to 2:1:1. Table 1 and Table 2 also show that the single amounts (weight in grams or moles) of histidine, phenylalanine, methionine and tryptophan are preferably decreasing (i.e. the amount of histidine is greater than phenylalanine, which is greater than methionine, which is greater than tryptophan) and the amount (weight in grams or moles) of cystine (and/or cysteine) is preferably greater than tyrosine. [0052] Renal Function-BUN Test. [0053] The present inventor performed a study—during a period of 20 months—directed to assess the renal function as blood urea nitrogen (BUN) by the Reflotron test (Roche Diagnostics, Indianapolis). Blood samples of control rats (control group) and rats supplemented with AA-composition (AA-treated group) for BUN determination were collected at different time intervals after cisplatin injection. BUN levels exceeding 30 mg/dl were considered abnormal. [0054] Rats were from Charles River, Italy and the treatment was performed in accordance with the international guidelines. Male rats of 4 months were caged separately and divided in 2 groups (control and AA-composition treated group) of 40 animals each. [0055] The rats were fed a standard diet ad libitum (18.8% protein content; Dottori Piccioni, Gessate, Milan, Italy) with water ad libitum (control group) or a diet supplemented with AA-composition in the form of a solution (AA-treated group) that provided 1 g/kg/day of AA-composition in the drinking water for 20 months. The composition of AA-composition used in the present experiment is shown in Table 1. The body weight and water or AA-composition consumption of each animal were monitored daily. [0056] Transmission Electron Microscopy. [0057] One kidney from each animal were removed, fixed with 3% glutaraldehyde in PBS (pH 7.4, 0.1M), and postfixed for 1 hour with 1% OsO 4 in the same buffer. The samples were processed with standard procedures for embedding in Araldite (Sigma Chemical Co, Milan, Italy). Thick sections (about 1 μm) were stained with toluidine blue. Ultrathin sections (70 nm) were stained with a saturated aqueous solution of uranyl acetate and lead citrate and examined with a Philips CM10 electron microscope. [0058] Morphometry. [0059] All measurements were obtained using standard morphometric techniques, as previously described (2, 3). The number of glomeruli (Nglo), the mean area of glomeruli (Aglo), the mean area of the renal corpuscle (Acor), and total area of the renal parenchyma (Atot) were evaluated on thick plastic sections stained with toluidine blue. From glomerular data the ratio between Aglo and Atot (Aglo/Atot) and the number of glomeruli per unit area, also called the glomerular density (Nglo/mm 2 ) were calculated. [0060] Histochemistry [0061] Sirius Red. [0062] Collagen deposition and fibrosis were evaluated by a Sirius Red staining method using a modified picrosirius procedure as previously described (4). Briefly, the sections were deparaffinized, rehydrated in distilled water, and immersed in 1% phosphomolybdic acid (Sigma-Aldrich, St. Louis, Mo., USA) for 5 min and then covered with 0.1% (w/v) Sirius Red F3B (C.I.35780 Science Lab, Huston, Tex., USA) in saturated picric acid solution for 1 h at room temperature. The sections were then washed in water and rapidly dehydrated, cleared in xylene, and mounted. All sections stained with Sirius Red were analyzed using a light microscope (Olympus BX50, Tokyo, Japan) under normal light and polarized light obtained with a polarizer filter (Olympus U-ANT, Tokyo, Japan) in order to analyze the initial collagen organization and the fibrosis, respectively. Under these conditions, collagen fibres of different thickness are coloured differently. Whereas the birefringent (anisotropic) colour is more a measure of collagen fibre size than of collagen type, usually the thicker and denser type I collagen fibres are detected as orange to red, whereas the thinner type III collagen fibres appear yellow to green (5, 6). [0063] Immunohistochemistry. Sections were incubated overnight with primary anti-iNOS (NOS2-N20-sc651), anti-eNOS (NOS3-C20-sc654), or anti-VEGF (C-1-sc7269) polyclonal antibodies from Santa Cruz Biotechnology Inc. (Santa Cruz, Calif., USA) diluted 1:100 with PBS. The sections were processed in accordance with the manufacturers' protocols, visualized with a rabbit ABC-peroxidase staining system kit (Santa Cruz Biotechnology), and mounted with DPX. The reaction product was visualized using 0.3% H 2 O 2 and DAB at room temperature. The immunohistochemistry control was performed by omitting the primary antibody in the presence of isotype-matched IgGs. To exclude incorrect interpretation of the immunostaining due to the presence of endogenous biotin (7), the present inventor also carried out experiments using the peroxidase-anti-peroxidase detection system, but obtained similar results. Each set of experiments was done in triplicate, with each replicate always carried out under the same experimental conditions. [0064] The staining intensity on both histochemical and immunohistochemical slides was evaluated using an optical Olympus BX50 microscope equipped with an image analysis program (Image Pro Plus, Immagini e Computer, Milano, Italy) and analyzed quantitatively. The integrated optical density (IOD) was calculated for arbitrary areas, by measuring 10 fields for each sample using a 40× objective. Data were pooled to obtain a mean value, and a statistical analysis was applied to compare the results obtained from different experimental groups. [0065] Statistics. [0066] Morphometric data are expressed as mean±SD unless otherwise stated. The statistical significance of the differences between means was assessed with one-way ANOVA followed by the Student-Newman-Keuls test or with a Student t-test. A probability of less than 5% (P<0.05) was considered significant. [0067] Results [0068] To test the effect of AA-composition on renal health, the diet of M-aged rats was supplemented with AA-composition dissolved in drinking water. Young and M-aged rats fed a standard diet were used as controls. At the end of the treatments, the young animals were 5 months old and the M-aged animals were 21 months. Body weight, kidney weight, and mean daily consumption of water and AA-composition in form of solution are summarized in Table 3. No significant differences in body or kidney weight between M-aged and M-aged+AA animals were observed (Table 3). The water and AA-composition intake did not differ between groups. [0000] TABLE 3 Body weights Kidney weights liquid consumption a (g) (g) (ml/day) Young (n = 5) 416 ± 12 b 3.4 ± 0.2 21.48 ± 3.6 M-aged (n = 6) 553 ± 27* 4.1 ± 0.1* 25.31 ± 4.1 M-aged + AA 577 ± 15* 4.2 ± 0.3* 23.02 ± 6.8 (n = 6) F value F = 104.86 F = 8.66 F = 2.57 a Young and M-aged rats consumed water, M-aged + AA consumed AA-composition dissolved in water. b Values are given as mean ± SD. *P < 0.05 versus young animals, Student-Newman-Keuls test. [0069] Morphometry [0070] Glomeruli. [0071] The present inventor did not observe any significant differences of glomerular number (Nglo/mm 2 ) among groups. However, M-aged rats had significantly smaller glomeruli (Aglo), reflected in a reduction in Aglo/Atot of about 40% relative to young rats. Animals in the M-aged+AA group were not statistically different from young animals on these measures ( FIG. 1 ). [0072] Histology and Histochemistry [0073] Sirius Red staining. The M-aged animals occasionally showed signs of interstitial fibrosis and glomerulosclerosis of moderate intensity. In contrast, the M-aged animals supplemented with AA-composition of table 1 did not show these morphological signs of incipient senescence. [0074] Immunohistochemistry [0075] Immunohistochemical staining for various markers in the three experimental groups were performed. The values are summarized in table 4, wherein integrated optical density values (±SD) in the three experimental groups are reported. [0000] TABLE 4 Young M-aged M-aged + AA n = 5 n = 6 n = 6 F value VEGF 14 ± 2    4 ± 0.6* 11 ± 1.4°* 124.2 eNOS 53 ± 4.1 20 ± 2.3* 45 ± 3.7°* 55.99 iNOS  5 ± 1.1 13 ± 1.8* 6 ± 0.8° 38.52 *P < 0.05 versus young; °P < 0.05 versus M-aged, Student-Newman-Keuls. [0076] Vascular Marker (VEGF) [0077] M-aged animals showed significantly lower VEGF expression relative to young animals. In particular, the glomerular endothelia and Bowman's capsule cells of M-aged animals did not show VEGF expression. In contrast, the animals supplemented with AA-composition of table 1 showed intense VEGF expression mainly in glomeruli and to a lesser extent inside the Bowman's capsule cells ( FIG. 2 ). [0078] Nitrosactive Markers [0079] Endothelial nitric oxide synthase (eNOS). Inside the tubular cells of young animals, eNOS expression was very strong. In the M-aged animals, eNOS expression decreased, whereas AA-composition supplementation restored the intense immunostaining in the tubular compartment to levels similar to those in the young group. No or very faint immunostaining was seen inside the glomeruli in all experimental groups ( FIG. 3 ). [0080] Inducible Nitric Oxide Synthase (iNOS). [0081] Young animals showed intense iNOS expression only in some cells of the distal tubules, whereas animals in the M-aged group showed increased expression in glomeruli and in the distal and proximal tubules. M-aged animals supplemented with AA-composition showed intense iNOS expression restricted to cells of the distal tubules and, as in young rats, no expression was seen inside the glomeruli or in other tubular cells ( FIG. 4 ). [0082] BUN Test [0083] The present inventor observed a decrease of renal function of the control group during the 20 month period of treatment (t 0 to t 4 ), i.e. an increase of BUN, while the AA-treated group surprisingly maintained renal function within the limits (BUN<30 mg/dl). The data (expressed an mean±SD) are reported in table 5. At the end of the treatments, the animals were 24 months-old. [0000] TABLE 5 Months of treatment Parameters t 0 = 0 t 1 = 6 t 2 = 10 t 3 = 14 t 4 = 20 Control Body weight (g) 24 ± 0.6 32 ± 2.1 37 ± 2.7 44 ± 3.1 46 ± 3.2 BUN (mg/dl) 23 ± 0.5 28 ± 0.8 32 ± 1.1 35 ± 1.3 39 ± 1.2 AA- Body weight (g) 24 ± 0.7 31 ± 2.2 37 ± 2.5 43 ± 3.3 46 ± 3.4 BUN (mg/dl) 24 ± 0.4 25 ± 0.5  27 ± 0.7*  29 ± 0.9**  31 ± 1.1** *p < 0.05 **p < 0.01± REFERENCES [0000] 1. Pellegrino M A, et al., Effects of voluntary wheel running and amino acid supplementation on skeletal muscle of mice. Eur J Physiol 2005; 93: 655-64. 2. Weibel E and Elias H. Quantitative methods in morphology. Berlin-Heidelberg, New York,: Springer-Verlag, 1987. 3. Corsetti G, et al., Ultrastructural study of the alterations in spinal ganglion cells of rats chronically fed on ethanol. Ultrastructural Pathology 1998; 22: 309-19. 4. Dayan D, et al., Are the polarization colors of picrosirius red-stained collagen determined only by the diameter of the fibers? Histochemistry 1989; 93: 27-9. 5. Vranes D, et al., Cellular mechanisms of diabetic vascular hypertrophy. Microvasc Res 1999; 57: 8-18. 6. Koren R, et al. Capsular collagen staining of follicular thyroid neoplasm by picrosirius red: role in differential diagnosis. Acta Histochem 2001; 103:151-157. 7. Nayler S, et al., Biotin inclusions: a potential pitfall in immunohistochemistry. Histopathology 1998; 33: 87-94.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention is directed to an apparatus for the implementation of a physiologically controlled measurement at a living subject. [0003] 2. Description of the Prior Art [0004] In a number of examinations of living subjects, meaningful and diagnostically relevant measurements are possible only at specific points in time or during specific phases within a physiological cycle. In computer-tomographic examinations of internal organs that, for example, move in the rhythm of the heart beat or respiration, it can be easily understandable that only slice projections that were acquired during comparable phases of the organ movement can be meaningfully compiled to form a tomography image that is capable of being interpreted. Such measurements therefore are temporally controlled according to a suitably selected physiological signal. One or more relative points in time that are utilized for the time-control of the measurement are thereby defined on the basis of the physiological signal. [0005] Methods referred to as triggered methods are known for defining these relative points in time. In these methods, a trigger pulse in the physiological signal is employed as a reference time. The relative points in time are then defined in temporal reference to this trigger pulse. Their definition ensues, for example, by indicating a waiting time (delay time) after every trigger pulse and by defining the length of an actual measurement time window (scan acquisition window) that begins after the delay time has passed and within which the measured data are to be registered. The parameters of “delay time” and “scan acquisition window” are usually entered in numerical form as input by the user via a keyboard. The scan acquisition window is derived from a number of other parameters that the user can set, for instance on the basis of a number of sub-measurements that are to be implemented per scan acquisition window. The length of the scan acquisition window then is derived from a multiplication of this number of sub-measurements by the time duration (repetition time) that is to be expended for every sub-measurement and which can likewise may be potentially set. [0006] Further, there are methods referred to as gating methods. In these, a time window (gate) controlling the measurement is usually defined by amplitude thresholds of the physiological signal. When the physiological signal passes through such a threshold, then this is considered as a switch-on or switch-off time of the time window. Given a breathing-controlled measuring method, for example, a suitable percentage of the respiratory motion can be selected as threshold. [0007] A problem associated with physiologically controlled measurements is that the signal parameters of the physiological signal employed as reference are often not constant but instead can be subject to considerable fluctuations. In particular, the signal parameters, for instance the signal cycle or the maximum or the average signal amplitude, can change between one phase of the measurement preparation and the phase of the actual measurement implementation, due, for example, to an increase of the heartbeat or respiration rate. When suitable values for the aforementioned parameters of waiting time, length of the scan acquisition window, threshold height and the like have been set in the preparatory phase, these parameter values may no longer be suitable in the following implementation phase of the measurement, and lead to measurement results that have little diagnostic utility. SUMMARY OF THE INVENTION [0008] It is an object of the present invention to provide a simple arrangement for reliably monitoring whether the (at least one) relative point in time to be employed for the time control of the measurement is still suitable—as soon as it has been set and compared to the current curve of the physiological signal—in order to be able to meaningfully implement the measurement. [0009] This object is achieved in accordance with the invention in an apparatus for the implementation of a physiologically controlled measurement in a living subject, having a signal acquisition arrangement for acquiring a physiological signal of the subject, display for the graphic display of a time curve of the physiological signal, and a time-setting unit which sets at least one relative point in time that is referenced to the time curve of the physiological signal and that is to be employed for the control of the time sequence of the measurement. [0010] In accordance with the invention the display is configured for also graphically displaying the at least one relative point in time in its temporal relationship to the physiological signal. [0011] Due to the simultaneous, graphic display of the at least one relative point in time, the invention makes it possible for the user to continuously visually check whether the respective relative point in time has been suitably set or must be adapted, by comparing the displayed relative point in time to the displayed, current signal curve of the physiological signal. This is possible at first glance because the relative point in time is displayed in temporal relationship to the physiological signal, i.e. based on the same time scale. A mere numerical value for the relative point in time is thus not merely mixed in the displayed information on the screen; rather, the time position of the relative point in time relative to the physiological signal is shown. [0012] In a preferred embodiment of the invention, at least two different relative points in time can be set with the time-setting arrangement, with the display being configured for graphically displaying a time window lying between two relative points in time in temporal relationship to the physiological signal. Further, the display can be configured for graphically displaying a time window lying between a relative point in time and a reference point in time of the physiological signal in its temporal relationship to the physiological signal. The time windows can be especially easily visually recognized in an embodiment wherein they are displayed in the form of a time bar. In the case of a number of simultaneously displayed time windows, for example, different colors for the time bars can be employed. [0013] It can be desirable in some instances for the display to display the physiological signal and the at least one relative point in time with a stationary time axis. In other instances, however, it is also desirable that the display to display the physiological signal and the at least one relative point in time with a moving time axis. DESCRIPTION OF THE DRAWINGS [0014] [0014]FIG. 1 is a schematic block diagram of the measurement arrangement according to the invention. [0015] [0015]FIG. 2 shows an example of a graphic display on a picture screen of the measurement instrument during a measurement preparation phase in accordance with the invention. [0016] [0016]FIG. 3 shows an example of a graphic display on the picture screen during a measurement implementation phase in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0017] In FIG. 1, the body of the human or animal to be examined is referenced 10 . A detector arrangement 12 registers a physiological signal of the body 10 and conducts this to an electronic measurement control unit 14 . For example, the detector arrangement 12 can register the electrical heart currents as employed for an electrocardiogram (ECG) as the physiological signal. Alternative possibilities are the respiratory motions of the body, pulse, diaphragm movements, etc. The measurement control unit 14 employs the physiological signal for the time control of tomographic or other arbitrary measurements that are implemented at the body 10 with a measurement arrangement 16 . The measurement arrangement 16 can, for example, be a magnetic resonance tomography apparatus or an x-ray computed tomography apparatus. When such tomographic examinations are undertaken at cyclically (though not necessarily regularly) moving internal organs such as, for example, the heart or lung, then tomographic images that are diagnostically relevant are obtained only when the number of individual measurements that are needed for the reconstruction of the tomographic image are implemented during corresponding cycle phases, i.e., for example, during phases when the heart is at rest. For this reason, the measurement control unit 14 controls the measurement arrangement 16 such that its measuring activities occur only during a specific measurement time window within the cycle of the detected physiological signal. [0018] This measurement time window is not defined by the measurement control unit 14 itself. On the contrary, the user defines the length and relative position of the measurement time window (i.e., starting and ending time) within the signal cycle by the user entering values for one or more parameters via a keyboard 18 connected to the measurement control unit 14 . For example, these parameters can be: one or more amplitude thresholds of the physiological signal (in gating methods) or a waiting time until the beginning of the measurement time window after a pulse spike of the physiological signal employed as a trigger, the number of individual measurements to be implemented during the measurement time window and the measurement time to be made available per individual measurement (given trigger methods). [0019] The user can then graphically view the measurement time window defined by entering the parameter values on a picture screen of a display 20 driven by the measurement control unit 14 . The physiological signal as well as the measurement time window are mixed in the image on the display 20 , the latter in such a way that its time position and extent relative to the physiological signal can be immediately seen. Preferably, the measurement time window is represented by a bar or a line that extends in the same time scale as the physiological signal along the latter. If the user is not satisfied with the position and size of the measurement time window, the user can correct the parameter values until the measurement time window that has been set is the one desired. [0020] [0020]FIG. 2 shows an example graphics on the display 20 in the case of an ECG-triggered measurement. An ECG signal 22 thereby serves as physiological reference signal. This is displayed on the display 20 along a horizontal time axis 24 . In addition to the ECG signal 22 , an arrangement of, preferably, differently colored horizontal bars 26 , 28 , 30 is also displayed on the display 20 . The middle bar 28 thereof represents the measurement time window that has been set for the implementation of the measurement, the left bar 26 represents a time delay after a R-spike 32 of the ECG signal employed as trigger pulse, and the right bar 30 denotes a remaining time. This remaining time is derived from the difference between a maximum time duration (user acquisition window) that is available overall and is prescribed by the user as additional parameter and the sum of time delay and measurement time window. [0021] In a phase preparatory to a measurement, the displayed physiological signal curve 22 is cyclically updated, for example after every trigger pulse or respectively following a predetermined time duration, for instance respectively every three seconds. At each updating, the curve 22 is re-plotted, whereby the point in time of the trigger pulse 32 (the middle spike of the QRS complex in the ECG signal) remains standing at a fixed point in the display window of the picture screen 20 . Given gating methods that, for example, employ a respiratory signal as physiological reference signal, the reaching of a threshold can be accepted as fixed point. The stationary but repeatedly updated image of the physiological signal thus arises on the display 20 given a stationary time axis 24 . As a result of the surveyable, additional mixing-in of the bars 26 , 28 , 30 , with reference to which the user can recognize the current setting of the measurement parameters, it is especially easy for the user to find the most suitable values for these parameters. [0022] In the exemplary graphic of FIG. 2, arrows 34 indicate two successive R-spikes in the ECG signal 22 that are employed as trigger pulses; a cross 36 references a recognized extra systole. Two vertical lines 38 —the left line thereof lying at the time location of the trigger pulse 32 employed as fixed point for the graphic display—indicate the average interval between two successive R-spikes of the ECG signal 22 . A region between the left line 38 and a broken line 40 represents an overall time window (“system acquisition window”) recommended to the user on the basis of a long-term statistics and within which the measurement events should occur. This system acquisition window is derived from the average R-R interval reduced by twice standard deviation. The latter corresponds to the region between the line 40 and the right line 38 . For better visualization, the system acquisition window and the region of twice the standard deviation can have differently colored backgrounds. [0023] The signal curve 22 with the bars 26 , 28 , 30 is displayed on the picture screen of the display 20 not only during preparation for the measurement but also during the implementation of the actual measurement. Separate display windows for the preparation for the measurement and the measurement implementation can thereby be established on the display 20 in order to already begin preparing a subsequent measurement simultaneously with the implementation of a measurement. FIG. 3 shows an example of a graphic display on the display 20 for the measurement implementation. Corresponding elements are thereby referenced with the same reference characters as in FIG. 2. During the measurement implementation, the signal curve 22 is preferably plotted in continuous form, i.e. is pushed through the display window (along an arrow 42 from right to left here) with a moving time axis 24 as close as possible to real time. Simultaneously, the bars 26 , 28 , 30 also are plotted in terms of their relative position and extent with reference to the signal curve 22 and are likewise moved through the display window. The user can thus very easily recognize whether the setting of the parameters implemented in the phase of preparing for the measurement is suitable or, for example, requires adaptation due to a faster heart beat. [0024] The next trigger pulse in the form of the R-spike 32 of the ECG signal 22 may already (unexpectedly) occur before the expiration of the measurement time window that has been set (correspondingly before the end of the bar 28 ). This is illustrated in the right half of FIG. 3. This case can be visualized for the user by a bar 44 , that extends up to the end of the user acquisition window set by the user, being mixed in beginning with the point in time of the interruption. A signal color, for example red, may be specifically reserved for this purpose. The user can thus immediately recognize when the heart rhythm or, in general, the rhythm of the physiological signal, increases so greatly that the measurement should be interrupted and should only be restarted after modified parameter values have been set. [0025] Numerical values for those points in time that mark the starting or ending points in time of the bars, also can be displayed on the picture screen 20 in addition to the bars 26 , 28 , 30 . [0026] Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

1a

FIELD OF THE INVENTION This present invention concerns a device obtain lengthening of the limbs and/or other parts of the body of a puppet, such as for example a doll including in a semiautomatic form, as reaction determined by a specific electronic device, on use of the toy. STATE OF THE ART It is well-known that in the field of toys there is continuous research to create objects that stimulate children's imagination and make their toys more interesting and involving. In the doll field, for example, a great many models have been created that imitate the sounds and movements of the newborn, of infants and adults in such a way that the child who plays with them can easily immerse itself in the role of the mother, of the newborn or of the adult, but until now no one has been able to produce a device that would allow a doll or other puppet to vary the length of the limbs and/or other parts of the body in such a way as to simulate growth by simple and therefore durable and cheap means. The solution has been sought, but the mechanisms created have been complex and costly, using pneumatic systems that inflate an outer covering, or mechanical systems with gears, or others such as those described in the patents listed below. In U.S. Pat. No. 4,622,021 of 1986 there is described a rod connected to a thread which is pulled from the outside and gives the sensation of lengthening. In U.S. Pat. No. 5,125,865 of 1992 there is described a mechanism which, creating a depression on the mouth, with manual action, simulates chewing and thus the doll grows thanks to the external manual action. In U.S. Pat. No. 4,828,528 of 1981 there are described cloths sewn in the form of bellows which inflate one by one when a thread is pulled, giving the sensation of growth In U.S. Pat. No. 4,246,722 of 1981 there are described internal gears by means of which a post to which the head of the doll is fixed is operated. The necessary energy is supplied manually operating a spring-loaded system from the outside. It is thus evident from what has been briefly described that the devices described do not solve brilliantly the requirement to make the limbs of a doll or similar grow. FUNDAMENTALS OF THE INVENTION The object of this present invention is a device by means of which simulation of the lengthening of shortening of, for example, a limb is achieved by creating a telescopic structure, sliding of which to create lengthening of shortening is controlled by threads that are rolled or unrolled on a disc shaped like one or more side-by-side pulleys, thanks also to the action of a counteracting spring. The movement of the spools is controlled by a circuit that registers shaking and therefore playing with the toy according to the equation, more playing=more growth (that is, more shaking more growth). Growth of the toy determines a further phase of play that coincides with the need, for example, to change the doll's clothes, since its growth has made them too small. The device will be described in the attached drawings in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a view in longitudinal section of the device applied to a doll FIG. 2 shows a view in longitudinal section of the detail of an arm connected by an appropriate thread to a pulley FIG. 2.1 shows a view in longitudinal section of the detail of an arm connected to a disk with cam FIG. 3 shows a view in longitudinal front section of the trunk FIG. 4 shows a front and side view of a 2-stage pulley to obtain two different degrees of lengthening with the same angular rotation FIG. 5 shows a front and side view of a 3-stage pulley to obtain three different degrees of lengthening with the same angular rotation, with a wedge also present on one face FIG. 6 shows a front and side view of a 4-stage pulley to obtain four different degrees of lengthening with the same angular rotation, with a wedge tangential to the pulley also present FIG. 7 is the side view of the doll where the left part of the Figure is sectioned close to one of the breast passage holes, and the details within are seen unsectioned. FIG. 7.1 shows a view from above of the external container. In other words, the doll's thorax, which is sectioned in such a way as to show what happens inside when the breast also grows. The rear part is on the left of the Figure and is sectioned near the electric motor, whereas the front part is on the right and sectioned near the breast passage holes. FIG. 8 is the view from above of the preceding Figure, where the left part of the Figure is sectioned close to the electric motor whereas the right part is sectioned near one of the breast passage holes and shows the extruded breast from the side. FIG. 8.1 shows a sectioned lateral view of the external container, in other words the thorax of the doll, which is sectioned in such a way as to show what happens internally when the breast grows, The rear part of the Figure is sectioned near the breast passage holes. FIG. 9 is the side view of the doll in which the left part of the Figure is sectioned near the electric motor and the right part near one of the breast passage holes and the details within are shown not sectioned. The motor and pulley are inclined in such a way that the axis of rotation is almost parallel to the mobile plate and to the posterior part of the body. DESCRIPTION OF THE INVENTION With reference to the said figures, the simulation for example of the growth of a limb is obtained with the particular ( 1 ) in thermoplastic in the form of a tube with a restriction of the internal section supporting a spring ( 2 ) at the part ( 1 . 1 ) and supporting the gluing to the remaining part of the limb at the part 1 . 2 , whereas at the other extremity 1 . 3 it is tapered to obtain an aesthetically correct coupling with the particular 3 , which represents the sliding part of the extensible arm, because, at extremity 3 . 1 , it allows the reaction with the spring 2 , which is compressed or released according to whether the cable 4 , connected in 3 . 2 , or fixed with a section of yielding metal cylinder 3 . 2 a , appropriately deformed by squashing, is extended or withdrawn. Extension or withdrawal of the cable 4 takes place by action of the pulley 5 , with a fixing hole 5 . 1 for the cable 4 , governed by the motor 6 , controlled by an electronic circuit 7 powered by an accumulator 8 . The particular 3 has a joint 3 . 3 for connection by joint or gluing of the front part of the extensible organ 3 to the rest of the limb. According to this present invention as shown in FIG. 1, in a toy that requires elongation of the limbs or other parts of the body, for example a doll, there is an electronic control circuit ( 7 ) which recognises whether the user has used, touched or moved the toy. This requisite is important, because if the user relates to the toy, the growth that the toy's mechanisms make available becomes visible almost immediately. The electronic circuit 7 has, as said, a device for recording the number and frequency of the shakes the toy receives. These are the parameters utilised to give consent to growth. That happens because, in the presence of the events described, the electronic circuit 7 sends a command and the necessary energy, taken from the accumulator 8 , to the electric motor 6 —connected by the electric wires 6 . 1 —which starts up and drives the reducer 8 a , connected through pulley 5 and the cables 4 to the extremity of the extensible organ 3 , permitting the amount of extension provided for. The electric motor 6 , following consent from the electronic circuit 7 , rotates and draws with it the cams 5 . 1 a positioned on the disc 5 a or the pulley 5 of FIG. 2 which—see FIG. 2 . 1 —slackening the cable 4 . The spring 2 is no longer compressed and expands, moving the particular 3 , providing evidence of the lengthening of the limb. At that point the doll's clothes have become short and tight and the user has to change them, thus meeting a natural need which will be learned quickly and indelibly. The electronic circuit is calibrated in such a way that if, for example, the toy is not used for 100 hours, the limbs and other parts of the body shrink and retract to the original position of FIG. 1, showing an evident and apparent slovenly aspect, because the clothes have suddenly become too large and too long. FIG. 3 shows a preferential section of the bust in which it can be seen that the device of FIGS. 2 and 2 . 1 consists of an outer piece 9 and an inner piece 3 which are connected by slotting in to the lower and upper part of the bust respectively and keep the spring 2 compressed thanks to the action described above of the cable 4 . They represent a solution for lengthening and shortening the limbs and other parts of the toy's body. Again in FIG. 3, one sees an alternative solution for extension of the bust by which the lengthening and shortening of this part of the body is obtained by the spring 2 a , which is compressed between the upper and lower parts of the bust thanks to the reaction points 12 . 1 and 15 . 1 , when the lower part is connected directly to the pulley 5 . through the weakly elastic cable 4 a fixed to the support 12 . 2 . This is possible because the two sections of the bust slide over each other like the sections of a telescope, like the particulars indicated in FIGS. 2 and 2 . 1 , and also because the distance the thread moves to ensure the functioning is appropriately determined through idler pins and bearings to reduce friction and hence the size of the motor. In FIG. 3 we see the result achieved for the pelvis. In FIG. 1 the same extension elements of FIG. 2 —jointed or glued in the points 15 . 2 and 15 . 3 through the cable 4 connected to the pulley 5 —keep the spring 2 compressed or determine an extended position for it, managing to show the extension envisaged for the neck, too. FIG. 4 shows the reason why the legs connected with thread 4 lengthen more that the arms. As can be seen, the pulleys differ in their radius and pulley 20 has a greater radius than pulley 21 . For the same number of rotations, therefore, cable 4 is wrapped less around pulley 20 than it is around pulley 21 . When, for the reasons described, the electronics 8 give permission to slacken cable 4 , the pulley moves through an fixed angle, whereas the two cables travel different distances. FIG. 5 shows a pulley 5 formed of 3 pulleys 20 , 21 and 22 coupled in such a way as to create different extensions for the arms, legs and neck, or vice versa; as can be seen this pulley also presents the wedge 24 . FIG. 7.1 sketches the breast of a doll seen from the side in longitudinal section performed on the outer casing. The same view but from above appears in FIG. 7 . From both the Figures one notes that pulley 5 is fitted with wedge 24 . When it rotates in the release stage, the wedge pushes the mobile plate 25 which is held in the retracted position by the action of the spring 26 positioned around the pin 27 solid with the outer casing and held by the locking ring 28 . When the motor 8 has consent to release the cables 4 , these lengthen, because the pulley 5 rotates and in the presence of the wedge 24 it will act on the mobile plate 25 , which overcomes the reaction of the spring 26 , allowing the mobile plate 25 to run, guided by the pins 27 until the wedge 2 and the mobile plate 25 reach the position indicated in FIGS. 8 and 8 . 1 , where the breast 29 is shown, Connected to the mobile plate 25 it has emerged fully from the aperture 30 . FIG. 6 shows a wedge 24 placed radially on the outside of the pulley 5 , because in some cases the motor could work inclined 90° with its axis parallel to the mobile plate 25 as indicated in FIG. 9, and then, to push the mobile plate 25 , only the position of the wedge in relation to the pulley changes. It can be observed from FIG. 2 that when all the components have been mounted, the spring 2 is mounted, with the cable 4 running within it, and then the spring 2 is allowed to run within the piece 9 and then the pieces 9 and 3 are brought into position, connecting the cable to the pulley 5 at point 5 . 1 to make it wrap around the pulley. The operations described are repeated for the two arms, the two legs and the neck and the front halves of the bust are mounted. The accumulator and controlling electronics had been mounted earlier, so that the toy is then ready for use with few and simple operations.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 13/112,084, filed on Aug. 20, 2011, now U.S. Pat. No. x,xxx,xxx, which claims priority from U.S. Provisional Patent Application Ser. No. 61/346,976, filed May 21, 2010. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to the art of orthopedic cutting tools, and more particularly, to a disposable cutter used for shaping and preparing the femoral bone for implant insertion. [0004] 2. Prior Art [0005] Cutting tools used in orthopedic procedures are designed to cut bone and associated tissue matter. Specifically, cutters of the present invention are designed to cut and shape the end of a long bone such as a femur or humerus. Typically, the end of the long bone is cut and shaped for insertion of an implant. As such, these cutters are required to be sterile and sharp. Using a dull cutter generates heat that typically leads to tissue necrosis and results in undesireable patient outcomes. A non-sterile cutter blade typically results in an infected and damaged bone that may lead to other problems for the patient. [0006] Depicted in FIGS. 1 and 1A are images of a prior art bone cutter 10 designed to cut and shape the femoral head 12 of the femur 14 . As shown in the figures, the prior art cutter 10 is similar to that of a “hole saw” drill. These prior devices 10 generally comprise a hollow cylinder in which a series of cutting teeth slots 16 are formed within the cylinder wall thickness 18 . However, these prior devices 10 do not remove all the bone 14 required to properly fit an implant. Therefore, additional procedures are required to remove this extra bone material 22 and smooth the surface of the bone end 24 . [0007] As shown in FIG. 1A , the prior cutter device 10 imparts a channel 20 within the end 24 of the bone 14 . This channel 20 and associated bone material 22 proximate the channel 20 , must be removed to properly fit the implant (not shown) on the end 24 of the bone 14 . Typically, hand tools such as rongeurs are used to remove this extra bone material 22 . [0008] Such a bone removal procedure makes it difficult to properly fit an implant over the end 24 of the bone 14 . The extra bone material 22 must be intricately removed to produce a smooth surface and ensure that the bone 14 is shaped to meet the exacting dimensions of the implant. If the implant is not properly fit over the end 24 of the bone 14 , undesirable implant wear or improper implant operation could result. [0009] In addition to the inefficient bone removal limitations, traditional bone cutters are typically reused multiple times. That is because of their high cost. Such multiple reuses require that the cutter be cleaned and sterilized before each use. Furthermore, over time, as these cutters are used and reused, they become dull, thus requiring resharpening. Therefore the blades of the cutter are required to be resharpened, cleaned and sterilized. However, these resharpening and sterilization processes add additional costs and increase the possibility of infection. In addition, resharpening tends to deform the dimensions of the cutter. These dimensional changes could adversly impact the optimal fit and function of the implant. Furthermore, there is a high likelihood that the cleaning and sterilization process may not remove all possible infection agents such as bacteria, machining lubricants, and the like. [0010] Accordingly, the present invention provides a cost effective single use bone cutter with a novel blade and assembly design that improves cutting efficiency. The enhanced bone cutting and shaping efficiencies of the present invention ensure proper implant fit and reduced implant wear. In addition, the improved bone cutting efficiencies afforded by the present invention, decrease procedural time and minimize patient trauma. Furthermore, the bone cutter of the present invention ensures proper cutter sharpness and cleanliness that promotes optimal patient outcomes. SUMMARY OF THE INVENTION [0011] The present invention provides a disposable bone cutter device comprising a cutter assembly and guide rod for orthopedic surgical applications. Specifically, the cutter device of the present invention is designed to re-shape the head of a femur for joint revision surgeries. [0012] The cutter assembly comprises a disposable housing and a series of insert blades or a cutter disc arranged in circumferential manner within the assembly. The series of insert, blades or cutter disc are preferably secured in the cutter assembly through an interference fit at a distal base portion of the cutter assembly. [0013] The housing comprises two cylinders that are joined together at a distal portion of the housing. In a preferred embodiment, a first cylinder is positioned such that its inner diameter circumferentially surrounds the outer diameter of a second cylinder. Both the first and second cylinders are positioned such that they share a common central longitudinal axis. A series of radial connectors loin the two cylinders together along the distal base portion of the assembly. In a preferred embodiment, these connectors may take the form of a bar or rod or alternativly be formed into a blade enclosure designed to secure and house the individual insert cutter blades. [0014] Furthermore, it is preferred that the distal base portion of the centrally located second cylinder is recessed or offset from the distal base of the first cylinder. This recess establishes an offset rim formed by the wall thickness of the first cylinder. The depth of the offset rim is determined by the gap between the distal base plane of the first cylilnder and the distal base plane of the second cylinder. The offset rim provides a barrier that prevents unintentional damage to nearby bone and/or tissue resulting from contact with the cutting surface of the insert blades or cutting disc. [0015] Located at the proximal end portion of the assembly, within the interior of the inner diameter of the centrally located second cylinder, is a boss. The boss comprises a central throughbore that is positioned such that the throughbore is coaxial with the common longitudinal axis. The throughbore of the boss provides an alignment aid to the axis of the desired cut. [0016] Another feature of the boss is that it acts as a “stop” to prevent overcutting of the bone. As will be explained in greater detail, the distal end of the boss comes into contact with the end of the bone thus preventing further advancement of the cutter. As such, the position of the boss preferably determines the depth of cut into the bone and prevents unintentional overcutting of the end of the bone. [0017] The boss is joined within the interior of the second cylinder through a series of rods which radially extend between the exterior wall surface of the boss and an interior wall surface of the inner diameter of the second cylinder. In addition, these rods serve as an interfacing feature by which the cylindrical cutter attaches to a handle or a motor that rotates the cutter in a clockwide or counterclockwise direction. In a preferred embodiment, the housing can be produced as a single component using an injection molding process. [0018] The insert blades are universal and can be manufactured to a minimal size to accommodate all sizes of the cutter. In a preferred embodiment, the series of individual cutter blades are secured within their respective blade enclosures. These blades are preferably of an “L” shape and are designed to provide a cutting edge that extends into the interior of the centrally located second cylinder. [0019] The cutter insert blades preferrably include a slot, residing within the surface that extends along the width of the blade. The slot is designed to interface with a post positioned within the blade enclosure. The interaction between the post and slot secures the insert blade therewithin. [0020] In this embodiment, the cylindrical cutter is assembled by pressing the insert blades into the blade enclosures of the assembly. The insert blades are designed such that they snap into the blade enclosure. This low cost production process, along with the economical production of the component parts, avoids the need for expensive machining and grinding operations that are common with the prior art. [0021] In an alternate embodiment, a cutter disc having a plurality of cutting teeth openings, resides within the distal base portion of the assembly. In a preferred embodiment, the cutting disc comprises an outer diameter, an inner diameter, and a planar surface therebetween. The plurality of cutting teeth are positioned at spaced intervals throughout the planar surface. [0022] In operation, the femoral head is first shaped to accept a replacement shell of an implant utilizing the present invention. The shaping of the femoral head is accomplished by first establishing an axis of cut on the femoral head. This axis is established by drilling a guide hole into the femoral head and placing a guide rod into the bone. This guide rod serves to align the axis of the cylindrical cutter to the axis of the intended cut. The cutter of the present invention is then attached to the handle—driver assembly and positioned over the guide rod by means of the hollow boss within the cylindrical cutter. The powered driver provides a means of rotating the cylindrical cutter and advancing the cutter against the femoral head. BRIEF DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is a perspective view of a prior art bone cutter and bone. [0024] FIG. 1A is a cross-sectional view of the prior art bone cutter and bone shown in FIG. 1 . [0025] FIG. 2 is a perspective view of the cutter housing of the present invention. [0026] FIG. 3 is an alternate perspective view of the cutter housing of the present invention. [0027] FIG. 4 is a cross-sectional view of the cutter housing of the present invention. [0028] FIG. 5 is a perspective view of an embodiment of a cutter blade of the present invention. [0029] FIG. 6 is a side view of the embodiment of the cutter blade shown in FIG. 5 . [0030] FIG. 7 is a perspective view of an alternate embodiment of a cutter blade of the present invention. [0031] FIG. 8 is a perspective view illustrating an assembly step of the present invention. [0032] FIG. 8A is a perspective view illustrating a preferred embodiment of an assembled bone cutter assembly of the present invention. [0033] FIG. 9 is a perspective view of a preferred embodiment of a cutter disc of the present invention. [0034] FIG. 10 is a perspective view of the cutter disc and an alternative cutter housing embodiment of the present invention. [0035] FIG. 10A is a perspective view of an assembled alternate embodiment of the bone cutter assembly of the present invention shown in FIG. 10 . [0036] FIG. 10B is a cross-sectional view of an assembled alternate embodiment of the bone cutter assembly of the present invention shown in FIG. 10 . [0037] FIG. 11 is a cross-sectional view of an embodiment of the bone cutter of the present invention, being used to shape the end of a bone. [0038] FIG. 11A is a cross-sectional view illustrating the shaped end of a bone after using the bone cutter of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0039] Now turning to the figures, FIGS. 2-11A illustrate embodiments of a bone cutter 30 of the present invention. In a preferred embodiment, the bone cutter 30 comprises a cutter housing 32 , cutter blades 34 or cutter disc 78 , and a guide rod 36 ( FIGS. 11 , 11 A). [0040] As shown in FIGS. 2-4 , 8 , 8 A, and 10 - 11 A, the cutter housing 32 preferably comprises two cylinders, a first cylinder 38 and a second cylinder 40 that are joined therebetween. In a preferred embodiment, the first cylinder 38 comprises a first cylinder inner diameter 42 , a first cylinder outer diameter 44 , and a first cylinder wall thickness 46 therebetween. The second cylinder 40 comprises a second cylinder inner diameter 48 , a second cylinder outer diameter 50 , and a second cylinder wall thickness 52 therebetween. [0041] In addition, the first cylinder 38 comprises a first cylinder height 54 extending from a first cylinder distal base portion 56 to a first cylinder proximal end portion 58 . In a preferred embodiment, the distal base portion 56 of the first cylinder 38 is co-planar with an imaginary first cylinder base plane BB ( FIG. 4 ). This imaginary base plane B-B preferably extends outwardly from the outer diameter 44 of the first cylinder base portion 56 . [0042] The second cylinder 40 comprises a second cylinder height 60 extending from a second cylinder distal base portion 62 to a second cylinder proximal end portion 64 . In a preferred embodiment, the distal base portion 62 of the second cylinder 40 is co-planar with an imaginary second cylinder base plane CC ( FIG. 4 ). This imaginary base plane CC preferably extends outwardly from the outer diameter 50 of the second cylinder base portion 62 . [0043] In a preferred embodiment, the first and second cylinders 38 , 40 are joined such that the outer diameter 50 of the second cylinder 40 is positioned within the inner diameter 42 of the first cylinder 38 . The first and second cylinders 38 , 40 are further positioned such that they are co-axial to a common central longitudinal axis A-A as shown in FIGS. 2-4 , 8 , 8 A, and 10 - 11 A. [0044] In a preferred embodiment, the outer diameter 44 of the first cylinder 38 ranges from about 5 cm to about 10 cm, the inner diameter 42 of the first cylinder 38 ranges from about 4.5 cm to about 9.95 cm and the height 54 of the first cylinder 38 ranges from about 1 cm to about 4 cm. The wall thickness 46 of the first cylinder 38 preferably ranges from about 0.05 cm to about 0.5 cm. [0045] In a preferred embodiment, illustrated in FIGS. 2-4 , 8 , 8 A, and 10 - 11 A, the height 60 of the centrally located second cylinder 40 is greater than that of the height 54 of the first cylinder 38 . Furthermore, the height 60 of the centrally located second cylinder 40 ranges from about 5 cm to about 10 cm. The outer diameter 50 of the second cylinder 40 ranges from about 3 cm to about 6 cm and the inner diameter 48 of the second cylinder 40 ranges from about 2 cm to about 6 cm. The wall thickness 52 of the second cylinder 40 ranges from about 0.05 cm to about 0.5 cm. [0046] The two cylinders 38 , 40 are joined together by a connector 66 that interfaces between the two cylinders 38 , 40 at a distal end portion 67 of the housing 32 as shown in FIG. 10 . The connector 66 can be of many non-limiting forms such as a bar, a rod, a rectangle or a sphere such that one surface interfaces with the interior wall surface 68 of the inner diameter 42 of the first cylinder 38 and an opposite surface interfaces with the exterior wall surface 70 of the outer diameter 50 of the second cylinder 40 . In a preferred embodiment, a plurality of two or more connectors 66 , radially extend between the inner and outer diameters 42 , SO of the first and second cylinders 38 , 40 , respectively, and join them therebetween as shown in FIG. 10 . [0047] In a preferred embodiment, the connector 66 can be designed as a blade enclosure 72 such that individual insert blades 34 ( FIGS. 2-3 , and 8 - 8 A) are disposed therewithin. This preferred blade enclosure 72 embodiment, will be discussed in more detail. [0048] As shown in the embodiments illustrated in FIGS. 3-4 , 8 - 8 A, and 10 - 10 A, the housing 32 is preferably constructed such that an offset rim 74 is formed by a portion of the wall thickness 46 of the first cylinder 38 . The depth 76 of the offset rim 74 is defined by the distance between the first and second imaginary distal base planes B-B, C-C as shown in the cross sectional view of FIG. 4 . In a preferred embodiment, the offset rim 74 preferably has a depth 76 that ranges from about 0.01 cm to about 0.05 cm. The offset rim 74 preferably extends around the perimeter of the first cylinder 38 at the distal base portion 56 . The thickness of the offset rim 74 is defined by the wall thickness 46 of the outer first cylinder 38 . [0049] The offset rim 74 is designed to prevent the cutter blades 34 or cutter disc 78 ( FIG. 9 ) from inadvertently damaging nearby bone or tissue, particularly preventing a proximal bone or tissue from being cut or nicked. However, it is contemplated that the housing 32 could be constructed such that the first and second imaginary planes B-B, CC are coplanar, therefore constructing a housing 32 without an offset rim 74 . [0050] It is preferred that both the first and second cylinders 38 , 40 have a hollow interior 80 , 82 within their respective inner diameters 42 , 48 . Such a hollow interior 80 , 82 allows for efficient removal of bone debris as the debris can freely flow through the cutter assembly 84 ( FIGS. 8 , 8 A). It is also contemplated that such a housing 32 , could be constructed with a cylinder having a solid or partially solid interior. [0051] In a preferred embodiment shown in FIGS, 2 , 4 , 8 A, and 11 - 11 A, the cutter housing 32 has a boss 86 that is positioned within the inner diameter 48 of the second cylinder 40 . More specifically, the boss 86 is centrally positioned within the inner diameter 48 of the second cylinder 40 . In a preferred embodiment, the boss 86 comprises a throughbore 88 . The boss 86 is preferably further positioned within the inner diameter 48 of the second cylinder 40 such that the throughbore 88 is co-axially aligned with the central axis A-A of the housing 32 as shown in FIGS. 2 , 4 , 8 A, and 11 - 11 A. [0052] In a preferred embodiment, illustrated in FIG. 4 , the boss 86 is constructed with a distal planar edge 90 . This distal planar edge 90 is designed to act as a “stop” to prevent further advancement of the cutter 30 into the end 24 of the bone 14 . The boss 86 is preferably positioned with the interior 82 of the second cylinder 40 such that a cut depth 92 is defined between the distal planar edge 90 of the boss 86 and the imaginary second cylinder base plane C-C. It is contemplated that this distal planar edge 90 can be positioned anywhere within the interior 82 of the centrally located second cylinder 40 to establish an optimal cut depth 92 for a particular implant (not shown). In a preferred embodiment the cut depth 92 ranges from about 2 cm to about 10 cm. [0053] A plurality of bars 94 secure the boss 86 within the inner diameter 48 of the centrally located second cylinder 40 . A plurality of bars 94 , having a length 96 from about 4 cm to about 8 cm and a thickness 98 from about 0.5 cm to about 1 cm, fluidly extend from the interior wall surface 68 of the inner diameter 48 of the first cylinder 38 to the exterior wall, surface 70 of the outer diameter 50 of the second cylinder 40 within the proximal portion 64 of the housing 32 . It is preferred that a plurality of at least two bars 94 , connect the boss 86 within the interior 82 of the second cylinder 40 . [0054] It is preferred that the housing 32 be composed of a biocompatible material. In a preferred embodiment, the cutter housing 32 is composed of a biocompatible thermoplastic such as, but not limited to, Acrylonitrile Butadiene Styrene (ABS), Polyarylamide (PAA), or Polyetheretherketone (PEEK). [0055] Furthermore it is preferred that the series of cutter blades 34 are positioned in a radial fashion about the outer diameter 50 of the second cylinder 40 as illustrated in FIGS. 8 and 8A . More specifically, these cutter insert blades 34 are positioned between the exterior surface 70 of the outer diameter 50 of the second cylinder 40 and the interior surface 68 of the inner diameter 42 of the first cylinder 38 at the distal base portion 56 of the housing 32 . [0056] Preferred embodiments of the cutter insert blade 34 , 130 are shown in FIGS. 5-7 . As illustrated, insert blades 34 , 130 comprise a blade proximal portion 100 and a blade distal portion 102 . The widths 104 , 106 of the proximal and distal portions 100 , 102 are not necessarily equal. In a preferred embodiment, the width 106 of the distal portion 102 is greater than the width 104 of the proximal portion 100 . An insert blade cutting surface 108 preferably extends along the distal width 106 of the insert blade 34 , 130 . In a preferred embodiment, when inserted into the bone cutter housing 32 , the plurality of these blade cutting surfaces 108 align to form an imaginary blade cutting surface plane DD ( FIG. 4 ). It is further preferred that this imaginary blade cutting surface plane D-D reside between the imaginary first and second cylinder planes B-B, C-C. [0057] As shown in FIGS. 5 , 7 and 8 A, the distal width 106 of the insert blade 34 , 130 is greater than the proximal width 104 of the blade 34 , 130 . This extra “width portion.” of the insert cutter blade 34 , 130 is defined as the blade extension portion 110 . The blade extension portion 110 is designed such that when the cutter blade 34 , 130 is inserted into the housing 32 , the extension portion 110 protrudes past the inner diameter 48 of the second cylinder 40 towards the interior 82 of the second cylinder 40 ( FIGS. 8 and 8A ). [0058] In addition, the blade extension portion 110 acts as a “free end”. This “free end” extension is designed to cut into the head 12 of the bone 14 . As such, this “free end” extension 110 defines a new diameter 112 of the bone head 12 as illustrated in FIG. 11A . If such an extension 110 were not present, the interior wall 69 of the second cylinder 40 would prevent cutting of the bone 14 . In a preferred embodiment, the blade extension 110 has a width from about 0.05 cm to about 0.10 cm. [0059] As illustrated in FIGS. 5 and 6 , a groove 114 is preferably formed within the surface 116 of the distal end portion 102 of the insert blade 34 . In a preferred embodiment, the groove 114 has a “V” shape. The groove 114 is designed to establish a rake angle θ of the insert blade 34 . The rake angle θ is defined as the intersection between the distal surface 120 of the “V” cut out portion 114 and a perpendicular line E-E to the cutting edge surface 108 as shown in FIG. 6 . It is preferred that rake angle θ range from about 4° to about 30°. [0060] A relief angle φ, as illustrated in FIG. 6 , is formed between the intersection of the distal end surface 124 of the blade 34 and a tangent line FF to the blade cutting edge 108 . It is preferred that the relief angle φ range from about 4° to about 20°. [0061] Each cutter blade 34 , 130 is preferably positioned within the cutter blade enclosure 72 as shown in FIGS. 8 and 8A . In a preferred embodiment, the insert blade 34 , 130 is positioned in the housing 32 such that the proximal end portion 104 of the insert blade 34 , 130 resides inside the blade enclosure 72 and the cutting surface 108 of the insert blade 34 , 130 lies outside the blade enclosure 72 . Furthermore, it is preferred that the cutting surface 108 of the insert blade 34 lies parallel to an imaginary cutting plane D-D as shown in FIG. 4 . As shown in FIG. 4 , the imaginary cutting plane D-D lies between the first cylinder imaginary plane B-B and the second cylinder imaginary plane C-C. The blade extension 110 preferably is positioned towards the central axis A-A of the assembly 84 . [0062] In a preferred embodiment shown in FIGS. 2 and 3 , each cutter blade enclosure 72 has a post 126 therewithin, The post 126 is preferably designed to snap-fit into a slot 128 within the proximal end portion 100 of the cutter blade 34 ( FIGS. 5 and 6 ). Once the post 126 snaps into the slot 128 , the insert blade 34 is locked within the cutter blade enclosure 72 . [0063] In an alternative embodiment, as shown in FIG. 7 , the insert blade 130 can be designed without a groove 114 and slot 128 . In this embodiment, the cutting edge 108 is formed at the intersection of the side blade surface 116 and the distal end surface 124 . It is preferred that a portion of the surface 116 at the proximal end portion 100 of the insert blade 130 has a roughened finish 132 . This roughened surface finish portion 132 provides for a more secure fit when positioned within the blade enclosure 72 . [0064] In a preferred embodiment, insert blades 34 , 130 are secured within the blade enclosure 72 with an induction bonding process. Alternatively, the insert blade 34 , 130 can be secured by an alternate means not limited to adhesives, overmolding, press fitting, induction bonding, and the like. [0065] In an alternate embodiment, the cutting disc 78 is positioned at the distal end portion 67 of the housing 32 . The cutting disc 78 embodiment provides an additional means of bone removal which is illustrated in FIGS. 9-10A . An embodiment of this alternate cutter assembly 146 is shown in FIG. 10A . The assembly 146 of this embodiment comprises the housing 32 and the cutter disc 78 . [0066] The cutting disc 78 preferably comprises an outer disc diameter 134 , an inner disc diameter 136 and a planar surface 138 therebetween. The cutting disc 78 is positioned between the wall thickness 46 of the first cylinder 38 and the wall thickness 52 of the second cylinder 40 at the distal end portion 67 . More specifically, it is preferred that the cutting disc 78 be placed between the inner diameter 42 of the first cylinder 38 and the inner diameter 48 of the second cylinder 40 such that the planar surface 138 of the cutting disc 78 is parallel to the first and second cylinder imaginary planes B-B, C-C ( FIG. 10B ). [0067] Positioned throughout the surface 138 of the disc 78 are a series of openings 140 . These openings 140 are preferably positioned throughout the surface 138 of the disc 78 in a helical pattern. Protruding from the opening 140 is a cutting tooth 142 . The cutting teeth 142 are designed such that a cutting surface 144 is positioned outwardly from the planar surface 13 $ of the disc 78 . Alternately, the cutting surface 144 may protrude inwardly from the surface 13 $ of the disc 78 . In a preferred embodiment, these cutting surfaces 144 of the cutting teeth 142 align to form an imaginary cutting disc plane G-G. This imaginary plane G-G preferably resides between the first and second imaginary cylinder planes B-B, C-C ( FIG. 10B ). [0068] It is preferred that the cutter insert blades 34 , 130 and the cutting disc 78 are composed of a biocompatible metal. In a preferred embodiment, such biocompatible metals include, but are not limited to, stainless steel, MP35N, titanium, and combinations thereof. It is most preferred that cutter blades 34 , 130 and the cutting disc 78 are composed of a 300 series stainless steel. [0069] In a preferred embodiment, the cutter housing 32 is first molded from a biocompatible polymer as previously mentioned. After the housing 32 has been molded, the cutter blades 34 , 130 or cutter disc 78 are then inserted in the distal base portion 67 of the housing 32 . As previously mentioned, an induction bonding process is preferably used to secure the cutter blades 34 , 130 or cutter disc 78 to the molded assembly 84 , 146 . Alternatively, adhesives, over-molding, press fitting, and the like may also be used. [0070] In this preferred bonding embodiment, electromagnetic current is used to heat the blades 34 , 130 or blade disc 78 . Heat generated from the current, melts the surrounding assembly polymer material, causing the material to flow and engage the cutter blades 34 , 130 or disc 78 . It is well known that alternative processes such as cross pinned engagements, direct insert molding, or ultrasonic insertion may also be used to strengthen the connection or act as a primary means to join the bone cutter 30 of the present invention. [0071] FIGS. 11 and 11A illustrate the use of the bone cutter 30 of the present invention. Initially, a guide-hole 148 is drilled into the end 24 of a bone 14 . The guide rod 36 is placed into the guide-hole 148 and the cutter assembly 84 , 146 is placed over the rod 36 as shown. In a preferred embodiment, the guide rod 36 is preferably positioned through the central axis AA of the bone cutter 30 . [0072] Once in place over the end 24 of the bone 14 , the cutter 30 is rotated in either a clockwise or counterclockwise direction. This rotational movement of the cutter 30 , removes bone material from the end 24 of the bone 14 with a smooth surface finish with a bone diameter 112 suitably sized for insertion of an implant (not shown). Once the bone head 12 is properly shaped, the cutter 30 and guide rod 36 are removed. An implant (not shown) is then positioned over the end 24 of the bone 14 . [0073] Now, it is therefore apparent that the present invention has many features and benefits among which are promoting proper implant fit, decreased procedural times and minimized patient trauma. While embodiments of the present invention have been described in detail, such is for the purpose of illustration, not limitation.

1a

BACKGROUND OF THE INVENTION The present invention relates to a process for producing an improved filling mix and on hydration without cooking or baking produces a smooth, creamy and firm texture with a sliceable pie cut characteristic on setting. The trend requires food preparation to be of the type of instanteous use. This means that in instant pudding or instant filling preparations, these foods are prepared from a dry mix without cooking. The difficulty associated with these conveniences is that starting materials used to prepare these high quality instant foods must be carefully controlled and the tolerance of these controls are exceptionally tight wherein many of these formulations are not considered satisfactory and require recycling, reworking, etc. of the finished dry mixes increasing the costs of production. U.S. Pat. No. 4,361,592 issued to Carpenter et al. describes a pudding mix composition which, when combined with milk produces a desirable, creamy, glossy pudding. This is accomplished using fine particles of pregelatinized starch having less than a maximum of 1% by weight of the starch having a particle diameter greater than 63 microns (i.e., retained on a 230 mesh U.S. Standard Screen). A regular starch would generally have a particle size wherein less than 50% by weight of the starch particles pass through a 400 mesh U.S. Standard Screen with a substantial amount of the starch being retained on a 230 mesh U.S. Standard Screen (e.g., greater than 10%, usually greater than 25-50% by weight of the starch). U.S. Pat. No. 4,438,148 issued to O'Rourke et al. describes the use of controlled sized finely divided starch and controlled sized finely divided sugar particles to achieve a desirable, creamy, glossy pudding while U.S. Pat. No. 4,469,712 issued to Katcher et al. claims an improved dry instant pudding mix made from controlled sized starch and sugar. U.S. Pat. No. 2,554,143 issued to Hinz et al. teaches that finely divided starch particles can be used in an instant pudding mix, only if their rate of hydration is retarded. Hinz et al. achieve the hydration rate retardation by coating the starch with a hydrophobic rate retardation by coating the starch with a hydrophobic material such as a lipid or talc. The problem Hinz et al. recognized is that when fine starch particles hydrate, there is a tendency for these particles to lump to the point when it is quite difficult to prepare a smooth pudding product. U.S. Pat. No. 4,518,622 issued to Wison et al. describes a product and process for the making of a dry mix capable of being hydrated in an aqueous medium to form, without need for cooking, a firm gelled mass suitable for use as a pastry or pie filling having textural and organoleptic properties similar to those possessed by a cooked, starch-based filling. This product is produced by mixing sugar, starch, food-grade acidulant and appropriate amounts of flavorants and/or colorants. The starch component provides specific properties of viscosity and texture to the hydrated product. This procedure, however, provides a very grainy, lumpy appearance resembling an apple sauce product. This appearance is not desired in the production of pie fillings or puddings. In a copending application U.S. Ser. No. 802,544 filed Nov. 27, 1985 now U.S. Pat. No. 4,636,397, issued Jan. 13, 1987, being commonly assigned to this application, there is a method described which provides an instant mix, and on reconstitution or hydration a no bake pie-filling mix is produced which has an improved glossy, smooth, creamy and firm texture with a sliceable pie cut characteristic on setting. This is accomplished by uniformity oil coating the natural carbohydrate sweetener solid particles with a liquid hydrogenated or partially hydrogenated edible oil, then dry mixing the oil coated sweetener with a rapid hydratable cold water swelling starch, maltodextrin, flavorants and the like to provide a flowable powder. This is accomplished in two steps to provide a highly desirable product in the presence of maltodextrin. SUMMARY OF THE INVENTION The present invention provides another process for making an improved instant filling mix which on reconstitution produces a highly desirable glossy, smooth, creamy and firm texture with a sliceable pie cut characteristic on setting made from standard and finely divided particles, normally sized ingredients of filling mix such as starch, sugar or other sweeteners as well as other materials. DETAILED DESCRIPTION OF THE INVENTION A process has been discovered for making an improved instant filling mix which on hydration produces a smooth, creamy and firm texture with a sharp pie cut characteristic on setting. The process includes the following steps: (A) Dry mixing (1) a natural carbohydrate sweetener solid particles; (2) a rapid hydratable cold water swelling starch; (3) maltodextrin having a dextrose equivalent between about 5 and about 20; (4) flavor(s) and (5) edible food acid(s) for a period of time sufficient to obtain a substantially uniform mix. (B) The product of (A) is mixed with about 4 to about 6 weight % of the total mixture of a liquid hydrogenated or partially hydrogenated edible oil until a uniform mixture of a flowable powder is obtained. It has been discovered in this invention that if all the ingredients of sweetener, starch, malto-dextrin and/or flavor and edible foods are uniformly mixed and an edible oil in amounts ranging from about 4 to about 6 weight percent of the total composition is mixed with the premixed ingredients, the resulting product, on hydration, produces a smooth, creamy and firm texture with a sliceable pie cut characteristic on setting. If the maltodextrin or starch present in the mix, is added with oil prior to use with the remaining ingredients, a smooth and creamy filling will not be obtained in some instances because uniform distribution of the ingredients will not be achieved and, if a smooth and creamy filling is achieved, the set pie filling on prolonged setting will be syneresed to the point where the set will break down. To assure the smooth and creamy texture of the filling made by this invention, malto-dextrin is used to aid the uniform distribution of the ingredients on hydration. If maltodextrin is not used, the resulting product is lumpy, grainy and not acceptable as a high quality filling mix. The weight percentage of ingredients used in the process of this invention based on the total composition are as follows: ______________________________________Ingredients Weight Percentage______________________________________natural carbohydrate sweeteners about 55 to about 80% preferably about 60 to about 68%rapid hydratable cold water about 16 to about 20%swelling granular starch preferably about 17 to about 19%malto-dextrin having a dextrose about 5 to about 15%equivalent between about 5 to preferably about 8 toabout 20 preferably about 9 to about 10%about 12edible oil about 4 to about 6% preferably 4.5 to about 5.5%flavor below about 1% preferably about 0.2 to about 0.5% as needededible food acid 0 to about 5% preferably about 1.0 to about 1.5%color as needed______________________________________ Additional ingredients, if desired, can be used in the above combination of materials to enhance taste, flavor, sweetness and whatever is needed to provide a satisfactory food product. In this invention, the natural carbohydrate sweetener which can be used is sugar from any source available in dry granular form such as sucrose or dextrose as well as other solid sweeteners such as fructose, corn syrup solids, or mixtures thereof among other natural sweeteners. These sweeteners must be free flowing particles of suitable size to make instant mixes. Various maltodextrins (hydrolyzed cereal solids) which are starch hydrolysates produced by converting pure refined corn starch into nutritive saccharides through the use of acids or specific enzymes, are used in this invention. The carbohydrate composition of maltodextrin is arranged to yield a dextrose equivalent from about 5 to about 20, preferably 7 to about 12. These are typically bland in flavor and without appreciable sweeteners. This maltodextrin is a free-flowing powder and its presence is for aiding the uniform distribution of all ingredients on hydration. The rapid hydratable cold water swelling starch of this invention are being used as a thickening agent. These starches are obtained from a variety of starch sources such as tapioca, corn, high amylose, sweet potato, potato, waxy maize, canna, arrowroot, sorghum, waxy sorghum, waxy rice, sago rice and the like. The essential feature of the starch is that it is a rapid hydratable cold water swelling starch, preferably granular, which will set up on hydration with all the remaining ingredients present at room temperature in a reasonable time preferably in less than 2 hours and preferbly less than 1 hour in a smooth, creamy and firm texture with a sliceable pie cut characteristic. The type of starches that can be used can include the types of starches described in U.S. Pat. No. 3,949,104 issued to Hsiung Cheng, among other and commercially available, cold-water swelling starches identified as NU-COL 231, NU-COL 326, NU-COL 4227, MIRA-GEL 463 (manufactured and sold by the A. E. Staley Manufacturing Company, Decatur, Ill.). The preferred starch is the MIRA-GEL 463 which is a cold water swelling starch which hydrates in water at ambient temperatures, first forming to a thick smooth consistency and then setting to a resilient colloidal gel structure. The particle size of the starch is that which is normally used in the instant pudding or pie fillings, i.e., particle size wherein 95% passes through 100 Mesh U.S. Standard Screen and at least 65% passes through a 200 mesh U.S. Standard Screen. Finer particles can be used if desired. It is essential that the size particles of the starch are such that in the combination of the other ingredients a free-flowing powder is available. The term "cold water swelling" as used herein relates to the use of water for hydration below the boiling point of water, preferably below 150° F. and more preferably below 120° F. and ideally at room temperature or ambient temperatures. The edible oil which is used herein is a liquid at use and preferably liquid at room temperature and can be any food acceptable hydrogenated or partially hydrogenated edible oil. The preferred oils are the hydrogenated vegetable oil including, among others: coconut oil, palm kernel oil, cottonseed oil, peanut oil, soybean oil, canola oil, corn oil and mixtures thereof. The oils used herein cannot have a taste or flavor which would interfer with the desirable taste and flavor of the filling mix. The flavors used in this invention can be any acceptable flavors. These include among others, lemon, cherry, almond, pecan, strawberry, orange, lime, blueberry, raspberry and the like. The edible food acids which can be used include, among others, citric acid, malic acid, adipic acid, fumaric acid, tartaric acid, or mixtures thereof. After all the ingredients have been dry mixed, prior to the hydration step, the resulting product must be a flowable powder. On hydration, the product of this invention produces, without cooking or baking, a smooth, creamy and firm texture with a sharp pie cut characteristic on setting. The following examples are presented for the purpose of further illustrating the present invention and are not to be taken as limiting. EXAMPLE I No Bake Lemon Pie ______________________________________ Weight Weight %Ingredients Grams of Total______________________________________Sugar 160 65.7Rapid Hydratable Cold Water 45 18.3Swelling Granular StarchMIRA-GEL 463 (Staley)Malto-dextrin (Lodex 10) 22 8.96dextrose Equivalent 10Hydrogenated Oil 13 5.2Citric Acid 3.0 1.2Lemon Flavor 2.0 0.81Yellow Color 0.007 0.002Trisodium Citrate 0.5 0.20Total 245.5 100______________________________________ Mixing procedure: All of the dry ingredients were thoroughly mixed in a Mixmaster® Blender. When the mix was a homogeneous mix, the hydrogenated oil was added and mixed for 10 minutes until a homogeneous flowable powder product was obtained. In a mixer containing 2 cups of hot water at 120° F., where the beaters are increased in the water and rotating, 245.5 grams of the above flowable powder product was slowly sprinkled on top of the water until all the product was added. The mixing continued (two minutes) until the product mixture was smooth and lump free. The resulting product was poured into a container and allowed to set up for 45 minutes. The product has a smooth, creamy and firm texture with a sliceable pie cut characteristic on setting. EXAMPLE II No Bake Lemon Pie ______________________________________ Weight Weight %Ingredients Grams of Total______________________________________Sugar 182 74.1Rapid Hydratable Cold Water 45 18.3Swelling Granular StarchMIRA-GEL 463 (Staley)Hydrogenated Oil 13 5.2Citric Acid 3.0 1.2Lemon Flavor 2.0 0.81Trisodium Citrate 0.5 0.20Yellow Color 0.007 0.002Total 245.5 100______________________________________ The sugar content of Example II was increased over Example I to provide the same solids content since Example II was prepared without maltodextrin. The mixing procedure of Example I was followed wherein the hydrogenated oil was added to the homogenous dry mix without maltodextrin and mixed for 10 minutes until a homogeneous flowable powder product was obtained. In a mixer containing 2 cups of hot water at 120° F.; where the beaters are immersed in the water and rotating, 245.5 grams of the above flowable powder product was slowly sprinkled on top of the water until all the product was added. The mixing continued for two minutes. The resulting product was poured into a container and allowed to set up for 45 minutes. The product was a very grainy, lumpy pie filling resembling an apple sauce product. This is not acceptable in regard to the required creamy and smooth property of Example I. The texture, however, was firm and had a sliceable cut characteristic. EXAMPLE III The process of Example I was repeated except the hydrogenated vegetable oil was mixed with the malto-dextrin. The starch was added to the oiled malto-dextrin and mixed thoroughly. The remaining dry ingredients were added to the oiled maltodextrin and starch and mixed for 15 minutes. The resulting product was added to 2 cups of hot water (120° F.) and mixed until smooth. Two egg yolks and one tablespoon of melted butter, used to add body, were added to the mixture and mixed again. The mixture was poured into a pie plate and set in one hour. The filling was smooth and creamy, however, on prolonged sitting, the product syneresed to the point where the set broke down. EXAMPLE IV The procedure of Example III was repeated except the starch was mixed with hydrogenated vegetable oil and the remaining ingredients were dry mixed with the oiled starch. The result of this example was similar to that of Example III that being a smooth product but the break down in set occurred on prolonged sitting. The above disclosure has provided a description of the invention for the purpose of enabling the person skilled in the art how to make and use the same and has not been made for the purpose of detailing all things known or obvious to the skilled worker. Upon reading this disclosure, many modifications and variations be included within the scope of the present invention which is defined by the following claims.

1a

CLAIM OF PRIORITY [0001] This application claims the benefit of Korean Patent Application No. 10-2014-0129040, filed Sep. 26, 2014, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a nanoformulated self-assembled pharmaceutical composition for photodynamic therapy. More particularly, the present invention is directed to a self-assembled pharmaceutical composition for photodynamic therapy comprising a photosensitizer, a ligand A which is separated at a specific pH range, and a ligand B of which surface charge changes at a specific pH range and a process for preparing the same. BACKGROUND OF THE INVENTION [0003] A cancer is caused by uncontrolled growth of cells (neoplasia) and there are over 100 cancer types. Abnormal growth of cells creates a mass of cells (tumor), and this mass of cells penetrates surrounding tissues and spreads to other parts of the body (metastasis). [0004] An important matter to consider when administering an effective drug for the treatment of a disease or the diagnosis of the disease region to a human body is how much of the administered effective ingredient reaches the disease region, that is, the problem of drug delivery efficiency. The effective ingredient may reach an unwanted normal tissue and act to cause side effects, and the amount of drug that reaches the disease region may decrease, resulting in the failure of treatment. [0005] The drugs that have treatment effects for some diseases show strong toxicity to normal tissues or cells and, therefore, they pose problems of which their side effects or cell toxicity are greater than the treatment effect for the disease. Anti-cancer drugs act on normal tissue cells and have adverse effect on normal tissue cells, rather than removing cancer tissues or having treatment effect. [0006] Over 1,300 anti-cancer drugs are known to the public. However, such anti-cancer drugs are often toxic to normal tissue and, thus, have side effects. In addition, since the delivery of anti-cancer drugs to cancer tissues are low due to the characteristics of cancer tissues, the treatment effects are low compared to the side effects. [0007] Particularly, due to heterogeneity, that traces and administers drugs by using the affinity the phenomenon that cancer tissue cells produce various type of replicated tumor cells, it is difficult to utilize a method that traces cancer cells and administers drugs by using the affinity between the receptor of cancer cells and the nanoformulated ligands, which is frequently used for nanoformulated drugs. Thus, it is difficult to treat cancers by using the nanoformulated drugs. [0008] Furthermore, such heterogeneous extracellular matrix of cancer tissues impedes drug penetration which reduces drug exposure and gradually induces drug-resistance. The cancer tissues having these characteristics are difficult to be treated by targeted therapy using antibody markers due to the heterogeneity of cancer cells. [0009] However, due to abnormally rapid division rate of cancer cells and fast growth rate of cancer tissues, cancer tissues are loose and have intercellular cavities therein, compared to normal tissues. In addition, the surface of a cancer tissue includes a number of holes of approximately 100 nm size, has the acidity of less than pH 6.0, and is negatively charged. [0010] Tumors in patients generally contain heterogeneous cell populations, and tumor heterogeneity greatly influences the effectiveness of the receptor-ligand targeting strategies that are most popularly used in cancer nanotechnology. In addition, the heterogeneous tumoral extracellular matrix impedes drug penetration which reduces drug exposure and gradually induces drug-resistance. The tumor microenvironment exhibits an increased interstitial fluid pressure caused by leaky vasculature, poor lymphatic drainage, and a high density of cells and their related matrices. [0011] Therefore, the penetration of nanoparticle-based drugs is limited to the tumor peripheral region with little diffusion of therapeutic nanoparticles into the tumor interstitial space. The physiological and physical mechanism of drug resistance as a whole is a major cause of the failure of most cancer treatments. Although nanoparticles of small size and multi-functionality are emerging as the next-generation anti-cancer agents, there remain great challenges to the development of ‘smart’ nanoparticles that can specifically respond to tumor-related stimuli in order to overcome the aforementioned tumoral barriers. [0012] Self-assembly provides a simple, reproducible and inexpensive way of producing ensembles of nanoparticles with unique plasmonic, photoluminescent, and magnetic properties in a controllable manner. Several stimulus-responsive assembled nanostructures have been thoroughly examined as bio- or chemo-sensors in vitro (Rosi, N. L.; Mirkin, C. A. Chem. Rev. 2005, 105, 1547; Cao, Y C.; Jin, R.; Mirkin, C. A. Science 2002, 297, 1536; Zagorovsky, K.; Chan, W. C. W. Angew. Chem., Int. Ed. 2013, 52, 3168; Taton, T. A.; Mirkin, C. A.; Letsinger, R. L. Science 2000, 289, 1757; Pan, Y; Du, X.; Zhao, F.; Xu, B. Chem. Soc. Rev. 2012, 41, 2912). However, thus far, these types of “smart” ensembles have rarely been investigated in vivo owing primarily to these inherent physiological obstacles. One commonality among tumors is acidity; the microenvironment usually has a pH of ˜6.8 and endo/lysosomes experience even lower pH values of 5.0-5.5. [0013] Magnetic resonance imaging (MRI) is the most effective imaging diagnosis equipment up to date that can form images of the organs of living humans or animals in a non-invasive way in real time. MRI contrasting agent helps each tissue and blood vessel to be shown more clearly, so that more precise diagnosis is possible. [0014] There are two types of MRI contrasting agent: T 1 , which makes the target site brighter and T 2 , which makes it darker. Paramagnetic gadolinium complex is widely used as T 1 contrasting agent, but low molecular weight of gadolinium complex makes the residence time within the blood vessel and body short, making exact diagnosis of vessel disease more difficult, and there has been a report that it may cause systemic fibrosis in a person with degraded kidney function. [0015] Photodynamic therapy is a treatment that uses a photosensitizer which causes chemical reactions along with light and oxygen to selectively kill cells of a tissue in need of treatment. Unlike general anti-cancer drugs or radiation therapies which have an effect on normal tissue cells, photodynamic therapy has the advantage of greatly reducing the side effects of the anti-cancer drugs or radiation therapies, due to targeting and killing the cells of diseased tissues and selectively killing them. [0016] The object of the present invention is to provide a pharmaceutical composition for photodynamic therapy, of which particle size is smaller than below 100 nm-sized holes on cancer tissue surface, wherein the surface charge of the composition changes from negative to positive when the composition reaches cancer tissues, thereby allowing for approach and penetration of the composition to the cancer tissues, and wherein the photosensitizer can selectively and effectively penetrate to the cancer tissues due to a linker which separates at an acidic condition of the cancer tissues, and thereby effectively killing cancer tissue cells by forming a large amount of reactive oxygen species activated by light and the photosensitizer. SUMMARY OF THE INVENTION Technical Problem [0017] The primary object of the present invention is to provide a self-assembled pharmaceutical composition for photodynamic therapy comprising a photosensitizer, a ligand A which is separated at a specific pH range, and a ligand B of which surface charge changes at a specific pH range. [0018] Another object of the present invention is to provide a process for preparing self-assembled pharmaceutical composition for photodynamic therapy, comprising: (i) preparing the ligand composition by adding solution comprising a ligand A which is separated at a specific pH range, and a ligand B of which surface charge changes at a specific pH range to chloroform; and (ii) separating the nanoformulated pharmaceutical composition for photodynamic therapy from the ligand composition. Technical Solution [0019] The primary object of the present invention can be accomplished by providing a self-assembled pharmaceutical composition for photodynamic therapy comprising a photosensitizer, a ligand A which is separated at a specific pH range, and a ligand B of which surface charge changes at a specific pH range. [0020] The photosensitizer may be chlorin E6. Also, the photosensitizer may be bonded to the ligand A or ligand B. [0021] The ligand A may contain PEG, imidazole group, catechol and chlorin E6 (Ce6). The hydrophilicity of the PEG helps the ligand composition retain its form; the imidazole group makes the ligand composition change its form in response to pH change; the catechol bonds to extremely small iron oxide nanoparticles (ESIONs); and the Ce6 emits reactive oxygen species (ROS) that destroy cancer cells when exposed to a proper light. [0022] Furthermore, the ligand B may contain PEG, imidazole group, phenyl group and Ce6. The hydrophilicity of the PEG helps the ligand composition retain its form; the imidazole group makes the ligand composition change its form in response to pH change; the lipophilicity of the phenyl group helps the ligand composition retain its form; and the Ce6 emits reactive oxygen species (ROS) that destroy cancer cells when exposed to a proper light. [0023] In an embodiment of the self-assembled pharmaceutical composition of the present invention, the ligand A may be a compound of formula (I), as shown in FIG. 19 , wherein n and m are independently 5-500. Also, the imidazole group of the formula (I) may be substituted by triazole or piperazine group. [0024] Furthermore, in an embodiment of the self-assembled pharmaceutical composition of the present invention, the ligand B may be a compound of formula (II), as shown in FIG. 20 , wherein n and m are independently 5-500. Also, the imidazole group of the formula (II) may be substituted by triazole or piperazine. In addition, the phenyl group of the formula (II) may be substituted by naphthyl or indole group. [0025] In one embodiment of the self-assembled pharmaceutical composition of the present invention, the pH range at which ligand A separates or the surface charge of ligand B changes may be 4-7.2. [0026] In one embodiment of the self-assembled pharmaceutical composition of the present invention, the composition may further comprise an MRI contrasting nanoparticle. The MRI contrasting nanoparticle may be an iron oxide nanoparticle. Furthermore, the size of the iron oxide nanoparticle may be 1 nm-100 nm [0027] Another object of the present invention can be achieved by providing a process for preparing self-assembled pharmaceutical composition for photodynamic therapy, comprising: (i) preparing the ligand composition by adding to chloroform a mixture solution which contains a ligand A which is separated at a specific pH range, and a ligand B of which surface charge changes at a specific pH range; and (ii) separating the nanoformulated pharmaceutical composition for photodynamic therapy from the ligand composition. [0028] In an embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the photosensitizer may be chlorin E6. Also, the photosensitizer may be bonded to the ligand A and ligand B. [0029] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the ligand A may be a compound of formula (I) and the ligand B may be a compound of formula (II). [0030] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the pH range at which ligand A separates or the surface charge of ligand B changes may be 4-7.2. [0031] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the solvent of the mixture solution may be DMSO (dimethyl sulfoxide), DMF (dimethylformamide) or THF (tetrahydrofuran). Also, the organic solvent may be chloroform, dichloromethane or 1,2-dichloroethane. [0032] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the ligand A may be produced by a method comprising: (i) preparing poly(ethylene glycol)-poly(β-benzyl-L-aspartate) (PEG-PBLA) by polymerizing β-benzyl-L-aspartate N-carboxy anhydride (BLA-NCA) in the mixture of DMF and CH 2 Cl 2 ; (ii) preparing platform ligand by bonding chlorin E6 (Ce6) to the PEG-PBLA; and (iii) preparing ligand A by the aminolysis of the platform ligand using 1-(3-amynopropyle)imidazole and dopamine. [0033] Furthermore, in an embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the ligand B may be produced by a method comprising: (i) preparing poly(ethylene glycol)-poly(β-benzyl-L-aspartate) (PEG-PBLA) by polymerizing β-benzyl-L-aspartate N-carboxy anhydride (BLA-NCA) in the mixture of DMF and CH 2 Cl 2 ; (ii) preparing platform ligand by bonding chlorin E6 (Ce6) to the PEG-PBLA; and (iii) preparing ligand A by the aminolysis of the platform ligand using 1-(3-amynopropyle)imidazole and 3-phenyl-1-propylamine. [0034] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, the composition may further comprise mixing the ligand composition of the step (i) with an MRI contrasting nanoparticle. [0035] In one embodiment of the process for preparing self-assembled pharmaceutical composition of the present invention, MRI contrasting nanoparticle may be iron oxide nanoparticle. Also, the size of the iron oxide nanoparticle may be 1 nm to 100 nm. Advantageous Effects [0036] The nanoformulated pharmaceutical composition for photodynamic therapy of the present invention is a self-assembled nanostructure that reacts to the acidic stimulation of tumors and functions to deliver the pharmaceutical composition selectively to cancer cells. Therefore, the nanoformulated pharmaceutical composition for photodynamic therapy of the present invention allows for effective photodynamic therapy of heterogeneous and drug-resistant tumor on early stages. BRIEF DESCRIPTION OF THE DRAWINGS [0037] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. [0038] FIG. 1 shows H-NMR analysis of the platform ligand (PEG-PBLA-Ce6) synthesized in Example 1 of the present invention. [0039] FIG. 2 shows H-NMR analysis of the ligand A (PEG-p(API & DOPA- L -Asp)-Ce6) synthesized in Example 1 of the present invention. [0040] FIG. 3 shows H-NMR analysis of the ligand B (PEG-p(API & PPA- L -Asp)-Ce6) synthesized in Example 1 of the present invention. [0041] FIG. 4 shows GPC curves of the platform ligand, ligand A and ligand B synthesized in Example 1 of the present invention. [0042] FIG. 5 a shows pH-dependent structural transformation change in pH-sensitive magnetic nanoformulation (PMN): self-assembly of iron oxide nanoparticles and pH-responsive ligands (inset of (a): TEM images of PMNs at pH 7.4, 6.8, and pH 5.5, DLS measurement of PMN colloidal dispersion at pH 7.4 showing an average diameter of ˜70 nm). [0043] FIG. 5 b shows schematic representation of pH-dependent structural transformation and related magnetic/photoactivity change in PMNs. [0044] FIG. 5 c shows zeta-potential and DLS size measurement of PMNs (0.1 mg/mL) as a function of pH following a 1 h incubation (n=3) (DLS measurements were conducted using a material refractive index of 2.42, solvent refractive index of 1.33 (water) and a viscosity of 0.8872). [0045] FIG. 6 a shows size distribution by number. [0046] FIG. 6 b shows size distribution by intensity. [0047] FIG. 6 c shows raw correlation data of InS-NP colloidal dispersion at pH 7.4. [0048] FIG. 7 a shows transmittance of PMN suspension measured at selected pH values (the inset presents data for pH-dependent turbidity of the PMN solution with a transition pH value of about 6.0. The pH was gradually changed from 4.0 to 7.5 () and from pH 7.5 to 4.0 (∘)). [0049] FIG. 7 b shows pH-dependent fluorescence intensity and near-infrared fluorescence imaging of (1) self-assembled ligands and (2) PMNs. [0050] FIG. 7 c shows pH-dependent singlet oxygen generation of (1) self-assembled ligands and (2) PMNs. [0051] FIG. 7 d shows optical, fluorescence, and MR phantom images (examined in a clinical 1.5 T MRI scanner) of a concentration gradient of PMNs at three different pH values. [0052] FIG. 7 e shows pH-dependent magnetic relaxation properties of PMNs. [0053] FIG. 8 shows the XRD patterns of PMNs and 3 nm-sized ESIONs (extremely small iron oxide nanoparticles). [0054] FIG. 9 a shows the magnetic properties of PMNs through an M-H curve between the magnetic field of 20 kOe and −20 kOe, and [0055] FIG. 9 b shows the magnetic properties of PMNs through an M-T curve for PMNs under 100 Oe with the temperature varying from 300 K to 4 K. [0056] FIG. 10 shows MR phantom images of a concentration gradient of InS-NPs at three different pH values. [0057] FIG. 11 a shows cellular uptake of PMNs (equivalent to 1 μg/mL Ce6) for HCT116 cancer cells at pH 7.4 or 6.8 (4 h incubation) analyzed by flow cytometry (the inset shows near-infrared fluorescence imaging of HCT116 cancer cells treated with different concentrations of PMNs at pH 7.4 and 6.8 (4 h incubation)). [0058] FIG. 11 b shows confocal microscopy images of activated PMNs in HCT116 cancer cells (the endosomes/lysosomes were stained with Lysotracker Green which selectively labels lysosomes). [0059] FIG. 11 c shows BioTEM images of PMN uptake by HCT116 cancer cells. [0060] FIG. 11 d shows MTT assays of HCT116 cells exposed to PMNs and free Ce6 without laser irradiation. [0061] FIG. 11 e shows MTT assays of HCT116 cells exposed to PMNs and free Ce6 with laser irradiation. [0062] FIG. 11 f shows fluorescence (upper) and MR (lower) images of HCT116 cancer cell pellets (1×10 6 cells) incubated with various concentrations of PMNs (0, 12.5, 25, or 50 μg Fe/mL) for 4 hours. [0063] FIG. 12 a shows in vivo T 1 -weighted MR images and color-mapped images of tumor sites before and 1 or 2 hours after intravenous injection of InS-NPs into nude mice bearing HCT116 tumors (the dashed regions indicate tumor site) (the dashed regions indicates tumor sites). [0064] FIG. 12 b shows in vivo T 1 -weighted MR images and color-mapped images of tumor sites before and 1 or 2 hours after intravenous injection of PMNs into nude mice bearing HCT116 tumors (the dashed regions indicate tumor site) (the dashed regions indicates tumor sites). [0065] FIG. 12 c shows plot of signal intensity enhancement (ROI i /ROI 0 ) versus time after injection of PMNs and InS-NPs. [0066] FIG. 12 d shows blood circulation data (plasma iron concentration vs time) for PMNs and InS-NPs in nude mice (see inset; n=3 for each group). [0067] FIG. 12 e shows inductively coupled plasma atomic emission spectroscopy (ICP-AES) analysis of tumor tissue showing >2-fold increase of PMNs than InS-NPs in HCT116 tumors at 12 h after intravenous injection. [0068] FIG. 12 f shows in vivo NIR imaging of nude mice bearing HCT116 tumors after intravenous injection of PMNs, InS-NPs or free Ce6 (equivalent to 0.2 mg/kg Ce6) (the dashed region indicates tumor site). [0069] FIG. 12 g shows CLSM shows Ce6 uptake by tumor cells in tumor tissue of nude mice after intravenous injection of PMNs. [0070] FIG. 13 a shows fluorescence images of organs extracted 24 hours post-treatment. [0071] FIG. 13 b shows measured signal intensities of organs extracted 24 hours post-treatment. [0072] FIG. 14 a is a photograph showing a PMN-based targeted photodynamic therapy (PDT). [0073] FIG. 14 b is a schematic illustration and comparison of PDT efficacy of PMNs and InS-NPs in homogeneous and heterogeneous tumors. [0074] FIG. 14 c shows immunohistochemical staining of heterogeneous tumors for SDF-1, P-gp and CD31. [0075] FIG. 14 d shows images of mice bearing homogeneous HCT116 tumors before and after PDT activation (upper), and Hematoxylin and eosin (H&E) and terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) staining of tumor tissue sections in order to determine treatment effectiveness in terms of tumor cell death by apoptosis (below). [0076] FIG. 14 e shows homogeneous HCT116 tumor volumes in the four treatment groups after treatment. [0077] FIG. 14 f shows images of mice bearing heterogeneous tumors before and after PDT activation (upper), and H&E and TUNEL staining of tumor tissue sections in order to determine treatment effectiveness in terms of tumor cell death by apoptosis (below). [0078] FIG. 14 g shows heterogeneous tumor (solid dots) volumes in the four treatment groups after treatment. [0079] FIG. 15 shows body weight measurements throughout the PDT treatments for HCT116 tumor-bearing mice ( FIG. 15 a ), and heterogenetic CT26 tumor-bearing mice ( FIG. 15 b ). [0080] FIG. 16 a shows serum biochemistry results for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and D-lactate dehydrogenase (D-LDH) from nude mice (n=4) administered with PMNs or PBS buffer. [0081] FIG. 16 b shows histological examination images of heart, kidney, liver, lung and spleen stained with haematoxylin and eosin (H&E) (100×). [0082] FIG. 17 shows the PMNs were fabricated by co-assembly of ESIONs, ligand A and ligand B. [0083] FIG. 18 shows self-assembly of ESIONs into colloidal magneto-core shell structures. [0084] FIG. 19 shows an embodiment of ligand A. [0085] FIG. 20 shows an embodiment of ligand B. [0086] FIG. 21 shows the template for synthesis of ligands A and B. DETAILED DESCRIPTION OF THE INVENTION [0087] Hereinafter, the present invention will be described in greater detail with reference to the following examples. The examples are given only for illustration of the present invention and not to be limiting the present invention. EXAMPLE 1 Synthesis of Ligands [0088] As shown in FIG. 21 , ligands A and B were synthesized by using poly(ethylene glycol)-poly(β-benzyl-L-aspartate) (PEG-PBLA) as a template. [0089] In order to prepare PEG-PBLA, β-Benzyl-L-aspartate N-carboxy anhydride (BLA-NCA) (3 g, 12 mmol) was polymerized in a mixture of DMF (20 mL) and CH 2 Cl 2 (50 mL) at 40° C. by initiation from the terminal primary amino group of α-methoxy-ω-amino-poly(ethylene glycol) (MW=2,000 Da, 240 mg, 120 μmol). PEG-PBLA was purified by precipitation in ether (3 L) three times. In order to synthesize PEG-PBLA-Ce6 (platform ligand), Ce6 was attached to the amine groups of PEG-PBLA via the conventional carbodiimide reaction. The PEG-PBLA (0.5 g, 32.5 μmol,) and a mixture of Ce6 (23.4 mg, 39.0 μmol), dicyclohexylcarbodiimide (9.6 mg, 46.8 μmol), and N-hydroxysuccinimide (5.4 mg, 46.8 μmol) were dissolved separately in DMSO (5 mL) and the solutions were stirred thoroughly for 3 h prior to the condensation reaction. The two reactant solutions were then mixed and stirred at room temperature. After 24 h, the reaction mixture was filtered to remove the insoluble by-products (e.g., dicyclohexylurea) and dialyzed against deionized water for 2 days (Spectra/Por; molecular weight cutoff size, MWCO: 1,000 Da). The final solution was lyophilized to obtain the platform ligand. The hydrogen nuclear resonance spectroscopy (“H-NMR”) analysis of the platform ligand (PEG-PBLA-Ce6) at 300 MHz with DMSO-d 6 is illustrated in FIG. 1 , where δ=9.7 ppm (1H, s, —CH═ of Ce6), 8.1 ppm (1H, s, —NH—), 7.3 ppm (5H, s, —CH 2 C 6 H 5 —), 5.0 ppm (2H, —C H 2 C 6 H 5 —), 4.6 ppm (1H, m, —NHCHC═O—), 3.5 ppm (182H, s, —CH 2 CH 2 O— of mPEG), 3.2 ppm (3H, s, CH 3 — of mPEG) and 2.9-2.5 ppm (2H, m, CHCH 2 C═O). [0090] Ligand A was synthesized via aminolysis of the platform ligand with 1-(3-aminopropyl)imidazole (API) and dopamine. PEG-PBLA-Ce6 (0.5 g, 18.5 μmol) was dissolved in DMSO (5 mL), followed by the reaction with dopamine (0.1 g, 0 7 mmol) under nitrogen atmosphere at 25° C. for 1 h. Then, API (0.5 g, 3.9 mmol) was added under nitrogen at 25° C. and stirred for 4 h. The reaction mixture was added dropwise into a cooled aqueous solution of 0.1 N HCl (20 mL) and dialyzed against a 0.01 N HCl solution three times (Spectra/Por; MWCO: 1,000 Da). The final solution was lyophilized to obtain ligand A. The H-NMR analysis of ligand A (PEG-p(API & DOPA-L-Asp)-Ce6) at 300 MHz with DMSO-d 6 is illustrated in FIG. 2 , where δ=7.8 ppm (1H, s, —NCH═N— of imidazole ring), 7.7 ppm (1H, s, —NCH═CH— of imidazole ring), 7.3 ppm (1H, s, —CHCH═N— of imidazole ring), 6.6-6.5 ppm (1H, m, —CH 2 ═CHCH— and —CH 2 CH═CH— of dopa), 6.4 ppm (1H, m, ═CHCO— of dopa), 4.5 ppm (1H, m, —NHCHC═O—), 4.2 ppm (2H, m, ═NCH 2 CH 2 ), 3.5 ppm (182H, s, —CH 2 CH 2 O— of mPEG chain), 3.0 ppm (2H, m, —NHCH 2 CH 2 —), and 2.8-2.5 ppm (2H, m, CHCH 2 C═O). [0091] Ligand B was synthesized via aminolysis of the platform ligand with API and 3-phenyl-1-propylamine (PPA). PEG-PBLA-Ce6 (0.5 g, 18.5 μmol) was dissolved in DMSO (5 mL), followed by reacting with PPA (0.1 g, 0.9 mmol) under nitrogen at 25° C. for 1 h. Then, API (0.5 g, 3.9 mmol) was added under nitrogen at 25° C. and stirred for 4 h. After the reaction, the mixture was added dropwise into a cooled 0.1 N HCl solution (20 mL) and dialyzed against an aqueous solution of 0.01 N HCl three times (MWCO: 1,000 Da). The final solution was lyophilized to obtain ligand B. The H-NMR analysis of ligand B (PEG-p(API & PPA- L -Asp)-Ce6) 300 MHz with DMSO-d 6 is illustrated in FIG. 3 , where δ=7.8 ppm (1H, s, —NCH═N— of imidazole ring), 7.7 ppm (1H, s, —NCH═CH— of imidazole ring), 7.3 ppm (1H, s, —CHCH═N— of imidazole ring), 7.3-7.2 (5H, m, —CH 2 C 6 H 5 — of PPA), 4.5 ppm (1H, m, —NHCHC═O—), 4.2 ppm (2H, m, ═NCH 2 CH2), 3.5 ppm (182H, s, —CH 2 CH 2 O— of mPEG chain), 3.0 ppm (2H, m, —NHCH 2 CH 2 —), and δ2.8-2.5 ppm (2H, m, CHCH 2 C═O. [0092] In the GPC measurements ( FIG. 4 ), all polymeric ligands showed unimodal molecular weight distribution indicating no homopolymer residues in the copolymer products. The Ce6 content of the ligand was examined by the fluorescence spectroscopy (λ ex =650 nm and λ em =675 nm, Table 1). [0000] TABLE 1 Structural characteristics of platform ligand, ligand A and ligand B. DP DS DS DS DS Code Copolymer (BLA) a (API) b (PPA) c (Dopa) d (Ce6) e PDI f M n g Platform PEG 1 -PBLA 60 -Ce6 1 60 — — — 1 1.11 16.000 Ligand Ligand A PEG 1 -p(API 55 & 60 55 — 5 1 1.14 17.200 Dopa 5 -L-Asp) 60 -Ce6 1 Ligand B PEG 1 -p(API 50 & 60 50 10 — 1 1.09 16.100 PPA 10 -L-Asp) 60 -Ce6 1 a Degree of polymerization of BLA on the basis of the 1 H-NMR results. b Degree of substitution of API on the basis of the 1 H-NMR results. c Degree of substitution of PPA on the basis of the 1 H-NMR results. d Degree of substitution of Dopa on the basis of the 1 H-NMR results. e Degree of substitution of Ce6 on the basis of the fluorescence spectroscopy. f Number-averaged (M n ), weight-averaged molecular weight (M w ) and polydispersity index (PDI = M w /M n ) were determined by GPC g As determined by 1 H-NMR. EXAMPLE 2 Synthesis of ESIONs [0093] ESIONs were synthesized via thermal decomposition of iron-oleate complex in the presence of oleyl alcohol using the previously reported method (Kim, B. H.; Lee, N.; Kim, H.; An, K.; Park, Y. I.; Choi, Y.; Shin, K.; Lee, Y.; Kwon, S. G.; Na, H. B.; Park, J. G.; Ahn, T. Y.; Kim, Y. W.; Moon, W. K.; Choi, S. H.; Hyeon, T. J. Am. Chem. Soc. 2011, 133, 12624). Briefly, 1.8 g of iron-oleate complex (2 mmol), 0.57 g of oleic acid (2 mmol), and 1.61 g of oleyl alcohol (6 mmol) were dissolved in 10 g of diphenyl ether at room temperature. The mixture was heated to 250° C. at a constant heating rate of 10° C./min and then kept at this temperature for 30 min under inert atmosphere. As the reaction proceeded, the initial brown transparent solution turned black. After the reaction, the mixture containing nanoparticles was removed from the heater and allowed to cool to room temperature and, then, 50 mL of acetone was added to precipitate the nanoparticles. The nanoparticles were pelleted by centrifuging at 40,000 rpm for 4 hours, the supernatant decanted and the nanoparticles redispersed in n-hexane or chloroform. EXAMPLE 3 Fabrication of PMNs [0094] For self-assembly, a solution prepared by mixing 15 mg of Ligand A and 15 mg of Ligand B in 3 mL of DMSO was added slowly to 5 mL of colloidal ESIONs (0.4 mg Fe/mL) in chloroform. The mixture was incubated on a shaker at room temperature for 30 min. Chloroform was then completely removed by evaporation under vacuum and deionized water was added to the colloidal suspension in DMSO to reach a total volume of 5 mL. The DMSO was completely substituted with deionized water using a dialysis membrane (Spectra/Por; MWCO: 12,000 Da). Excess ligands were removed by centrifugation and washed 3-5 times with spin filter (Millipore, MWCO: 100,000 Da, 10,000×g, for 10 min) The resulting nanoparticles were re-dispersed in water. EXAMPLE 4 Fabrication of Self-Assembled Ligands [0095] A mixed solution of 15 mg of Ligand A and 15 mg of Ligand B in 3 mL of DMSO was added slowly to 5 mL of chloroform. The mixture was incubated on a shaker at room temperature for 30 min. Then, chloroform was removed completely by evaporation under vacuum. Thereafter, deionized water was added to the colloidal solution in DMSO to reach a total volume of 5 mL. DMSO was completely substituted with deionized water using a dialysis membrane (Spectra/Por; MWCO, 12,000 Da). Excess ligands were removed by centrifugation or washed with spin filter (Millipore, MWCO: 100,000 Da, 10,000×g, for 10 min) 3-5 times. The resulting nanoparticles were re-dispersed in water. EXAMPLE 5 Fabrication of pH-Insensitive Nanoparticle Assembles (InS-NPs) [0096] A solution prepared by mixing 30 mg of platform ligand in 3 mL DMSO was added slowly to 5 mL of a colloidal ESIONs (0.4 mg Fe/mL) suspension in chloroform. The mixture was incubated on a shaker at room temperature for 30 min. Then, chloroform was removed completely by evaporation under vacuum. Thereafter, deionized water was added to the colloidal solution in DMSO to reach a total volume of 5 mL. DMSO was completely substituted with deionized water using a dialysis membrane (Spectra/Por; MWCO, 12,000 Da). Excess ligands were removed by centrifugation or washed with spin filter (Millipore, MW, 100,000 Da, 10000×g, for 10 min) 3-5 times. The resulting nanoparticles were re-dispersed in water. EXAMPLE 6 Characterizations of Materials [0097] TEM measurements were performed on a JEOL EM-2010 microscope operated at 200 kV. The powder X-ray diffraction patterns were obtained with a Rigaku D/Max-3C diffractometer equipped with a rotating anode and a Cu Kα radiation source (λ=0.15418 nm). The present inventors performed elemental analysis by inductively coupled plasma atomic emission spectroscopy (ICP-AES) using an ICPS-7500 spectrometer (Shimadzu) and inductively coupled plasma-optical emission spectrometer (ICP-OES) (Perkin-Elmer Optima 4300 DV). UV/visible absorption spectra were collected on UV-2450 spectrophotometer (Shimadzu, Japan). Particle size and zeta potential were measured with Zetasizer Nano ZS (Malvern Instruments, Malvern, UK). For the analysis of size, the following parameters, material refractive index (2.42), material absorbance (0.2), dispersant refractive index (1.33), and dispersant viscosity (0.8872) were used. The magnetic properties were investigated using a superconducting quantum interface device (SQUID) magnetometer (Quantum Design MPMS XL). Hydrodynamic sizes were obtained using dynamic light scattering (DLS) (Zetasizer Nano ZS (Malvern Instruments, Malvern, UK)) instrument at 25° C. EXAMPLE 7 Measurements of Critical Aggregation Concentration (CAC) [0098] A stock solution of Hoechst 33342 (1.4×10 −3 M) in double-distilled water was prepared and stored at 4° C. The Hoechst 33342 solution was mixed with solutions containing the samples at the concentrations of 1.0×10 −3 mg/mL to 1.0 mg/mL. The final concentration of Hoechst 33342 in each sample solution was 7.0×10 −4 M. The resultant fluorescence was measured on a RF-5301PC (Shimadzu, Japan) with λ ex =355 nm and λ em =457 nm and the slit widths were ex=3 nm and em=3 nm, respectively. EXAMPLE 8 Transmittance Measurement of PMNs at Different pH [0099] The light transmittance measurements of PMN solutions (2 mg/mL, without Ce6 attachment) were obtained using a UV-Visible spectrophotometer at 500 nm while the pH value of solution was gradually decreased from 7.5 to 4.0 by adding 0.1 N HCl, and increased from 4.0 to 7.5 by adding 0.1 N NaOH solution. EXAMPLE 9 pH-Dependent Fluorescence Intensity Measurement [0100] The fluorescence intensity of PMNs or self-assembled ligands (2 mg/mL, 650 nm excitation and 675 nm emission) was measured using a fluorescence plate reader (Tecan Genios, Durham, N.C.), while the pH of the solution was gradually decreased from 7.5 to 4.0 by adding 0.1 N HCl solution. EXAMPLE 10 pH-Dependent Singlet Oxygen Generation (SOG) Measurement [0101] In order to evaluate the SOG, samples (2 mg/mL, 100 μL) at different pH were mixed with singlet oxygen sensor green (SOSG, 2.0 μM, 100 μL). SOG was induced by irradiation with a 670 nm laser source (Institute of Electronics) at 5 mW/cm 2 intensity for 4 min. SOSG fluorescence was detected (λ ex =494 nm and λ em =534 nm) after irradiation to determine the SOG of the samples. SOG was evaluated by SOSG fluorescence enhancement compared to the background. EXAMPLE 11 Cell Culture [0102] HCT116 (human colon cancer, KCLB No. 10247) cells, CT26 (murine colorectal carcinoma cell, KCLB No. 80009) and M2-10B4 (murine bone marrow stromal cell, KCLB No. 21972) were obtained from the Korean Cell Line Bank. HCT116 cells were cultured in 10 mL of Roswell Park Memorial Institute (RPMI-1640) medium supplemented with 10% fetal bovine serum (FBS) and 1% penicillin/streptomycin. CT26 cells were cultured in Dulbecco's Modified Eagle Medium (DMEM) supplemented with 10% FBS and 1% penicillin/streptomycin. M2-10B4 was cultured in RPMI-1640 medium supplemented with 10% FBS and 1% penicillin/streptomycin. Culturing conditions for all cells were 37° C. in 100% humidity and 5% CO 2 . Drug resistant CT26 cells (CT26/MDR) were developed by exposing CT26 cells to increasing doses (1, 5, 10, 25, 50, 100, 500, 1,000, and 5,000 ng/mL) of DOX for 24 h followed by 3-4 days of recovery before exposing to the next dose. CT26/MDR was then frozen and stored in liquid nitrogen. Fresh aliquots of CT26/MDR were used in all experiments to ensure that they did not revert to a drug sensitive phenotype. EXAMPLE 12 pH-Dependent Cell Uptake [0103] HCT116 cells were exposed to PMNs, InS-NPs and Ce6 at different pHs to verify their cellular uptake respectively. The cells were incubated for 2 h, washed, harvested, and re-suspended with DPBS. In vitro cellular uptake was quantified using a flow cytometer (Beckman, San Jose, Calif., USA). For each sample 10,000 cells (gated events) were counted, and free Ce6 fluorescence was detected with logarithmic settings (FL4; λ em =670 nm). Cells were counted as positive if their fluorescence (FL4) was higher than that of cells from an untreated cell suspension. Each experiment was analyzed statistically using the CXP Analysis Program. EXAMPLE 13 Confocal Laser Scanning Microscope [0104] Confocal laser scanning microscope (LSM 510 Meta; Zeiss, Germany) was used to carry out fluorescence imaging. An optimal pinhole size of 120 μm was selected to exclude fluorescent light emitted from out-of-focus planes above and below the focusing plane. The excitation/emission wavelengths were 340/488 nm for DAPI, 490/520 nm for FITC, 555/578 nm for RITC, and 650/670 nm for Ce6. Fluorescence images were analyzed using LSM Image Browser software (Zeiss). EXAMPLE 14 Cell MR Imaging [0105] In order to label the cells with PMNs, HCT116 cells were seeded onto culture dishes in 10 mL of media and grown overnight. Subsequently, PMNs of 0, 12.5, 25, and 50 μg/mL were added. After 4 h, the cells were washed twice with PBS and detached by adding 1 mL of trypsin/EDTA. After centrifugation, cells were dispersed in culture media and transferred to a 1.5 mL test tube. Cell pellets were prepared by centrifugation at 1,000 rpm for 5 min. T 1 -weighted MR images were acquired with a head coil on a 1.5 T MR scanner (Signa Excite, GE Healthcare). EXAMPLE 15 Pharmacokinetic Analysis [0106] For the plasma concentration-time experiment, the mice were injected with PMNs and InS-NPs respectively (2 mg Fe/kg) via the tail vein. Blood was collected at 1 min, 30 min, 1 h, 3 h, 8 h and 20 h after the injection. Plasma was isolated from red blood cells by centrifugation at 1,000 rpm for 10 min The plasma (100 μL) for each blood sample was subsequently mixed with 70% nitric acid (1 mL) at room temperature for 12 h followed by centrifugation (10,000 rpm for 5 min), and the supernatant was used for inductively coupled plasma optical emission spectrometer analysis (ICP-OES, Optima 4300 DV, Perkin-Elmer) after 5-fold dilution with 2% nitric acid. Fe uptake in the tumor was measured 12 h after PMNs or InS-NPs injection (2 mg Fe/kg). Dissected tumor tissues were weighed, homogenized, and treated with scintillation mixtures. A volume of 60% nitric acid was added to each sample and tissue was incubated for 24 h at 60° C. after which the solutions were centrifuged at 13,000 rpm for 30 min and the supernatant was diluted 10-fold with 2% nitric acid. Determination of Fe uptake content in tumor was performed by ICP-OES, and the nanoparticle uptake in tumor was calculated as gram of Fe content per gram of tissue (g Fe/g Tissue). EXAMPLE 16 Immunohistochemistry [0107] Tumor tissues were fixed in 10% neutral buffered formalin and frozen sectioned into 5 micron thick slices. SDF-1 and P-gp were immunolabeled with anti-SDF-1 antibody (abcam) and anti-P-glycoprotein antibody (abeam), then the samples were incubated for 60 min at ambient temperature with RITC (λ ex /λ em , 555/578 nm) or FITC (λ ex /λ em , 490/520 nm) conjugated secondary antibody for further confocal laser scanning microscope analysis. EXAMPLE 17 Tumor Histology [0108] For histology analysis, tumor tissues from control and treated mice were fixed in 10% neutral buffered formalin and frozen sectioned into 5 micron thick slices, stained with hematoxylin & eosin (H&E) and terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL), and were examined by a digital microscope (Leica QWin) and a confocal laser scanning microscope (LSM 510 Meta; Zeiss, Germany). EXAMPLE 18 In vivo Toxicity Evaluation of PMNs [0109] Healthy nude mice were intravenously injected with a suspension of PMNs or normal saline (control group). After 2 weeks, the mice were sacrificed and major viscera collected. The heart, liver, spleen, kidney, and lung were stained with H&E. Reagent kits of ALT, AST, ALP and D-LDH were employed to analyze the serum which was isolated from blood sampled by eyeball extirpation. EXAMPLE 19 In vitro Cellular Uptake [0110] The tumor cellular uptake of PMNs was monitored at different pH conditions (pH 7.4 and 6.8) using a KODAK In vivo Image Station (Image Station 4000 MM; Kodak, New Haven, Conn., USA) and a flow cytometer (Beckman, San Jose, Calif., USA). HCT116 cells (1×10 5 cells/mL) were incubated with each sample for 2 h in RPMI-1640 medium (pH 7.4 or 6.8, with 1% penicillin-streptomycin) at 37° C. and then analyzed. To ameliorate photobleaching during microscope observation, a drop of anti-fade mounting solution (5% N-propyl gallate, 47.5% glycerol, and 47.5% Tris-HCl, pH 8.4) was added to the cells. EXAMPLE 20 In vivo Studies [0111] All in vivo studies conformed to the Guide for the Care and Use of Laboratory Animals published by the National Institutes of Health, USA (NIH publication no. 85-23, 1985, revised 1996), and mice were maintained under the guidelines of an approved protocol from the Institutional Animal Care and Use Committee (IACUC) of the Catholic University of Korea (Republic of Korea). EXAMPLE 21 Characterization of pH-Sensitive Magnetic Nanogrenades (PMNs) [0112] Ce6 grafted poly(ethylene glycol)-poly(β-benzyl-L-aspartate) (PEG-PBLA-Ce6) was synthesized to provide a platform ligand in which the flanking benzyl ester groups readily react with primary amines via nucleophilic attack. Imidazole (pKa, ˜6.8) was then easily incorporated as an ionizable group to impart pH sensitivity to the tumor microenvironment. On the basis of this platform, the present inventors further engineered two ligand derivatives: ligands A and B. For ligand A, catechol groups were added to facilitate self-assembly as they can act as high-affinity anchors for iron oxide nanoparticles. In contrast, the hydrophobicity of ligand B was tuned using 3-phenyl-1-propylamine to produce a critical phase transition of PMNs that is activatable by tumor endo/lysosomal pH of ˜5.5. The PMNs were fabricated by coassembly of ESIONs, ligand A and ligand B (Scheme 2) ( FIG. 17 ). [0113] Since ESIONs (about 3 nm) were much smaller than the hydrodynamic dimensions of the peptide block of the ligands (about 60 residues; length of about 20 nm), the catechol-anchored ligand A could wrap around the periphery of the ESIONs. These functionalized ESIONs can thus be considered polymer-metal analogues of conventional amphiphilic diblock copolymers since the functionalization permitted directed selfassembly of ESIONs into colloidal magneto-core shell structures (Scheme 3) ( FIG. 18 ). The hydrophobic core is then composed of the ESIONs and hydrophobic blocks of the tumor-sensing polymeric ligands. [0114] Transmission electron microscopy (TEM) ( FIG. 5 a ) revealed the particle size of PMNs is ˜60 nm They were well dispersed in water, and the hydrodynamic diameter measured by dynamic light scattering (DLS) was found to be 70±5 nm ( FIG. 5 a ), which is appropriate for the enhanced permeability and retention (EPR) effect for passive tumor targeting. As a control, the present inventors fabricated pH-insensitive nanoparticle assemblies (denoted as InS-NPs) by assembling ESIONs and the platform ligand, which were similarly sized to PMNs ( FIG. 6 ). [0115] New ligand design of the present invention enabled a two-stage pH activation leading to surface charge reversal in the tumor periphery for increased cell adsorption and permeation as well as endo/lysosomal pH dependent theranostic activity of PMNs. This pH-dependent structural transformation is schematically presented in FIG. 5 b . First, PMNs are slightly negatively charged at pH 7.4. The drop in pH within the tumor environment causes increased imidazole ionization which reverses the polarity of the complex causing it to swell ( FIG. 5 c ), thereby enhancing their payload delivery and cell internalization due to electrostatic interactions with the vicinal anionic cells. Upon internalization, the particles further ionize as the endosomal pH decreases to 5.5-6.0. Here the hydrophobic interactions of the core of the PMNs weaken, and the ionized unimers repel each other leading to complete dissociation as confirmed by both DLS ( FIG. 5 c ) and TEM ( FIG. 5 a ). Acid-base titration ( FIG. 7 a ) demonstrated a sharp drop in transmittance (% T) at the critical pH range of 5.5-6.0. When the pH was increased again, % T recovery was hysteretic, thereby demonstrating a reversible pH-dependent assembly/disassembly process. Consequently, the photoactivity, i.e. singlet oxygen generation (SOG) and fluorescence, of PMNs was quenched at pH 7.4 due to fluorescence resonance energy transfer. At pH<6, the photoactivity was dramatically recovered upon disassembly, similar to that observed for the other self-assembled polymeric ligands ( FIGS. 7 b and 7 c ). Interestingly, PMNs showed a 2-fold lower critical aggregation concentration (˜0.01 mg/mL) than the self-assembled polymeric ligands possibly due to polymer chain entanglement indicating their improved colloidal stability. [0116] The X-ray diffraction (XRD) pattern of PMNs was similar to that of ESIONs ( FIG. 8 ), and the PMNs show a weak magnetization because of the spin-canting effect, as illustrated in FIGS. 9 a and 9 b . The pH-dependent structural transformation of PMNs in water is expected to affect proton relaxation. Considering the large number of high-spin Fe(III) ions with five unpaired electrons (S=5/2) on the surface of ESIONs, direct water coordination with Fe 3+ species is a major contributor to the longitudinal relaxivity (r1) of PMNs. The intensity variation of the T 1 MR phantom of PMNs at different pH values (same Fe concentration) was well matched with the corresponding fluorescent imaging results ( FIG. 7 d ). PMNs showed an r1 of 3.30 mM −1 ·s −1 with a transverse relaxivity (r2) of 43.95 mM −1 ·s −1 at pH 7.4, and a concomitant r1-increase and r2-decrease was observed as the pH decreased from 7.4 to 5.5 ( FIG. 7 e ). It is assumed as pH decreases, ligands become protonated and gain hydrophilicity. Consequently, both the number of coordinated water molecules and the duration of their coordination with Fe 3+ will increase. Moreover, as pH-induced disassembly occurs, separated ESIONs exhibit a lower r2 compared to initial PMNs. Although the efficiency of the contrast effect is evaluated in terms of relaxivity (r1), the r2/r1 ratio also plays an important role in positive T 1 imaging as an excessively high r2 may preclude their use as T 1 contrast agents. As the pH decreases, the r2/r1 ratio of PMNs significantly decreases along with r2. Finally, the PMNs have a specific r1 value of 3.87 mM −1 ·s −1 and a low r2/r1 ratio of 5.8 at pH 5.5, which results in a bright signal in T 1 -weighted imaging. Therefore, the positive T 1 MR contrast of PMNs was quenched at pH 7.4 but greatly recovered at pH 5.5, which indicates PMNs can be used for sensitive T 1 MR imaging of acidic tumor regions. In contrast, MR contrast of InS-NPs was not dependent on pH ( FIG. 10 ). To the best of the present inventors knowledge, this is the first demonstration of biocompatible iron oxide nanoparticles showing pH-sensitive T 1 contrast that can be used for tumor pH-sensitive T 1 MR imaging. Although Gd 3+ -based T 1 contrast agent can also be designed to respond to pH stimulus, they generally have short blood half-lives, preventing their accumulation in tumors for high-resolution tumor imaging. Furthermore, Gd 3+ -based contrast agents can be potentially toxic; severe side effects were observed in patients with renal failure that received gadolinium-containing contrast agents, such that the U.S. FDA recently released a warning regarding Gd 3+ -based MR contrast agents and nephrogenic system fibrosis (NSF). While such side effects are quite rare, occurring in less than 5% of patients, the present inventors believe iron oxide nanoparticles may provide a more biologically and metabolically compatible alternative. The use of biodegradable polymeric peptides for iron oxide-based PMN fabrication gives the final product a longer blood half-life and a greater biocompatibility for clinical translation. EXAMPLE 22 In vitro and In vivo MRI [0117] MRI investigations were conducted using a 1.5 T MR scanner (Signa Excite; GE Healthcare) by using a Litz Coil (diameter, 100 mm; length, 85 mm; DOTY Scientific Inc., NC, USA). Spin-lattice and spin-spin relaxation times (T 1 and T 2 ) were measured using fast spin echo (FSE) sequence for different concentrations of PMNs in media with different pH values at room temperature. For T 1 measurements, the Field of View (FOV) was set to 75×75 mm, slice thickness (SL)=3 mm, Echo time (TE)=9.3 ms and Repetition Time (TR)=505.2, 525.0, 545.0, 565.0, 585.0, 605.0, 625.0, 645.0, 665.0, 685.0, 705.0, 730.0, 755.0, 805.0, 855.0, 905.0, 955.0, 1005.0, 1055.0, 1105.0 ms. For T 2 measurements, the following parameters were used: FOV=100 mm*100 mm, SL=3 mm, TR=4,000 ms, TE=10.9, 21.7, 43.5, 54.4, 65.2, 87.0, 119.6, 141.3, 163.1, 174.0 ms. The longitudinal (r1) and transverse (r2) relaxivities were calculated from r i =(1/T i −1/T i0 )/c, where c is the Fe concentration of PMNs in mM, T i is the relaxation time at concentration c, T i0 is the relaxation time of water, and i=1 and 2 for T 1 and T 2 . The cellular MR images were acquired using FSE sequence (FOV=100 mm*100 mm, SL=3 mm) For T 1 measurement, TR=400 ms and TE=10 ms were used, whereas for T 2 measurement, TR=4,000 ms and TE=86.72 ms were used. For the MR diagnosis of tumor in vivo, PMNs were injected through the tail vein at a dose of 2 mg Fe/kg body weight. Mice were then placed in a 1.5 T MR scanner (Signa Excite, GE Healthcare), and FSE sequence was used with the followed parameters: FOV=90 mm×90 mm, SL=2 mm, Flip angle (FA)=90°, for T 1 MR imaging, TR=400 ms, TE=10 ms, and for T 2 MR imaging, TR=3,000 ms, TE=101 ms. The transverse section images were obtained and analyzed using Onis Dicom Viewer (DigitalCore, Tokyo, Japan). [0118] PMNs showed higher cellular uptake at pH 6.8 than at pH 7.4 as evidenced by both fluorescence and flow cytometry results ( FIG. 11 a ). In contrast, the cellular uptake of Ce6 and InS-NPs was not affected by changes in pH. For cell uptake, the present inventors followed the iron oxide nanoparticles by TEM ( FIG. 11 c ) which shows uptake in endosomes. The present inventors also followed the Ce6 dye by confocal laser scanning microscopy (CLSM) ( FIG. 11 b ) which shows the fluorescence of PMNs merges perfectly with that of Lysotracker Green. The existence of the Ce6 signal suggests PMNs indeed disassembled for fluorescence dequenching here in the endosome. Consequently, PMNs showed no cytotoxicity in the dark ( FIG. 11 d ) but induced cell death much more efficiently than Ce6 under illumination ( FIG. 11 e ) at pH 6.8. MR contrast and fluorescence of human colorectal carcinoma (HCT116) cells labeled with PMNs ( FIG. 11 f ) further confirmed their dual-modal imaging capability. [0119] The present inventors performed in vivo early stage tumor diagnosis with PMNs. Without conjugation of any tumor-targeting moiety and in contrast to InS-NP injection, PMN injection resulted in significant T 1 enhancement of ultrasmall HCT116 tumors of ˜3 mm in diameter ( FIGS. 12 a -12 c ), thus confirming their successful tumor targeting and pH-dependent T 1 MR contrast effect. pharmacokinetic studies showed both PMNs (t 1/2,PMN =2.90 h) and InS-NPs (t 1/2,InS-NP =2.19 h) had long blood circulation times ( FIG. 12 d ). However, notably, PMN accumulation in tumors was >2-fold higher than that of InS-NPs ( FIG. 12 e ). Moreover, PMNs also enabled high-resolution fluorescent imaging of tumors in mice ( FIG. 12 f ). Macroscopic fluorescent imaging of excised organs demonstrated significant tumor accumulation of PMNs ( FIG. 13 ), and subcellular CLSM confirmed uptake of PMNs by tumor cells ( FIG. 12 g ). These results indicate PMNs are promising candidates for highly efficient early diagnosis of cancer. EXAMPLE 23 In vitro and In vivo PDT [0120] For in vitro PDT, HCT116 cells (5×10 4 /well) were incubated with the materials described above. Photosensitization experiments were then performed by irradiating the cells with a 670-nm laser source (Institute of Electronics) for 2 min The power at the level of the cells was fixed at 5 mW/cm 2 . Cell viability was assessed using the MTT assay. Absorbance intensity was measured at 595 nm using a microplate reader (Bio-Tek, VT, USA). A parallel set of control cells was also used in which cells incubated with the respective materials were not exposed to laser irradiation. For in vivo PDT, HCT116 tumors were developed in the flanks of 6-week-old male BALB/c nude mice by subcutaneously implanting HCT116 cells in 100 μL of a 1:1 mixture of Matrigel (BD Biosciences, Franklin Lakes, N.J.) and serum-free medium. Heterogeneous CT26 tumors were developed in the flanks of 6-week-old male BALB/c nude mice by subcutaneously implanting a mixture of CT26 (1×10 5 cells), CT26/MDR (1×10 5 cells), and M2-10B4 cells (1×10 5 cells) in 100 μL of serum-free medium. Ten days after inoculating the tumor cells, PDT treatment was performed as follows: group 1, saline only; group 2, free Ce6 only; group 3, InS-NPs; and group 4, PMNs (equivalent to 2 mg/kg body of Ce6). NIR images were obtained using KODAK image station (Image Station 4000 MM; Kodak, New Haven, Conn.) at 2 h post-injection. Laser treatment was performed in groups 1 through 4 by irradiating the tumor region with a 670-nm laser (250 mW/cm 2 , for 20 min) at 12 h post-injection. The PDT treatment described above was repeated 5 days later. The tumor size was measured 3 times a week after the first PDT treatment by using a Vernier caliper, and tumor volumes were calculated from width (a) and length (b) measurements (V=a 2 ×b/2, where a≦b). All mice were killed when the tumor measured 1,000 mm 3 , at the first sign of suffering, or between 15 and 21 day post-transplantation. [0121] In order to explore the therapeutic effect of PMNs, in vivo photodynamic therapy (PDT) was performed ( FIG. 14 ). PDT is a clinically approved, minimally invasive therapeutic procedure for cancer treatment that relies on photosensitizers to produce cytotoxic singlet oxygen generation (SOG) upon irradiation. However, currently available photosensitizers lack tumor selectivity which causes undesirable damage to normal tissues. In our PMN system, the activity of the photosensitizer can be self-quenched until it reaches the target tumor site where this suppression can be rapidly reversed by tumor pH stimulus, in particular intracellular pH stimulus, leading to a highly specific region of effect. HCT116 tumor-bearing mice injected with PMNs and then irradiated showed significant tumor regression relative to mice treated with InS-NPs or free Ce6 ( FIGS. 14 d and 14 e ). In particular, at 1 week post-injection, the tumors were almost completely destroyed with only scar tissue remaining. The enhanced antitumor effect was confirmed by hematoxylin and eosin staining (H&E) and terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) staining. These results clearly demonstrated that pH-targeted PDT using PMNs was successful in homogeneous HCT116 xenografts. [0122] In order to be a better match to clinical cancer treatment, the present inventors further demonstrated the therapeutic effect of PMNs in tumors of more heterogeneous and drug-resistant nature. The present inventors hypothesized the pH-targeting approach of PMNs would not be influenced by tumor heterogeneity, and since PDT kills by a nonspecific mechanism, drug-resistant cells are equally as susceptible as their naive counterparts. To test this hypothesis, the present inventors developed highly heterogeneous and drug-resistant CT26 tumors in mice. The heterogeneous CT26 tumors overexpress P-glycoprotein (P-gp), which is involved in the active efflux of anti-cancer agents, and stromal cell-derived factor-1 (SDF-1), which induces angiogenesis (CD31) ( FIG. 14 c ). Consequently, the CT26 tumors provided a physiologically relevant model of clinical tumors with a much faster growth rate than homogeneous HCT116 tumors. Notably, InS-NPs produced some minor tumor growth inhibition in both the homogeneous HCT116 and heterogeneous CT26 tumors ( FIGS. 14 f and 14 g ) compared to the untreated control. However, the heterogeneous model grows much more aggressively such that the positive effects observed for InS-NPs are still far too weak. In contrast, PMNs provided the same dramatic tumor destruction in both CT26-tumor-bearing mice and homogeneous HCT116-tumor-bearing mice ( FIGS. 14 f and 14 g ). In the PMN-treated group, many cells in the tumor tissue and microvasculature as well as fibroblasts showed considerable destruction, whereas no obvious damage was observed in groups treated with InS-NPs or Ce6 ( FIGS. 14 f and 14 g ). Therefore, pH targeting appears to play an important role in the improved anti-cancer therapeutic efficacy of PMNs. Consequently, for the first time, the present inventors successfully demonstrated treatment of drug-resistant heterogeneous tumor via pH-sensitive PDT, indicating PMNs can be applicable to various tumor treatments including highly drug-resistant heterogeneous tumors. Furthermore, no significant loss in body weight was observed throughout the PDT treatment ( FIG. 15 ), and a series of in vivo biocompatibility tests including a histopathology examination and serum chemistry test ( FIG. 16 ) demonstrated PMNs are highly biocompatible.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Pursuant to 35 USC §119, this application claims the benefit of and priority to German patent application no. 102016204481.8, filed on Mar. 17, 2016, which is herein incorporated by reference in its entirety. FIELD OF THE DISCLOSURE [0002] The present disclosure relates to a stripper device for reducing adhesions on a pressing apparatus interacting with a bale in an agricultural round baler. BACKGROUND [0003] Known stripper devices are frequently used on balers having movable parts that come into contact with baling material to be processed in the baler. The stripper devices have scraping bars that cooperate with the movable parts of the baler in order to counteract adhesions of baling material and other material such as dirt, soil, baling material residues etc., or to remove already existing adhesions or deposits. The movable parts are frequently pressing means in the form of straps or belts. Stripper devices are also known that correspondingly interact with rollers or cylinders of a baler. [0004] Such balers are used both in the agricultural field and in the industrial field. Corresponding agricultural balers are used, for example, to form crop bales, in the form of round bales for example, and frequently produce substantially cylindrical bales of crop in the form of straw, hay, chopped forage etc. Industrial balers are used for compacting trash, textiles or other materials and/or pressing them to form bales. [0005] Stripper devices for pressing means in the form of straps or belts are known, having a scraping bar carrier that bears a scraping bar and is movably mounted on a baler. Such stripper devices often do not work optimally, particularly under difficult harvesting conditions such as wet crop. SUMMARY [0006] The problem addressed by the disclosure is considered that of specifying a stripper device, a baler and a method of the type mentioned above by which the above-mentioned disadvantages can be overcome. [0007] This problem is solved by the teaching of one or more of the independent claims. Additional advantageous configurations and refinements of the disclosure are specified in the dependent claims. [0008] A stripper device for reducing adhesions to a movable component of a baler, such as a pressing means interacting with the bale, has a scraping bar carrier bearing a scraping bar. The scraping bar carrier is movably connectable to the baler and can assume at least a first position, in which the scraping bar is operatively abutted against the pressing means, and a second position, in which the scraping bar is withdrawn from the pressing means. It is conceivable that the scraping bar carrier can be displaceable or movable in some other manner. In some embodiments, it is pivotably connectable to the baler. It is provided that the scraping bar assumes the withdrawn position cyclically. The regular withdrawal of the scraping bar from the pressing means, which takes place in a cycle, counteracts a buildup of scrapings on the scraping bar, because the scrapings can fall off or down from the scraping bar as well as the scraping bar carrier or the stripper device itself during withdrawing or while in the withdrawn state, and thus when the scraping bar is in the state remote from the pressing means. Congestion and/or malfunctions of the type that can occur due to accumulation and clumping of material, particularly during wet conditions and/or with damp baling or crop material, can be effectively counteracted in this manner. This is also aesthetically advantageous. The baler is designed in the form of an agricultural round baler. The stripper device can also be used in other balers, for example, on industrial balers. The applications are also not limited to use in round balers. [0009] The pressing means is advantageously designed in the form of an endless pressing means, such as a pressing belt or strap and/or has at least one endless pressing means, such as a pressing belt or strap. There can also be a plurality of endless pressing means or, according to the one embodiment, two such endless pressing means. The pressing means can also be designed in the form of a roller or cylinder or in any other suitable manner, or can comprise these. [0010] It is conceivable that the cycle can be determined by a control or regulating device of the baler. The cycle can be determined by an assembly or by an assembly of the baler that already follows a cyclical process. A separate control or regulation of the stripper device can be avoided in this manner, since the cycle or the sequence is already defined by this assembly, the function thereof or the control or regulation thereof. The cycle or operation of the stripper device can also be synchronized with one or more assemblies of the baler in this manner, without having to take elaborate measures for this purpose. The cycle can be determined by a tensioning mechanism of the baler, such as a tensioning mechanism for the pressing means. [0011] The tensioning mechanism can have at least one tensioning arm, which can be connected directly or indirectly to the bale press so as to pivot or rotate and can interact with a tensioning element. During formation of the bale or after conclusion of the bale formation and/or during ejection of the bale, such tensioning arms can follow a substantially cylindrical movement process. If the tensioning arm is operatively connected to the scraping bar carrier, the scraping bar carrier can follow a movement of the tensioning arm at least in certain areas. In this manner, the cyclical movement process of the tensioning arm can be transmitted in a simple manner to the scraping bar carrier and/or at least partially synchronized or dependent pivoting can be implemented. [0012] It can be advantageous if the scraping bar carrier is provided to be jointly pivotable with an articulated lever about an axle on the frame. The articulated lever can cooperate via a connecting means with the tensioning arm. If the connecting means has at least one connecting element and a spring means interacting therewith, then these elements can function as overload protection by allowing the scraping bar to pivot away if there is an overload due to a stone or a particularly large or hard adhesion of material, so that damage to the stripper device can be avoided. Such a mechanism can alternatively or additionally be used to ensure contact of the scraping bar or to hold and/or maintain a predetermined tension on the pressing means. The operation of the stripper device can be further improved in this manner. [0013] It is conceivable to provide the scraping bar of a rigid material and/or integral with the scraping bar carrier. If the scraping bar is designed as a separate component, for example one that is detachably connectable to the scraping bar carrier, then it can be produced from a different material than that of the scraping bar carrier and/or can be exchanged in case of wear and/or damage, or can also be adapted to different harvesting conditions. Adjusting the position of the scraping bar relative to the scraping bar carrier is also possible in this manner. In some embodiments, the scraping bar is flexible, at least in certain areas, and can be designed in the form of a hard rubber strip or lip. [0014] It is especially favorable if a tensioning mechanism is provided, among other things, to maintain a specifiable tension of the pressing means during opening of the baling chamber and/or ejection of the bale, and/or to absorb slippage that occurs. It is also conceivable that the tensioning mechanism applies tension to the pressing means during the bale formation or in some other manner. [0015] If a baler is equipped with one or more of the previously described stripper devices, this can support the operation of the baler by precluding adhesions or deposits on one or more pressing means in an advantageous manner. The stripper device or one or more stripper devices can be arranged in an area of the baling chamber facing a drawbar. This arrangement can be favorable because the stripper device can be relatively well protected from external influences in this area. An arrangement in a different area, such as the rear area of the baler, is also conceivable. In some embodiments, the stripper device cooperates with an outer side of the pressing means, a side and/or surface facing away from the baling chamber or facing a frame of the baler in the embodiment shown. It is also conceivable for the stripper device to cooperate with the corresponding inner side of the pressing means, especially if the pressing means is designed as an endless pressing means, in the form of a pressing belt or strap for example, or comprises such a belt or strap. The baler can be an agricultural baler for forming cylindrical bales. The press can also be used in the industrial field, for example for forming bales of paper, trash, fabric or other materials. Use in a baler for forming cuboid or other bales is also possible. [0016] According to a method for operating a baler of the type mentioned above, the stripper device can cooperate with the pressing means during the formation of the bale in the baling chamber in such a manner that deposits that have adhered, for example to the outer side of the pressing means, can be removed at least partially by the stripper device or the scraping bar from the pressing means or the outer side thereof. During opening of the baling chamber to eject a bale or during ejection of a bale, the stripper device does not (continue to) cooperate with the pressing means, or the scraping bar is brought into a position withdrawn or distant from the outer side of the pressing means, in such a manner that previously stripped-off deposits can fall off the stripper device or the scraping bar. [0017] If the stripper device is operatively connected to a tensioning mechanism, which can provide an optionally specifiable tension of the pressing means and/or absorbs slippage possibly occurring while the baling chamber is being opened and/or a bale is being ejected from the baling chamber, the stripper device and/or one or more of the components thereof can follow the cyclical mode of operation of this tensioning mechanism in a simple manner. It is additionally conceivable that the tensioning device may have one/more alternative and/or additional functionalities. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The disclosure, as well as further advantages and advantageous refinements of the disclosure and configurations of the disclosure, will be described in more detail and explained with reference to the drawing, which shows an embodiment of the disclosure. [0019] Therein: [0020] FIG. 1 shows a side view of a baler having a stripper device, [0021] FIG. 2 a shows an enlarged view of the stripper device of FIG. 1 in a first position, and [0022] FIG. 2 b shows an enlarged view of the stripper device of FIG. 1 in a second position. DETAILED DESCRIPTION [0023] FIG. 1 shows an embodiment of a baler 10 , having a frame 12 that is supported via a chassis 14 on the ground 16 . The baler 10 shown is designed in the form of a round baler and can be used both in the agricultural field and in the industrial field for producing a cylindrical bale, typically referred to as a round bale, from crop material, but also from trash, paper, sheet material or fabric, cotton, tobacco etc. Such a baler 10 can be towed by a working vehicle, for example in the form of an agricultural tractor, not shown, or can be constructed to be self-propelled. [0024] According to the embodiment shown, a drawbar 20 is provided on the front side of the frame 12 in order to be able to hitch the baler 10 to an agricultural tractor, not shown, and tow it across a field. A receiving device 22 in the form of a pickup is used for receiving crop lying on the ground 16 , e.g. hay or straw deposited in a swath. The crop picked up by the receiving device 22 is fed to an inlet 24 of a baling chamber 26 and wound up there in a spiral shape to form a cylindrical bale, tied and subsequently deposited on the ground 16 . [0025] A lower stationary roller 28 and two upper stationary rollers 30 , 32 are positioned at the inlet 24 of the baling chamber 26 . The baling chamber 26 is additionally formed by an endless pressing means 34 , which is designed in the present embodiment in the form of two adjacent pressing belts side by side and is guided about a plurality of stationary rollers 36 , 38 , 40 , 42 and movable rollers 44 , 46 , 48 , 50 , 52 , 54 , 56 . The pressing means 34 has an outer side 34 a facing the frame 12 and an inner side 34 b. [0026] While the baling chamber 26 is surrounded peripherally substantially by the pressing means 34 and the rollers 28 , 30 and 32 , it is delimited laterally by side walls that are not shown. [0027] Four rollers 50 , 52 , 54 , 56 among the movable rollers 44 - 56 are mounted freely rotatably in a lower region 58 of a delta-shaped carrier 60 , which is pivotably articulated at its upper vertex 62 about an axle 64 running transversely to the forward direction and can be brought by an actuator (not shown) from the bale-forming position shown in FIG. 1 into a bale ejection position, pivoted upward and to the rear. [0028] A tensioning mechanism 66 for tightening the pressing means 34 has a tensioning lever 68 that cooperates with a first tensioning element, not shown, and a tensioning arm 72 that cooperates with a second tensioning element 70 . Both the tensioning element that is not shown and the tensioning element 72 can be designed in a conventional manner as, and/or can comprise, a mechanical spring or a hydraulic motor. [0029] The tensioning lever 68 is mounted in the region of the side walls, not shown, about an axle 74 running horizontally and transversely to the forward direction and bears, in an end region 76 facing away from the axle 74 , two of the movable rollers 46 , 48 and cleaning rollers 46 a , 48 a associated with these rollers 46 , 48 . The tensioning arm 72 is mounted correspondingly about an axle 78 and bears one of the movable rollers 44 in an end region 80 . In addition, the tensioning arm 68 is operatively connected at one end to the tensioning element 70 and at the other end to the baler or the frame 12 thereof, in a manner not shown. [0030] The pressing means 34 is pressed by the tensioning arm 70 sufficiently firmly against the rotationally driven stationary roller 38 that the pressing means is driven. The roller 36 is also driven rotationally. The pressing means 34 assumes an initial position, in which it spans, stretched in a straight line, the inlet 24 , and a final position, in which it wraps around the bale like a large loop. The baling chamber 26 is therefore variable in size, i.e. its diameter increases with the size of the bale 18 . The bale is located during formation thereof in the baling chamber 26 and is largely wrapped by the pressing means 34 , but falls out of the baling chamber 26 to the rear onto the ground 16 as soon as the carrier 60 is pivoted upward by the movable rollers 50 - 56 , counterclockwise as viewed in the drawing. Alternatively, the bale can also be deposited onto a device downstream of the baler 10 in the form of a device for wrapping the bale with a net or film of material. [0031] The embodiment of the baler shown here is disclosed in detail in EP 1 308 078 A1. Other possible embodiments are described in DE 198 51 470 A1, DE 102 41 215 A1 and EP 1 264 531 A1. The disclosures of these documents are incorporated by reference into the present documents. [0032] In a region 82 of the baler 10 that faces the drawbar 20 , a stripper device 84 is provided in order to be able to scrape off or strip off deposits or adhesions on the pressing means 34 or the outer side 34 a thereof, such as in the form of wet or moist crop such as grass, dirt or other material, for example, from the pressing means 34 or the outer region 34 a thereof. The stripper device 84 has a scraping bar carrier 86 and a scraping bar 88 . The scraping bar carrier 86 is pivotably connected via a joint 90 to a frame region 12 a of the baler 10 at one and, at the other end bears the scraping bar 88 , consisting, according to the present embodiment, of a flexible plastic material, which can be formed in the manner of a hard rubber strip or lip, for example. [0033] The reader is now referred to FIGS. 2 a and 2 b , in which the stripper device 84 is shown in further detail. The scraping bar carrier 86 is pivotably connected, together with an articulated lever 92 , to a region 12 a of the frame 12 via the joint 90 . The articulated lever 92 is in turn connected via a connecting element 94 and a connecting means 98 having a spring means 96 to a tensioning arm lever 100 , which is mounted pivotably with the tensioning arm 72 about the same axle 78 in such a manner that it can also pivot jointly with the tensioning arm. [0034] The mode of operation of the stripper device 84 will be dealt with in detail below. Reference is made for this purpose to FIG. 1 and FIGS. 2 a and 2 b. [0035] During the bale-forming process, the tensioning arm 72 assumes the position shown in FIG. 2 a , pivoted downward and to the right relative to the baling chamber 12 . After termination of the bale-forming process and a possible subsequent tying or wrapping with net or film material, a delta-shaped carrier 60 is pivoted backward and upward. The rollers 50 and 56 provided on the carrier 60 drive the pressing means 34 into exactly the same position, whereby the bale, previously surrounded in the baling chamber 26 by the pressing means 34 , is discharged from the baling chamber 26 by the pressing means 34 and deposited on the ground 16 or on a connected device such as a device for wrapping the bale with a net or film material. [0036] If the delta-shaped carrier 60 , and thus the rollers 50 , 56 mounted thereon and the pressing means 34 , pivot backward and upward, then the tensioning lever 68 begins to move back in the direction of its lower position shown in FIG. 1 . The tension of the pressing means 34 is briefly maintained by an upward movement of the tensioning arm 72 . Any slippage that may occur can thus be absorbed and/or prevented. The tensioning arm 72 pivots briefly upward about the axle 78 , whereby the pivot arm lever 100 pivots downward. This downward-directed movement is transmitted via the connecting means 98 to the articulated lever 92 , which brings the scraping bar carrier 86 , and thus the scraping bar 88 , downward, shown in FIG. 2 b , into the withdrawn position or, in other words, into the position remote from the pressing means 34 or the outer area 34 a of the pressing means 34 . In this position, the deposited material that may have been removed by the stripper device 84 or the scraping bar carrier 86 and/or the scraping bar 88 can fall downward. Then the tensioning arm 72 pivots back, due to the action of the tensioning means 70 , into its position shown in FIG. 2 a , in which it adjoins the outer region 34 a of the pressing means 34 . The spring means 96 can ensure in this position that the scraping bar 88 uniformly contacts the outer region 34 a of the pressing means 34 and/or can allow escape of the scraping bar 88 , the scraping bar carrier 86 and the articulated lever 92 in case of an overload produced in this area by a stone, highly compacted deposits or the like, for example. Damage to the stripper device 84 can be prevented in this manner and/or optimal function can be achieved.

1a

FIELD OF THE INVENTION The present invention refers to a system associated to a device applicable in opthalmology, developed to obtain an image of the retina and to carry out diagnosis of the fundus. BACKGROUND TECHNIQUE Conventional equipments projected to obtain fundus images are mainly based on a technique widely known and used in opthalmology, which predicts the wide and uniform lighting of the fundus wall, followed by frontal capture of the reflected light in this process. The light beam used for lighting should according to this technique, penetrate in the back portion of the eyeball through its periphery c region, allowing that the region near to the optical axis be free of intense lighting, in order to not contaminate with spurious lighting the reflected beam that returns bringing the image of the fundus. In order to achieve these objectives, it was adopted for the lighting beam, as more appropriate an annular form, since it has a cylindrical symmetry, so, allowing distribute the light beam on the whole circle of the pupil periphery. This annular beam must have its focal position adjusted in the iris region, which coincides with the pupil plan, and shows in this plan a diameter slightly less than the pupillary opening. However, said beam must also have a elevated divergence from its focal position, to reach the fundus with a wide and uniform energy distribution. The lighting beam should have necessarily an elevated intensity, so that a significant quantity of scattered light by the fundus returns through the pupillary opening, and be sufficient to sensitive the used camera. This is necessary because the fundus wall has the characteristics of a diffuse irradiator, working better as a scatter surface as a light-reflecting surface. The light reflectivity is a function of the surface properties, the incidence angle, and light wavelength, being more accented in higher wavelengths, near to the red visible limit. So, the fundus wall has a low inherent reflectivity. This necessary elevated intensity is another good reason that the lighting beam presents a ring form, because the excessive spatial concentration of the lighting beam energy would affect in a adverse form the intraocular medium, which it is formed by the cornea, anterior chamber, iris, lens and pupillary opening. The annular form provides a regular distribution of light energy on the whole extension of the peripheral line of the frontal part of the eye, even that it is considered that the line of light ring has a narrow width in its focal position. This method also allows a more uniform lighting of fundus by the cylindrical symmetry that the ring form provides. The geometry of the construction and the depth of focus should be adjusted in order to obtain the most wide and uniform possible lighting. The simultaneous capturing of the scattered light by the fundus portions undergone to this lighting is carried out, still according with this technique, with an optical system and a device to register the image. In some old equipment models the lighting beam has not the ring form, but a simple beam form that reaches the eye in the pupil periphery and projects the light straightly in a small region of the fundus. This beam has a small angle in relation to the eye optical axis, whereas the capturing is generally frontal. In these equipment models the inspection of fundus is carried out by regions, which increases the examination difficulty and increases the risk for the patient due to excessive intensity of a punctual beam. The anterior part of the eye and the intraocular medium have differentiated structures, in whose interfaces occurs an accented scattering of incident light, this is the principal reason for which the lighting must pass this region by its periphery and in a beam form as narrow as possible, to avoid possible scattering in these structures may contribute with undesirable light stains in the image fundus. The appearance of reflexes from the peripheral region is reduced because the annular beam reaches the cornea in a remote point of the optical axis, in which the incidence angle away from the normal to the surface makes that the principal reflection be launched far from of the optical axis, and out of the capturing lens. The means must have a part of its optical paths in common, due to an inevitable spatial superposition of both beams in the intraocular medium and in the region immediately in front of the eye, causing that the capturing lens should capture the light coming from the fundus and focalize the lighting beam in the pupil plane. The most used solution in order to combine said optical means, is to put between the capturing lens and the others means components, an oblique mirror having a central hole, which function is allow the partial sharing of the optical axis by both optical means, so that the capturing beam passes by the central hole of the mirror and propagates backwards, while the lighting beam fall on obliquely on the mirror being reflected from that to the eye. The mirror position is calculated in order to be in the focus of a primary and real image of the light ring projected by a first optical set of the lighting means, and also be conjugated to the iris position by the capturing lens. The image formed in the mirror by the first optical set is generally produced by placing two screens shutters in the same plan, one circular and other with a circular hole, whose diameter is a bit higher than the first one. The first optical set of the lighting means must be used to focus the ring in a position near to the mirror plan. As the lighting should be intense and sufficient to that the reflected light by the fundus be above of the threshold sensibility of the image sensor, and as the intensity of the return beam is less than the intensity of the lighting beam, it is essential remove the reflections of the most intense beam. The principal reflections take place in the cornea, in the eye internal interfaces and in the lenses used in common by the two optical means, because the reflected light may contaminate the capturing beam, causing stains and brighten points in the image, besides elevating the bottom intensity level of the image. The basic proceeding adopted to remove the reflections in this model, is the use of polarizers placed in the lighting and capturing means, in that the polarizer of the capturing means is orientated perpendicularly to that placed in the lighting means, that is, the fundus is illuminated by polarized light and the capturing means receives light only with crossed polarization. The polarizer of the lighting means is constituted of an object with an annular form, with dimensions slight bigger than the thickness of the ring light, and placed in front of the outlet end of the optical fibers arrangement. The technique is based on a physical principle that establishes the properties of light interaction with the material means, and defines the effects on the light in accordance with the characteristics of the material. The materials which surface is polished, or smooth, reflect light with higher efficiency, because the most part of the bright energy is reflected by an angle equal to the incidence angle, in a so called situation of speculate reflection, while materials with rough, or wrinkled surface, reflect light in a diffuse way, scattering the incident radiation in a wide angular band. These phenomena have consequences on the polarization of incident light, so that the speculate surfaces reflect light with polarization almost equal to the incident light, at least for angles near to normal, while the diffuse surfaces not polarizes the incident radiation, reflecting light with random polarization. This physical process establishes a criterion to distinguish the light originating from the fundus from that originated by reflections coming from speculate surfaces of the eye and from the optical means, since the crossed polarizer of the capturing means blocks all light with parallel polarization to the lighting beam, allowing that only the light with perpendicular, or orthogonal polarization, to the lighting beam, passes. The capturing beam has a considerable fraction of light that passes by the polarizer, since its polarization has a random distribution, and so, always has a parallel component to the polarizer direction. To reach efficiency the system must be optimized so that the light beams pass the most lenses surfaces in angles near to a normal of the surface, so that the polarization phenomenon by reflection does not affect the system, since this phenomenon is characteristic of angles near to Brewster. There are varied light source used in the construction of lightning means, such as incandescent lamps and halogens, which have a wide spectral band and relatively high intensity in wavelengths in the visible band, from infrared and of ultraviolet. Tungsten incandescent lamps are more stable and have more simple operation, while the halogen lamps support better a continuous operation regime. The spectral curve of halogen lamps is shifted for shorter wavelengths in relation to incandescent lamps, presenting a reasonable intensity in the ultraviolet band, although this curve vary during the use, its intensity remains quite stable. The fluorescent light, as the high-pressure xenon, also having a wide spectral band are used in more complex and expensive equipments. All these lamps present common difficulties, as the excessive divergence of irradiated light that makes necessarily the use of diaphragms, the low energetic efficiency accompanied by high heat dissipation, and the compulsory placing of filters to cut undesirable wavelengths in determined examinations. The divergence makes difficult the beam collimation and the efficiency in the capturing of emitted energy, producing not uniform lighting in the fundus if the optical means is not well corrected. The necessity of illuminating a wide region in the fundus demands a light source with a relatively big emission surface, positioned in the focal point of the lighting means, due to placing of screens shutters, also big, with the ring form. The light emitting diodes (LED) and laser diodes also can be used alternatively as light source, since they present less divergence in the light emission. But the predominant necessity of wide spectral band and elevated intensity makes difficult the option for these components. The use of light emitting diodes (LED) is extremely advantageous as a low cost option for multiple images acquisition, using the light pulses (flashes) synchronized to the acquisitions, because the others light sources demands an excessive wait time for the electronic reload. SUMMARY OF THE INVENTION With the objective in overcome the above-described drawbacks, its is provided, according to the present invention, a system to obtain a fundus image constituted basically by two different optical means, called lighting means and capturing means, which has coaxial optical paths and partially superimposed. The lighting means has the function in projects in the fundus a light beam that will be scattered in all directions by the structures of the fundus wall. While, the capturing means has the function in registers the retina image and other structures of the fundus wall, capturing a reflected light portion that emerges from the pupillary opening. The two mainly optical means which compose this equipment are supported by structures and mechanical devices, fixed and adjustable, and by electric and electronic circuits, servomechanisms, computer and software, which are used for controlling the equipment, data acquisition, images processing and displaying the results. Said lighting means projects a light beam which cross section has a fine ring form of light in the pupil passage, but presents divergence from this point, reaching fundus with a uniform distribution of energy. This light ring must pass the pupil plan with a diameter slightly less than the pupillary opening, so that the circle of the ring is adjusted in said opening with the ring line going through its periphery. The ring focal position coincides with the pupil plan making the circular line of the ring as narrow as possible in this plan. The capturing means includes an optical set as a Kleperian astronomical telescope shaped in the situation of conjugated infinite, characterizing an afocal optical system. This mean is made by a set of capturing lenses placed immediately in front of the eye to be examined, and a set of lenses that work like its afocal complement. The afocal optical system transmits the fundus image to a high sensibility digital camera made with a focal lens in front of an image sensor, in which the optical elements of the focal lens are placed in a mechanical adjustable device, which allows optimizing the image focus exactly on the image sensor. Considering that the eye optical elements itself contribute to the capturing means, the composition of the afocal system with the eye, works exactly like an altered system of an astronomical telescope associated to the eye of the observer, with the difference that in this case the fundus is not the receiver of the image, but the object to be observed. The lighting and capturing optical means follows to known principles in opthalmology, which establishes that there must be a partial superposition of lighting and capturing beams, since the optical elements of the eye contribute to both means. Besides, in order to obtain a uniform lighting of the fundus and a frontal capturing of the returned image, it is convenient that the optical axis coincide and the capturing lens be used like a common element to the two main optical means of equipment. All these requisites lead to geometry with cylindrical symmetry for the system set. Said lighting means also presents a common architecture in the equipments existing in the market. However, it includes an innovation developed for the present invention, the use of a specific optical fibers geometrical arrangement simplifying its construction and alignment. Said optical fibers arrangement has excellent coupling to the light source in one end of the fibers, a light emitting object with a ring form in another end and an opening for passage of capturing beam by the center of this ring. The spurious reflections presents in the image are removed using light polarizers, used in the two means. The polarizers placed in the capturing and lighting means are disposed orthogonal, that is, the polarizers have crossed directions. This arrangement of the polarizers reduces with great efficiency the light originating from reflections in the lenses of the optical system and in the interfaces of the eye itself, like the cornea, and represents another innovation in this invention. The appliance set is supported in a mechanical device suited in a table with adjustable height, in order that the equipment can be positioned in the best situation for examination, there is a support and fixation structure for the patient head, which allows a quick placing of the eye in examination through a gauntlet that makes possible the movement of the equipment set in the horizontal plan and in the vertical direction, besides rotation on the axis that passes vertically by the center of the eye. The optical axis of lighting and capturing beam must be near to the optical axis of the eye during the examination. The optical, mechanics, electronic, and computational resources, besides the applicable program incorporated to the equipment set allow its configuration in four operational ways and the realization of four different types of opthalmologic examinations. Through the selection of optical filters, with specific passages bands, that can be inserted in the optical paths of lighting and capturing means, it is possible to enable the equipment for differentiated examinations, with the optical system that allows a complete mapping of fundus with good quality images, besides be quickly, easiness and operational comfort. The device herein proposed, on the contrary of the conventional models, uses a projector made with an optical fibers bundle molded in a single piece, which it is placed between the light source and the capturing lens in substitution of the holed mirror, which is expendable in this model, since that the optical fibers outlet is adapted in the ring form. Besides the mirror, the set of lenses for the formation of the primary image also becomes expendable, since the optical fibers outlet itself is the object to have its image projected. This formed piece substitutes with advantage the optical systems and screens shutters generally used in order to project the ring. The other end of this fibers optical bundle is molded in a terminal with excellent coupling on the light source, which increases considerably the efficiency in inserting the light in the fiber, and the use of the bright energy of the lamp using a simple parabolic mirror system and lenses that focus the light emitted by the halogen lamp to the inlet end of an intermediary optical fiber, which drives the light from the source to the optical fibers arrangement. The advantage of this system is that the new light emitting object, the optical fibers ring, has light points with reduced dimensions, small divergence and Gaussian angular distribution in the beam intensity, allowing the reduction in the size of the projector, and makes the collimation and beam focusing more simple, besides provide a more fine beam and with great brightness. The line of light obtained is much more fine, avoiding the use of circular diaphragms in the system, and the presence of a oblique branch of lighting beam. The simplicity achieved with this arrangement practically removes any difficulty in the optical alignment of the system making the equipment compact, reduced, light and with great impact resistance. The system emits light in a safe power level and appropriate to each used wavelength, and with spectral band defined for each type of examination, selected through insertion of the respective sets of filters in the optical paths of each mean. These instruments are configured to carry out up to four types of different opthalmologic examinations, and are destined to obtain basically images, which after processed allow to determine the characteristics of the retina, its blood vessels and many others details of fundus. The system for obtaining a fundus image, object of the present invention, accomplishes to the requisites and concepts presented previously, and add innovations that make easy its implementation and perfect its performance. DETAILED DESCRIPTION OF THE DRAWINGS Other objectives, characteristics and advantages of the system for obtaining an fundus image, subject of present invention, will be more apparent from the detailed description, according the drawings as follows: FIG. 1 —is a schematic representation of the technique presenting the basic principles used in the construction of the system; FIG. 2 —Shows a detailed lateral view of lighting means and of the eye in examination; FIG. 3 —Shows a detailed lateral view of capturing mean and of the eye in examination; FIG. 4 —Shows details the arrangement in ring form built with optical fibers; FIG. 5 —Shows details of the ends of optical fibers arrangement, where occurs the coupling to the light source and the emission of the beam in a ring form; and FIG. 6 —Shows a lateral view of the system, showing the fixed base, the adjustable tower, the support base of the chin, the table and the gauntlet that allow the adjust of the patient eye. DETAILED DESCRIPTION OF INVENTION As showed by figures, where identical numeric references identifying equivalents parts, the system for obtaining a fundus image, object of present invention is constituted basically by two different optical means, which are typical of a retinograph, and called lighting means and capturing means. These means are described separately and present optical coaxial paths 1 , with the superposition in a passage of its distances between the fundus 16 and the arrangement outlet end of the optical fibers 7 . The optical means are implemented in a equipment that has mechanical structures, fixed and adjustable, to support the components, besides electronic circuits, computer and applicable program, used for control the equipment, images acquisition, image processing and displaying the results. The first optical mean has the function to illuminate the fundus with a light beam that, must present two essential characteristics, whereas the first characteristic is to pass the frontal part of the eye by its peripheral region, while the second characteristic is to reach the fundus with a uniform distribution of energy. The requisite that the beam trajectory is contained exclusively in the peripheral region of the frontal part of the eye has the objective in avoid the reflection and light scattering in the intraocular medium, leaving the pupil central region free of intense lighting. The second optical means has function in capturing the image produced in the lighting process being constituted by two lenses sets and a high sensibility digital camera. These lenses sets form a system characterized like an altered afocal telescope, in that the first set is called of capturing lens, or eyepiece, and the second set is constituted by its lens, working like the afocal complement of the capturing lens. The FIG. 1 shows the used technique showing a complete scheme of the two main optical means, and its basic working principles, whereas the elements 7 , 8 , 9 , 10 , 11 and 13 correspond to the optical components of the principal part of the lighting means, and its optical axis 1 . The elements 14 , 15 and 16 represent the eye being deeply illuminated; with the beam reaching the fundus wall 16 , after passes by the frontal part of the eye 14 , which includes the cornea, anterior camera, iris, lens and pupillary opening 15 . The complete capturing means includes the elements 2 , 3 , 4 , 5 , 6 , 8 and 13 herein represented by the digital camera 2 , 3 ; and by capturing lens, or eyepiece of the mean 13 , its afocal complement, or means lens 6 , optical set of filters 5 and light polarizer 4 , which proceed the image acquisition formed by the light reflected on the fundus 16 . The camera is constituted by a focal lens 3 , which registers the image formed on a CCD image sensor type 2 . The optical axis 1 common in both optical means must be adjusted during the measure proceeding in order to approximately coincide with the optical axis of the eye in examination 14 , 15 , and 16 . Also in the FIG. 1 there are the distances that define the plans of the pupil 15 and the arrangement outlet end of the optical fibers 7 as conjugated distances by actuation of the capturing lens 13 , when considered as an integrant element of the lighting means. However, when considered as an integrant element of the capturing means, the capturing lens 13 collects the light that goes out from the pupil 15 and a fundus primary real image 12 is formed between this capturing lens 13 and the passage orifice 8 of the capturing beam, in a position 12 that can present a small variation depending on the patient eye diopter 14 , 15 , 16 . Said primary real image 12 , is focused on the image sensor 2 , by the afocal system lens 6 together with camera focal lens 3 , after the capturing beam passes the orifice 8 of the optical fibers arrangement 7 , 8 , 9 , 10 . It should be observed that the eye optical element 14 acts together with the capturing lens 13 in the formation of the primary real image 12 . In the FIG. 2 it is shown in details, the complete lighting means in a lateral view, whereas the used technique in this means is shown up, in that an annular light beam is produced to penetrate the eyeball 14 , 15 , 16 through the periphery of the eye anterior part 14 and illuminates uniformly the whole extension of the fundus 16 . The called optical fibers arrangement is obtained from a piece 7 , 8 , 9 , 10 made with a bundle of optical fibers 9 shaped in a curved geometrical form and lengthened, been like a pipe, which ends 7 and 10 are fixed by steel rings, in order to obtain the coupling of the light source at the end 10 , a light emitting object with ring form at the end 7 and an opening 8 for the passage of the capturing beam by the centre of this ring. The annular beam is projected from the fibers outlet end 7 passing the light polarizer 11 , also in a ring form, in order to not obstructing the orifice 8 , whereas the capturing beam passes. The light source used in this specific projector is a halogen lamp 23 coupled to the entry end 21 of an intermediary optical fibers bundle 19 , 20 , 21 associated to a concave mirror 22 , which has the function in focusing the maximum possible amount of light emitted by the lamp in the entry of the fibers bundle, considering the diameter of these fibers and its numerical opening. The intermediary optical fibers bundle 19 , 20 , 21 , has the outlet end 19 coupled to a entry end of the optical fibers arrangement 10 , with the set of condensing lenses 18 , whose function is focuses the light emitted by the intermediary bundle in the entry of fibers arrangement by coupling its respective numerical openings and diameters. Said halogen source 23 , emits light in a wide specter of wavelengths, including the ultraviolet band, all near the visible and near infrared, optical filters are used to blockade the ultraviolet band. The intermediary couplings between the halogen lamp 23 and the entry end 10 of optical fibers arrangement 9 were designed in order to maximize the light entry in the said optical fibers 9 and homogenize the distribution of light along the line of the ring formed in the optical fibers outlet end 7 . The optical filters set 17 of the lighting means is positioned immediately before the optical fibers arrangement 7 , 8 , 9 , and 10 . It is possible through mechanical adjusts set the focal distances and placing the couplings ends between the optical fibers bundles 9 , 20 , in order to allow the maximum insertion of energy in the fibers. Alternatively, it can be used as a light source, a set of light emitting diodes (LED) covering a wide band, which would allow the midriatic use, in that the fundus is illuminated by a set of infrared LED's. In order to obtain a colorful fundus image or “Red Free”, with visible radiation, the LED is blinked quickly, offering more comfort to a patient. Said means projects an annular light beam relatively intense, when compared with the quantity of light that returns reflected by the fundus 16 , in the same optical path 1 , which represents a small fraction of the intensity of the lighting beam. The beam has the form of an extremely fine ring in its passage by the pupil 15 , with a diameter slightly less than the pupillary opening and approximately concentric to the optical axis of the eye. As observed in the FIG. 2 , in a lateral view, this light beam been emitted peripherical in the outlet end 7 of the optical fibers arrangement, reaching the capturing lens 13 , being focused in the circle that defines the periphery of the pupil 15 , and diverging from that, in order to illuminating uniformly the fundus 16 . The FIG. 3 shows in details a lateral view of the complete capturing means formed by elements 2 , 3 , 4 , 5 , 6 and 13 , that should capture and register a good quality image of fundus 16 . The capturing lens 13 is placed against the eye in examination 14 , 15 , 16 , and should receive the whole light that passes by the pupillary opening 15 bringing back from the fundus 16 , subtended by an angle less than 22.5° of semi-opening, while the afocal lens 6 , projects in front the afocal beam produced. The capturing lens 13 must be positioned quite near and in front of the eye 14 , 15 , 16 , so it is necessary that said capturing lens 13 , be a common component to the two optical means, and that combines the two beams in a unique optical path whose axis 1 coinciding. The most appropriate construction to become the beams be coaxial, is that the capturing beam passes by the ring orifice 8 formed by the optical fibers arrangement 7 , 8 , 9 , 10 proposed in this technique. The functional project of the capturing lens 13 and of central orifice 8 of the optical fibers arrangement must be satisfactory to the requisites of these two means simultaneously. The digital camera 2 , 3 that also composes the capturing means is constituted by a set of lenses that form the camera focal lens 3 , which project the fundus image 16 on a sensor 2 made with a matrix of photosensitive elements. In the capturing means, the set of optical filters 5 and the light polarizer 4 are strategically positioned between the afocal system 6 and 13 and the camera focal lens 3 , because in this region the rays of the capturing beam are parallel having just surfaced the afocal system. The focusing lens set 3 of the image, placed in front of the image sensor 2 , as well as the lens 6 of the afocal system, do not interfere in the performance of the lighting means since they are not in the same optical path. The system magnification is maintained fixed by the self-characteristics of the afocal system 6 , 13 , whose lenses are maintained rigidly in its positions, in that important bonds of the system are not altered. However, the focuses adjust in the focal lens of camera 3 produces a small alteration in the magnification. The FIG. 4 a shows an inferior view of the optical fibers geometrical arrangement 7 , 8 , 9 , 10 . The FIG. 4 b shows a frontal view of the optical fibers geometrical arrangement 7 , 8 , 9 , 10 and an opening e in the optical fibers bundle, The FIG. 4 c shows a lateral view of the optical fibers geometrical arrangement 7 , 8 , 9 , 10 and an opening e in the optical fibers bundle, The FIG. 4 d shows a superior view of the optical fibers geometrical arrangement 7 , 8 , 9 , 10 . The fibers of the bundle, in the figures above mentioned, are configured in a geometrical curved and lengthened form, producing a piece 9 that is likened to a pipe, where in the outlet end 7 , or superior, the fibers are positioned side by side, forming a fine and circular line, while in another extremity of the piece 10 , or inferior, the fibers are accumulated on an intense light source. The optical fibers arrangement has an optimized geometry to capture the maximum of light in its entry end 10 and conformed to produce a light ring in its outlet 7 , by placing of the fibers side by side, in a circular line with diameter of 7 millimeters and with a line width from 50 to 200 microns, since they are formed by fibers of this diameter. The FIG. 5 a , shows the frontal view of the outlet end, of the optical fibers arrangement, with an opening e of optical fibers bundle, details of the endings of the fibers bundles, in that the outlet end of the bundle with the fibers aligned side by side form a ring. The FIG. 5 b , shows a frontal view of the entry end, in that the bundle end entry with the fibers is accumulated around a point. The FIG. 6 shows a lateral crossed view of the system integrated and mounted on its compartment. The system has a fixed base of sustenance from which it is possible to adjust the body of the system with the projection and capturing means. These means are mounted in a sliding base in the body of the system, in the horizontal plan when in images acquisition operation. The system can be configured in four operational ways that carry out four types different of opthalmologic examinations, increasing its applicability. The selection of the spectral band of work is effectuated by a specific combination of optical filters in accordance with the type of examination to be carried out. The optical means of lighting and capturing were optimized to correct aberrations, mainly the chromatic aberration in the band between the blue and the infrared, between 400 and 950 nanometers, due to four types of examinations that will be effectuated. Which are: examination with normal colorful image, also called colorful retinography or “color”, where light polarizers are used and a combination of optical filters which allow lighting and capturing in the whole range of the visible; examination with absence of red light, called aneritry retinography or “red free”, also with the use of light polarizers and combination of optical filters which promote lighting with green light and capturing in the whole range of the visible; examination called fluorescein angiography, in that is used the property of fluorescence of this substance, which injected in the blood current makes possible an accented contrast of the image obtained in examination of the superficial blood vessels fundus, when filters are used for projection of blue light and capturing of light in the green-yellow band; and examination in the infrared band, so-called indocianine green (ICG), where the property of fluorescence is used in the infrared band of this substance, which injected in the blood current makes possible a contrast accented in examination of the deep blood vessel fundus, when filters are used for projection and capturing of infrared light, respectively in different bands of wavelength, in that this examination allows a deep examination of the choroids since the retina is semitransparent to the infrared. The Program that controls the acquisition and processing of images, besides displaying results obtained from the images, also was developed for the scheme of operational compatible mode with the configurations described above. This program (software) allows, from each digital image produced and its processing, obtain points to outline the profile of anomalies present in the retina and in the structures of the wall fundus, resulting in the determination of its form and dimension, including dimensional measures for diagnosis. The equipment handling has total operational comfort because it is portable and suitable to be placed where it will be more convenient for the execution of the work. The appropriate adjust to the patient eye is carried out through a gauntlet.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of provisional application Ser. No. 60/029,039, filed Oct. 28, 1996. FIELD OF THE INVENTION The present invention relates to polymer-associated liposomes (PALs) and their method of preparation, to drug compositions containing a PAL and a drug, and to the administration of the drug compositions to individuals. More particularly, the present invention relates to a new drug delivery system comprising a PAL, wherein the PAL contains a liposome that is noncovalently bound, i.e., is complexed, to an anionic polymer having a plurality of acid moieties in a salt form. A PAL is prepared by interacting the anionic polymer and a liposome, in an aqueous medium, to form a liposome/polymer complex, isolating the complex in water from an organic solvent, and rehydrating the complex to form the PAL. The PAL can be incorporated into a variety of drug compositions, including liquid and solid phase drug composition, for administration of a therapeutic agent orally or by injection. BACKGROUND OF THE INVENTION It is well known that modern day drugs are very efficacious with respect to treating acute and chronic diseases. However, several diseases, and especially chronic diseases, are associated with complications that are not treated by administration of the drug. For example, the standard treatment for diabetes is administration of insulin. An individual suffering from diabetes does not produce sufficient insulin, and hence the individual cannot burn and store glucose. Diabetes cannot be cured, but diabetes can be treated by periodic injections of insulin. FIG. 1 shows that serum insulin levels rise from a low fasting value to a peak after about 30 to 60 minutes, then fall back to a low value after about 120 minutes. In mild diabetics, the rise in serum insulin is lower compared to normal individuals. In severe diabetics, no insulin is produced, and the rise in serum insulin levels is negligible. As a result, excess glucose accumulates in the blood of a diabetic, which can result, for example, in a loss of weight and loss of strength. However, insulin injections to treat diabetes do not treat, or alleviate, the serious vascular complications associated with diabetes, including nephropathy, retinopathy, neuropathy, heart disease, and reduced blood circulation in the limbs, i.e., "diabetic foot," that can lead to gangrene. Another disadvantage with respect to the present therapeutic compositions used to treat diabetes is that insulin must be injected. Insulin cannot be administered orally because insulin is destroyed by the strong acid conditions of the stomach. Therefore, it would be advantageous to develop a method of both treating a disease, and preventing or reversing complications associated with the disease. It also would be advantageous to develop easier methods of administering a drug to treat the disease. As set forth in detail hereafter, the present invention is directed to novel PALs, and to drug compositions containing a PAL and a therapeutic agent, i.e., a drug, to reduce, eliminate, or reverse complications associated with a disease. The present invention is further directed to a method of manufacturing a PAL, and to improved drug delivery systems for administering difficult to administer drugs, like insulin. With respect to diabetes, glycosaminoglycans (GAGs) are a class of negatively charged, endogenous polysaccharides composed of repeating sugar residues (uranic acids and hexosamines). GAGs have been shown to bind a variety of biological macromolecules, including connective tissue macromolecules, plasma proteins, lysosomal enzymes, and lipoproteins. In addition, exogenous GAGs have been shown to bind to the cell surfaces of a variety of different cell types, including liver cells (hepatocytes), fibroblasts, and importantly, endothelial cells. Exogenous GAGs therefore can be internalized. Furthermore, GAGs have been implicated in the regulation of cell proliferation and in cell-cell communication, shown to interact with cell-surface receptors (cell adhesion molecules), and shown to modify the behavior of cells in culture. In addition, GAGs were shown to be highly potent, selective inhibitors of HIV replication and giant cell formation. These findings suggest that exogenously administered GAGs have the potential to target a variety of important in vivo sites. GAG-receptor interactions are characterized by the formation of noncolavent, self-assembling macromolecular complexes. These transient, interpoly-electrolyte complexes mediate many biological functions including enzyme-substrate binding, antigen-antibody interactions, leukocyte-endothelial cell adhesion events, drug-receptor binding, and protein--protein interactions. Furthermore, secondary binding forces, such as hydrogen bonds, vander Waals forces, and hydrophobic interactions, govern interpoly-electrolyte formation, and, ultimately, influence the resulting pharmacologic response to the complex. G. Gambaro et al., Kidney Int., 46, pages 797-806 (1994) discloses that exogenously administered GAGs have a favorable effect on morphological and functional renal abnormalities in diabetic rats, and appear to revert established diabetic renal lesions. Furthermore, D. M. Templeton, Lab. Invest., 61 (2), pages 202-211 (1989) and C. W. Marano et al., Invest. Ophthalmology Vis. Sci. , 33 (9), pages 2619-2625 (1992) disclose that diabetic patients have a decreased glycosaminoglycan content in glomerular basement membranes. Additionally, an increase in total GAG serum levels in diabetic patients was disclosed in K. Olczyk et al., Acta Biochimica Polonica, 39, pages 101-105 (199). The authors observed an increase in protein-bound GAGs, such as keratan sulfate, hyaluronic acid, heparin sulfate, and heparin in diabetic patients. Gambaro et al. also discloses an increase in the urinary excretion rate of GAGs from insulin-dependent diabetic patients. Therefore, publications show that glycosaminoglycans play an important, yet unexplained, role in the vascular changes associated with lifelong insulin therapy. In particular, administration of GAGs to diabetic animals has inhibited or reversed some vascular abnormalities. The publications also strongly suggest that exogenous insulin plays a role in elevating the level of GAGs in the urine and serum of diabetic patients. Furthermore, the publications clearly show that glycosaminoglycans bind to a multitude of biological macromolecules, including proteins. These observations appear to suggest utilizing glycosaminoglycans as an adjuvant to insulin therapy. However, GAGs are anticoagulants and long term use of GAGs with insulin would thin the blood of an individual to unacceptable levels. Furthermore, the risks associated with a long term use of GAGs are unknown. In addition, GAGs are heterogeneous, having a relatively wide molecular weight range of about 8,000 to about 20,000, and accordingly are difficult to reproduce. Therefore, although persons skilled in the art have used GAGs as therapeutic agents, e.g., heparin, GAGs have not been used for extended periods of time, or for the treatment of a chronic disease, like diabetes. The present invention is directed to finding drug delivery systems that provide the benefits of a drug-GAGs complex, but that avoid the disadvantages associated with long term administration of a GAG compound. SUMMARY OF THE INVENTION The present invention is directed to a novel drug delivery system, wherein a liposome is complexed, noncovalently, with an anionic polymer having a plurality of acid moieties in a salt form to form a PAL. A PAL is formulated with a drug or a therapeutic agent to provide a drug composition that treats an underlying disease, e.g., insulin to treat diabetes, and also treats complications associated with the disease, e.g., prevent or reverse the vascular problems associated with diabetes. The present PALs can be formulated with either water-soluble or water-insoluble drugs, or both. Therefore, a drug composition containing a PAL and a drug can be administered in a variety of dosage forms. Furthermore, because different anionic polymers have an affinity for different specific cell surfaces, site-specific drug delivery can be achieved by a proper selection of the anionic polymer of the PAL. More particularly, the present invention is directed to a polymer-associated liposome (PAL) containing a liposome and an anionic polymer having: (a) a plurality of acid moieties in a salt form, and (b) a weight average molecular weight (M W ) of about 1,000 to about 1,000,000. The liposome comprises a phospholipid, like lecithin, for example. In accordance with an important aspect of the present invention, the PAL contains a liposome that is electrostatically bound to, or complexed with, the anionic polymer, as opposed to forming a covalent bond between the liposome and anionic polymer. The anionic polymer contains a plurality of acid moieties, in the salt form, to achieve complexation with the liposome. The free acid moiety of the polymer can be a carboxyl group, sulfate group, sulfonate group, phosphonic acid group, phosphoric acid group, phenolic group, or a similar acid moiety. In the preparation of a PAL, the acid moieties of the anionic polymer are present predominantly in the anionic, or salt, form, as opposed to the free acid form. Preferred drugs used in a drug composition containing a PAL are polypeptides, genes, or proteins. Therefore, one aspect of the present invention is to provide a PAL wherein the anionic polymer is a naturally occurring polymer or a synthetic polymer. Another aspect of the present invention is to provide a PAL containing a liposome and an anionic polymer in a weight ratio of liposome to anionic polymer of about 80 to about 20 to about 95 to about 5. Yet another aspect of the present invention is to provide a drug composition containing a drug and PAL, wherein the composition can be administered to an individual in a liquid form either orally or by injection. Still another aspect of the present invention is to provide a drug composition containing a drug and a PAL in a lyophilized form, such that the drug can be administered to an individual in a solid form. Such a solid composition is especially useful for the oral administration of a drug to an individual. Another aspect of the present invention is to provide a drug composition containing a drug, i.e., a therapeutic agent, and a PAL that can be administered to an individual to treat an acute or chronic disease and to alleviate, eliminate, or reverse complications associated with the disease. In preferred embodiments, the drug is a gene, insulin, methotrexate, isoniazid, chloroquine phosphate, a polypeptide, or a protein. Another aspect of the present invention is to provide PALs that remain intact and do not dissociate in the vascular system shortly after administration, and that are capable of releasing the drug over time in vivo to treat a disease. Yet another aspect of the present invention is to provide a drug composition containing a drug and a PAL that is site specific for improved delivery of the drug and improved treatment of the disease of concern. Another aspect of the present invention is to provide a PAL containing liposome comprising a phospholipid having a quaternary ammonium nitrogen atom, and a salt form of a polymer selected from the group consisting of polyvinylsulfonic acid, polyacrylic acid, polyvinylphosphonic acid, and mixtures thereof. Yet another aspect of the present invention is to provide a drug composition containing insulin and a PAL that treats diabetes and that prevents, alleviates, or reverses vascular complications that are associated with diabetes and that are left unchecked by conventional insulin formulations. One other aspect of the present invention is to provide alternate routes of administration for the safe, easy, and effective delivery of a drug to a specific target site, especially to provide an oral route of administration for the drug. These and other novel features and aspects of the present invention will become apparent from the following detailed description of the preferred embodiments. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plot showing insulin levels (μU/mL) over time (minutes) for normal individuals and diabetics; FIG. 2 is a plot of lipid-bound polymer concentration (mg/mL) vs. concentration of polymer (mg/mL) added to a liposome; FIG. 3 is a plot of lipid-bound polymer concentration (mg/mL) vs. incubation time (hrs.); and FIG. 4 is a plot of relative fluorescent intensity vs. time (min.). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS It is well known that a wide range of biological functions are mediated by the formation of noncovalent, macromolecular complexes. Examples include enzyme-substrate binding, antigen-antibody interactions, leukocyte-endothelial cell adhesion events, drug-receptor binding, and protein-protein interactions. However, utilization of macromolecular complexes as drug delivery systems is relatively new and uninvestigated. The present application discloses a novel drug delivery system which utilizes a PAL containing a liposome and a naturally occurring or synthetic anionic polymer. The PAL is useful for the oral, parenteral, sublingual, transdermal, conjunctival, intraocular, intranasal, aural, intrarespiratory, rectal, vaginal, or urethral delivery of therapeutic agents. The therapeutic agent can be, for example, but not limited to, genes, peptides, proteins, antibacterials, antifungals, antineoplastics, antiprotozoals, antiarthritics, and antiinflammatory agents. In a preferred embodiment, the therapeutic agent is a gene, a polypeptide, or a protein. In especially preferred embodiments, the therapeutic agent is insulin. As will be discussed in detail hereafter, the physicochemical properties of the present PALs were investigated. The interactions of liposomes with anionic polymers were monitored using particle size analysis, and by zeta potentials. The physical evidence confirmed the presence of a PAL, wherein an anionic polymer is electrostatically associated, i.e., noncovalently complexed, with a liposome. In accordance with an important feature of the present invention, the anionic polymer is intertwined through the bilayer structure of the liposome, and, accordingly, is present on the external surface of the liposome, the internal surface of the liposome, and within the phospholipid bilayer that forms the liposome. Analysis of an aqueous suspension of a PAL indicated that the physicochemical properties of a PAL are different from a conventional liposome mixture and from a liposome that is surface coated with an anionic polymer. Furthermore, data indicates that PAL formation results from kinetic and thermodynamic equilibria. These studies show that a PAL is well suited for oral delivery of therapeutic agents. The following discussion is particularly directed to PALs containing a liposome prepared from lecithin and an anionic polymer based on a salt form of polyvinylsulfonic acid or polyvinylphosphonic acid. However, persons skilled in the art are aware that other phospholipids and anionic polymers similarly can be used to provide a PAL of the present invention. As previously discussed, a drug, like insulin, can treat and control a disease, like diabetes, but cannot prevent, attenuate, or rectify complications associated with the disease, such as vascular problems, like heart disease and "diabetic foot." Therefore, it would be advantageous to administer insulin to a diabetic in a form that not only treats the disease, but also prevents, alleviates, or reverses complications associated with the disease. A composition containing a drug, like insulin, and a PAL provides these advantages. An important additional advantage would be to provide a method of administering a drug, like insulin, orally. Insulin, and other drugs, and especially genes and many protein and polypeptide-based drugs, cannot be administered orally because the drug is altered in the stomach, and, therefore, is unavailable to the body in a form to combat or control a disease. With respect to diabetes, it is known that glucose can complex with proteins to produce toxic by-products. Such toxic by-products have been theorized as the cause of the complications associated with diabetes. It also has been observed that diabetics have elevated levels of GAGs in serum and urine, and a lower GAG content in their kidney cell membranes. It also is known that administration of GAGs to diabetic animals inhibited and/or reversed some vascular abnormalities associated with diabetes. Diabetics also have altered blood chemistries, including elevated levels of various enzymes in addition to glucose. Therefore, the following has been hypothesized, but is not relied upon, as a cause for the complications associated with diabetes. In particular, the interior of vascular walls are lined with endothelial cells. Branching from the endothelial cells are proteoglycan molecules. Glucose is able to bond with these surfaces of the endothelial cells. However, GAGs also are known to be present on the proteoglycan branches on the surface of endothelial cells. In addition, insulin also is known to have the capability to complex with the GAG compounds. It is hypothesized, therefore, that insulin complexes with the GAGs present on the branches of the endothelial cells, and that the GAGs-insulin complexes are removed from the cell by enzymatic activity, thereby leaving the surfaces endothelial cells devoid of GAGs compounds. An increased insulin dosage provides sufficient insulin to account for the insulin lost as a result of the insulin-GAGs interaction. But the sloughing of GAGs from endothelial cells exposes the vascular surface to numerous unwanted reactions, including repeated glycosylation. Repeated glycosylation can be exacerbated by the naturally elevated levels of serum glucose in a diabetic. Therefore, it has been found that the interaction between insulin and the GAGs on the endothelial cells can be circumvented by complexing insulin such that the insulin is unavailable to interact with the GAGs on the surface of endothelial cells. Since the present investigators have found evidence of a GAGs complex with insulin, the present investigators considered complexing insulin with a GAG, and thereby protect vascular endothelial cells from the harmful effects of constant exposure to insulin. Then, the insulin would not be available to complex with GAGs on the surface of endothelial cells. As a result, the endothelial cells would not be vulnerable to glycosylation as a result of a sloughing off of the GAGs-insulin complex. However, GAGs are well known anticoagulants and their long term effects on a diabetic are unknown. As a result, a GAG could not be administered to an individual on a long term basis because, for example, the blood of the individuals would be thinned too greatly. In accordance with the present invention, insulin, and other drugs, can be administered with a suitable PAL to provide a drug delivery system that avoids the interaction between insulin and a GAG on the surface of an endothelial cell. It is hypothesized that the vascular endothelial cells therefore are spared from undesirable reactions, like glycosylation, and vascular complications associated with diabetes can be eliminated or attenuated. Furthermore, the present PALs make the insulin available to the individual, such that diabetes is controlled. Similarly, other drugs, in addition to insulin, can be administered in conjunction with a PAL, and are available to treat the disease of concern. The use of a PAL containing a suitable naturally occurring or synthetic anionic polymer as a drug delivery system also avoids the harmful side effects of GAGs (e.g., anticoagulation), and insures the quality, reproducibility, and uniformity of the drug delivery system because the anionic polymers have a reproducible chemical makeup, and the molecular weight can be controlled. Furthermore, by a proper selection of an anionic polymer, the in vivo behavior of insulin can be controlled to optimize the pharmacologic response of insulin, and the route of administration can be regulated. The proper selection of an anionic polymer also provides a drug delivery system that is site specific because different anionic polymers have an affinity to different specific cell surfaces. A drug administered with a PAL can be essentially any drug or therapeutic agent. The drug can be a naturally occurring or synthetic drug. The drug can be monomeric, or oligomeric or polymeric, like a gene, a polypeptide, or a protein. In addition, the drug can be water soluble or water insoluble, or a mixture thereof. Water-soluble drugs are microencapsulated by the PAL. Water-insoluble drugs reside in the hydrophobic bilayer of the liposome of the PAL. Preferred drugs are polypeptide or protein based. Preferably, the drug has at least one positively charged site. The positively charged site usually is a quaternary ammonium nitrogen atom. If the drug is a synthetic drug, the drug often contains a nitrogen atom that can be quaternized. If the drug is a naturally occurring drug, the drug often contains an amino acid having a positively charged site. These quaternized nitrogen atoms and positively charged sites are available to complex with the neutralized acid moieties of the anionic polymer. Other drugs that can be administered with a PAL of the present invention include, but are not limited to, genes; antiinflammatory drugs, like tereofenamate, proglumetacin, tiaramide, apazone, benzpiperylon, pipebuzone, ramifenazone, and methotrexate; antiinfective drugs, like isoniazid, polymyxin, bacitracin, tuberactionomycin, and ethryomycin; antiarthritis drugs, like penicillamine, chloroquine phosphate, glucosamine, and hydroxychloroquine; diabetes drugs, like insulin, and glucagon; and anticancer drugs, like cyclophosphamide, interferon a, interferon β, interferon γ, vincristine, and vinblastine. A PAL is prepared from a liposome and an anionic polymer having a plurality of acid moieties in a salt form. The anionic polymer in the salt form, therefore, has a plurality of negative charges. The liposome is prepared from a phospholipid. A liposome is a membrane vesicle prepared from a phospholipid. Structurally, a liposome is a bilayer spherical membrane having polar ends of phospholipids in one layer forming the external surface of the spherical membrane and the polar ends of phospholipids in a second layer forming the internal surface of the spherical membrane. The nonpolar, hydrophobic tails of the phospholipids in the two layers align to form the interior of the bilayer membrane. The bilayer liposomes can microencapsulate compounds, and transport the compounds through environments wherein the compound normally is degraded. Liposomes, therefore, have been suggested for use in drug delivery systems. However, liposomes typically are broken down in the liver, and, therefore, exist in the circulatory system for only a very short time, generally for a period of minutes. Liposomes, therefore, have not served as a good delivery system for drugs because a liposome-drug complex does not survive for a sufficiently long time in the vascular system to reach the target site for the drug. Liposomes have been modified to avoid rapid clearance in the liver. For example, STEALTH® liposomes, available from Liposome Technologies, remain in the vascular system for about 48 to about 96 hours, and have the ability to deliver drugs. These modified liposomes have polyethylene glycol (PEG) molecules covalently bound to the external surface of the liposome. However, these PEG-modified liposomes are difficult and expensive to manufacture. A second type of modified liposome is a conventional liposome coated with a polymer. A polymer-coated liposome is prepared by simply adding a polymer to an aqueous dispersion of a liposome. The polymer is merely coated on the exterior surface of the liposome. However, when the coated liposome is diluted in water or saline, the polymer and liposome dissociate to regenerate a conventional liposome and the polymer. As illustrated in detail hereafter, the present PALs, containing an anionic polymer that is electrostatically, i.e., not covalently, bound to a liposome, do not dissociate to a liposome and an anionic polymer upon water dilution. The first step in the preparation of a PAL is formation of a conventional liposome from phospholipids. The phospholipids used to form a liposome useful in the present invention are not limited. The liposome, therefore, can be prepared by conventional techniques from phosphatidylethanolamine (i.e., cephalin), phosphatidylcholine (i.e., lecithin), phosphatidylserine, phosphatidylinositol, phostidylglycerol, 3'-O-lysylphosphatidylglycerol, cardiolipin, sphingomyelin, and mixtures thereof, for example. In general, the phospholipid can be any glyceride esterified by C 6 -C 24 fatty acids at the 1,2-positions and having a phosphoric acid ester residue at the 3-position. Preferred phospholipids have a phosphoric acid ester residue containing a positive charge, typically a quaternary ammonium nitrogen. Such preferred phospholipids include, but are not limited to phosphatidylethanolamine, phosphatidylcholine, phosphatidylserine, and 3'-O-lysylphosphatidylglycerol. The positive charge on the preferred phospholipids permits an increased electrostatic binding between the liposome and the negatively charged sites on an anionic polymer. In accordance with an important feature of the present invention, it is not necessary to use a purified phospholipid to form the liposome. Commercial phospholipids, like commercial lecithin, can be used in the present invention, and, therefore, provide economies in providing a PAL of the present invention. Surprisingly, it also has been found that a crude commercial phospholipid, which contains a mixture of phospholipids, can provide a PAL having greater efficacy than a PAL prepared from a purified phospholipid. An anionic polymer used to prepare a PAL has a plurality of acid moieties. Any physiologically acceptable anionic polymer can be used as long as the anionic polymer contains sufficient acid moieties in the salt form to complex with the liposome. The anionic polymer is prepared by adding a base to an aqueous solution in the polymer. The base typically is an alkali metal hydroxide, like sodium hydroxide or potassium hydroxide. However, other physiologically acceptable alkalis can be used to neutralize the polymer. The acid moieties are present substantially, i.e., 30% or greater, in a salt form. Preferably, at least 50% of the acid moieties are present in the salt form. To achieve the full advantage of the present invention, at least 70% of the acid moieties are present in the salt form. Typically, the anionic polymer has sufficient acid moieties if the polymer can be solubilized in water by neutralizing the polymer with a base. Such polymers are prepared from a monomer, or mixture of monomers, wherein at least 25% of the monomers, by weight of the polymer, contain an acid moiety. Preferably, at least 40% of the monomers, by weight of the polymer, contain an acid moiety. To achieve the full advantage of the present invention, at least 60% of the monomers, by weight of the polymer, contain an acid moiety. If the polymer is a homopolymer, the monomers containing an acid moiety can be 100% by weight of the polymer. By proper selection of the anionic polymer, persons skilled in the art are able to regulate the site-specific delivery of the drug, the pharmacologic response of the drug, and the route of administration of a drug formulated with the PAL. The anionic polymer can be a synthetic polymer or a naturally occurring polymer. In general, the anionic polymer has an M W of about 1,000 to about 1,000,000 and preferably about 2,000 to about 100,000. To achieve the full advantage of the present invention, the polymer has an M W of about 6,000 to about 50,000. With respect to synthetic polymers, preferred anionic polymers are linear polymers. However, lightly cross-linked anionic polymers also can be used. A lightly crosslinked polymer has one to about five crosslinks crosslinking the linear chains of the polymer molecule and is soluble in water. An important feature of the polymer is that the polymer is water soluble, and contains acid moieties, such as carboxyl, phosphate, phosphonate, sulfate, sulfonate, phenolic, or any other moiety having a labile hydrogen that can be removed from the moiety to provide a negatively charged site on the polymer. The anionic polymer typically is an acrylic polymer containing a sufficient amount of acid-containing monomers, like acrylic acid, methacrylic acid, vinylsulfonic acid, or vinylphosphonic acid. The acid-containing monomer can be, but is not limited to, acrylic acid, methacrylic acid, maleic acid, fumaric acid, itaconic acid, mesaconic acid, citraconic acid, vinylsulfonic acid, vinylphosphonic acid, and similar α, β-unsaturated carboxylic acids and α, β-unsaturated dicarboxylic acids. The polymer is in a salt form when utilized to prepare a PAL. The anionic polymer can be a homopolymer of an acid-containing monomers, like α, β-unsaturated carboxylic acids, or can be a copolymer. For example, a suitable copolymer can be an acid-containing monomer that is copolymerized with ethylene, propylene, or a similar C 4 -C 5 alkene, or a C 1 -C 12 ester of an α, β-unsaturated carboxylic acid, vinyl propionate, acrylamide, or methacrylamide, or that is copolymerized with an aromatic monomer, like styrene, α-methyl toluene, or vinyl toluene. Other comonomers include vinylpyrrolidone, vinyl alcohol, vinyl acetate, and vinyl alkyl ethers. Examples of anionic polymers include, but are not limited to, polyacrylic acid, polyvinylphosphonic acid, polyvinylsulfonic acid, polystyrenesulfonic acid, polymaleic acid, polymethacrylic acid, polyvinylsulfuric acid, poly(2-methacroyloxyethane-1-sulfonic acid, poly(4-vinylbenzoic acid), poly(3-(vinyloxy)propane-1-sulfonicacid), poly(3-(vinyloxy)-propane-1-sulfonic acid), poly(3-methacryloxypropane-1-sulfonic acid), polymethacrylic acid, poly(4-vinylphenol), poly (4-vinylphenyl sulfuric acid), and poly(N-vinylsuccinamidic acid). In other embodiments, an anionic polymer containing an aromatic monomer can be sulfonated or sulfated to position acid groups on the aromatic monomer. Preferred anionic polymers are salt forms of polyacrylic acid, polyvinylsulfonic acid, and polyvinylphosphonic acid. With respect to naturally occurring anionic polymers, the above-discussed disadvantages resulting from using a GAG limits the naturally occurring polymers to those that do not adversely effect an individual over the long term, i.e., a strong anticoagulant should not be used as the polymer. However, GAGs that act as anticoagulants have a relatively high molecular weight of about 12,000 or greater. Therefore, analogs of GAGs that do not act as strong anticoagulants can be used as the polymer. Such polymers have a structure that is similar to a GAG compound, but have a lower M W , i.e., less than about 12,000. Therefore, useful naturally occurring anionic polymers have an M W of about 1,000 to about 12,000, and preferably about 2,000 to about 8,000, and do not act as coagulants at the level they are administered in the PAL, i.e., about 2 mg/day. This dose is less than the 20 mg/day dose required to observe anticoagulation effects and, therefore, mild anticoagulants can be used as the polymer. Furthermore, the low M W , naturally occurring polymers have a greater bioavailability. For example, heparin having an M W of about 6,000 is 85% bioavailable, but as the M W increases, bioavailability decreases exponentially. Suitable naturally occurring anionic polymers therefore include, but are not limited to, heparin, dermatan sulfate, chondroitin sulfate, keratan sulfate, heparan sulfate, hyaluronic acid, the various forms of carrageenan, and mixtures thereof, having a molecular weight (M W ) of about 1,000 to about 12,000. Overall, a synthetic anionic polymer is preferred over a naturally occurring anionic polymer because synthetic polymers are more uniform chemically, and a desired M W is more easily achieved. A PAL of the present invention, therefore, is a novel drug delivery system containing a synthetic or a natural anionic polymer electrostatically complexed with a liposome. In general, a PAL is manufactured by first preparing a conventional liposome from phospholipids by techniques known in the art. Then a liposome/polymer complex is formed by incubating the liposome with an anionic polymer in an aqueous medium. During this step, the anionic polymer electrostatically binds to the exterior surface of the liposome. The liposome/polymer complex is isolated, then solubilized in an organic solvent and dried. The PAL is formed by adding an aqueous medium to the dried liposome/polymer complex. It should be noted that a PAL is formed only when an anionic polymer is incubated with a liposome. The addition of an anionic polymer to a phospholipid prior to formation of a liposome does not result in a PAL. The organic solvent used to solubilize the liposome/polymer complex is a nonpolar solvent, preferably having a low boiling point. Useful organic solvents include hydrocarbons and chlorinated hydrocarbons, like pentane, heptane, benzene, toluene, chloroform, carbon tetrachloride, methylene chloride, trichloroethane, and perchloroethylene, for example. As illustrated in detail hereafter, a PAL is substantially different from the liposome/polymer complex. The liposome/polymer complex is a liposome having its exterior surface coated with a polymer. This complex dissociates when dissolved in aqueous media. In contrast, a PAL does not dissociate in water. It is theorized that, during hydration of the dried liposome/polymer complex to form a PAL, the polymer no longer merely coats the exterior surface of the liposome, but is intertwined throughout the two layers of the liposome. Accordingly, a portion of the polymer is electrostatically bound to the external surface of the liposome, and a portion of the polymer is electrostatically bound to the internal surface of the liposome. In addition, the polymer chain extends from the external surface, through the two layers of the liposome, to the internal surface of the liposome. The PAL structure, therefore, is analogous to a thread of anionic polymer that is repeatedly strung to and from the external surface of the liposome, through the phospholipid bilayer, and to and from the internal surface of the liposome. The polymer, therefore, is unable to dissociate from the liposome when the PAL is diluted in water. The following example illustrates the preparation of a PAL of the present invention. EXAMPLE Conventional liposomes were prepared according to the film cast method by placing about 150 mg (milligrams) of egg yolk lecithin (available from Sigma Chemical Co., St. Louis, Mo.) in a 50 mL (milliliter) round-bottomed flask, then dissolving the lecithin in 20 mL of chloroform. The chloroform was evaporated from the lecithin solution using a rotary evaporator, leaving a dried film of lecithin on the bottom of the flask. Then, 10 mL of pure water was added to the flask, and the resulting suspension was sonicated in a bath sonicator for about 5-7 minutes to provide conventional lecithin liposomes. Next, about 10 mL of an aqueous solution containing 5 mg/mL of polyvinylsulfonic acid was added to 10 mL of the lecithin liposome suspension containing 15 mg/mL of the liposome to form a liposome/polymer complex. The resulting suspension was mixed on a magnetic stirrer, under a constant flow of nitrogen, for an incubation time of about 1 to about 96 hours at about 25° C. Water then was removed from the suspension by rotary evaporation, and the liposome/polymer complex was dried to form a film. Next, about 10 mL of chloroform was added to the liposome/polymer complex to dissolve the liposome/polymer complex. The resulting solution was filtered through a 5 μM syringe filter to remove uncomplexed polyvinylsulfonic acid that precipitated from the solution. The chloroform filtrate was evaporated by rotary evaporation, and the liposome/polymer complex was dried to a film under nitrogen. The PAL was prepared by hydrating the liposome/polymer complex film with about 10 mL of pure water, and bath sonicating the resulting suspension for about 5 minutes. The PALS, having a diameter of about 10 microns, were reduced in size to about 5 microns, by extruding the suspension through a 100 nm polycarbonate filter. The size-reduction step provides a PAL of sufficiently small size (e.g., about 0.1 to about 5 microns) to pass through the vascular system. The PALs also can be reduced in size by sonication. In addition, if desired, an aqueous isotonic buffer solution, rather than pure water, can be used to hydrate the liposome/polymer complex and form a PAL. The isotonic buffer solution has a pH of 7.4, and contains 10 mM HEPES buffer, 140 mM sodium chloride, and 10 mM potassium chloride. The PAL prepared in the above example can be formulated with a water-soluble drug, a water-insoluble drug, or a mixture thereof. A water-soluble drug is encapsulated by the PAL, whereas a water-insoluble drug is positioned in the hydrophobic bilayer of the PAL. A present PAL also provides negatively charged sites on the anionic polymer chain to electrostatically bind a drug having a positive charge. As illustrated hereafter, the PAL remains intact in the vascular system for up to several hours, thereby allowing the drug to reach its target site. The PAL also is capable of releasing the drug such that the drug can perform its intended function. Studies were performed to elucidate the structure of a PAL. In one experiment, a test was performed to determine if the anionic polymer could be detected in an aqueous dispersion of the PAL of the above Example. In this test, an aqueous suspension of the lecithin-polyvinylsulfonic acid PAL of the above example was prepared, and an aqueous solution of polyvinylsulfonic acid was prepared in a separate vessel. Each mixture was evaporated to dryness, and a volume of chloroform then was added to each residue. The chloroform solutions were filtered through 5 μm syringe filters and the filtrates were evaporated to dryness. A known volume of water was added to each residue and the resulting aqueous solutions analyzed for the presence of polyvinylsulfonic acid. The presence of a polymer was not found in the aqueous solution derived from polyvinylsulfonic acid. The polyvinylsulfonic acid was precipitated by the chloroform. In contrast, polyvinylsulfonic acid was detected in the solution derived from the PAL. This test showed that anionic polymers can interact with liposomes to form noncovalent, chloroform soluble, PALs. Another test was performed to determine the relationship between the weight of anionic polymer added to the liposome and the weight of anionic polymer in the PAL. In this test, about 40 mL of a solution of conventional liposomes containing 15 mg/mL phospholipids was prepared as described in the above Example, and divided into four equal portions. Individual polyvinylsulfonic acid solutions containing 0.12, 1.2, 6.2, and 12.5 mg of polymer, respectively, were added to individual portions of the liposome, and each resulting solution was processed to form a PAL. The PAL was extracted into chloroform and analyzed for amount of anionic polymer. Each PAL was analyzed for the presence of polymer by a standard azure dye-binding assay. The results are summarized in FIG. 2. For each data point in FIG. 2, the liposomes were incubated with the polymer for 48 hours at room temperature. FIG. 2 shows that the concentration of a PAL increases as the amount of anionic polymer allowed to incubate with the liposome increase, as dictated by the kinetic binding constant for the particular liposome and polymer. Therefore, to achieve a PAL containing about 5% to about 20% by weight of an anionic polymer, the weight ratio of anionic polymer to liposome used in the preparation of a PAL is at least about 2:1, and preferably at least about 5:1. To achieve the full advantage of the present invention, the weight ratio of anionic polymer to liposome is at least about 10:1. Any excess, uncomplexed anionic polymer is removed when the liposome/polymer complex is dissolved in an organic solvent. The complex is soluble in the organic solvent, whereas the anionic polymer precipitates from the solvent, thereby allowing a facile separation by filtration. The data in FIG. 2 confirm that an anionic polymer is present in a PAL, and that the total amount of anionic polymer in the PAL is related to the initial concentration of anionic polymer incubated with the liposome. Another test examined the effect of incubation time on formation of the lipid/polymer complex. In this test, a stock solution containing 15 mg/mL conventional liposomes was incubated with polyvinylsulfonic acid for 96 hours. Aliquots were removed from the mixture periodically, then processed into PALs. The PALs were analyzed for anionic polymer content. The results are summarized in FIG. 3. The data in FIG. 3 indicate that the amount of anionic polymer in a PAL increases as incubation time increases, thereby showing that the lipid/polymer complex is a thermodynamically favored species. The above experiments show that the amount of anionic polymer in a PAL can be adjusted to a desired level by judiciously selecting the phospholipid and anionic polymer, by judiciously selecting the amount of anionic polymer added to the liposome, and by varying the incubation time. Useful PALs contain about 2% to about 30%, and preferably about 5% to about 20%, by weight of an anionic polymer. The particle size and zeta potential (i.e., charge on the liposome) of conventional liposomes, polymer-coated liposomes, and PALs, also were determined. As described above, polymer-coated liposomes consist of a simple mixture of conventional liposomes and an anionic polymer, like polyvinylsulfonic acid. A comparison among the three liposome forms is summarized in Tables 1 and 2. TABLE 1______________________________________Particle Size Analysis of Various LiposomesLiposome Type Diameter (nm).sup.1)______________________________________Conventional 131.9 ± 35.5PAL 120.1 ± 37.8Polymer coated 138.9 ± 45.1______________________________________ .sup.1) All size determinations were performed using a Nicomp Model 270 Submicron Particle Sizer. TABLE 2______________________________________Comparison of Zeta Potentials of Various LiposomesLiposome Type Zeta Potential (mV).sup.2)______________________________________Conventional -28.7 ± 1.4Polymer coated -35.0 ± 1.3PAL -50.8 ± 1.3______________________________________ .sup.2) All zeta potentials were measured using a Pen Kem Lazer Zee Meter Model 501. The particle size analysis shows that the PALs are the smallest of the three liposome types. The small PAL particle size suggests that the processing conditions used to prepare the conventional and polymer-coated liposomes have no effect on particle size. However, the small size of a PAL is consistent with the anionic polymer in a PAL threading in and out of the liposome shell, thereby making the PAL smaller in size compared to the two other liposome forms. A comparison of the zeta potentials for the three forms of liposomes strongly indicates that the surface charge of a PAL is significantly different from the surface charge of the other two liposome forms. The polymer-coated liposomes are only slightly more negatively charged than the conventional liposomes, where the PALs are more than 50% more negatively charged than the coated liposomes. This data suggests that the PALs are fundamentally different from both conventional and polymer-coated liposomes, and have a greater ability to bind to drugs, particularly drugs having a positive charge. As previously stated, conventional liposomes and polymer-coated liposomes are broken down in the liver within minutes, and, therefore, are unable to effectively deliver a drug to a target site. Such liposomes also are unable to direct a drug to a specific target site. However, a PAL is not broken down in liver quickly, but exists for several hours in the vascular system. Therefore, a PAL is an excellent delivery system to deliver a drug to a target site. In addition, a PAL can be designed to direct a drug to a specific target site. The PALs also have an ability to release the drug so that the drug can perform its intended function. To illustrate that PALs remain the vascular system for extended time periods, the lecithin-polyvinylsulfonic acid PAL of the Example was admixed with a fluorescent tag and the resulting composition was administered to rabbits by injection. As a comparison, conventional liposome was administered to different rabbits. At various time intervals, a blood sample was taken from the rabbits and the blood was assayed for relative fluorescent intensity. The data is summarized in FIG. 4, which contains a pharmokinetic profile showing that a PAL, in vivo, exists in a circulatory system for a much longer time than a conventional liposome. For example, about 75% of a conventional liposome was consumed one hour after injection, whereas only about 50% of a PAL was consumed one hour after injection. It also was observed that about 20% of the PAL remained in the circulatory system about 6 hours after in vivo injection. The results summarized in FIG. 4 show both the stability of a PAL and the effectiveness of a PAL as a drug delivery system. FIG. 4 shows that the PALs remain intact for a relatively extended time period, and do not dissociate immediately after intravenous in vivo administration. Therefore, in addition to demonstrating that a PAL can be formed, it also was demonstrated that a PAL is stable in the vascular system in vivo. The data also shows that a PAL has the ability to release a drug in vivo to treat a disease. In particular, an aqueous drug composition containing a drug and a PAL can be formed by admixing the drug and a PAL. Such aqueous compositions can be administered by injection or orally. Another important embodiment of the present invention is a solid drug composition containing a drug and a PAL, in a lyophilized form, that can be used to administer the drug orally. In this embodiment, an aqueous drug composition is formed, and the liquid composition then is lyophilized by conventional techniques. The present invention, therefore, discloses a novel drug delivery system for the oral, parenteral, sublingual, transdermal, conjunctival, intraocular, intranasal, aural, intrarespiratory, rectal, vaginal, or urethral delivery of therapeutic agents. The drug delivery system comprises a PAL, which contains a liposome and a salt form of a polymer having a plurality of acid moieties. The therapeutic agent can be, but is not limited to, genes, peptides, proteins, antibacterials, antifungals, antineoplastics, antiprotozoals, antiarthritics, and antiinflammatory agents. The polymers can be naturally occurring or synthetic, and are commercially available or can be readily synthesized. The specific physicochemical properties of the PAL can be adjusted by a judicious selection of the phospholipid used to form the liposome, the polymer, the M W of the polymer, and the number and type of anionic moieties on the polymer, by the weight ratio of liposome to polymer in the PAL, and by the incubation time. The proper selection of a PAL also permits the delivery of a drug to a particular target site. By selecting anionic polymer that has an affinity to the specific cell surface at the target site of interest, the drug delivery system can more effectively deliver a drug or therapeutic agent to the target site to act against the disease of concern. Many modifications and variations of the invention as hereinbefore set forth can be made without departing from the spirit and scope thereof, and only such limitations should be imposed as are indicated by the appended claims.

1a

This application is a U.S. National Phase application of PCT International Application No. PCT/ES2004/000212 filed May 13, 2004. FIELD OF THE INVENTION The present invention generally relates to a system and method for cooking-cooling food by immersion under forced and diffuse convection and more specifically to a system and method for cooking-cooling food arranged in molds housed in support trays stacked inside a tank adapted to be filled and emptied with a cooking or cooling liquid subjected to a forced and diffuse convection in turbulent flow. BACKGROUND OF THE INVENTION International patent application WO 03/096815, of this applicant, discloses an instillation for cooking-cooling food comprising a plurality of tanks which are used to receive the food to be cooked, and automatic means for loading and unloading said food through a side loading and unloading opening existing in each of said tanks, said opening of each tank being equipped with a hermetically sealing side sliding door. The installation includes means for filling each tank with at least one cooking or cooling liquid, and means for subsequently emptying it. Each tank includes means for heating the cooking liquid therein, for example, by bubbling steam through the cooking liquid, although optionally the cooking liquid can be totally or partially pre-heated. International patent application PCT/ES 2004/000145, of this applicant, describes a hermetically sealing side sliding door that is able to withstand internal pressure and is suitable to be applied to the tanks of the installation described above. The food to be cooked and/or cooled is preferably arranged in molds housed in support trays stacked inside each tank, preferably forming at least one lower stack and at least one upper stack supported in corresponding lower and upper supporting means inside the tank. In the mentioned prior document, the cooking or cooling of the food is carried by a traditional system. In this traditional model, a stack of product molds is deposited in a tempered hot water bath, where the transfer of heat to the product is virtually static; i.e. almost exclusively by heat conduction. Furthermore, most of the elements involved in the system have a high specific heat, as corresponds to water and especially the equivalent of the product, since in addition to its merely physical heat capacity, the heat energy required by the physical and chemical cooking reactions is also considered. There is only a minor heat transfer by the more effective heat convection method (due to the movement of the surrounding water, not of the product) which consists of two types, alternatively: by natural convection, in which slightly cooled water tends to move downwards to the bottom due to its greater density; and by the replacement of hot water intended to temper the water of the cooking bath. However, the limited proportion of metal in the product mold in contact with the heating or cooling water makes natural convection affect a minimal surface of the total surface corresponding to all of the molds in the basket. Even the existence of narrow water channels between the inner vertical walls of the mold in the basket does not entail a significant additional advantage because they are long, narrow and above all, horizontal, virtually any natural convection being prevented and the stagnant water of such channels acting as a mere heat conducting element. With respect to the most efficient manner of transferring heat from a hot focus to a cold one, which is transfer by radiation (proportional to the difference between the absolute temperatures to the power of four), it virtually does not exist in this system, in which there are no significant temperature gradients between parts. Therefore, with the traditional system, the cooking process as well as the cooling process (although the latter in a minor extent because there is no chemical reaction heat involved with the product but only the sensible heat of the product) are very slow. Although the installation described in the mentioned document prevents other drawbacks associated to the amount and slowness of the necessary manual operations in a conventional process where the product cells are introduced and extracted through the upper part of the water tubs by raising and immersing them, and in triplicate: first in hot water baths, then in water at room temperature and finally in cooled water, the drawbacks associated to the mentioned natural convection movement of the liquid persist, which movement has been shown to be insufficient for ensuring a fast and efficient heat exchange between the liquid and the food in different regions of the tank. The present invention provides a system and a method for cooking-cooling food by immersion under forced and diffuse convection in turbulent flow that is able to maximize the heat exchange and optimize the heat efficiency of the process, providing an effective reduction of the energy costs and a regular cooking-cooling process. SUMMARY OF THE INVENTION The present invention contributes to achieve the previous and other objectives by means of a system for cooking-cooling food by immersion under forced and diffuse convection, of the type comprising at least one tank for housing the food to be cooked-cooled, filling means for filling said tank with a cooking or cooling liquid, emptying means for draining said cooking or cooling liquid from the tank, and heating means for heating the cooking or cooling liquid. The system is characterized in that the tank comprises at least one lower region and one upper region, circulating means being arranged for taking in cooking or cooling liquid from the inside of said lower region through at least one lower outlet located in a first lower side wall of the lower region and introducing it inside said upper region through at least one upper inlet located in a first upper side wall of the upper region and for taking in cooking or cooling liquid from the inside of the upper region through at least one upper outlet located in a second upper side wall of the upper region and introducing it inside the lower region through at least one lower inlet located in a second lower side wall of the lower region. The first lower side wall is preferably opposite to and facing said second lower side wall, whereas said first upper side wall is opposite to and facing said second upper side wall, thus facilitating a transverse circulation of the cooking or cooling liquid in both the upper and lower regions in opposite directions. To contribute to the diffusion of the flow of said transverse circulation, the system comprises a plurality of said lower outlets distributed in a significant area of said first lower side wall of the lower region, a plurality of said upper inlets distributed in a significant area of said first upper side wall of the upper region, a plurality of said upper outlets distributed in a significant area of said second upper side wall of the upper region, and a plurality of said lower inlets distributed in a significant area of said second lower side wall of the lower region. Furthermore, the lower outlets are connected to the upper inlets through at least one first duct and the upper outlets are connected with the lower inlets through at least one second duct. To force a turbulent transverse circulation of the cooking or cooling liquid in the lower and upper regions of the tank, the system includes pumping means connected so as to propel the cooking or cooling liquid inside said first duct. The aforementioned heating means can be outside the tank, therefore the cooking liquid would be introduced already heated to the tank, or they can be arranged to heat the cooking liquid inside than tank, or a combination of both. The system can optionally include cooling means, usually outside the tank, to cool the cooling liquid. When the heating means are inside the tank, they preferably comprise a plurality of lower steam inlets arranged to bubble steam through the cooking liquid inside the lower region of the tank and a plurality of upper steam inlets arranged to bubble steam through the cooking liquid inside upper region, said lower steam inlets being adjacent to said lower liquid outlets and said upper steam inlets are arranged adjacent to said upper liquid outlets. A plate adapted to restrict the vertical circulation of the cooking or cooling liquid is interposed between the lower region and the upper region of the tank. However, this plate comprises perforations to allow the draining of the cooking or cooling liquid from both the lower and upper regions by the emptying means, which are arranged in relation to the lower region of the tank. On the other hand, the tank comprises lower supporting means for supporting a lower stack of support trays inside the lower region and upper supporting means for supporting an upper stack of said support trays inside the upper region. The mentioned support trays are adapted to support the food to be cooked-cooled, preferably arranged in molds. The mentioned lower and upper stacks are sized so as to leave reduced spaces therearound inside the tank to contribute to accelerate and direct the transverse circulation of the cooking or cooling liquid. Furthermore, each support tray includes, for example, a double bottom joined at its bottom by transverse partitions for the purpose of delimiting spaces facilitating the transverse circulation of the cooking or cooling liquid from one side of the support tray to the other even when the support tray forms part of one of the lower or upper stacks in one or the other of the lower and upper regions of the tank. The tank of the system of the present invention is preferably of the type having a side loading-unloading opening with a hermetically sealing side sliding door, and is applicable to the installation described in the aforementioned international patent application WO 03/096815, of this applicant. However, the system of the present invention can also be applied to a tank with an upper loading-unloading opening. The present invention also provides a method for the cooking-cooling of food by immersion under forced and diffuse convection, of the type comprising arranging the food to be cooked-cooled inside at least one tank; filling said tank with a cooking or cooling liquid; optionally heating said cooking or cooling liquid inside the tank; and draining the cooking or cooling liquid from the tank, said method being characterized in that it further comprises taking in cooking or cooling liquid from the inside of a lower region of the tank through at least one lower outlet located in a first lower side wall of said lower region; and introducing it inside an upper region of the tank through at least one upper inlet located in a first upper side wall of said upper region; and taking in cooking or cooling liquid from the inside of the upper region through at least one upper outlet located in a second upper side wall of the upper region and introducing it inside the lower region through at east one lower inlet located in a second lower side wall of the lower region. The method of the present invention preferably comprises facilitating a transverse circulation in opposite directions of the cooking or cooling liquid in the lower region and in the upper region, respectively, by arranging said first lower side wall opposite to and facing said second lower side wall and said first upper side wall opposite to and facing said second upper side wall. The method also comprises diffusing said transverse circulation of the cooking or cooling liquid by arranging a plurality of said lower outlets distributed in a significant area of the first lower side wall of the lower region, a plurality of said upper inlets distributed in a significant area of the first upper side wall of the upper region, a plurality of said upper outlets distributed in a significant area of the second upper side wall of the upper region, and a plurality of said lower inlets distributed in a significant area of the second lower side wall of the lower region. The method also comprises forcing a turbulent transverse circulation of the cooking or cooling liquid in the lower and upper regions of the tank by connecting the lower outlets with the upper inlets through at least one first duct, connecting the upper outlets with the lower inlets through at least one second duct, and propelling the cooking or cooling liquid at least inside said first duct by means of pumping means. The method also comprises restricting a vertical circulation of the cooking or cooling liquid between the lower region and the upper region of the tank by interposing a plate therebetween, allowing at the same time to drain the cooking or cooling liquid from both the lower and upper regions by emptying means arranged in relation to the lower region of the tank by providing perforations in said plate. The system and/or method of the present invention achieves maximizing the heat exchange and optimizing the heat efficiency of the process, providing an effective reduction of the energy costs and a highly regular cooking-cooling process, resulting in a microbiologically safe food product with a high organoleptic quality. With the system and method of the present invention, in addition to the reduction in the mechanical movement times provided by the document cited above, there is a significant reduction in the cooking and cooling time, because the proportion of heat transfer by forced convection increases upon stirring the hot or cold inner water by internal closed recirculation. Furthermore, the new system can achieve an energy and operational advantage with respect to traditional systems. Thus, when heat is transferred from heated water to the product, in the case of cooking, and from the product to the cooling water, in the case of cooling, by forced convection of the water in turbulent flow, the heat transfer times can be reduced by one-fifth or one-sixth (provided that the rate of heat transfer does not affect to the chemical, physical and biochemical reactions required for the better quality of the product). Therefore, in an installation with several tanks in which a sequential processing is carried out, one or more of the first tanks can be ending the total process even before it has started in the last tanks, enabling a consequent transfer of self-stored hot and cold water in the new production tanks. A nocturnal tempering may be unnecessary by providing a good internal insulation of the tanks. The pre-cooling water from the main water supply can even be ecologically re-used and its consumption reduced if sufficient tanks are available for storing it. From a heating energy point of view, the system and method of the present invention involves 100% use of the energy (enthalpy) of the steam, given that the latter is mixed directly by injection with the cooking water, preventing the losses corresponding to the steam-water heat transfer in heat exchangers, plus the corresponding and inevitable heat losses (despite a suitable heat insulation) in the operation and control equipment, long pipes and large, necessarily outer deposit for accumulating and tempering the cooking water. From a productivity point of view, the system and method of the present invention provides a considerable decrease of the cooking and cooling time, given that now they are not carried out by simple static natural convection and heat conduction, but by the stirring of the water caused by the internal recirculation forced by pumping. The injection of steam further allows a fast heating of water for cooking (a prior tempering is not strictly required), plus an additional thermodynamic stirring thereof caused by holes in a device for the ejection of steam under high pressure and temperature, which additionally increases the cooking speed required. In an installation like the one described in the cited document, and equipped with the system and method of the present invention, this considerable increase in the speed and efficiency of the heat transfer is reinforced by an optional design of the molds corresponding to each product, which cause a pronounced increase in the heat and cold transmission coefficient due to the turbulent and fast passage of water through suitably design new conductions and narrowings provided in the stacks of support trays. This considerable increase in the speed and efficiency of heat transfer due to heat transmission by forced and diffuse convection also provides a great heat regularity within the entire boiler, thus ensuring the consistency and regularity of the heat process, thus guaranteeing the quality and the microbiological safety of the final food product. Additionally, the decrease of the daily production time provided by the application of the present invention opens up the possibility of making good use of most of the calories contained in the hot water after cooking and frigories contained in the cold water after cooling by storing it in the production boilers themselves, without requiring the large outer deposits for storing and tempering the necessary fluids for the production of the following day in many traditional installations. With well experienced concepts of the present invention, in the event of its application in a plant which does not have steam generation systems because it is not needed in other production operations, there could be an energy and investment saving in auxiliary equipment of the order of 30% to 40%, using electronic heat pumps with a variable cooling output instead of the specific installation of a pirotubular boiler generating saturated steam at 4-6 bar. BRIEF DESCRIPTION OF THE DRAWINGS The previous and other advantages and features of the present invention will be more clearly shown in the following detailed description of an embodiment with reference to the attached drawings in which: FIG. 1 is a schematic front elevational view of a tank according to an embodiment of the system of the present invention; FIG. 1A is a schematic view similar to that of FIG. 1 showing stacks of support trays for food to be cooked-cooled loaded inside tank 1 ; FIG. 2 is a schematic cross-section view taken through the plane II-II of FIG. 1 ; FIG. 3 is a schematic view of a plate with a plurality of liquid outlets forming a side wall of one of the regions of the tank of FIG. 1 ; FIG. 4 is a perspective view of a support tray for supporting food to be cooked-cooled; and FIG. 5 is a perspective view of a stack of support trays to be introduced in one of the regions of the tank of FIG. 1 . DETAILED DESCRIPTION OF THE INVENTION Referring first to FIGS. 1 and 2 , reference numeral 1 generally indicates a tank or boiler forming part of the system for cooking-cooling food by immersion under forced and diffuse convection of the present invention. The mentioned tank 1 is designed to house the food which will be subjected to a cooking and subsequent cooling treatment, or cooking alone, or cooling alone, or another treatment, such as for example, pasteurization. The food to be treated is typically housed in metal molds arranged in support trays 15 stacked in different stacks 17 a , 17 b , as shown in FIG. 1A and as will be explained below in relation to FIGS. 4 and 5 . The mentioned tank 1 can form part of an installation like the one described in the mentioned international patent application WO 03/096815, of this applicant, and it preferably has a side loading and unloading opening 22 provided with a hermetically sealing side sliding door 23 ( FIG. 2 ) that is able to withstand internal pressure, such as for example, the one described in the mentioned international patent application PCT/ES 2004/000145, of this applicant. Nevertheless, the system and method of the present invention can also be applied to a tank with an upper loading-unloading opening. The tank 1 is provided with filling means 24 for filing said tank 1 with a cooking or cooling liquid and emptying means 25 for draining said cooking or cooling liquid from tank 1 . These filling and emptying means 24 , 25 can usually comprise conduits, valves and pumping means for connecting the tank with other tanks, deposits, other liquid sources, drains, etc. the installation can include heating means and cooling means for heating or cooling the liquid before it is introduced in the tank. In the embodiment shown in the figures, tank 1 includes heating means for heating the liquid inside the tank which comprise, as is known, a series of steam inlets 14 a , 14 b arranged to bubble steam through the cooking liquid inside tank 1 . These steam inlets 14 a , 14 b are incorporated in steam nozzles located strategically inside tank 1 and connected to a steam supply conduit 26 . However, these heating means inside tank 1 are not essential for the application of the system and method of the present invention. Tank 1 comprises a first outer side wall 7 and a second outer side wall 8 opposite to and facing the first one, and at least two distinguished regions: a lower region 1 a and an upper region 1 b having respective first lower side wall 7 a and first upper side wall 7 b associated to said first outer side wall 7 and respective second lower side wall 8 a and second upper side wall 8 b associated to said second outer side wall 8 . There is a lower outlet chamber 9 a formed between the first lower side wall 7 a and the first outer side wall 7 of tank 1 , which chamber is communicated through a first duct 11 with an upper inlet chamber 10 b formed between the first upper side wall 7 b and the first outer side wall 7 . In a similar manner, there is an upper outlet chamber 9 b between the second upper side wall 8 b and the second outer side wall 8 , which chamber is communicated through a second duct 12 with a lower inlet chamber 10 a formed between the second lower side wall 8 a and said second outer side wall 8 . Each of the first and second lower side walls 7 a , 8 a of the lower region 1 a and of the first and second upper side walls 7 b , 8 b of the upper region 1 b are carried out in respective plates, each of which incorporates a plurality of holes forming corresponding lower outlets and inlets 3 a , 4 a and upper outlets and inlets 3 b , 4 b . Pumping means 13 are connected to said first duct 11 to propel the cooking or cooling liquid therein for the purpose of establishing a transverse circulation of the cooking or cooling liquid inside the upper and lower regions 1 a , 1 b of the tank. This circulation is established by taking in the cooking or cooling liquid from the inside of the lower region 1 a through the lower outlets 3 a located in the first lower side wall 7 a and introducing it inside said upper region 1 b through the upper inlets 4 b located in the first upper side wall 7 b , and taking in cooking or cooling liquid from the inside of the upper region 1 b through the upper outlets 3 b located in the second upper side wall 8 b and introducing it inside the lower region 1 a through the lower outlets 4 a located in the second lower side wall 8 a. The mentioned pumping means 13 are adapted and sized so as to force a turbulent circulation of the cooking or cooling liquid inside the lower and upper regions 1 a , 1 b of tank 1 . As indicated by means of arrows in FIG. 1 , the transverse circulation of the cooking or cooling liquid in each of the lower and upper regions 1 a , 1 b preferably occurs in opposite directions. In FIG. 2 , the continuous line arrows indicate the circulation in the upper region 1 b whereas the dotted line arrows indicate the circulation in the lower region 1 a in an opposite direction. This transverse circulation forms a forced and diffuse convection in turbulent flow. For the purpose of diffusing the mentioned transverse circulation in both the upper and lower regions 1 a , 1 b of tank 1 as much as possible, the lower outlets and inlets 3 a , 4 a and the upper outlets and inlets 3 b , 4 b are distributed in a significant area of their corresponding first and second lower side walls 7 a , 8 a and first and second upper side walls 7 b , 8 b . FIG. 3 shows, by way of example, a possible distribution of the upper inlets 4 b of a plate forming the upper side wall 7 b . It will be observed that the upper inlets 4 a comprise a large number of small holes distributed regularly on the entire plate except in a central area 27 which is facing the outfall of the duct 11 in the upper inlet chamber 10 b . Thus, a jet of cooking or cooling liquid leaving duct 11 collides with said hole-free central area 27 and the flow is distributed throughout the entire upper inlet chamber 10 b until it leaves through the holes 4 a in a substantially uniform manner. The plates forming the remaining side walls 7 b , 8 a , 8 b of the upper and lower regions 1 a , 1 b have similar dimensions and have a similar configuration and distribution of holes. The vertical circulation of the cooking or cooling liquid between the lower region 1 a and the upper region 1 b of tank 1 is restricted by a plate 5 interposed between them. As will be observed in FIG. 1 , the mentioned emptying means 25 are arranged in relation to the lower region 1 a of tank 1 , and said plate 5 comprises perforations 6 to allow the draining by gravity of the cooking or cooling liquid from both the lower and upper regions 1 a , 1 b through the emptying means 25 . Each of the lower and upper regions 1 a , 1 b is provided with one of the mentioned steam nozzles. Thus, a lower steam nozzle comprises a plurality of lower steam inlets 14 a arranged to bubble steam through the cooking liquid close to the lower outlets 3 a inside the lower region 1 a of tank 1 , and an upper steam nozzle comprises a plurality of upper steam inlets 14 b arranged to bubble steam through the cooking liquid close to the upper outlets 3 b inside the upper region 1 b . This arrangement prevents the formation of pockets of steam that are detrimental to the cooking process because the steam is mixed with the cooking liquid in the lower and upper intake inlets 3 a , 3 b in the respective lower and upper regions 1 a , 1 b. In reference to FIG. 4 , this figure shows one of the mentioned support trays 15 for supporting the food to be cooked-cooled. The support trays 15 are designed to be stacked forming stacks 17 a , 17 b (one of which is shown in FIG. 5 ) that are suitable for being handled by automatic handling means and for being loaded and unloaded inside tank 1 , as described in the cited international patent application WO 03/096815. To that end and as shown in FIGS. 1 and 1A , tank 1 comprises lower supporting means 16 a for supporting one or more lower stacks 17 a of support trays 15 inside the lower region 1 a and upper supporting means 16 b for supporting one or more upper stacks 17 b of support trays 15 inside the upper region 1 b . In the embodiment shown in FIG. 2 , tank 1 has depth that is enough to house two lower stacks 17 a in the lower region 1 a and two upper stacks 17 b (shown by means of dotted lines) in the upper region 1 b . Accordingly, the circulation means comprise two lower outlet chambers 9 a (not shown) communicated through respective first ducts 11 with two respective upper inlet chambers 10 b , and two upper outlet chambers 9 b communicated through respective second ducts 12 with two respective lower inlet chambers 10 a (not shown), for the purpose of generating the transverse circulation of the liquid mainly where the lower and upper stacks 17 a , 17 b are housed. The two first ducts 11 can meet at their middle part for the installation of a single pump 13 . As can be observed in FIG. 1A , the lower and upper stacks 17 a , 17 b are sized to leave reduced spaces therearound inside tank 1 to contribute to accelerate and direct the circulation of the cooking or cooling liquid. It is evident that the depth of the tank can be enough for a single stack in each region or for more than two. The tank could also be easily extended to more than two regions in the vertical direction by means of one or more additional dividing plates and a corresponding adaptation of the liquid circulation means and heating means. To facilitate the transverse circulation of the cooking or cooling liquid from one side of the support tray 15 to the other, even when the support trays 15 form part of one of the lower or upper stacks 17 a , 17 b in one or the other of the lower and upper regions 1 a , 1 b of tank 1 , each support tray 15 ( FIG. 4 ) includes at least one configuration comprising at least one double bottom 18 joined to a bottom 20 of the support tray 15 by transverse partitions 21 delimiting spaces 19 for the transverse circulation of the cooking or cooling liquid. Thus, each lower or upper stack 17 a , 17 b (one of which is shown in FIG. 5 ) comprises multiple transverse passages allowing the circulation of the liquid therethrough. The present invention also comprises a method suitable to be carried out by means of the system described above. The method for cooking-cooling food by immersion under forced and diffuse convection according to the present invention comprises well known steps, such as first arranging the food to be cooked-cooled inside at least one tank 1 , filling said tank with a cooking or cooling liquid, optionally heating said cooking or cooling liquid inside tank 1 in the event of cooking, and only if necessary, and finally draining the cooking or cooling liquid from tank 1 . The method of the invention also comprises taking in cooking or cooling liquid from the inside of a lower region 1 a of tank 1 through at least one lower outlet 3 a located in a first lower side wall 7 a of said lower region 1 a , and introducing it inside an upper region 1 b of tank 1 through at least one upper inlet 4 b located in a first upper side wall 7 b of said upper region 1 b , and simultaneously taking in cooking or cooling liquid from the inside of the upper region 1 b through at least one upper outlet 3 b located in a second upper side wall 8 b of the upper region 1 b and introducing it inside the lower region 1 a through at least one lower inlet 4 a located in a second lower side wall 8 a of the lower region 1 a . The method further comprises facilitating a transverse circulation in opposite directions of the cooking or cooling liquid in the lower region 1 a and in the upper region 1 b respectively, by arranging said first lower side wall 7 a opposite to and facing said second lower side wall 8 a and said first upper side wall 7 b opposite to and facing said second upper side wall 8 b. For the purpose of diffusing said transverse circulation of the cooking or cooling liquid, the method comprises arranging a plurality of said lower outlets 3 a distributed in a significant area of the first lower side wall 7 a of the lower region 1 a , a plurality of said upper inlets 4 b distributed in a significant area of the first upper side wall 7 b of the upper region 1 b , a plurality of said upper outlets 3 b distributed in a significant area of the second upper side wall 8 b of the upper region 1 b , and a plurality of said lower inlets 4 a distributed in a significant area of the second lower side wall 8 a of the lower region 1 a . The method also comprises forcing a turbulent transverse circulation of the cooking or cooling liquid by connecting the lower outlets 3 a with the upper inlets 4 b through at least one first duct 11 , connecting the upper outlets 3 b with the lower inlets 4 a through at least one second duct 12 , and propelling the cooking or cooling liquid at least inside said first duct 11 by means of pumping means 13 . It is also a part of the present method to restrict a vertical circulation of the cooking or cooling liquid between the lower region 1 a and the upper region 1 b of tank 1 by interposing a plate 5 between them, allowing however the draining of the cooking or cooling liquid from both the lower and upper regions 1 a , 1 b through emptying means arranged in relation to the lower region 1 a of tank 1 by providing perforations 6 in said plate 5 . The method of the invention also comprises arranging the food to be cooked-cooled in a plurality of support trays 15 that are stacked forming at least one lower stack 17 a inside the lower region 1 a and at least one upper stack 17 b inside the upper region 1 b , and accelerating and directing said transverse circulation of the cooking or cooling liquid by sizing said lower and upper stacks 17 a , 17 b so as to leave reduced spaces therearound inside tank 1 . The method further comprises facilitating the transverse circulation through said lower and upper stacks 17 a , 17 b by including in each support tray 15 at least one configuration by way of a suitable channel for the transverse circulation of the cooking or cooling liquid from one side of the support tray 15 to the other even when the support tray 15 forms part of one of the lower or upper stacks 17 a , 17 b in one or the other of the lower and upper regions 1 a , 1 b of tank 1 . The application of the system and method of the present invention considerably increases the temperature distribution and recirculation speeds, while at the same time eliminating any type of fluid dynamic and thermal short-circuits inside the tank or boiler (that the system itself might create) thus maximizing the heat transfer between the heating or cooling liquid and the product to be heated or cooled. The efficiency of the cooking and cooling process also increases considerably with the reduction of the cooking and cooling times. Depending on the formats, said reduction can be between 15 and 25% in relation to traditional systems, which offers the possibility of increasing the number of treated batches per day. It also provides a great heat regularity within the entire boiler, thus ensuring the consistency and regularity of the heat process, which ensures the microbiological quality and safety of the end food product. Furthermore, the arrangement of a single steam nozzle protected by each region of the tank prevents irregular over-heating in some areas in the products. All of the above entails a lower energy cost of the process. On the other hand, a direct steam feed provides 100% use of the energy (enthalpy) of the steam, since it is mixed directly by injection with the cooking water and since the losses corresponding to the steam-water heat transfer in heat exchangers, plus the corresponding and inevitable heat losses are prevented, which allows obtaining the desired cooking temperature quickly. Furthermore, the new design of the support trays of the molds in which the product is arranged allows a transverse circulation flow through the channels optimizing the forced convection and maximizing the energy efficiency and contributing to homogenizing the heat regularity. The application of the system and method of the present invention to an installation like the one described in international patent application WO 03/096815, of this applicant, allows decreasing the daily production time depending on the production mixture proportion, opening up the possibility of using most of the calories and negative calories contained in the hot water after cooking and in the cold water after cooling, by means of storing it in the production tanks or boilers themselves, without requiring the large external deposits for storing and tempering the necessary fluids for the production of the following day in traditional installations. A person skilled in the art will be able to introduce modifications and variations in the embodiments that are shown and described merely by way of a non-limiting and illustrative example without departing from the scope of the present invention as its is defined in the attached claims.

1a

BRIEF SUMMARY OF THE INVENTION A normally spherical pellet has an energy-absorbing, clayey, deformable core encased in a substantially spherical, knit or open-work, two-way stretch fabric cover carrying a marking powder dislodged upon impact of the pellet with a hard surface. PRIOR ART OF INTEREST Reference is made to the following United States patents found in a preliminary Patent Office search on this disclosure. U.S. Pat. No. 3,325,168 Fyanes U.S. Pat. No. 3,634,280 Dean et al. U.S. Pat. No. 3,637,220 Fraley U.S. Pat. No. 4,065,126 Mantz U.S. Pat. No. 4,150,826 Baldorossi et al. None of these patents is possessed of the structural features or performance characteristics of the structure disclosed and claimed herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric perspective showing a game playing setup in which the pellet of the invention is utilized. FIG. 2 is a cross-section through a typical pellet constructed in accordance with the invention. DETAILED DESCRIPTION In order to permit a player to practice his golf swings, particularly for longer shots rather than putting, there is afforded a setup which can be utilized indoors and in the usual size room. On the room floor there is erected a target board 6, usually of plywood or the like, arranged substantially upright and adequately supported against impact. The face 7 of the board is conveniently demarked or decorated to illustrate a golf hole 8 and a surrounding green 9 as well as accompanying rough 11 or comparable typography. While there is no particular scale involved, it is convenient to have the green 9 appear to an observer just as a practical green would appear to him if he were many yards distant. In the same room and disposed on the floor a short distance from the target 6; for example, about six or eight feet away, is a mat 12 conveniently of a flexible material having upstanding bristles 13 therein and also carrying a deposit 14 of a clayey material so as to receive the stem of a golf tee 16 of the customary construction. The arrangement is such that the tee stands above the mat 12 very much as a tee would appear under normal exterior circumstances, the clayey material 14 serving as a substitute for the earth. For use in connection with this equipment there is provided a pellet 21. This is a substantially spherical body of a clayey, energy-absorbing material 22 of approximately the same configuration and size as the customary golf ball and approximately of the same weight. The precise material used can be any of several variations, such as modelling clay, some waxes and the like, preferably with an additive such as sand grains of different sizes. These increase the weight of the pellet, and they are readily reworked with the main pellet material as the pellet is reshaped after impact. The material 22 in generally spherical form is first encased in a pocket-like enclosure 23 of two-way stretch woven, knit or other fabric having small interstices 24 therethrough. The fabric is brought around the spherical core 21 and has its edges gathered and sewn together at a closure 26 so that in effect the exterior appearance of the pellet is substantially spherical and uniform and is like that of a golf ball. In addition, the pellet is provided with a particular area marker 27. This can be accomplished in various different ways, but in the present case the cover at one site is provided with a number of extending filaments 28 of a readily visible color. The cover 24 is especially provided with and carries a fine powder, which does not show in the drawing but is interrelated with the cover and occupies many of the interstices therein. The powder is a relatively fine, readily visible talc, preferably white. During normal handling of the pellet, the powder remains well in place. Nevertheless, upon hard impact of the pellet with a surface, the powder is shaken loose or dislodges and deposits on the impacting surface. In the normal use of the structure, the powdered and covered pellet, in its generally spherical configuration, is placed on the tee 16 in the usual way of a golf ball. The player, standing on or near the mat 12, addresses the pellet in the usual fashion, customarily with an iron club with which he particularly desires to practice. He makes the customary swing against the pellet and dislodges and drives or impels the pellet toward the target 6, endeavoring to land the pellet in the vicinity of the hole 8. As he does so, two things occur. First, the impact of the golf club face against the pellet dislodges some of the powder onto the club face so that the area or zone of impact can be readily discerned upon later looking at the club face. Also, the club face, usually not flat but scored or serrated, makes a comparable imprint in the surface of the deformable pellet. Upon examination thereof subsequently it can readily be determined just where and at what orientation the club face contacted the pellet. In addition, the pellet absorbs much of the impact energy by deforming out of the spherical shape to afford a flattened face where the club head hit it and where it hits the target. The pellet does not spring back nor restore itself to its initial shape. The second thing that occurs is that when the pellet hits the target, the impact is sufficient so that additional powder leaves the pellet covering and deposits on the target so as to afford an indication of the location where the target impact occurred. If desired, the target 6 can contain a number of indicating markers 31 with indicia 32 simulating arbitrarily the number of yards that the pellet has travelled comparable to the true flight of an actual golf ball. At the target the pellet is likewise flattened and so eventuates with two flattened faces the relationship of which to the initial position of the pellet and to each other is more readily gauged by reference to the marker 27 and filaments 28. The impact of the club face leaves a corresponding approximately flat area on the pellet, and the customary grooves on the club face leave corresponding marks on the pellet. These can be visually compared with a corresponding flat area due to impact with the target as to location in order to estimate closely just how the pellet was hit and in what direction it rotated during flight. A close estimate of hooking or slicing can be made. By the use of this structure the player can determine accurately where the impact of his club with the pellet has occurred, both as to position on the club face above the teedup portion and laterally with respect to the club shank. Furthermore, by observing the powder mark on the target he can determine how well his swing has propelled the ball to the desired target area; that is, whether there has been rotation during flight resulting in a hook or a slice. Following a single use of the pellet, it can be retrieved and after examination can manually be pressed back into substantially its original spherical form for reuse. Since the pellet is highly energy absorbing and soft and not springy, it cannot cause any substantial damage even if it misses the panel completely and hits other objects in the room. It has been found that by repeated use of the setup described with the characteristic pellet that it is possible to improve the accuracy of golf shots sufficiently to reduce the number of strokes required in an actual game.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention herein disclosed relates to a planter for holding plants and soil and, more particularly, to a planter with a convertible base component having reservoirs and associated capillary wells which render the planter self-watering. 2. Description of the Related Art Prior art inventions which provide, generally, planters having bases are known and are disclosed in the following U.S. patents: Rothe U.S. Pat. No. 2,550,602, issued; Hille U.S. Pat. No. 2,802,304, issued; Reynolds U.S. Pat. No. 3,058,263, issued; Green U.S. Pat. No. 3,220,144, issued; Delogne U.S. Pat. No. 3,676,953, issued; Daenen U.S. Pat. No. 3,906,666, issued; Kay U.S. Pat. No. 4,315,382, issued; Holtkamp U.S. Pat. No. 4,434,577, issued; and Tardif U.S. Pat. No. 4,912,875, issued. These prior art inventions, however, relate to planters having bases which are either non-detachable or, if detachable, are not convertible. Further, none of the prior art planters provide for a convertible base in combination with associated capillary wells and reservoirs. For example, as disclosed in U.S. Pat. No. 4,315,382 to Kay, there is shown and described only a planter consisting of a pot and a tray which snap lock by way of a plurality of protuberances disposed in the tray and corresponding apertures in the pot. Nowhere therein, however, is it shown or described that the tray is convertible or that associated capillary wells and reservoirs comprise the invention. The Kay disclosure is representative of the prior art inventions and it illustrates that the art has lacked a planter apparatus having a base which is versatile, conveniently nestable, relatively inexpensive to manufacture and which provides a means for supplying water to plant life contained therein continuously, following conventional watering, and for an extended period of time. The invention disclosed herein provides a planter apparatus which achieves these advantages in a manner not revealed by the prior art. SUMMARY OF THE INVENTION Various planter configurations are conventionally known. For example, planters constructed of wood, clay, plaster and metal have been in existence for many years. Quite often, planters such as these have been configured such that a tray is provided below the planter to collect surplus water not absorbed by the soil or the plants therein contained following watering. Where a tray is not so provided, planters such as these are often configured simply with drainage holes at the bottom of the planter to allow water to pass directly out of the planter and onto whatever surface is below the planter. In either case, despite whether a tray is provided, the operation of plant watering has been an inefficient process. This is because, where a tray has not been provided, no measure is provided for utilizing or recycling water that passes through the planter without being absorbed by either the plant life or soil contained therein. Where a tray is provided, it is commonly used only to collect surplus water so as to protect the surface below the planter. Thus, conventionally, planters have not included structure which efficiently recycles surplus water following watering. More recently, planters made of plastic have become known. Plastic planters often include detachable trays. Like earlier planters, however, many of the plastic planters having trays make no provision for recycling surplus water collected in the tray following watering. Certain devices, however, are known which provide for the watering of plants as by capillary action. For example, in U.S. Pat. No. 3,220,144 to Green, a system which includes a feed tube, a reservoir and a water tower is disclosed. As explained in Green, water travels from the tower through a port to the reservoir. The water is then absorbed through the feed tube, which is packed with sand and disposed within a planter, by capillary action. In U.S. Pat. No. 3,676,953 to Delogne wicks, which extend from a plant container into a water-filled reservoir, supply plant life therein contained with water by capillary action. Also, in U.S. Pat. No. 4,434,577 to Holtkamp there is disclosed a similar invention which provides for the capillary transmission of water from a water containing tray to a pot by way of a water pervious pad having one or more hinged, movable tabs which can be bent downwardly through an opening for submergence in the water in the tray. Despite that they relate to the watering of contained plants by capillary action, however, none of the above-described inventions, disclose or teach the capillary watering of contained plants by associated wells and reservoirs as in the present invention. Further, despite that consumers have grown increasingly particular and, now more than ever before, demand that consumer products including planters adapt for variable use, planters are not known which have convertible base components and which provide structure for effectively recycling surplus water collected in the base in either of its upright or inverted configurations. The present invention provides such a planter having a convertible base in combination with associated capillary wells and reservoirs. Thus, the planter of the present invention generally comprises a container component and a base component wherein the container has disposed at its bottom a plurality of capillary wells and wherein the base component, in either of its upright or inverted positions, has disposed thereon associated reservoir means. When the base component is in its upright configuration, it functions as a tray. Because the planter thus configured is readily adaptable for use either by direct placement upon a supporting surface or, as by hanging, connecting means are provided in the present invention to assure that the tray remains secured to the container component when the base is secured thereto in either of its upright or inverted configurations. When the present invention is disposed upon a supporting surface, a user has the option of inverting the base component in which case the base functions as a pedestal thereby giving the planter a wholly distinct appearance. When so configured, a downwardly depending annular ring in the bottom of the container fits into a corresponding annular channel disposed on the inverted surface of the base. In both its upright and inverted configurations, the base provides reservoir means for the collection of water and for communication with the capillary wells which depend downwardly from the outside surface of the container bottom. BRIEF DESCRIPTION OF THE DRAWINGS Further objects and features of the present invention are revealed in the following Detailed Description of the Preferred Embodiment of the invention and in the drawing figures wherein: FIG. 1 is a top, plan view of the apparatus of the present invention; FIG. 2 is a side, elevational view of the apparatus of the present invention showing the container and base components, the base being shown in both its inverted position and upright position as depicted in phantom; FIG. 3 is a partial cross-section of the apparatus of the invention taken in the plane of line 3--3 of FIG. 1 and showing the base component in its attached, inverted configuration; FIG. 4 is a partial cross-sectional view of the invention, similar to FIG. 3, showing the base component in its attached, upright configuration; FIG. 5 is an enlarged partial cross-section detailing the connection between the container and base components of the apparatus of the present invention; FIG. 6 is a partial bottom plan view of the base component in its inverted configuration; and FIG. 7 is an enlarged fragmentary view of the press-fit means by which the base component connects to the container when the base is in its upright configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now by reference numerals to the drawings which depict the invention in its preferred embodiment, attention is initially directed to FIGS. 1 and 2. It will be understood that shown therein is a planter 10 generally comprising a container 12 and a convertible base 14. The base 14 is depicted in FIG. 2 in both its upright 16 (phantom lines) and inverted 18 configurations. In FIG. 1, it can be seen that the container 12 generally comprises an upper lip 20, an inner wall 22 and a bottom 24. Disposed between the inner wall 22 and the bottom 24 is an annular ring 26 which is stepped-down from both inner wall 22 and bottom 24. Upper lip 20, inner wall 22, annular ring 26 and bottom 24 are all integrally formed as by injection molding. Thus, while any suitable materials can be employed for manufacturing the components of the present invention, it is preferred that moldable thermosetting and thermoplastic synthetic resinous materials such as olefin polymer and copolymeric materials like polypropylene and polyethylene be used. Desirably, these materials provide a sufficient degree of rigidity while retaining a degree of resiliency. As can be seen in FIGS. 1, 3 and 4, there are disposed radially about inner wall 22 a plurality of stanchions 28 which support base lip 30 when one planter 10 is placed within another. While planter 10 can be stacked or nested with base 14 in either of its upright 16 or inverted 18 configurations, it is preferred that nesting be performed with base 14 in its upright 16 configuration in order to achieve optimum compactness. Disposed within bottom 24 are a plurality of capillary wells 32. As clearly shown in FIGS. 2, 3 and 4, capillary wells 32 are molded to bottom 24 such that they depend downwardly therefrom. The capillary wells 32 each include a plurality of cut-outs 34, as best shown in FIGS. 1 and 3, which facilitate the passage of water into and out of the container 12. Positioned below both inner wall 22 and bottom 24 of the container 12 is molded and stepped-down annular ring 26. Radially disposed therein are a plurality of star-shaped connectors 36 and slots 38. Like cut-outs 34 in capillary wells 32, both connectors 36 and slots 38 also facilitate the passage of water into and out of the container 12. When it is desired to attach container 12 to base 14 in its upright 16 configuration, such as is shown in phantom in FIG. 2 and in FIG. 4, capillary wells 32 are aligned with corresponding well reservoirs 40 which depend downwardly from the bottom 42 of base 14 when in its upright 16 configuration. Preferably both capillary wells 32 and well reservoirs 40 are circular, the diameter of each capillary well being slightly smaller than that of each corresponding well reservoir 40. Once the corresponding structures are aligned, the capillary wells 32 are lowered into the corresponding well reservoirs 40. Because the capillary wells 32 depend downward from the bottom 24 of container 12 to a distance slightly less than the distance the corresponding well reservoirs 40 depend downward of the bottom 42 of the base 14 in its upright 16 configuration, a suitable clearance is established within each well reservoir 40 to permit the unrestricted flow of water therein and into each capillary well 32. This relationship is shown particularly in FIG. 4. With the capillary wells 32 and well reservoirs 40 in registry, star-shaped connectors 36 align with tray nipples 44 which are stepped-up from and circumferentially disposed thereabout the bottom 42 of the base 14 in its upright 16 configuration. As shown particularly in FIGS. 1, and 4 and more particularly in FIGS. 5 and 7, star-shaped connectors 36 include individual tabs 46 which yield to graspingly engage tray nipples 44 when sufficient downward pressure is applied to container 12 when it is aligned with base 14 in its upright 16 configuration. It should be noted that, because tray nipples 44 are molded in such a way as to project upwardly from spacers 48, sufficient clearance is provided between the underside 50 of annular ring 26 and the tray 52 region of base 14 in its upright 16 configuration so as to permit the unrestricted passage of water through slots 38 and connectors 36 disposed within the annular ring 26. As can be appreciated, the passage of water through these structures and either into or out of the container 12 occurs in both directions depending upon how full the tray 50 is with water. In operation, the planter 10 of the present invention (when configured with its base 14 in its upright 16 position) is readily adaptable to be placed upon a supporting surface or, following the attachment of appropriate suspension means (not shown) for use as a hanging planter. Once the base 14 is secured to the container 12, as described, it is only detachable when sufficient prying force is applied. As configured, when plants contained within the planter are watered, water migrates through the soil toward the bottom 24 of the container 12. Once the water reaches the bottom 24, it flows both into the individual capillary well 32/well reservoir 40 structures and also into the stepped-down annular ring 26 where it disperses onto tray 52 after having passed through slots 38 and star-shaped connectors 36. Provided that sufficient watering occurs to fill the well reservoir 40 structures and the tray 52, water will then be absorbed by the plant life until such time as the water is either totally absorbed or evaporated. As indicated at the outset, and as depicted generally in FIG. 2, the base 14 is convertible such that, in addition to being adapted for connection to the container 12 in its upright 16 configuration, it is also adapted for use in its inverted 18 configuration whereupon it functions as a pedestal. FIG. 3 provides, perhaps, the best depiction of the planter 10 of the present invention when adapted for use with base 14 in its inverted 18 configuration. In FIG. 3 it can be seen that the underside 50 of annular ring 26 fits between concentric inner 54 and outer 56 annular ribs which extend upwardly and away from the bottom exterior surface 58 of the base 14. Basically, the distance between the inner and outer ribs 54 and 56 forms a channel 60 the width of which corresponds with the width of the underside 50 of the annular ring 26. Thus, when so configured, the container 12 rests securely within the channel 60 as shown in FIGS. 3 and 6. Pedestal nipples 61, shown in FIGS. 3 and 6 and particularly in FIG. 4, are also provided and are disposed circumferentially within and upwardly from channel 60. When base 14 is attached to container 12 in its inverted 18 configuration, these structures function in conjunction with star-shaped connectors 36 in the same manner as do tray nipples 44 when base 14 is in its upright 16 configuration. This structure is shown in FIGS. 3 and 6. Thus, base 14 securely attches to container 12 in both its upright 16 and inverted 18 configurations thereby facilitating ease of handling and movement of planter 10 both when empty and when filled with soil and plant life. Also shown in FIG. 3 is the cavity reservoir 62 which is formed when container 12 is mated with base 14 in its inverted 18 configuration. While not shown in FIG. 3 (rather See FIG. 4), well reservoirs 40 which depend downwardly from the bottom 24 of base 14 in its upright 16 configuration project upwardly into cavity reservoir 62 when the base 14 is in its inverted 18 configuration. Thus, to properly position the container 12 with the base in this configuration, the container need only be rotated slightly until the capillary wells 32 are out of alignment with well reservoirs 40. When water is added to plants contained within the planter 10 in its pedestal configuration, the water migrates to the bottom 24 of the container whereupon it is dispersed into cavity reservoir 62 through capillary wells 32. Also, as can be seen in FIG. 6, gaps 64 in the annular inner 54 rib allow any water that migrates through slots 38 and/or star-shaped connectors 36 to flow into cavity reservoir 62. As is true when base 14 is assembled with container 12 in the upright 16 configuration, when sufficient water is added to fill cavity reservoir 62 of planter 10 with base 14 inverted, water can then be absorbed by the contained plant life until such time as as the water is either totally absorbed or evaporated. As can readily be appreciated, base 14 easily and conveniently separates from container 12 for cleaning or removal of any debris impeding water flow in either of its upright 16 or inverted 18 configurations. The foregoing description of specific embodiments of the present invention has been presented for purposes of illustration and description. It is not, however, intended to limit the invention to the precise embodiments disclosed because, obviously, modifications and variations are possible in light of the above teaching. The described embodiments were chosen in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention and various modifications as are suited to the particular use contemplated. Thus, while the present invention has been described by reference to specific embodiments, it should be understood that modifications and variations of the invention may be constructed without departing from the scope of the invention as defined by the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The field of invention relates to fluid dispenser apparatus, and more particularly pertains to a new and improved mouthwash dispenser kit apparatus wherein the same is arranged to accommodate mouthwash fluid for selective dispensing. 2. Description of the Prior Art Various fluid dispensing apparatus is available in the prior art and set forth in U.S. Pat. No. 4,660,746 to Wright wherein a liquid closure cap is arranged for mounting to an upper end of a fluid container. U.S. Pat. No. 3,734,106 to Zimmerman sets forth a toothbrush mouthwash rinser kit arranged to secure a toothbrush and liquid cap structure mounted to a handle portion of the toothbrush member. U.S. Pat. No. 4,903,848 to Chattman sets forth a mouthwash packaging structure having a cap mounting a toothbrush thereto. As such, it may be appreciated that there continues to be a need for a new and improved mouthwash dispenser kit apparatus as set forth by the instant invention which addresses both the problems of ease of use as well as effectiveness in construction and in this respect, the present invention substantially fulfills this need. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known types of mouthwash dispensing apparatus now present in the prior art, the present invention provides a mouthwash dispenser kit apparatus wherein the same is arranged to selectively direct mouthwash fluid therefrom. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved mouthwash dispenser kit apparatus which has all the advantages of the prior art mouthwash dispensing apparatus and none of the disadvantages. To attain this, the present invention provides a wall plate arranged for selective reception of a support member having a floor, with an internally threaded cylindrical skirt arranged to receive a mouthwash dispensing fluid container therewithin, with a valve plate reciprocatably mounted relative to a bottom surface of the floor to permit selective fluid flow therethrough. The apparatus is further arranged to include an adapter head arranged to receive a mouthwash bottle thereon having a truncated, conical directional conduit to receive an outlet opening of the fluid bottle. My invention resides not in any one of these features per se, but rather in the particular combination of all of them herein disclosed and claimed and it is distinguished from the prior art in this particular combination of all of its structures for the functions specified. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. Those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. It is therefore an object of the present invention to provide a new and improved mouthwash dispenser kit apparatus which has all the advantages of the prior art mouthwash dispensing apparatus and none of the disadvantages. It is another object of the present invention to provide a new and improved mouthwash dispenser kit apparatus which may be easily and efficiently manufactured and marketed. It is a further object of the present invention to provide a new and improved mouthwash dispenser kit apparatus which is of a durable and reliable construction. An even further object of the present invention is to provide a new and improved mouthwash dispenser kit apparatus which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such mouthwash dispenser kit apparatus economically available to the buying public. Still yet another object of the present invention is to provide a new and improved mouthwash dispenser kit apparatus which provides in the apparatuses and methods of the prior art some of the advantages thereof, while simultaneously overcoming some of the disadvantages normally associated therewith. These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is an illustration of the wall support structure of the invention. FIG. 2 is an isometric illustration of the mouthwash dispenser bottle of the invention. FIG. 3 is an orthographic view, taken along the lines 3--3 of FIG. 2 in the direction indicated by the arrows. FIG. 4 is an isometric illustration of an adapter head structure for use by the invention. FIG. 5 is an isometric illustration of the adapter head mounted to the mounting skirt structure of the invention, as indicated in FIG. 1, in cooperation with a cup dispenser flange. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1 to 5 thereof, a new and improved mouthwash dispenser kit apparatus embodying the principles and concepts of the present invention and generally designated by the reference numerals 11 through 47 will be described. More specifically, the mouthwash dispenser kit apparatus of the instant invention essentially comprises a wall plate 11 having a top surface 12 orthogonally oriented relative to a front surface 13, with a rear surface 14 arranged for contiguous mounting to a support wall (not shown) employing mounting apertures 17 to receive fasteners therethrough for direction into the wall. The top surface 12 includes a plurality of T-shaped slots 15 directed into the wall plate originating through the top surface 12, with a front wall slot opening 16 in communication with an upper portion of the T-shaped slot and a lower portion of each T-shaped slot arranged for receiving a locking plate of a first width substantially equal to the first widths of each lower portion of each T-shaped slot. The upper portion of each T-shaped slot is arranged to receive a locking plate head 25. A plurality of such locking plate heads 25 are provided, as illustrated in FIG. 1, in association with a plurality of locking plates 24. The locking plate heads 25 are defined by a second width greater than the first width to be received within an upper portion of the T-shaped slot, with each front wall slot opening 16 arranged for receiving a support leg 23 orthogonally and medially bisecting each respective locking plate head 25. A cylindrical internally threaded mounting skirt 18 includes a support floor 19 having a floor opening 20 directed coaxially therethrough coaxially aligned with the cylindrical mounting skirt 18. An annular seal 21 is arranged in surrounding relationship relative to the floor opening 20 and may optionally include a piercing blade 22 arranged for projecting through a typical foil seal of an associated commercially available container. The support legs 23 are integrally mounted to an exterior surface of the mounting skirt 18 orthogonally oriented relative to its axis. A support plate 26 is positioned below the floor 19 having confronting support ledges 27 on opposed sides of the support plate 26 slidingly receiving a valve plate 28 therebetween. The valve plate 28 has a valve plate bore 29 arranged for selective alignment with the floor opening 20, whereupon the valve plate 28 is biased by a valve plate spring 30 into a displaced position to displace the valve plate bore 29 relative to the floor opening 20, whereupon manual depressing of the valve plate 28 permits alignment of the valve plate bore relative to the floor opening 20 permitting fluid flow therethrough. A valve plate handle 31 projecting exteriorly of the support plate 26 is arranged for convenient manual grasping for displacement of the valve plate as noted above. The FIGS. 2 and 3 illustrate the use of a fluid container 32 utilized by the invention having a fluid container externally threaded outlet opening 33 for reception within an outlet opening head 34. The outlet opening head 34 has a head outer threaded portion 35 for threaded engagement within the internally threaded mounting skirt 18. Head inner threads 36 engage the fluid container's externally threaded outlet opening 33. A head central opening 37 directed medially of a top wall of the outlet opening head 34 includes a surrounding head central opening seal 38 for engagement with the annular seal 21 to permit fluid flow through the floor opening 20 only. The FIG. 4 illustrates the use of a container adapter 39 employed by the invention as a portion of the kit structure to include a lower externally threaded cylindrical adapter head 40 arranged for selective reception within the mounting skirt 18. An adapter head floor 41 has a truncated conical receiving tube 42 coaxially aligned relative to the adapter head 40 projecting above the floor 41 within the adapter head formed of a resilient polymeric material to receive a fluid container opening thereabout in a sealing relationship (see FIG. 5). A plurality of support ribs 43 extend upwardly in a parallel relationship relative to the receiving tube axis 42a of the receiving tube 42, and a support rib plate 44 is provided having support rib slots 45 therethrough, with each slot arranged to receive an individual support rib 43 of the plurality of support ribs 43 to assist in alignment of the commercially available fluid container, as illustrated in FIG. 5. The use of the valve plate structure, as illustrated in FIG. 1, is employed by the organization, as illustrated in FIG. 5, and wherein the FIG. 5 structure further includes a cup holder flange 46 orthogonally mounted to the wall plate front surface 13 having a cup holder flange opening 47 directed therethrough to accommodate commercially available cup members in a convenient manner relative to the fluid dispensing structure for use by individuals. As to the manner of usage and operation of the instant invention, the same should be apparent from the above disclosure, and accordingly no further discussion relative to the manner of usage and operation of the instant invention shall be provided. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

1a

[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 61/534,967 filed Sep. 15, 2011, incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to methods for delaying bud break in plants by applying abscisic acid analogs to the plants before the plants become dormant in response to exposure to colder temperatures. BACKGROUND OF THE INVENTION [0003] Controlling the timing of bud break of perennial plants by delaying the emergence of their green shoots from their buds could significantly decrease cold temperature damage to the plants. In some spring seasons, there is an unexpected period of warm weather early in the season. If this period of warm weather causes bud break, the buds are vulnerable to exposure to freezing temperatures that could damage or kill the buds. The death of the buds could eliminate the plants' potential to produce harvestable products. Obviously, this scenario could devastate the growers' profits for the year and would be undesirable. Unfortunately, there is no way to predict if there will be a period of time in early spring when there is unseasonably warm weather. Therefore, there is a need to delay the time of bud break until after the risk of frost and cold stress is reduced in the area in which the plants are growing. [0004] Researchers have attempted to use chemicals to delay bud break. Spraying eco dormant grapevines with solutions of alginate or various oils in early spring have been shown to delay bud break (Dami, et al., American Journal of Enology and Viticulture, Vol. 51(5):73-76 (2000)). However, growers have not adopted the use of these treatments to delay bud break because the delay is not very long and the oil treatment can cause the very severe side effect of bud mortality. One researcher, Gianfagna reported that a fall application of the ethylene releasing agent ethephon delayed bud break of peaches the following spring (Gianfagna, et al., Acta Hort. (ISHS) 239:203-206 (1989)). Few growers, however, have used ethephon treatments due to the potential negative side effect of increased gummosis. In summary, although some researchers have indicated that chemicals such as alginate, ethephon, or oils could delay bud break, these chemicals did not provide a practical solution to growers because of the negative side effects. [0005] S-(+)-Abscisic acid (“ABA”) is a naturally-occurring hormone found in all higher plants (Cutler and Krochko. Formation and Breakdown of ABA . Trends in Plant Science, 4:472-478 (1999); Finkelstein and Rock, Abscisic acid Biosynthesis and Signaling , The Arabidopsis Book, ASPB, Monona, Md., 1-52 (2002)). S-(+)-Abscisic acid is reported to be found in all photosynthetic organisms (Cutler and Krochko, 1999; Finkelstein and Rock, 2002). ABA is involved in many major events of plant growth and development including dormancy, germination, bud break, flowering, fruit set, growth and development, stress tolerance, ripening, abscission, and senescence. ABA also plays an important role in plant tolerance to environmental stresses such as drought, cold, and excessive salinity. [0006] Minimal research has been conducted with ABA and the role ABA has on dormancy is unclear. One study showed that exogenous ABA application to birch tree seedlings enhanced freezing tolerance and accelerated growth cessation in seedlings grown in short day conditions (SD, 12-hour photoperiod at 18′C), and slightly enhanced freezing tolerance in seedlings grown at low temperature (LT, 24-hour photoperiod at 4° C.) in both ecotypes tested (Li, et al., Tree Physiology 23; 481-487 (2003)). Li, et al., also reported that development of freezing tolerance and dormancy release induced by low temperatures was accompanied by changes in ABA levels. Alterations in ABA levels paralleled with development of freezing tolerance and preceded bud dormancy release in both ecotypes tested (Li, et al., Plant Science 167: 165-171 (2004)), Rimie showed that bud burst in Betula could be delayed by application of synthetic ABA (Rinne, et al., Tree Physiol. 14:549-561 (1994)). However, Hellman has reported that spring application of ABA on grapes had little effect on bud break (Hellman et al. Journal of the American Pomological Society 60(4): 178-186 (2006)). [0007] The precise role of ABA in maintaining dormancy is not known. However, ABA has been postulated to be involved in the induction of endo-dormancy. By this hypothesis, endogenous ABA levels increase in the fall and act as a signal of shorter day length. This in turn hypothetically results in the inhibition of shoot growth, promotion of terminal bud set, and induction of endo-dormancy of buds (Arora, et al., HortScience Vol 38(5):911-921 (2003)). Furthermore, this scenario assumes that ABA levels decrease during the winter as chilling hours accumulate. When ABA levels or sensitivity to ABA decline below a threshold level, endo-dormancy ends and eco-dormancy continues to delay bud break. When temperatures increase in the spring, eco-dormancy ends and buds begin to grow and bud break occurs. However, this hypothesis has been questioned. [0008] In order to determine the role ABA had on perennial plant bud break, Applicants conducted field studies for several years. After many experiments. Applicants determined that ABA had no appreciable effect on bud break, even when applied at high levels. Further, the timing of application of the ABA did not matter, because it failed to appreciably effect bud break at each and every application time. [0009] In some situations, ABA analogs appear to be more potent than ABA, however analogs are thought to work in a similar way as ABA (i.e. some analogs effectively produce an ABA-like effect in reducing water use, see U.S. Pat. No. 6,004,905). Therefore, because ABA was unsuccessful at changing bud break timing, Applicants predicted that ABA analogs would also have no appreciable effect on bud break timing in perennial plants. [0010] Further, ABA and ABA analogs are thought to be quickly metabolized by plants and, therefore, would not have long-term effects on the plants' growth. Therefore, Applicants thought that fall applications of ABA analogs would not affect the plants' reaction to changes in temperature several months later in the spring. [0011] Therefore, there is a need in the art for an effective and practical way to delay bud break in perennial plants. Other researchers have failed to provide a solution and early cold temperature damage continues to plague growers and results in significant damage to crop-producing perennial plants. Applicants attempted to find a solution but unfortunately found that ABA was ineffective and speculated that ABA analogs would similarly fail to provide a much needed solution. SUMMARY OF THE INVENTION [0012] Applicants unexpectedly found that ABA analogs will delay bud break in plants if the ABA analogs are applied before the plants enter dormancy. Specifically, Applicants found that ABA analogs provided delayed bud break and thus protection from cold temperature stress in perennial plants. Applicants found that even though they applied ABA analogs to the plants several months before the cold weather stress, the ABA analogs still provided excellent protection. Importantly, Applicants found that application of ABA analogs to perennial plants did not result in negative side effects. [0013] In one aspect, the invention is directed to methods for applying ABA analogs to perennial plants prior to their cold temperature induced dormancy, for example, during the fall season. This application will successfully protect the plants for many months from the dangers of early emergence during the time when there is a risk of frost or near freezing temperatures, for example, during the early spring season. [0014] The Examples provided below support Applicants assertion of unexpected results. In Examples 1-3, Applicants have shown that application of ABA and ABA analogs to plants in the spring does not affect the timing of bud break, In Example 4 (in part), Applicants have shown that application of ABA in the fall is also ineffective, as a soil drench. In contrast and unexpectedly, Applicants have shown in Examples 4 (in part) and 5-7 that ABA analogs, when applied in the fall, are very effective in prolonging the timing of bud break in perennial plants. In fact, ABA analogs produce delays in bud break when the analogs are applied at a fraction of the rate of ABA, and when ABA failed to show any delay. For example, in Example 6, Applicants unexpectedly found that ABA analog PBI-429 is about 100 times more potent than ABA when used on nectarine trees. DETAILED DESCRIPTION OF THE INVENTION [0015] Embodiments of the present invention are directed to methods for delaying bud break in perennial plants comprising applying an ABA analog to the plants prior to cold temperature induced dormancy. This cold temperature induced dormancy can be due to the end of the summer growing season and the beginning of the fall dormancy season. [0016] In an embodiment of the invention, the ABA analog is applied to the plant before the plants' leaves are abscised in reaction to exposure to colder temperatures. [0017] In a further embodiment, the ABA analogs that are applied to the plants include at least one of PBI-425, PBI-524, PBI-429, PBI-696, and PBI-702. [0018] In another embodiment, the ABA analog is applied to a grape plant. The ABA analog can be applied by spraying the grape vine, spraying the grape vine and grape leaves, or drenching the soil. [0019] When the ABA analog is sprayed or used in a drench solution, it can be mixed with a solvent, such as water, to produce an appropriate concentration for spraying or drenching. In embodiments of the invention, the grape plant may be sprayed or drenched with a solution containing an ABA analog at a rate of from 10 to about 10,000 ppm. Preferably, the ABA analog is applied at a rate of from about 50 to about 2,000, and most preferably, the ABA analog is applied at a rate of from about 100 to about 1000 ppm. [0020] The ABA analog may be applied to the grape plant at a rate of from about 3 to about 3,000 grams per acre (an acre is approximately 4046.86 square meters), preferably from about 15 to 600 grams per acre, more preferably at a rate of 30 to 400 grams per acre, and most preferred at a rate of from about 37.8 to about 378 grams per acre. [0021] The ABA analog may be applied to the grape plant at a rate of from about 0.01 to about 2.0 grams per plant, preferably from about 0.04 to about 0.4 grams per plant, and most preferred at a rate of from about 0.125 grams per plant. [0022] In a further embodiment, the ABA analog may be applied to only the part of the grape plant that will not be pruned the following spring, or the time following the cold temperature induced dormancy period. In this embodiment, resources are preserved because it allows for less ABA analog to be applied to the plant and may provide the same results as when the entire plant is sprayed. In this embodiment, the ABA analog may be applied to the specific parts of the grape plant at a rate of from about 0.01 to about 1.0 grams per vine, preferably at a rate of from about 0.004 to about 0.041 grams per vine. Alternatively, the ABA analog may be applied to the grape plant at a rate of about 0.05 to 40 grams per acre, or more preferably at a rate of from about 3 to about 40 grams per acre, and most preferably at a rate of from about 3 to about 4 grams per acre. [0023] Spraying the part of the plant that will not be pruned involves directing the spraying apparatus to spray the buds and vines. This technique is known by those skilled in the art. For example, ProTone® Plant Growth Regulator (available from Valent® Biosciences) is effective for coloring grapes when the ProTone® is applied to just the clusters on the grape vines and the entire vine and leaf surface of the plant does not need to be sprayed. Similarly, spraying only an area of the plant that will develop the grapes the following spring (the buds near the cordon of the grape vine) may be an effective treatment resulting in desirable delays in bud break while being cost effective. In this case, growers could apply up to 90% less product to a limited amount of the plant and achieve the same results as spraying the entire plant. For example, instead of applying from about 30 to about 400 grams per acre, growers could apply just from about 3 to about 40 grams per acre of the ABA analog to the non-pruned parts of the plant. [0024] In another embodiment, the ABA analog is applied to a stone fruit tree. The stone fruit tree can be an apricot, nectarine, peach, cherry, or plum tree. In a preferred embodiment, the ABA analog is applied to a nectarine tree. The ABA analog can be applied to the stone fruit tree, including the nectarine tree, at a rate of from about 10 to about 200 grams per acre. [0025] The entire canopy of the tree may be sprayed, or alternatively, only the portion of the tree that will not be pruned the following spring may be sprayed, in this embodiment, a fraction of the amount of ABA analog may be applied to the portion of the tree that will not pruned the following spring. For example, from about 1 to 100 grains per acre, or from about 5 to about 50 grams per acre. [0026] The method of only spraying the part of the canopy that is anticipated to not be pruned in the spring preserves resources because it allows for less ABA analog to be applied and may provide the same results as when the entire canopy is sprayed. This method provides a cost effective solution for growers concerned about early bud break. [0027] It is understood that the concentration of the ABA analog can vary widely depending on the water volume applied to plants as well as other factors such as the plant age and size, and plant sensitivity to ABA analogs. [0028] ABA analogs that selectively antagonize ABA activity that are useful in the present invention include PBI-51 (Abrams and Gusta, 1993, U.S. Pat. No. 5,201,931; Wilen, et al., 1993, Plant Physiol. 101: 469-476): [0000] [0029] Presently preferred ABA analogs and derivatives useful in the present invention include PBI-425, PBI-429, PBI-524 PBI-696 and PBI-702. [0030] For the purposes of this Application, ABA analogs are defined by Structures 1, 2 and 3, wherein for Structure 1: [0031] the bond at the 2-position of the side chain is a cis- or trans-double bond, [0032] the bond at the 4-position of the side chain is a trans-double bond or a triple bond, [0033] the stereochemistry of the alcoholic hydroxyl group is S-, R- or an R,S-mixture, [0034] the stereochemistry of the R 1 group is in a cis-relationship to the alcoholic hydroxyl group, [0000] R 1 is ethynyl, ethenyl, cyclopropyl or trifluoromethyl, and R 2 is hydrogen or lower alkyl [0000] [0000] wherein lower alkyl is defined as an alkyl group containing 1 to 4 carbon atoms in a straight or branched chain, which may comprise zero or one ring or double bond when 3 or more carbon atoms are present. [0035] For PBI-425, R1 is ethynyl, the orientation of the bonds for R1 and the hydroxyl group relative to the ring is alpha—in both cases, and the terminal carboxyl group is in the 1-orientation. [0036] For PBI-429, R 1 is ethynyl and R 2 is a methyl group. [0037] For PBI-524, R 1 is ethynyl and R 2 is hydrogen. [0038] For PBI-696, R 1 is cyclopropyl and R 2 is a methyl group. For Structure 2: [0039] the bond at the 2-position of the side chain is a cis- or trans-double bond, [0040] the bond at the 4-position of the side chain is a triple bond, [0041] the stereochemistry of the alcoholic hydroxyl group is S-, R- or an R,S-mixture, [0000] R 1 is hydrogen or lower alkyl [0000] [0000] wherein lower alkyl is defined as an alkyl group containing 1 to 4 carbon atoms in a straight or branched chain, which may comprise zero or one ring or double bond when 3 or more carbon atoms are present. [0042] For PBI-702, R 1 is a methyl group. For Structure 3: [0043] the bond at the 2-position of the side chain is a cis or trans-double bond, [0044] the bond at the 4-position of the side chain is a trans-double bond, [0045] the stereochemistry of the alcoholic hydroxyl group is S-, R- or an R,S-mixture, [0000] R 1 is hydrogen or lower alkyl [0000] [0000] wherein lower alkyl is defined as an alkyl group containing 1 to 4 carbon atoms in a straight or branched chain, which may comprise zero or one ring or double bond when 3 or more carbon atoms are present. [0046] It is understood by one skilled in the art that the methods of the present invention can also include applying the ABA analogs with other ingredients useful for assisting in the ABA analogs uptake into the plant, such as surfactants. For example, Silwet L-77 or Brij® 98 or other surfactants may be used in methods of the present invention. [0047] As used herein, a delay in bud break means that the buds do not show green tissue when warm temperature conditions would usually initiate bud break. The desired delay is at least from about 5 days to about 10 days to sufficiently protect the buds from any freezing damage. It is preferable that the delay is at least 8 days. [0048] As used herein, the season fall refers to the season in temperate climates that marks the transition from summer into winter, During this time, temperatures tend to decrease and the amount of daylight per day is reduced. Fall occurs around September/October in the Northern Hemisphere and around March/April in the Southern Hemisphere. As used herein, the season spring refers to the season in temperate climates that marks the transition from winter into summer. During this time, temperatures tend to increase and the amount of daylight per day is increased. Spring occurs around March/April in the Northern Hemisphere and around September/October in the Southern Hemisphere. It is understood that the beginning of the seasons is relative to the specific geographical location and climate of a region. [0049] Throughout the application, colder or cooler temperatures are associated with the seasonal changes associated with the approaching winter season, and warmer temperatures are associated with the seasonal changes associated with the approaching summer season. [0050] It is also contemplated that salts of ABA analogs may be utilized in accordance with the present invention. [0051] As used herein, the term “salt” refers to the water-soluble salts of ABA analogs. Representative such salts include inorganic salts such as the ammonium, lithium, sodium, calcium, potassium and magnesium salts and organic amine salts such as the triethanolamine, dimethylethanolamine and ethanolamine salts. [0052] As used herein, all numerical values relating to amounts, weight percentages and the like, are defined as “about” or “approximately” each particular values plus or minus 10% 10%). For example, the phrase “greater than 0.1%” is to be understood as encompassing values greater than 0.09%. Therefore, amounts within 10% of the claimed values are encompassed by the scope of the invention. [0053] The percentages of the components in the formulations and comparative formulations are listed by weight percentage. [0054] When dilute solutions of ABA analogs are prepared, the amounts are often listed in “ppm” referring to the parts per million of the ABA analogs that are present in the solution. The solution contains a solvent and may contain other excipients. [0055] It is understood that the foregoing detailed description and accompanying examples are merely illustrative and are not to be taken as limitations upon the scope of the invention, which is defined solely by the appended claims and their equivalents. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications, including without limitation those relating to the active agents and excipients of the invention, may be made without departing from the spirit and scope hereof. [0056] The following examples are offered by way of illustration only, not to limit the scope of this invention, as represented by the claims list attached herein. EXAMPLES [0057] Examples 1, 2 and 3 demonstrate the ineffectiveness of soil drench or spray application of ABA or ABA analog to eco-dormant grapevines near the time of bud break. Examples 4-7 demonstrate the efficacy of soil drench or spray applications of ABA analog, but not ABA, in the fall for delaying bud break the following spring. [0058] Chemical solutions were prepared with distilled water. Abscisic acid (S-ABA; ABA; S-(+)-abscisic acid; +-ABA, (+)-(S)-cis,trans-abscisic acid, (+)-(S)-cis,trans-ABA; S-ABA; (S)-5-(1-hydroxy-2,6,6)-trimethyl-4-oxo-2-cyclohexen-1-yl)-3-methyl-(2 Z,4E)-pentadienoic acid; CAS no. 21293-29-8, 10% active ingredient. ABA analog 8′acetylene-ABA methyl ester (PBI-429), was synthesized by Plant Biotechnology Institute, National Research Council of Canada (Saskatoon, Saskatchewan, Canada). Example 1 [0059] A study was conducted to evaluate the effect of spraying eco-dormant Concord grape vines with ABA or ABA analog plus surfactants on bud break. Mature field grown Concord grape vines were sprayed to runoff 2 times in the spring after pruning and before bud swell. Three replicates of 3 vines each were treated with each treatment solution. Treatments were arranged in a randomized complete block design down a single vineyard row, Bud break was monitored by counting the number of broken buds of the distal 5 buds on 4 proximal canes on the middle vine of each 3 vine replicate. Bud break was only very slightly delayed by any of the treatments compared to the water sprayed control (Table 1). [0000] TABLE 1 Effect of ABA or ABA analog spray on bud break of field grown Concord grapevines. N = 3 replicates of 3 vines each/treatment. Average percent broken buds 100 ppm Bud Break 1,000 ppm 1,000 ppm 10,000 ppm PBI-429 Evaluation ABA plus plus 0.5% ABA plus plus 0.5% Date Water 0.5% Brij 98 Pentrabark 0.5% Brij 98 Brij 98 April 24 10 8 2 5 8 April 30 20 13 13 18 18 Example 2 [0060] A study was conducted to determine the effect of ABA applied to the soil of potted grapevines near the time of bud break. Eco-dormant bare-root Seyval Blanc and Canadice grapevines were purchased from Concord Nurseries, North Collins, N.Y. Vines were planted in pots of Promix potting mixture and held in a 5° C. dark chamber prior to treatment. Plants were moved from the 5° C. chamber to a greenhouse set to 20° C. night/25° C. day with a 12 hour light and 12 hour dark light cycle to promote bud break. One group of 5 plants was treated with 250 ml of 1000 ppm ABA (250 mg) as a soil drench 2 days after moving the vines to warm conditions. Another group of vines was treated 6 days after warming and another group of 5 plants was treated 10 days after warming. With the Seyval Blanc grapevines one group of 5 plants was treated at all 3 timings 2, 6, and 10 days after warming (750 mg total). Another group of 5 vines was not treated and acted as an untreated control. The number of broken buds (showing green tissue) per vine was determined 13, 14, 15, and 16 days after treatment fbr Seyval Blanc (Table 2) and 13, 14, 15, 16, 17 and 18 days after treatment for Canadice grapevines (Table 3). [0061] Application of 1000 ppm ABA soil drench 13-16 days before bud break delayed bud break, but only for 3.5 days. The desired delay is 5-10 days to protect against late freezes. Soil drench treatment in the spring is not a desirable application situation due to high volume of water the grower would have to apply. A foliar spray would be preferable but the lack of leaves makes spray application in the spring an inefficient way to deliver active ingredients to the plant. [0000] TABLE 2 Effect of ABA soil drench on bud break of potted Seyval Blanc grapevines. N = 5 vines/treatment. Average number of broken buds per vine 1000 ppm Bud Break 1000 ppm 1000 ppm 1000 ppm ABA 2, 6 Evaluation ABA 2 Days ABA 6 Days ABA 10 and 10 Days (Days After After After Days After After Warming) Untreated Warming Warming Warming Warming 13 2.6 0.4 0.2 1.8 1.2 14 5.0 2.2 1.6 6.0 4.4 15 7.6 3.6 2.6 8.6 4.8 16 9.8 6.8 6.8 11.4 7.0 [0000] TABLE 3 Effect of ABA soil drench on bud break of potted Canadice grapevines. N = 6 vines/treatment. Average number of broken buds per vine Bud Break 1000 ppm 1000 ppm 1000 ppm Evaluation ABA ABA ABA (Days After 2 Days After 6 Days After 10 Days After Warming) Untreated Warming Warming Warming 13 0.7 0 0.2 0.5 14 2.5 0 0.7 1.8 15 3.2 0.8 1.2 2.3 16 3.3 1.2 1.7 2.3 17 3.3 1.7 2.3 2.3 18 3.5 1.7 2.5 2.7 Example 3 [0062] A study was conducted to determine the effect of spraying Concord grapevines with ABA or ABA analog PBI-429 during bud break. Potted concord grapevines were placed in greenhouse conditions to promote bud break and the vines were repeatedly sprayed with ABA or ABA analog solutions. The vines were sprayed 2, 4, 8, 12 and 14 days after exposure of the vines into bud break promoting temperatures. Bud break was rated 6, 7, 8, 11, 12, 13, 14, 15, 19 and 20 days after vines were placed in warm bud break promoting conditions. The average number of broken buds (buds showing green) was not significantly impacted over time by repeated spray application of ABA or ABA analog during the bud break period (Table 4). [0000] TABLE 4 Effect of foliar application of ABA or ABA analog to potted Concord grapevines during the bud break period on the number of broken buds per vine. N = 6 vines per treatment Bud Break Average number of broken buds per vine Evaluation 0.05% 1000 ppm ABA 100 ppm PBI-429 (Days After Silwet in 0.05% Silwet in 0.05% Silwet Warming) Water L77 L77 L77 6 0 0.2 0.2 0.7 7 0 0.3 0.2 0.7 8 0.5 0.7 0.8 1.7 11 2.3 3.3 2.8 2.5 12 3.0 3.5 3.2 2.5 13 3.8 4.7 3.8 3.0 14 3.8 4.8 4.8 3.0 15 4.2 6.2 5.3 4.0 19 4.8 6.8 7.0 4.3 20 4.8 6.8 7.0 4.3 Example 4 [0063] A study was conducted to determine the effect of application of ABA or ABA analog as a soil drench in the fall on bud break of potted Concord grapevines the following spring. Two year old eco-dormant Concord grapevines were obtained from a Concord Nurseries in the spring. Bare-root vines were planted in 14 liter pots filled with Promix BX (available from Premier Horticulture Inc. Quakertown, Pa.) and grown outside for about 5 months (May October) prior to treatment. Plants received irrigation as needed and fertilized weekly (1 g/L all purpose fertilizer 20-20-20, The Scotts Company, Marysville, Ohio). Uniform plants were selected for the study. A total of 1000 mL of water or chemical solution was applied to the soil of each plant. [0064] After chemical treatment, the ten replicate plants per treatment were arranged in a randomized complete block experimental design. The potted vines were surrounded by bark chips the depth of the soil in the pot to insulate the roots and prevent cold damage. The plants became dormant for the winter. In the following spring the vines were pruned to 5 buds per vine before bud break and bud break was monitored over time (Table 4). The buds were rated for bud break periodically on a scale from 1 for no growth to 6 for three or more leaves showing [0065] Potted Concord grapevines were treated with 1000 mL water, solution containing 1000 mg ABA or solution containing 100 mg PBI-429. The dose of RBI-429 was used at one-tenth of ABA dose based on the preliminary results. [0066] Bud break progression of vines treated with 1000 mg ABA was similar to that of untreated vines (Table 5). Surprisingly bud break of vines treated with 100 mg ABA analog PBI-429 in the all was delayed by about 2 weeks compared to that of ABA treated or untreated vines. [0000] TABLE 5 Effect of fall applied ABA and ABA analog PBI-429 on bud break of Concord grapevines in the following spring. Average rating of bud break (1-6 scale). 100 ppm PBI-429 1000 ppm ABA (100 mg PBI- Date Water (1000 mg ABA/pot) 429/pot) Apr. 23, 2008 1.1 1.0 1.0 April 28 1.6 1.6 1.0 April 30 1.7 1.8 1.0 May 2 1.8 1.8 1.0 May 5 2.1 2.1 1.0 May 7 2.5 2.6 1.0 May 9 2.8 2.9 1.0 May 12 3.0 3.0 1.0 May 14 3.3 3.0 1.0 May 16 3.6 3.4 1.0 May 19 4.4 4.2 1.2 May 21 4.5 4.6 1.2 May 23 5.0 4.9 1.8 May 28 5.5 5.4 2.7 Example 5 [0067] A study was conducted to determine the effect of spraying grapevines with ABA analogs in the fail on bud break the following spring. Mature Cabernet Franc grapevines growing in a research vineyard in Benton Harbor, Mich. were sprayed to drip with surfactant alone or surfactant and ABA analog on Oct. 25, 2008. Vines were sprayed with approximately 300 ml (113 grams ABA analog/acre) applied to each of 9 vines per treatment arranged in three replicates of three vines each. The following spring prior to bud break the vines were pruned to 3-6 buds per spur and bud break of 40 buds per vine (4 buds on each of 10 spurs) was rated periodically using the BBCH (Biologische Bundesanstalt, Bundessortenamt und Chemische Industrie) scale of development where a rating of 1 represents the first sign of bud swelling and 99 represents a defoliated plant re-entering dormancy at the end of the growing season. [0068] Unexpectedly foliar application ABA analogs PBI-429 and PBI-524 at about 0.125 grams per vine delayed bud break the following spring by about 15 days (Table 6). Significant bud break delay was unexpected due to the low dose per vine on large mature vines and the months between application and observed effect. Both analogs were very effective at delaying bud break without apparent impact on bud mortality. [0000] TABLE 6 Effect of fall foliar application of ABA analogs on bud break of Cabernet Franc grapevines the following spring. N = three 3 vine replicates Average BBCH rating of bud developmental stages. 300 ppm PBI-429 in 300 ppm PBI-524 in Date 0.1% Brij 98 0.1% Brij 98 0.1% Brij 98 May 1, 2009 1.8 0.1 0.0 May 5 2.8 0.4 0.4 May 12 5.0 1.0 1.0 May 21 8.1 3.2 3.7 May 28 14.2 6.0 6.7 [0069] Foliar application ABA analogs PBI-429 and PBI-524 at about 0.125 grams per vine in the fall delayed maturation of the following crop of grapes as measured by juice pH and Brix (Table 7). [0000] TABLE 7 Effect of fall foliar application of ABA analogs on fruit maturity of Cabernet Franc grapevines the following fall. N = three 3 cluster replicates Average pH and Brix of grapes harvested on Oct. 24, 2009. 300 ppm PBI-429 in 300 ppm PBI-524 in 0.1% Brij 98 0.1% Brij 98 0.1% Brij 98 pH of juice 3.34 3.16 3.14 Brix of juice 20.84 19.32 19.37 [0070] When the control fruit had reached maturity three clusters of grapes were randomly harvested from each 3 vine replicate. Brix and pH measurements were made of the juice expressed by hand squeezing the grape clusters. Both the pH and Brix readings were lower for the grapes from the ABA analog treated vines indicating a delay of fruit maturity. Example 6 [0071] A study was conducted to determine the effect of spraying nectarine trees with ABA or ABA analogs in the fall on bud break the following spring. Mature PF-11 nectarine trees were sprayed to drip with surfactant alone or surfactant and ABA or ABA analog on Oct. 19, 2009. Trees were sprayed with approximately 500 ml (20.5 grams ABA analog/acre) applied to each of 6 trees per treatment arranged in a randomized complete block design. The following spring bud break on pre-selected branches was monitored. [0072] Surprisingly the delay of bud break from the ABA analog PBI-429 applied at 100 ppm was very similar to the delay from application of 10,000 ppm ABA (Table 8). The finding that the analog was about 100 times more potent than ABA was an unexpected result. In other bioassays and published accounts the most efficacious ABA analogs appear to be about 10 to 20 times more potent than ABA. [0000] TABLE 8 Effect of fall foliar application of ABA analogs on bud break of PF-11 nectarines the following spring. N = 2 branches on each of six single tree replicates Percentage of broken floral buds. 10,000 ppm ABA in 100 ppm PBI-429 in Date 0.1% Brij 98 0.1% Brij 98 0.1% Brij 98 April 8 100 78 56 [0073] Foliar application of the ABA analog PBI-429 and to nectarine trees in the fall reduced the number of fruit per tree the following spring (Table 9). [0000] TABLE 9 Effect of fall foliar application of ABA or ABA analog on fruit number per tree the following spring. N = six single tree replicates Average number of fruit per tree. 10,000 ppm ABA in 100 ppm PBI-429 in Date 0.1% Brij 98 0.1% Brij 98 0.1% Brij 98 June 10 114 55 75 [0074] Treatment of nectarine trees in the fall with the ABA analog delayed bud break and reduced fruitfulness the following spring similar to ABA applied at 100 times higher dose. Example 7 [0075] A study was conducted to determine the elect of spraying Cabernet Franc grapevines with ABA analog PBI-425 or PBI-524 in the fall on bud break the following spring. Mature Cabernet Franc grapevines growing in a research vineyard in Benton Harbor, Mich. were sprayed to drip with surfactant alone or surfactant and ABA analog on Oct. 21, 2011. Vines were sprayed with approximately 300 ml applied to each of 9 vines per treatment arranged in three replicates of three vines each. Applied at about 100 gallons per acre 100 ppm treatment represents 37.8 grams per acre and 1000 ppm represents 378.4 grams per acre. In the spring after treatment prior to bud break the vines were pruned to 3-6 buds per spur and bud break of the entire vine was determined in the spring. [0076] Surprisingly foliar application ABA analogs PBI-425 and PBI-524 at about 0.03-0.3 grams per vine delayed bud break the following spring (Table 10). Significant bud break delay was unexpected due to the low dose per vine on large mature vines and the months between application and observed effect. Both analogs were very effective at delaying bud break without apparent impact on bud mortality. [0000] TABLE 10 Effect of foliar application of ABA analogs in the fall on bud break of Cabernet Franc grapevines the following spring. Average number of broken buds per vine on Apr. 11, 2012 100 ppm PBI- 1000 ppm PBI- 100 ppm PBI- 0.1% Silwet 524 in 0.1% 524 in 0.1% 425 in 0.1% Brij 98 Silwet Brij 98 Silwet Brij 98 Silwet Brij 98 17 13 2 11

1a

[0001] This application claims the benefit of U.S. Provisional patent application Serial No. 60/458,682, filed Mar. 28, 2003, the entire disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention is directed to a pest control system comprising a low melting point polymer or copolymer, high levels of a solid fatty acid, and active compounds to produce a solid slow release generator of the active compounds. BACKGROUND OF THE INVENTION [0003] It is well known that high molecular weight fatty acids such as stearic acid will bloom to the surface when compounded into a plastic matrix. Stearic acid is used in polymers as a process lubricant and an anti-block agent because of this property. However, when more than one to two percent of stearic acid is used with a conventional polymer, the compound becomes very difficult or impossible to process on conventional equipment such as an extruder or injection molding machine. This is due to the vast differences in melting points of stearic acid and the polymers plus the incompatibility between the two materials. The stearic acid lubricates to the extent that the compound simply turns in the barrel of the extruder or molding machine. If a low melt polymer conventional pellet is used, the same incompatibility is demonstrated when higher levels (above about 2%) of stearic acid is used. SUMMARY OF THE INVENTION [0004] It has now been discovered by the applicant that by using small granules, small irregularly shaped particles or powder form of a low melting-point polymer, one is able to obtain a polymeric system containing high levels of a solid fatty acid, such as stearic acid. More particularly, the present invention is directed to a pest control system comprising a pest control formulation comprising a low melting polymer or copolymer (that is, a polymer or copolymer having a melt temperature of below 250° F., preferably below 200° F.), high levels of a solid fatty acid, and one or more active agents to produce a solid slow release generator of the active agents. By “high levels of a solid fatty acid” is meant from about 5 wt % to about 50 wt %, preferably from about 15 wt % to about 30 wt %, of the total formulation. The system is useful for making articles such as animal collars, ear tags, pest strips or blocks, and the like, for releasing the active agent from the article over an extended or prolonged period of time. By “extended or prolonged period of time” is meant for a period of activity longer than the period of activity exhibited by the raw active ingredient alone. [0005] The present invention is further directed to a method for preparing a polymeric pest control system comprising high levels of a solid fatty acid, the method comprising combining an active agent with from about 5 wt % to about 50 wt % of the solid fatty acid, heating the combination to a liquid state, and then adding the combination to granules of, small irregularly shaped particles of, or powder of a low melting polymer or copolymer to make a dry blend. This dry blend may then be processed into a shape on a conventional extruder or molding machine at low temperatures. The resulting active agent generator is formed by extrusion or molding the mix into any desired shape such as a flea and tick collar for animals, a film covering for preventing bacteria or fungal growth on beds, etc. DETAILED DESCRIPTION OF THE INVENTION [0006] As used herein, “a” and “an” mean one or more, unless otherwise indicated. [0007] The “fatty acid” or “solid fatty acid” useful in the present invention is any fatty acid of from about 16 to about 36 carbon atoms and being a solid at room temperature. Such fatty acids include, but are not limited to, stearic, palmitic, margaric, nonadecanoic, arachidic, heneicosanoic, dehenic, tricosanoic, tetracosanoic, pentacosanoic, and cerotic fatty acids. The solid fatty acid is present in the formulation of the invention in an amount of from about 5 wt % to about 50 wt %, preferably from about 15 wt % to about 30 wt %. [0008] The “low melting polymer or copolymer” is selected from those polymers or copolymers having a melt temperature of below 250° F., preferably below 200° F. Examples of polymers and copolymers useful in the present invention include, but are not limited to, polyethylene, polyvinyl acetate, polyethylene, ethylene acid copolymers, ethylene acrylates, polyurethanes, styrene-butadiene, polyvinyl acetate, polyvinyl butyral, and mixtures and copolymers thereof. In order to obtain compatibility with the solid fatty acid and to improve processing of the formulation in conventional equipment, the polymer or copolymer is used, partially or wholly, in the form of granules, small irregularly shaped particles or powder. Conventional pellets of polymers are very difficult to work with in this invention and can only constitute a small percentage (no greater than about 15 wt % and preferably below about 10 wt %) of the total amount of polymer or copolymer, if they are used at all. The low melting polymer or copolymer is present in the formulation of the invention in an amount of from about 40 wt % to about 80 wt %, preferably from about 50 wt % to about 70 wt %, of which at least about 40 wt % is in the form of granules, small irregularly shaped particles or powder. [0009] The pest control active agent may be an insecticide, bactericide, fungicide, acaricide, attractant, repellent, or any other biologically active ingredient that is compatible with the other components of the pest control system. In one presently preferred embodiment, the active agent is chosen from any active agent known to be useful in the control of insect or acarid pests. Exemplary pesticides and repellents which are effective against horn flies, face flies, stable flies, house flies, mosquitoes, lice, ticks, and mites are bioresmethrin, permethrin, tetramethrin, cypermethrin, decamethrin, pyrethrins, resmethrin, cyhalothrin, allethrin, dichlorvos, carbaryl, naled, citrus oils, citronella oil, pine oil, stirofos, fenvalerate, stabilene, benzyl benzoate, methyl nonyl ketone, N-butylacetanilide, di-n-propyl isocinchomeronate, 2-octylthioethanol, dimethyl carbate, dimethyl phthalate, N,N-diethyl-m-toluamide, and 2,3:4,5-bis (2-butylene)-tetrahydro-2-furfural. Many of these active ingredients are effective both as a pesticide and as a repellent, and the activity of many is enhanced by the inclusion of a synergist. Especially preferred synergists include piperonyl butoxide and N-octyl bicycloheptene dicarboximide. The active agent may be a liquid or a solid at room temperature. [0010] To prepare pest control systems according to the invention, the pest control active agent and the solid fatty acid are mixed together at a predetermined ratio, with the proviso that the fatty acid is present at a high level. Generally, the amount of fatty acid in the formulation should be at least about 5 wt %, preferably at least about 15 wt %. The active agent/fatty acid mixture is then heated to a liquid state and added to granules of, small irregularly shaped particles of, or powder form of a low melting polymer or copolymer to make a dry blend. This dry blend formulation may then be processed into a shaped article, such as a pet collar or an ear tag or the like, on a conventional extruder or molding machine at low temperatures (that is, at temperatures that will melt the low melting polymer or copolymer, which is generally below about 250° F.) by methods known in the art. [0011] If processing of the shaped article takes place at higher temperatures, the article should be cooled to room temperature as quickly as possible. In some cases when the article is not quickly cooled, there is excessive bloom on the surface, which can flake off. When this happens, the article can be annealed at 140° F. as a post operation to prevent the excessive bloom. [0012] Additional components may optionally be included in the pest control system of the invention. Such optional ingredients can include, but are not limited to, plasticizers, synergists, fragrances, coloring agents, preservatives, antioxidants, light stabilizers, and the like. [0013] After being processed into the desired shape, the active agent will, together with the solid fatty acid, bloom to the surface of the article, making the active agent available to an environment, such as an animal for example, for pest control purposes, such as, for example, the control of insects and/or acarids on the animal. The fatty acid/active agent combination blooms to the surface and stops until a part of the surface material is removed. When the surface material is removed, it is replaced by more of the combination of the fatty acid/active agent from the inter-matrix of the plastic. [0014] The following examples illustrate the practice of the present invention. Parts are given as percentages and temperature in degrees Fahrenheit unless otherwise noted. “RT” is room temperature. EXAMPLES Example 1 [0015] The formulation in Table 1 is prepared, and is then formed into an insecticidal dog collar, as follows: TABLE 1 Ingredients: Percentages: d-cyphenothrin (Gokilaht) Tech. 15.6 Safflower Oil 5.0 Stearic Acid 20.0 Polymer MU 760-00 59.3 Blaze Orange T-15 colorant 0.1 [0016] Sources: [0017] Gokilaht (d-cyphenothrin; synthetic pyrethroid) Technical—MGK Company. [0018] Microthene® Polymer MU 760-00 (ethylene-vinyl acetate copolymer, ground powder, melt index: 32 (EMI), particle size: 35 mesh)—Equistar Chemicals, LP. [0019] Colorant—Day Glow Color Corp [0020] Mixing Procedure: [0021] 1. The Gokilaht, safflower oil and stearic acid are weighed together. Heat is applied and the mixture brought to a liquid state at 165° F. [0022] 2. The polymer is weighed and placed into a mixing vessel. [0023] 3. The liquid active agent/stearic acid mixture is slowly added to the polymer while mixing. [0024] 4. The Blaze Orange is then added and the resulting blend is allowed to cool to room temperature. [0025] The blend is then extruded or molded into the shape desired, which, in this Example was a dog collar. [0026] These collars were subjected to efficacy evaluation against fleas and ticks. The tests consisted of a treated group of three dogs (one collar per dog) and a control group of three untreated dogs. The dogs were chosen from random breed adult dogs of mixed sexes and with reasonably uniform haircoat types, and the dogs were individually housed, fed and maintained. The dogs were treated once on day 0 by buckling the test collar around the dogs' necks, leaving at least space for 2 fingers. The dogs were infested with fleas ( Ctenocephales felis ) and ticks ( Rhipicephalus sanguineus ) on the day before treatment and then re-infested weekly thereafter, each re-infestation to be made approximately 24 hours before the first of the next series of flea and tick counts. Flea and tick timed finger counts were performed at 24 and 48 hours after treatment and at 24 hours after each re-infestation. Comb counts, by removing and discarding all fleas and ticks, were performed at 72 hours after treatment and after each re-infestation. [0027] The results are presented in Tables I-A and I-B below: TABLE I-A Three-Dog Group Mean Efficacy Against Fleas Day % Efficacy 1 53 2 71 3 86 7 79 9 85 14 76 16 87 21 91 23 96 28 79 30 94 35 84 37 91 43 84 45 91 [0028] [0028] TABLE I-B Three-Dog Group Mean Efficacy Against Ticks Day % Efficacy 1 70 2 74 3 76 7 80 9 84 14 90 16 91 21 95 23 96 28 97 30 95 35 91 37 95 43 98 45 99 Example 2 [0029] The formulation in Table 2 is prepared, following the procedures of Example 1: TABLE 2 Ingredients: Percentages: Propoxur (Sendran) Tech. 15.60 Nylar, 97% acitve 0.7 Safflower Oil 10.0 Stearic Acid 20.0 Polymer MU 760-00 58.6 Rocket Red colorant 0.1 [0030] Sources: [0031] Sendran (2-isopropoxyphenyl-N-methylcarbamate) Technical—Bayer, Inc. [0032] Nylar® comprises approximately 50% by weight pyriproxyfen and approximately 50% by weight corn oil and is available from MGK Company. Example 3 [0033] The formulation in Table 3 is prepared, following the procedures of Example 1: TABLE 3 Ingredients: Percentages: Permethrin Tech. 15.6 Nylar, 97% active 0.7 Safflower Oil 5.0 Stearic Acid 20.0 Polymer MU 760-00 58.6 Blue Pigment R6BL9019 0.1 [0034] Sources: [0035] Permethrin Technical—MGK Company. [0036] The material of the above formulation was subjected to a weigh loss test to ascertain if the non-polymer materials would release from the polymer matrix. The test consisted of extruding the material into dog collars, weighing the collars, wiping the surface of the collars with a clean paper towel and reweighing. The weight difference from each wiping demonstrates the weight loss as it might happen in actual use. A commercial cat pest control collar was similarly tested, as a comparison. While the weight loss of the collar of this invention was lower overall than that of the commercial collar, it followed the same profile of continuous loss over the course of the 25-day study. Also, while it was impossible in this study to ascertain the percent of active agents being released by the wipe test, visual observations show that the released material was a mixture of the oil phase materials and stearic acid. Example 4 [0037] The formulation in Table 4 is prepared, and is then formed into an insecticidal dog collar, as follows: TABLE 4 Ingredients: Percentages: d-cyphenothrin (Gokilaht) Tech. 14.2 Phosflex 390 5.1 Stearic Acid 6.4 Nylar, 98.8% active 0.6 Polymer MU 760-00 53.7 Elvax 150 10.0 [0038] Sources: [0039] Phosflex 390 (isodiphenyl phosphate)—Akzo Nobel. [0040] Elvax (ethylene-vinyl acetate copolymer; conventional pellets)—DuPont. [0041] Mixing Procedure: [0042] 1. The Gokilaht, phosflex, stearic acid and Nylar are weighed and added to a heatable mixing vessel. The materials are heated to 165° F. and mixed until a honogenous solution is achieved. [0043] 2. The MU 760-00 and the Elvax 150 polymers are weighed, placed into a mixing vessel and blended to uniformity. [0044] 3. While the polymers are mixing, the heated liquid active agent/stearic acid mixture is sprayed onto the polymers. Mixing continued until the mass reached room temperature. [0045] 4. The liquids should be applied to the polymer powder while the polymers are being mixed, so as not to cause large lumps to form. This should be done far enough in advance of extrusion (generally about 24 hours is sufficient) so that the liquids can solidify and a free-flowing powder is achieved. [0046] The resulting formulation was extruded into dog collars. The Extrusion Profile is: Extruder: Prodex 2½ inch; PE Screw 24/1 single stage; Screw rpm = 30 Zone temperatures: #1 #2 #3 #4 #5 Gate Die off off off 205 205 195 195 Screen Pack: 1-40 2-80 Collar dimensions and weight: 1 in. × 0.513 in. × 0.109 in. −0.748 grams; oval shape

1a

[0001] This application is being filed as a PCT International Patent application in the name of Mark Faupel and Danny Lincoln (both U.S. nationals and resident), designating all countries, on 22 May 2003. TECHNICAL FIELD [0002] The present invention is related to the extraction and monitoring of biological fluids. More particularly, the present invention is related to methods and systems including devices that extract biological fluids for subsequent monitoring of fluid parameters. BACKGROUND [0003] Biological fluids of patients such as blood, interstitial fluid, or other fluid types may be extracted and monitored by analyzing the fluid samples for various parameters. Components of a fluid sample may be analyzed to determine the current physical condition of the patient. Conventionally, the fluid sample may be taken through a sample collection device such as the Terumo CAPIJECT™. [0004] To extract a biological fluid sample using a collection device such as the CAPIJECT™, the skin of the patient is lanced with a suitable and relatively sizable lance. The tube of the CAPIJECT™ is placed in an upright position over the relatively sizable puncture site where a drop of fluid has developed by squeezing the lanced site. A collection port of the tube is placed in proximity with the drop, and the fluid sample is then allowed to flow by gravity into the tube of the CAPIJECT™ through the collection port until the tube is filled to a recommended marking. A cap is then placed on the tube of the CAPIJECT™ to prevent the fluid sample from leaking from the tube. After taking the sample, the puncture site is treated to stop any further bleeding or other fluid loss by applying pressure to the site using a gauze pad. [0005] Thus, while the use of the CAPIJECT™ obtains the necessary sample, there are drawbacks to its use. Notably, the patient experiences discomfort associated with the sizable puncture that is required to develop the drop of fluid. Furthermore, the puncture size must be treated as noted above to stop further fluid loss. Additionally, the puncture process recurs and a new CAPIJECT™ tube may be used each time a new sample is taken. Accordingly, the patient is inconvenienced by the extraction of biological fluid with the CAPIJECT™ device. SUMMARY [0006] Embodiments of the present invention address these issues and others by providing methods and devices that extract samples of biological fluids. A vacuum is created at an aperture on a surface of the device to draw fluid from the puncture into the device. The sample may then be accessed from an access point of the device for further analysis. [0007] One embodiment is a device for extracting biological fluid. The device has a body including a contact surface that defines a sampling aperture and a sensor surface that defines an access point. The device also has a pump and a sampling channel between the sampling aperture and the pump. The sampling channel is in fluid communication with the access point. [0008] Another embodiment is a method of extracting biological fluid. The method involves creating an artificial unobstructed opening in biological tissue. A contact surface of a sampling device is placed on the tissue, where the contact surface defines an aperture located proximate to the opening in the biological tissue. A pump of the sampling device is charged to develop a vacuum at the aperture and draw the biological fluid through the aperture into a sampling channel. The biological fluid is accessed through at an access point of the sampling device that is in fluid communication with the sampling channel. [0009] Another embodiment is a device for extracting biological fluid. The device has a body that includes a planar contact surface that defines a sampling aperture. The device also has a sensor surface that defines an access point and a ventilation surface that defines a ventilation opening. The device also includes a depressible self-restoring bulb sealed to the body and a sampling channel between the sampling aperture and the bulb. The sampling channel is in fluid communication with the access point, and a wick is disposed within the sampling channel between the extraction opening and the bulb. A ventilation channel interconnects the ventilation opening to the sampling channel, and the wick is disposed between the ventilation chamber and the sampling aperture. DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a top perspective view of an extraction device according to one embodiment. [0011] FIG. 2 is a bottom perspective view of an extraction device according to the embodiment of FIG. 1 . [0012] FIG. 3 is a cross-sectional view taken through the extraction device according to the embodiment of FIGS. 1 and 2 . [0013] FIG. 4 is a top perspective view of an extraction device according to another embodiment. [0014] FIG. 5 is a bottom perspective view of an extraction device according to the embodiment of FIG. 4 . [0015] FIG. 6 is a cross-sectional view taken through the extraction device according to the embodiment of FIGS. 4 and 5 . [0016] FIG. 7 illustrates a set of operations performed to extract a sample using an extraction device according to the embodiments of FIGS. 1-6 . DETAILED DESCRIPTION [0017] Embodiments of the present invention extract fluid samples from a patient by creating a vacuum over an opening on the biological tissue of the patient to draw the fluid into the device. The opening in the tissue may be of various sizes such as but not limited to relatively small openings such as a microporation puncture sites formed in the stratum corneum layer of the skin. Accordingly, the patient may experience less discomfort where such relatively small openings are created, and the relatively smaller openings in the tissue require little or no further treatment after the sample has been taken. Furthermore, upon placing the device over an opening in the tissue, the device may be fixed to the site so that multiple samples may be taken from the site over a period of time. [0018] FIG. 1 shows one embodiment of an extraction device 100 . The device includes a body 102 that provides several surfaces. The body 102 may be made of various materials, such as the Alphagary Dural 725 polyvinyl chloride (“PVC”) product. Such body materials are commonly approved by government regulations for use in biomedical devices. The body may be constructed of two separate pieces to simplify the construction and the pieces are then bonded together with an adhesive. For example at top piece may define a sensor surface 128 and ventilation surface 130 while a bottom piece defines a contact surface 110 as shown in FIG. 2 . [0019] A sensor surface 128 of the body 102 defines an access point, discussed in more detail below with reference to FIG. 3 , where the fluid sample may be accessed. The access point of this embodiment includes an extraction opening covered by an access door 106 . The access door 106 is held in place by access door retainers 122 covering over small tabs extending from each side of the door 106 . The retainers 122 are fixed to body 102 by an adhesive such as Loctite 4011 or alternatively may be integrally formed into the body 102 . The access door retainers 122 hold the access door 106 in position and allow the access door to be opened and closed relative to the extraction opening. The access door 106 may be made of various materials such as the PVC used for the body 102 and a seal 134 such as silicone rubber may be placed between the access door 106 and the body 102 to form a proper seal. The access door 106 may have a snap fit to the body 102 to hold the access door 106 closed against the silicone seal. [0020] A ventilation surface 130 of the body 102 defines a ventilation opening 118 , discussed in more detail below with reference to FIG. 3 , through which ventilation is provided to eliminate a vacuum created by the device 100 when the device 100 is to be removed from the patient. A ventilation plate 108 seals the ventilation opening to prevent ventilation when the vacuum is being created and sustained to draw fluid into the device 100 as discussed below. The ventilation plate 108 of this embodiment is held in place by a ventilation strap 124 that is adhesively attached to the body 102 and is removed when the ventilation plate 108 is to be removed to release the vacuum. The ventilation plate 108 and ventilation strap 124 may be made of various materials such as PVC, and a silicone rubber seal 132 may be positioned between the plate 124 and the body 102 to form a proper seal. [0021] The extraction device 100 also includes a pump 104 . In this embodiment, the pump 104 is a bulb that is sealed to the body 102 by application of an adhesive such as Loctite 4011 around the edges of the bulb. The bulb 104 is depressible and is self-restoring so that when the bulb 104 is depressed, air is forced out of the bulb and as the bulb restores its shape, a vacuum is created. The bulb 104 may be made of various resilient materials such as the ELASTOCIL® silicon rubber product. While the pump 104 is shown as a bulb, the pump 104 may be of other forms such as a syringe type pump that may be biased to self-restore the plunger position once it has been depressed or may rely on the user to restore the plunger manually to create the vacuum through the extraction device 100 . [0022] FIG. 2 shows the underside contact surface 110 of the body 102 . The contact surface may be planar or may have various curvatures, depending upon the area of the body where the sample may be extracted. For example, a planar contact surface 110 is adequate where the sample is taken from the relatively flat abdomen of the patient. The contact surface 110 defines a sampling aperture 112 . The sampling aperture 112 is a hole that extends from the exterior of the contact surface 110 into an internal sampling channel discussed below with reference to FIG. 3 . The sampling aperture 112 may be have a countersink shape such that the hole at the exterior has a larger diameter than the channel leading from the exterior to facilitate proper placement of the aperture 112 over the puncture site. [0023] FIG. 3 provides a cross-sectional view of the extraction device 102 as taken through the center of the bulb 104 , an extraction opening 116 forming an access point, a ventilation opening 118 , a wick 120 , and the sampling aperture 112 . As shown in this view, the interior of the bulb 104 is hollow so that the interior volume can be collapsed to evacuate the air upon the user depressing the bulb 104 . The bulb collapses toward the wick 120 that allows air to pass from the bulb and out through an available channel. For example, after the device 100 is installed and the ventilation opening 118 remains sealed, the air being evacuated from the pump 104 cannot pass through the ventilation channel 126 due to the seal and cannot pass through the extraction opening 116 to ambient due to the access door 106 being closed. However, the air may pass through the sampling channel 114 and out the sampling aperture 112 to the exterior of the device 100 as the sampling aperture 112 is not sealed to the patient. [0024] After the bulb 104 is released upon being depressed, the bulb 104 begins to restore its shape which creates a vacuum to establish suction through the wick 120 , sampling channel 114 , and sampling aperture 112 . The vacuum causes fluid to be drawn from the opening in the tissue through the sampling aperture 112 . The drawn fluid fills the portion of the sampling channel 114 up to the wick 120 but is prevented from entering the bulb 104 or the ventilation channel 126 by the wick 120 . The fluid pools into the extraction opening 116 . The sample can then be accessed from the access point defined by the extraction opening 116 which is in fluid communication with the sampling channel 114 upon opening the access door 106 . [0025] The wick 120 may be made of a material such as Whatman filter paper. As noted above, the wick is provided to allow air to flow while preventing the fluid from being drawn into the pump 104 and/or the ventilation chamber 126 . The wick 120 thereby reduces the amount of fluid that must be sampled to produce a pool at the extraction opening 116 . The wick 120 may also absorb the sample of fluid remaining after it has been satisfactorily accessed. [0026] FIG. 4 shows an alternative embodiment of the present invention. The embodiment of FIG. 4 is similar to that of FIG. 1 . However, the embodiment of FIG. 4 includes a sensor connector tube and corresponding electrodes so that the fluid sample may be accessed through contact of the electrodes with the fluid. Additionally, the embodiment of FIG. 4 has a repositioned wick and sampling aperture as well as a re-routed sampling channel, and this embodiment relies on a single adhesive piece to provide the ventilation seal. [0027] The extraction device 200 of FIG. 4 includes a body 202 that may be constructed of the materials used for the embodiment of FIG. 1 . Additionally, the device 200 includes a pump 204 such as a bulb sealed to the body 202 . The device 200 also includes a ventilation surface 230 of the body 202 and a ventilation cover 208 that covers a ventilation opening. The device 200 includes an sensor surface 228 that includes a tubular port 206 containing electrodes that extend into the sampling channel 214 of the body 202 to form an access point. While the tubular port 206 is shown as being integral to the body 202 , the tubular port 206 and the electrode contained within it may alternatively be detachable. [0028] FIG. 5 shows the underside contact surface 210 of the device 200 . As discussed above, the contact surface 210 may be planar or have a curvature. Additionally, the contact surface 210 defines a sampling aperture 212 that includes a hole at the exterior of the contact surface 210 and extends into an interior sampling channel. As discussed above, the sampling aperture 212 may have a countersink shape so that the larger diameter of the opening at the exterior facilitates placement of the aperture 212 over the opening in the tissue. [0029] FIG. 6 shows a cross-sectional view taken through the center of the bulb 204 , a ventilation opening 218 , the sampling aperture 212 , the tube 206 , and a wick 220 . As shown in this embodiment, the wick is positioned under the sensor surface 228 of the body 202 . Additionally, the sampling aperture 212 is positioned directly beneath the pump 204 . However, the sampling channel 214 is routed from the base of the pump 204 to the wick 220 , as indicated in phantom, and from the wick 220 to the sampling aperture 212 . [0030] The access point for accessing the fluid for testing includes the area where the electrodes enter and pass through the sampling channel 214 between the wick 220 and the sampling aperture 212 . The wick 220 continues to prevent fluid from being drawn into the pump and/or ventilation channel 226 so that less fluid is necessary to remain in contact with the electrodes. Accordingly, when the pump is depressed with the ventilation seal 208 closed, air is evacuated through the sampling aperture 212 by passing from the pump 204 through the wick 220 . Then, upon the pump 104 restoring its shape, a vacuum occurs and creates suction at the sampling aperture 212 so that fluid is drawn into the sampling aperture 212 and pools along the sampling channel 214 between the between the aperture 212 and the wick 220 where the electrodes are placed. [0031] The electrodes 222 are disposed within the tube 206 and extend through into the sampling channel 214 to form the access point 216 in fluid communication with the sampling channel 214 and where the electrodes 222 access the fluid. Thus, when fluid is drawn into the sampling channel 214 and pools between the wick 220 and the sampling aperture 212 , the electrodes 222 are immersed in the fluid. A sensor device (not shown) connected to the tube 206 in electrical communication with the electrodes 222 may then analyze the fluid through the exposure of the electrodes 222 to the fluid. The fluid analysis through the electrodes 222 may be performed by well-known techniques. [0032] When the extraction device 200 is to be removed from the patient, the ventilation seal 208 may be peeled back from the ventilation opening 218 to eliminate the vacuum that has been created by passing air from ambient through the ventilation channel 226 . The ventilation seal 208 may be of various forms such as an adhesive film that covers the ventilation opening 218 and that seals to the ventilation surface 230 of the body 202 . The device 200 is then removed from the patient once the vacuum has been eliminated. [0033] FIG. 7 provides one example of a set of steps performed to extract samples from a patient using one of the embodiments discussed above. At opening operation 302 , an artificial and unobstructed opening in the biological tissue of the patient is created. For example, the opening in the tissue may be created by a lancet, by a microporation device, by lasers, or by other techniques such as examples discussed in U.S. Pat. No. 5,885,211. The extraction device is then placed on the tissue of the patient with the sampling aperture positioned directly over the opening in the tissue at position operation 304 . The extraction device is fastened to the tissue of the patient such as by taping the device to the tissue at installation operation 306 . Adhesive tape may be applied to the contact surface of the extraction device such that when the device is placed on the tissue, the adhesive tape bonds to the tissue and holds the device in place. An example of such adhesive tape is ARcare® 7717. [0034] After the device has been positioned and fastened to the tissue of the patient, the pump of the device can then be charged. For the device embodiment that includes an access door as opposed to a tube to interface with a sensor, then the pump is charged to create a vacuum at the sampling aperture at charge operation 310 . For the device embodiment that includes the tube to interface with a sensor and electrodes to access the fluid, the sensor may be connected to the tube and electrodes of the extraction device at sensor operation 308 , and then the pump is charged at charge operation 310 . [0035] Once the pump has been charged to create the vacuum, the fluid sample is drawn by the suction into the extraction device where it can be accessed from the access point by physically accessing the fluid through the extraction opening or can be accessed from the access point defined by the electrodes extending into the sampling channel. The fluid is accessed accordingly at sample operation 312 . Then, if another sample is to be taken using the currently installed extraction device as decided at query 314 , the pump is charged again at some later time at charge operation 310 to create a new vacuum and draw a new fluid sample as the older sample has been absorbed by the wick the time this next sample is to be taken. [0036] If another sample is not to be taken using the currently installed extraction device, then the ventilation seal is removed to allow the vacuum to be eliminated at ventilation operation 316 . The extraction device is then unfastened and removed from the tissue of the patient at removal operation 318 . When a later sample must be taken, the process returns to the opening operation 302 . The extraction device may be replaced every 2-3 days by performing the process of FIG. 7 . [0037] The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Those skilled in the art will readily recognize various modifications and changes that may be made to the present invention without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.

1a

BACKGROUND OF THE INVENTION Free throw shooting is a pivotal part of basketball. All levels of basketball from amateurs, professionals and championships are won and lost at the free throw line. The Magic Arc allows a basketball player to improve in this important area of the game. The Magic Arc came to fruition from observing the mechanics of hundreds of players from different skill levels of basketball. The players who shoot a higher percentage from the free-throw line have more arcs on the ball. The present device will give the basketball player an optimal line of sight to the basket from the free-throw line. With this device a basketball player could actually see the correct arc and the basketball at its apex to make the basket. The Magic Arc can also be used to help a basketball player to improve their mid range jump shot. Therefore, this This product is a dual purpose shooting aid. BRIEF SUMMARY OF THE INVENTION A basketball free-throw shooting aid that helps a basketball player to envision and increase his/her ability to develop a consistent shooting arc from the free throw line to the basketball hoop. The Magic Arc is placed on the ground to stand directly in front of the free throw shooter. The vertical adjustable length pole is adjusted in height for the shooter's comfort. The next step is to attach the Tubular Are Guide to the front of the basketball rim. This will enable the shooter to develop a consistent shooting arc simply by shooting the basketball to follow the path of the Arc Guide in the direction of the basketball hoop. The player has also the capability of placing The Magic Arc in different shooting spots around the perimeter of the key area. By applying the same concept as shooting free throws but instead shoots mid range jump shots. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 . Is a side view of the base assembly, frame, connector piece and Tubular Arc Guide attached to basketball rim. FIG. 2 . Is an enlarged side view of the pole cut to size sealed onto the molding taken from FIG. 1 . FIG. 3 . Is an enlarged front view of the Connector Piece taken from FIG. 1 . FIG. 4 . Illustrates an enlarged side view of the Tubular Arc Guide attached to the basketball rim taken from FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENT 1 [.] Base assembly 2 [.] Form fitting hole located on the back of base assembly for pole to be inserted 3 [.] Metal circular rod attached inside vertical adjustable pole 4 [.] Assembly includes alien screw and washer to secure the vertical adjustable pole. 5 [.] Hole drilled in protrusion on front part of base assembly includes bolt, washer and nut to hold side pole 6 [.] side pole cut to size a molding is formed and attached at one end of the side pole to slide onto the adjustable pole 7 [.] Hose clamp wraps around at the bottom of the molding to secure in place. 8 [.] Vertical adjustable pole 9 [.] Holes on the side of pole to adjust to various height settings 10 [.] Metal mechanism used to adjust pole upward or downward 11 [.] Metal pipe fits over adjustable pole to stabilize the base assembly 12 [.] Inner pole smaller in diameter to fit in vertical adjustable pole to increase the height of the pole 13 [.] Hole drilled in the inner pole to hold the connector piece with assembly includes bolt, washers, circular spacers and nut 14 [.] Spacer attached inside inner pole in front 15 [.] Spacer attached to inner pole behind the connector piece 16 [.] Connector Piece 17 [.] Threaded hole drilled in the Connector Piece with a thumb screw to stabilize and suspend the Tubular Arc Guide in the air 18 [.] First section of the Tubular Arc Guide. 19 [.] Second section of the Tubular Arc Guide 20 [.] Third section of the Tubular Arc Guide 21 [.] Hole drilled through the Tube to connect to the Connector piece 22 [.] Connection piece molded at the end of Tubular Arc Guide with a threaded hole drilled through to connect the second section 23 [.] Hole drilled through the second tube to attach to the connection piece located at end of the first section 24 [.] Thumb screw 25 [.] Connection piece molded at end of tubular arc guide with a threaded hole drilled through to connect the third section 26 [.] Thumb screw 27 [.] Hole drilled through the third tubing to attach to the connection piece located at end of the second section 28 [.] metal hook inserted at the tip inside a circular molding 29 [.] basketball rim 4 [.] DETAILED DESCRIPTION OF THE INVENTION The Magic Arc of includes a base-assembly that is made of lightweight rigid material. The top side of the base-assembly has a form fitting hole located on the back of the base. In front of the base there is a protrusion. There are two poles made of lightweight material that attaches to the base-assembly to form a solid frame for support. The pole is attached to the protrusion by drilling a hole through the protrusion to connect the pole with a bolt, washer and nut. The pole is to be angled to be perpendicular from the base-assembly. Towards the top of the side pole it is cut to fit into a molding that slides onto the vertical adjustable length pole. The sturdy molding slides onto and around the vertical adjustable length pole, with a screw hose clamp attached around the bottom of the circular molding. The vertical adjustable length pole is inserted into the form-fitting hole, located on the back of the base-assembly. The adjustable length pole is secured to the base by an alien screw, located on the bottom of the base that screws into a threaded rod. The vertical adjustable length pole comprised of two poles. One pole is made slightly smaller in diameter to fit inside of the other pole. This allows the inner pole to adjust in height by sliding the metal mechanism that is attached to the inner pole. By pushing the metal mechanism inward and pushing the inner pole upward simultaneously into the various holes positioned on the side of the outer pole. Attached to the top of the inner pole section of the vertical adjustable length pole is a connector made from rigid material. The connector is attached via holes drilled through the inner pole and the connector attached by a bolt, washer, circular spacers and nut. The inner pole can be modified by cutting a U-shape form that will allow the connector to be inserted. A hole must be drilled through the connector to house a thumb screw. Inside the inner pole lie two spacers. The spacers are attached to both sides of the inner pole. Attached to the connector on the vertical adjustable length pole is a Tubular Arc Guide made from sturdy material, yet flexible in its application. The Tubular Arc Guide is formed into the shape of an arc. Each section has holes drilled on the end enabling thumb screws to attach all sections together by a connecting piece. At the end of the final piece of the Arc Guide is a metal hook that is inserted at the tip inside a circular mold. The metal hook attaches to the front of the basketball rim. To secure the base while utilizing the Magic Arc, a metal pipe has been cut to fit over and slide onto the adjustable pole. The metal pipe rest on the top of the base assembly located where the adjustable pole inserts into the hole. This enables the Magic Arc to remain stable on the ground while in use.

1a

BACKGROUND AND SUMMARY OF THE INVENTION [0001] 1. Technical Background: [0002] The present invention relates to a catheter, and more particularly to a catheter with a centering tip. [0003] 2. Discussion: [0004] Percutaneous transluminal coronary angioplasty (PTCA) and stenting are therapeutic medical procedures used to increase blood flow through the coronary arteries and can often be used as alternatives to coronary bypass surgery. In PTCA procedures, the angioplasty balloon is inflated within the narrowed or stenosed vessel, at the desired location for treatment, such as an atheroma or plaque deposit, in order to obtain an enlarged opening or lumen. In stenting, an endoluminal prosthesis of any appropriate type is implanted in the vessel to maintain patency following the procedure. In order to initiate these procedures, one must first introduce a guidewire into the lumen of the vessel to serve as a conduit for other interventional devices, such as angioplasty balloons and stent delivery systems. This guidewire must be advanced into a position past the location of the stenosis. Additional interventional devices, such as angioplasty balloon catheters and stent delivery systems, are then advanced over the guidewire and positioned at the site of the stenosis, to initiate therapeutic treatment of the lesion. [0005] A common treatment method for using such an angioplasty balloon catheter or stent delivery system is to advance the catheter into the body of a patient over the guidewire, by directing the catheter distal end percutaneously through an incision and along a body passage until the device is located within the desired site. One difficulty commonly encountered with the procedure is that irregularities of the lumenal surface and narrowing of the passageway may result in delivery difficulty, because the distal end of the balloon catheter or the stent delivery system may “catch” on the wall surface. This may cause a challenge in reaching the targeted position in the vessel, and therefore may inhibit successful treatment of the lesion. Another difficulty that is encountered with this procedure is that once the target lesion is reached, stent deployment may not be perfectly uniform if the stent delivery system is not centered within the vessel. This lack of centering may result in the stent cells around the circumference of the stent not opening up completely, resulting in non-uniform deployment. The end result may be reduced strength and incomplete stent scaffolding of the vessel, and a less than optimal clinical result. [0006] The general concept of a centering catheter for treating a body vessel with a radioactive source is well known in the art. See, for example, U.S. Pat. Nos. 6,224,535 and 6,267,775. [0007] However, the art has yet to disclose or suggest any devices for centering a non-radiation source catheter during its entire journey through the vasculature and to the treatment site, to facilitate access to tortuous anatomy, and then to promote uniform deployed stent expansion at the treatment site. [0008] The present invention provides for a centering catheter which operates to remain centered during its entire journey through the vasculature and toward the treatment site, as well as at the treatment site, and which overcomes many of the disadvantages associated with the use and operation of prior art devices. [0009] An objective of the present invention is to facilitate access to tortuous anatomy, so that a lesion location may be more easily reached and the vessel may be treated. Another objective of the present invention is to facilitate uniform deployed stent expansion by stabilizing the stent delivery system catheter and centering it in the vessel during stent deployment. [0010] The centering catheter of the present invention comprises an elongated catheter body having a proximal end and a distal end, and at least one centering device attached near the distal end of the catheter. The centering device comprises a proximal end and a distal end and at least two struts extending therebetween. The centering device has a smaller diameter for insertion into a lumen and a larger diameter for expanding to substantially equal the diameter of the lumen and to center the catheter within the lumen. The centering device also has a plurality of intermediate diameters, between the smaller diameter and the larger diameter. These intermediate diameters may be utilized as the centering device adjusts to diameter variations in the lumen of the vessel during the catheter journey through the vasculature and toward the treatment site. Once the site is accessed, the centering device may also facilitate uniform stent delivery for either balloon expandable or self-expanding stents, by centering the distal end of the catheter during the deployment of the stent. Uniform stent expansion may contribute to a successful clinical outcome by insuring that optimal scaffolding of the vessel has occurred and optimal radial strength has been achieved to resist elastic recoil of the vessel following an interventional procedure. The catheter may then be withdrawn from the lumen of the vessel. [0011] In accordance with one aspect, the present invention is directed to a catheter having at least one centering device attached near the distal end of the catheter. Each centering device comprises a proximal end and a distal end and at least two struts extending therebetween. Each centering device preferably has a variable diameter that centers the distal end of the catheter, steering the catheter away from the vessel wall during its insertion through the vasculature to the treatment site. [0012] In accordance with another aspect, the present invention is directed to a stent delivery system comprising at least one centering device attached near the distal end of the stent delivery system. Each centering device comprises a proximal end and a distal end and at least two struts extending therebetween. Each centering device preferably has a variable diameter that centers the distal end of the catheter during the process of stent deployment. [0013] An advantage of the present invention is that the sometimes-tortuous anatomy of the vasculature may be more easily traversed while avoiding lumen damage, and access to the lesion location may be facilitated by the availability of a centering device that centers the catheter throughout its introduction into the vessel. Another advantage of the present invention is that the centering device may stabilize the distal end of the catheter during stent expansion, and may therefore allow the operator to achieve a more uniform stent expansion with resultant clinical benefits to the patient. BRIEF DESCRIPTION OF DRAWINGS [0014] The foregoing and other aspects of the present invention will best be appreciated with reference to the detailed description of the invention in conjunction with the accompanying drawings, wherein: [0015] [0015]FIG. 1 is a diagrammatic, partial, enlarged, cross-sectional view of an example embodiment of the centering catheter, with the centering device on a balloon catheter, in accordance with the present invention. [0016] [0016]FIG. 2 is a diagrammatic, partial, enlarged, cross-sectional view of an example embodiment of the centering device, with the centering device on a stent delivery system, in accordance with the present invention. [0017] [0017]FIG. 3 is a diagrammatic, partial, enlarged, cross-sectional view of a non-centering stent delivery system catheter in an irregular and narrowed lumen of a tortuous vessel. [0018] [0018]FIG. 4 is a diagrammatic, partial, enlarged, cross-sectional view of an example embodiment of the centering catheter, with the centering device on a stent delivery system in an irregular and narrowed lumen of a tortuous vessel, in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0019] The centering catheter of the present invention is designed to facilitate access to a treatment site in a lumen of a vessel through tortuous anatomy, and to facilitate uniform stent deployment at the treatment site. The centering catheter of the present invention comprises an elongated catheter body having a proximal end and a distal end, and at least one centering device attached near the distal end of the catheter. The centering device comprises a proximal end and a distal end, and at least two struts extending therebetween. The centering device has a smaller first diameter for insertion into the lumen, a larger second diameter for expanding to substantially equal the diameter of the lumen of the vessel, and a plurality of intermediate diameters therebetween. [0020] The centering device may be employed in any type of flexible elongated medical device product, including catheters, cannulae, guidewires and scopes. Although the centering catheter may be utilized in conjunction with any type of device, for ease of explanation, the exemplary embodiments described below will refer to a balloon catheter and stent delivery system. [0021] While the present invention may be realized in a number of exemplary embodiments, for ease of explanation, two exemplary embodiments will be described in detail. Referring to the figures, there is illustrated in FIG. 1 a centering catheter 10 made in accordance with the present invention. The distal end of the centering catheter 10 comprises an inner member 20 , which extends longitudinally through the centering catheter 10 ; a catheter tip 25 ; at least one centering device 40 attached to the circumference of the inner member 20 ; and an angioplasty balloon 30 attached to the inner member 20 proximal to the at least one centering device 40 . Each centering device 40 comprises a proximal end 42 and a distal end 44 and at least two struts 50 extending therebetween. The struts 50 may be equally or unequally spaced. The struts 50 may be longitudinal, as illustrated in FIG. 1, or circumferential, or any number of other suitable configurations. As illustrated in FIG. 1, the centering device 40 has a larger diameter that substantially equals the diameter of the lumen, and substantially exceeds the diameter of the inner member 20 . Therefore, the centering device 40 may center the tip 25 of the centering catheter 10 in the lumen during and throughout insertion into the vessel, until the treatment location is reached. [0022] The at least one centering device 40 may be made from any number of suitable materials, and is preferably made from a superelastic alloy such as Nitinol. The struts 50 may alternatively be hingedly connected struts. The centering device 40 may be coated with any number of suitable materials, and is preferably coated with a lubricious or biologically compatible coating. The centering device 40 may be removably or permanently attached to the inner member 20 . The centering catheter may be any suitable configuration catheter, and may preferably be an over the wire or rapid exchange catheter. [0023] As illustrated in FIG. 1, the centering catheter may be advanced into the lumen of a vessel with the centering device 40 expanding to make contact with the walls of the lumen. The centering device 40 thus serves to center the distal end of the catheter 10 and its inner member 20 as it is pushed through the vasculature to the treatment site. The struts 50 are compressible and allow the centering device 40 to vary its diameter as the lumenal diameter varies, while always keeping the catheter tip 25 of the centering catheter 10 centered in the lumen. This may facilitate the pushability and trackability of the centering catheter 10 as it traverses the vasculature. [0024] [0024]FIG. 2 illustrates another exemplary made in accordance with the present invention. In this exemplary embodiment, a centering catheter 10 is a stent delivery system which comprises an inner member 20 , which extends longitudinally through the catheter 10 ; a catheter tip 25 ; at least one centering device 40 attached to the circumference of the inner member 20 ; an angioplasty balloon 30 attached to the inner member 20 proximal to the at least one centering device 40 ; and a stent 60 mounted on the angioplasty balloon 30 . Each centering device 40 comprises a proximal end 42 and a distal end 44 and at least two struts 50 extending therebetween. The struts 50 may be equally or unequally spaced. The struts 50 may be longitudinal, as illustrated in FIG. 2, or circumferential, or any number of other suitable configurations. As illustrated in FIG. 2, the centering device 40 has a larger diameter that substantially equals the diameter of the lumen, and substantially exceeds the diameter of the inner member 20 . Therefore, the centering device 40 may center the catheter tip 25 of the centering catheter 10 in the lumen during and throughout insertion into the vessel, and during stent deployment. Another centering device may also be added to the centering catheter 10 at the proximal end of the stent 60 to facilitate uniform stent deployment. [0025] The at least one centering device 40 may be made from any number of suitable materials, and is preferably made from a superelastic alloy such as Nitinol. The chronic outward force of the Nitinol may be increased, and/or the diameter of the centering device may be increased to enhance the stabilization of the system during stent deployment. The struts 50 may alternatively have hinges near their midpoints. The centering device 40 may also be coated with any number of suitable materials, and is preferably coated with a lubricious or biologically compatible coating. The centering device 40 may be removably or permanently attached to the inner member 20 . The centering catheter 10 may be any suitable configuration catheter, and may preferably be an over the wire or rapid exchange catheter. The stent 60 may be a balloon expandable stent, as illustrated in FIG. 2, or a self-expanding stent. [0026] As illustrated in FIG. 2, the centering catheter 10 may be a stent delivery system that is advanced into the lumen of a vessel, with the centering device 40 expanding to make contact with the walls of the lumen. The centering device 40 thus serves to center the distal end of the catheter 10 and its inner member 20 as it is pushed through the vasculature to the treatment site. The struts 50 are compressible and allow the centering device 40 to vary its diameter as the lumen diameter varies, while always keeping the catheter tip 25 of the centering catheter 10 centered in the lumen. This may facilitate the pushability and trackability of the centering catheter 10 as it traverses the vasculature. When the treatment site is reached, the centering device 40 may stabilize the stent delivery system in the lumen of the vessel to insure uniform stent 60 deployment. [0027] There is illustrated in FIG. 3 a non-centering catheter 100 in an irregular and narrowed lumen of a tortuous vessel 200 . The lumen may be narrowed by plaques and other deposits 210 on the lumenal surface. The tip 110 of the non-centering catheter 100 may therefore become uncentered and may “catch” on the lumenal surface. Delivery of the noncentering catheter 110 to the targeted position in the lumen of the vessel may be difficult. In addition, deployment of a stent 120 (shown mounted on a balloon 130 ) may not be perfectly uniform. [0028] There is illustrated in FIG. 4 a centering catheter 10 with the at least one centering device 40 on a stent delivery system in an irregular and narrowed lumen of a tortuous vessel 200 . The lumen may be narrowed by plaques and other deposits 210 on the lumenal surface. Delivery of the centering catheter 10 to the targeted position in the lumen of the vessel may be facilitated by the presence of the at least one centering device 40 , which tends to center the tip of the catheter 25 in the lumen of the vessel 200 . Deployment of a stent 60 , shown mounted on a balloon 30 , may be facilitated by the presence of the at least one centering device 40 , which tends to center the catheter 10 within the vessel and facilitate uniform stent deployment. [0029] Although shown and described are what are believed to be the preferred embodiments, it is apparent that departures from specific designs and methods described and shown will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the invention. The present invention is not restricted to the particular constructions described and illustrated, but should be constructed to cover all modifications that may fall within the scope of the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 08/701,812, filed Aug. 21, 1996, now U.S. Pat. No. 5,906,974, which is a continuation of U.S. patent application Ser. No. 08/340,987, filed Nov. 17, 1994, now abandoned. BACKGROUND OF THE INVENTION Kidney dialysis has been a therapeutic boon to thousands of patients a year, who have severely compromised or non-existent kidney function. However, many of these patients experience side effects and complications ranging from hypersensitivity to recurrent hypotension. For a general discussion of hemodialysis complications, see Levin, et al., "Complications During Dialysis", in Nissenson, et al., eds., Dialysis Therapy, Hanley & Belfes, Inc., 1986, p. 85. Among the most common of complications is hypotension, arising in 20-30 percent of all hemodialysis patients. Many of these patients experience chronic hypotension, some so severe that they cannot tolerate the procedure at all, and must resort to peritoneal dialysis or transplant. The incidence of intradialytic hypotension occurs most frequently in older patients and in women. The cause of intradialytic hypotension varies depending on whether it occurs early or late in the treatment phase. It may result when the rate of intravascular volume depletion during ultrafiltration exceeds replacement. The diffusion of replacement fluid into the intravascular space counteracts the normal compensatory response of increased peripheral resistance. Also, hypotension can occur even during volume overload because of the time dependency of refilling of the intravascular space. Similarly, if the patient's weight is below the "dry weight", volume shifts may no longer be adequate to maintain blood pressure. For a discussion of the causes of hypotension in hemodialysis, see Schulman, et al., "Complications of Hemodialysis", in Principles and Practices of Nephrology, Jacobson, et al., eds., B. C. Decker, Inc., 1991, pp. 757-759. Other causes of intradialytic hypotension have been described. Shulman, infra, p. 759 lists as early hemodialysis hypotension causes: dialyzer volume, bioincompatible membranes, various medications, sepsis, and pericardial tamponade; listed as late stage hypotension causes, in addition to ultrafiltration rate and a too low setting for dry weight: excessive weight gain, decline in osmolarity, acetate accumulation, arrhythmia, and autonomic neuropathy. It is significant to note that most of the common causes of intradialytic hypotension involve fluid volume changes for which the body is incapable of fully compensating. Treatment of intradialytic hypotension focuses on its suspected cause. If a too rapid removal of fluids is the suspected cause, dialysis is discontinued and the patient is placed in the Trendelenburg position to enhance venous return. (See Kidney Electrolyte Disorders, eds. J. C. M. Chan, et al., Churchill Livingstone, 1990). The most common pharmacologic intervention for hypotension is administration of isotonic or hypertonic saline, to restore fluid balance. Pressor agents are not generally recommended, in part because a high percentage of hemodialysis patients are older persons with manifest clinical hypertension. In fact, it is recommended in designing hemodialysis regimens for these patients, that all blood pressure medication be curtailed for at least four hours prior to treatment. SUMMARY OF THE INVENTION Since patients requiring hemodialysis generally must be treated two to three times weekly for several hours per treatment, it is medically desirable to minimize complications as much as possible to avoid sequelae requiring further intervention, and needless traumatization of the patient. This is especially desirable for predictably recurrent complications in particular patient subgroups, such as those having recurrent hypotension. It is therefore an object of the present invention to provide a preventive therapy in which an agent is administered prophylactically about the time dialysis commences, to achieve circulatory stability and maintain blood pressure at acceptable levels. From the standpoint of patient well-being it is preferable to prevent hypotension from occurring than to treat the condition once it is manifest. It is a further object of the invention to provide a therapy for intradialytic hypotension generally which prevents hypotension arising from multiple causes, and not just treating manifest hypotension once a suspected cause has been identified. In the method of the present invention, stroma-free hemoglobin is peridialytically administered in a low dose for stabilizing the circulatory system in hemodialysis patients susceptible to chronic episodes of blood pressure fluctuation, and for treating chronic hypotension in susceptible patients undergoing hemodialysis. The hemoglobin solution administered is stroma-free hemoglobin and preferably diaspirin cross-linked. It is advantageous to administer the solution over a period of 10 to 45 minutes after commencement of hemodialysis. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic showing the design of clinical trials. FIGS. 2a and 2b are graphs depicting the course of systolic (2a) and diastolic (2b) blood pressure during hemodialysis. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT While any patient undergoing renal hemodialysis may encounter complications because of the frequency and duration of treatment, certain patient subgroups appear to be especially prone to complications such as hypotension occurring early in the procedure or in the later stages. These recurrent hypotensive episodes can be generally of two types, (1) in which blood pressure fluctuates, sometimes erratically, or (2) the patient experiences a sudden drop in pressure resulting in dizziness and actual fainting. These episodes may be accompanied by cardiac arrhythmia, which actually contributes to the condition. Such sudden drops in pressure may occur more than once in a single dialysis procedure. In general, a hypotensive event is said to occur when blood pressure falls either suddenly or transiently about 10 minutes after procedure initiation, by greater than about 20 mm Hg, or when systolic blood pressure falls below 100 mm Hg although these criteria will vary and are often interpreted very subjectively. Patients who experience hypotension or blood pressure fluctuation can be identified from their file histories, and may be considered for the hemoglobin therapy of the present invention if routine adjustments in the dialysis procedure (lowering rate of ultrafiltration, salt concentration of the dialysate, etc.) do not produce a remission of the episodes. It will largely be a matter for the attending physician or nephrologist to ascertain those who qualify for hemoglobin therapy, taking into account factors such as the age and condition of the patient, secondary pathologies, drug regimens, the frequency and severity of hypotensive episodes, etc. Administration of hemoglobin suppresses blood pressure fluctuation, and largely prevents intradialytic hypotension. One unexpected benefit is to minimize and virtually obviate conventional therapeutic intervention, even for causes of hypotension classically associated with fluid imbalances. Infusions of albumin, iso- and hypertonic saline, are avoided, which enhances patient comfort and well-being during the dialysis procedure. The hemoglobin therapy of the present invention involves administration of hemoglobin in a pharmacologically effective amount, generally, at low doses. In the clinical studies set forth in the Example, three dose levels of 25, 50 and 100 mg hemoglobin/kg body weight were infused. In other studies, and from animal models, pharmacologic efficacy is achieved in dose ranges from 10 mg/kg to about 1200 mg/kg. Any dose in this range is "low" when defined as an amount of hemoglobin too low to serve as a one-for-one oxygen carrying replacement for whole blood in which blood loss results in hypotension at least as pronounced as is observed in susceptible patients undergoing hemodialysis. Response of individual patients to particular doses of hemoglobin will vary, as with any drug, and the physician will adjust the dose to achieve the optimal effect. In some patients a dose of 15 mg/kg may be adequate, but in others a dose towards the high end of the recommended dose range (1200 mg/kg) may be required. In the occasional patient a dose in excess of 1200 mg/kg may be needed to be pharmacologically effective, and is still considered by Applicants to be within the scope of the invention so long as the low dose definition set forth herein is met. While it is known that the pharmacologic effects of hemoglobin are dose dependent up to a certain threshold, the duration of the effects is affected by dose, with the effects obtained at a larger dose continuing longer. In patients having a history of primarily late stage hypotension, larger doses may be indicated so that an adequate level is present at later times in the dialysis treatment, when hypotensive episodes are anticipated. In some patients, it may be most beneficial to administer the hemoglobin in more than one dose, or even in a continuous dose, over the course of dialysis. Such variations are within the scope of the present invention, so long as administration occurs peridialytically in relation to the treatment. Timing of hemoglobin administration is preferably coincident with the commencement of dialysis, and continues by intravenous infusion over a 10 to 45 minute period. Although hemoglobin administration may be efficacious as a palliative during acute episodes of hypotension, the principal embodiment of the invention is to administer the hemoglobin prophylactically in advance of such episodes so as to prevent hypotensive episodes from occurring. The hemoglobin utilized in the treatment of this invention is stroma-free, substantially free of endotoxin, and sterile. While unmodified stroma-free hemoglobin is pharmacologically effective, it tends to dissociate readily into its subunits giving it a much reduced half-life in the bloodstream. Renal toxicity has also been reported. It is therefore preferable to utilize a cross-linked, or cross-linked polymerized hemoglobin manufactured according to a number of methods in the art, for example, as described in U.S. Pat. Nos. 4,826,811, 4,001,401, 4,412,989, and 5,084,558. Most preferred is diaspirin cross-linked hemoglobin made as disclosed in U.S. Pat. Nos. 4,600,531 and RE34,271 hereby incorporated by reference. The hemoglobin is further purified and sterilized as disclosed in U.S. Pat. Nos. 4,831,012, 4,861,867, and 5,128,452. Further advantages of the present invention will be apparent from the Example which follows: EXAMPLE Diaspirin cross-linked hemoglobin (DCLHb) in a 10 percent solution was infused into patients undergoing hemodialysis according to the randomized, single-blinded, cross-over protocol illustrated in FIG. 1. Approximately equal numbers of patients (n=3) for a test group and a control group receiving normal saline, for each of 3 treatment groups (25, 50, and 100 mg hemoglobin/kg of body weight) were infused on day 1 with either saline or DCLHb. At day 7 the groups were reversed and then infused with the opposite of either saline or DCLHb than they received on day 1. Since one patient received only the control solution and did not cross-over, an extra patient was added to the control group, bringing the total to 19. Patients were unaware of which treatment was received. Various physiologic parameters were monitored, including blood pressure and the incidence of conventional intervention for hypotension. FIGS. 2a and 2b depict the data for systolic and diastolic pressures. It is evident that the test and control groups at each dosage level do not differ at the commencement of dialysis, but thereafter out to about 210 minutes there is a significant elevation in both systolic and diastolic pressures. Thereafter, the groups once again become indistinguishable. Table 1 summarizes the combined systolic blood pressure data. Blood pressure increases are dose dependent averaging 2 mm Hg for 25 mg/kg dose and 29 mm Hg for the 100 mg/kg group. TABLE 1______________________________________Blood Pressure Change 25 50 100 mg/kg mg/kg mg/kg______________________________________Change in BPs DCLHb 2 ± 12* 15 ± 29* 29 ± 8*Change in BPs placebo -1 ± 9 4 ± 10 -4 ± 12______________________________________ *p < 0.05 vs. placebo; MANOVA Correspondingly, the control groups generally demonstrated a reduction in systolic blood pressure. The results in Table 2 indicate an increase in hypotensive events as indicated by increased administration of hypertonic saline. The frequency of hypertonic saline interventions were significantly less in the DCLHb groups. The stabilization of blood pressure as indicated by the number of hypertonic saline interventions (Table 2) indicates 1 hypotensive episode in one of 18 patients receiving DCLHb compared to 20 episodes in 9 of 19 patients while receiving the control solution. Thus, low dose hemoglobin administration incident to hemodialysis stabilizes blood pressure and significantly reduces the need for conventional hypotensive interventions. TABLE 2______________________________________Frequency of 23.4% NaCl IVP for Treatment or Prevention ofHypotension DCLHb Normal Saline # interventions # interventions (# patients) (# patients)______________________________________25 mg/kg 1 (1) 3 (2)50 mg/kg 0 (0) 9 (5)100 mg/kg 0 (0) 8 (2)Total Interventions 1 (1) 20 (9)(Total Patients)______________________________________

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a milking plant comprising a stall adapted to house one animal at a time for milking of the animal, and a device for automatic milking of the animal in the stall. 2. Description of the Prior Art EP-B1-452 381 discloses such a milking plant intended for automatic milking of loose housed cows at optional points of time. Since the known milking plant is relatively expensive it is important that it is efficiently utilized. A problem of the known milking plant, however, is that it has to be regularly closed for necessary cleaning and service of said automatic milking device. Furthermore, directly after milking of an ill or medically treated cow, the known plant has to be closed for an extra cleaning of the automatic milking device, in order to avoid contamination of the milk extracted from the next cows which are milked. Since a cleaning interval can last for about 45 minutes the known milking plant is therefore not satisfactorily utilized. The object of the present invention is to provide a milking plant of the kind described above, which can be utilized more efficiently as compared with the known milking plant. SUMMARY OF THE INVENTION This object is obtained by a milking plant of the kind initially stated, which is characterized in that said automatic milking device comprises a first milking unit with teatcups and a second milking unit with teatcups, and an attachment means adapted to attach the teatcups of either the first or the second milking unit to the animal's teats. As a result one milking unit can be used for milking of animals, while the other milking unit is subjected to some suitable treatment, such as service or cleaning. Consequently the utilization efficiency of the milking plant according to the invention is substantially improved, as compared with the known milking plant. Cleaning means may suitably be adapted to clean milk passages in one of the milking units, while the teatcups of the other milking unit are available for said attachment means. Said cleaning means may comprise a cleaning device adapted to be connected to the teatcups of one of said milking units. As an alternative, said cleaning means may comprise two cleaning devices adapted to be connected to the teatcups of the first milking unit and the second milking unit, respectively, when required. Hereby, any one of the cleaning devices can be subjected to necessary service, while the other is used for cleaning of any one of the milking units, which contributes to the improvement of the utilization efficiency of the milking plant. According to a preferred embodiment of the plant of the invention, a displacement means is adapted to displace the teatcups of the first milking unit and the second milking unit, respectively, between a milking position, in which the teatcups are available for said attachment means, and a stand-by position, in which the teatcups are not available for the attachment means. As an alternative the two teatcup clusters of the milking units may be placed in two different milking positions, respectively, and the attachment means be adapted to bring teatcups from and leave them in said two milking positions. The displacement means may be adapted to simultaneously displace the teatcups of the first milking unit and the second milking unit such that the teatcups of the first milking unit are displaced from their stand-by position to their milking position, while the teatcups of the second milking unit are displaced from their milking position to their stand-by position, and vice versa. For example, the milking position and the stand-by position, respectively, for the teatcups of the first milking unit may be the same as the milking position and the stand-by position, respectively, for the teatcups of the second milking unit. In this case the displacement means may comprise a holding means which carries the teatcups of both the first and second milking units, the holding means being rotatable about a (suitably vertical) shaft for displacing the teatcups between the milking and stand-by positions. Alternatively, the milking position for the teatcups of the first milking unit may be the same as the milking position for the teatcups of the second milking unit, whereas the stand-by positions for the teatcups of the first and second milking units are different. For example, the displacement means may comprise a holding means which carries the teatcups of both the first and second milking units, the holding means being movable back and forth for displacing the teatcups between the milking and stand-by positions. Advantageously, cleaning means may be adapted to be connected to the teatcups of the first milking unit and the second milking unit, respectively, when the teatcups are in their stand-by position. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic drawing showing a first embodiment of the milking plant according to the present invention; FIG. 2 is a schematic drawing showing a second embodiment of the milking plant according to the present invention; FIG. 3 is a top plan view of a stall and an automatic milking device of a milking plant of the embodiment shown in FIG. 1; and FIG. 4 is a top plan view of a stall and an automatic milking device of the milking plant of the embodiment shown in FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENTS In the figures, components which correspond to one another have been given the same reference numerals. In FIG. 1 there is shown a milking plant according to the invention comprising a first milking unit A and a second milking unit B, which are adapted to milk independently of each other. The first milking unit A comprises four teatcups A1, and a milk conduit A2, which is connected to the teatcups A1. The milking unit A further comprises a flow meter A3, a receiver A4, a pump A5 and a milk filter A6, which are connected to the milk conduit A2 in said order, as seen in the milk flow direction. The milk filter A6 is automatically exchangeable for a new milk filter as indicated in FIG. 1. The second milking unit B comprises four teatcups B1, a milk conduit B2, a flow meter B3, a receiver B4, a pump B5 and a milk filter B6, which are connected to one another in the corresponding manner described above in connection with the first milking unit A. Downstream of the milk filters A6 and B6 the two milk conduits A2 and B2 are connected to a milk tank 8 via two valves A7 and B7 and connected to two drain conduits A10 and B10 via two drain valves A9 and B9. A displacement means 12 is adapted to displace the teatcups A1 and the teatcups B1, respectively, between a milking position I and a stand-by position II. In FIG. I the teatcups A1 are in the milking position I, while the teatcups B1 are in the stand-by position II. A cleaning device comprises four cleaning cups 13, which are connectable to teatcups in the stand-by position II, and a cleaning apparatus 14, which is connected to the cleaning cups 13 via a cleaning conduit 15. The cleaning apparatus 14 is connectable to the milk conduit A2 between the milk filter A6 and the valve A7 via a valve 16, and to the milk conduit B2 between the milk filter B6 and the valve B7 via a valve 17. The displacement means 12 comprises a holding means 18, which carries the teatcups A1, B1 and which is rotatable about a vertical shaft 19, see FIG. 3. The teatcups A1 and B1 are arranged in respective rows on opposite sides of the shaft 19. A control unit 20 is adapted to control a device 21 for connection of the cleaning cups 13 and removal of these from teatcups which are in the stand-by position II, and to control the displacement means 12 to turn the holding means 18 180° about the shaft 19 to switch the teatcups A1, B1 between the milking position I and the stand-by position II. In FIG. 3 there is shown the teatcups A1 in their milking position I and the teatcups B1 in their stand-by position II. The holding means 18 carries the teatcups A1 close to a stall 22, which is adapted to house one animal 23 at a time for milking of the latter. An automatic milking device 24 has an attachment means in the form of a robot arm 25, which is adapted to bring teatcups, in this case the teatcups A1, from the milking position I and attach them to the teats of the animal. For example, the robot arm 25 may be of the type disclosed in EP-B1-452 381. The milking plant according to FIGS. 1 and 3 operates in the following manner. When the teatcups A1 are used for milking, the valves 16 and A9 are closed while the valve A7 is open, whereby extracted milk can flow through the conduit A2 via the flow meter A3, the receiver A4, the pump A5 and the milk filter A6 to the milk tank 8. If desired, the milking unit B may be cleaned simultaneously by activating the control unit 20 to control the device 21 such that the latter connects the cleaning cups 13 to the teatcups B1. Then the milk filter B6 is removed from the milk conduit B2 and the valve 17 is opened while the valve B7 is closed. The cleaning apparatus 14 supplies cleaning liquid through the cleaning conduit 15 to the cleaning cups 13. From the cleaning cups 13 the cleaning liquid is conducted via the teatcups B1, the flow meter B3, the receiver B4, the pump B5 and the valve 17 back to the cleaning apparatus 14. When the cleaning operation is finished the milking unit B is first drained off by removing the cleaning cups 13 and opening the drain valve B9. Then a new milk filter B6 is fitted in the conduit B2 and the valves 17 and B9 are closed while the valve B7 is opened, whereby the cleaned milking unit B is ready for use. When the milking unit A is to be cleaned the control unit 20 is activated to control the displacement means 12 to turn the holding means 18 180°, whereby the teatcups A1 are displaced to the stand-by position II while the teatcups B1 are displaced to the milking position I. Now an animal can be milked by means of the milking unit B. After the cleaning cups 13 have been connected to the teatcups A1 and the cleaning apparatus 14 has been connected to the milk conduit A2 by closing the valve A7 and opening the valve 16, and the milk filter A6 has been removed, the milking unit A can be cleaned in the corresponding manner described above for the milking unit B. FIG. 2 shows a milking plant which is identical to the milking plant according to FIG. 1, except that the displacement means is designed differently and that there is an additional cleaning device. Thus, the milking plant according to FIG. 2 has a displacement means 26, which comprises a holding device 27 carrying the teatcups A1 and B1 in two aligned rows, and a drive means 28, which is displaceable back and forth between two end positions along a guide rail 29 and which is rigidly connected to the holding means 27, see FIG. 4. When the drive means 28 is in one of its two end positions the teatcups A1 are in the milking position I while the teatcups B1 are in a stand-by position IIa, and when the drive means 28 is in its other end position the teat cups B1 are in the milking position I while the teatcups A1 are in a stand-by position IIb. By means of the device 21 the cleaning cups 13 are connectable to the teatcups B1, when the teatcups B1 are in their stand-by position IIa. Said additional cleaning device comprises four cleaning cups 30, which are connectable to the teatcups A1, when these are in their stand-by position IIb, and a cleaning apparatus 31, which is connected to the cleaning cups 30 via a cleaning conduit 32. The cleaning apparatus 31 is connectable to the milk conduit A2 between the milk filter A6 and the valve A7 via a valve 32. In this case the cleaning apparatus 14 is only connectable to the milk conduit B1 via the valve 17. A device 33 of the same kind as the device 21 is adapted to connect the cleaning cups 30 to and to remove these from the teatcups A1, when the teatcups A1 are in their stand-by position IIb. A control unit 34 is adapted to control the devices 21 and 33, and to control the drive means 28 for its displacement along the guide rail 29 between said end positions (indicated by an arrow in FIG. 4). When the teatcups B1 are in their stand-by position IIa, as illustrated in FIGS. 2 and 4, the milking unit B can be cleaned by activating the control unit 34 to control the device 21 such that the cleaning cups 13 are connected to the teatcups B1. The milk filter B6 is removed from the milk conduit B2 and the valve B7 is closed while the valve 17 is opened. When the cleaning operation is finished the milking unit B is drained off and is prepared for milking in the corresponding manner described above for the milking plant according to FIGS. 1 and 3. In case the teatcups A1 are in their stand-by position IIb and the milking unit B is utilized for milking, the milking unit A can be cleaned by activating the control unit 34 to control the device 33 such that the cleaning cups 30 are connected to the teatcups A1. The milk filter A6 is removed and the valve A7 is closed while the valve 32 is opened. When the cleaning operation is finished the milking unit B is first drained off by removing the cleaning cups 30 and opening the drain valve A9. Then a new milk filter A6 is fitted in the conduit A2 and the valves A9 and 32 are closed while the valve A7 is opened, whereby the cleaned milking unit A is ready for use.

1a

REFERENCE TO RELATED APPLICATIONS [0001] The present application is related to and claims priority from the following pending patent applications, the disclosure of which is hereby incorporated by reference: [0002] U.S. Provisional Patent Application No. 60/516,613. FIELD OF THE INVENTION [0003] The present invention relates to drug mixing systems generally. BACKGROUND OF THE INVENTION [0004] The following U.S. Patents and non-U.S. patent publications are believed to represent the current state of the art: [0005] U.S. Pat. Nos. 6,221,041; 6,715,520; 6,409,708; PCT US02/40596; WO 2004004806; WO 03086529; WO 9819724; WO 03/086530; WO 0035517 and WO 0211794. SUMMARY OF THE INVENTION [0006] The present invention seeks to provide an improved drug mixing system, operative for use with a luer fitted hypodermic syringe, which is particularly useful in handling toxic drugs such as antineoplastic drugs. [0007] There is thus provided in accordance with a preferred embodiment of the present invention a drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle, at least one vial adaptor adapted for connection to a vial containing a drug and at least one syringe adaptor adapted to be attached to a syringe and to at least one of the at least one receptacle port adaptor and the at least one vial adaptor, the system being characterized in that at least one of the at least one receptacle port adaptor, the at least one syringe adaptor and the at least one vial adaptor being vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form. [0008] There is also provided in accordance with another preferred embodiment of the present invention a drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle, at least one vial adaptor adapted for connection to a vial containing a drug and at least one syringe adaptor adapted to be attached to a syringe and to at least one of the at least one receptacle port adaptor and the at least one vial adaptor, the system being characterized in that the at least one vial adaptor being vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial. [0009] Preferably, the drug mixing system also includes a membrane vent operative to vent at least one of the at least one receptacle port adaptor, the at least one syringe adaptor and the at least one vial adaptor to the atmosphere. Additionally, the membrane vent includes a filter. Additionally or alternatively, the membrane vent includes a hydrophobic membrane. [0010] There is also provided in accordance with another preferred embodiment of the present invention a drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle, at least one vial adaptor adapted for connection to a vial containing a drug and at least one syringe adaptor adapted to be attached to a syringe and to at least one of the at least one receptacle port adaptor and the at least one vial adaptor, the system being characterized in that the at least one syringe adaptor is adapted to be brought into fluid communication and mechanically locked to at least one of the at least one receptacle port adaptor and the at least one vial adaptor in a single step. [0011] Preferably, at least one of the at least one vial adaptor, the at least one receptacle port adaptor and the at least one syringe adaptor are vented to the atmosphere without permitting potentially harmful contents of the vial to reach the atmosphere. [0012] Preferably, the drug mixing system also includes a stopcock connected to the at least one vial adaptor and to the at least one receptacle port adaptor. [0013] There is further provided in accordance with yet another preferred embodiment of the present invention a drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle and at least one vial adaptor adapted for connection to a vial containing a drug and connected to the at least one receptacle port adaptor, the system being characterized in that at least one of the at least one receptacle port adaptor and the at least one vial adaptor is vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial. [0014] There is even further provided in accordance with still another preferred embodiment of the present invention a drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle and at least one vial adaptor adapted for connection to a vial containing a drug and connected to the at least one receptacle port adaptor, the at least one vial adaptor including a venting and sealing element, operative to allow air into the drug mixing system and adapted to prevent air from escaping from the drug mixing system. [0015] Preferably, the venting and sealing element includes a hydrophobic membrane and a narrow bore. [0016] Preferably, the narrow bore is irreversibly filled with liquid upon flow of liquid from the fluid receptacle to the vial, thus preventing air from escaping. [0017] Alternatively or additionally, the receptacle port adaptor includes an elastomer covered needle and the receptacle port adaptor and the vial adaptor are integrally formed. Alternatively, the receptacle port adaptor includes an elastomer covered needle and the receptacle port adaptor, the syringe adaptor and the vial adaptor are integrally formed. [0018] Preferably, the at least one vial adaptor also includes a protective vial housing operative to prevent release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form in the event of breakage of the vial. [0019] In another preferred embodiment, the fluid receptacle includes a spike port and the at least one receptacle port adaptor includes a spike port adaptor. Additionally or alternatively, the fluid receptacle includes a needle port and the at least one receptacle port adaptor includes a needle port adaptor. Additionally, the needle port adaptor includes a needle, the needle being protected by a needle protector. Preferably, the needle protector includes a latex needle cover. [0020] Preferably, the drug mixing system also includes a vial head adaptor adapted for connection between the vial adaptor and the vial. [0021] In another preferred embodiment, the at least one receptacle port adaptor and the fluid receptacle are adapted to be connected to an intravenous cannula on a patient via an intravenous infusion set. [0022] Preferably, the at least one syringe adaptor and the syringe are adapted to be connected to an intravenous cannula on a patient via an intravenous infusion set using an infusion set adaptor. Additionally or alternatively, the syringe adaptor is covered by a syringe cover element. [0023] There is yet further provided in accordance with another preferred embodiment of the present invention a drug mixing system including at least one drug mixing element including atmospheric venting functionality, characterized in that it prevents potentially harmful drug material from being released to the atmosphere via the venting functionality, the potentially harmful drug material including at least one of solid, liquid, gas and aerosol. [0024] There is even further provided in accordance with yet another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, inserting a receptacle port adaptor into a port in a receptacle containing a fluid, attaching the syringe adaptor, having the syringe attached thereto, to the receptacle port adaptor, retracting the plunger, thereby at least partially filling the syringe with fluid drawn from the receptacle in a manner which ensures that the fluid remains sterile and that a user is not exposed to the fluid, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, pushing the plunger, thus injecting the fluid contained in the syringe into the drug containing vial, thereby producing a drug solution in the vial and retracting the plunger, thus drawing at least part of the contents of the vial into the syringe, wherein at least one of the receptacle port adaptor, the syringe adaptor and the vial adaptor being vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form. [0025] There is still further provided in accordance with yet another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, inserting a receptacle port adaptor into a port in a receptacle containing a fluid, attaching the syringe adaptor, having the syringe attached thereto, to the receptacle port adaptor, retracting the plunger, thereby at least partially filling the syringe with fluid drawn from the receptacle in a manner which ensures that the fluid remains sterile and that a user is not exposed to the fluid, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, pushing the plunger, thus injecting the fluid contained in the syringe into the drug containing vial, thereby producing a drug solution in the vial and retracting the plunger, thus drawing at least part of the contents of the vial into the syringe, wherein the syringe adaptor is adapted to be brought into fluid communication and mechanically locked to at least one of the receptacle port adaptor and the vial adaptor in a single step. [0026] There is yet further provided in accordance with another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, inserting a receptacle port adaptor into a port in a receptacle containing a fluid, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, retracting the plunger, thus drawing at least part of the contents of the vial into the syringe, connecting the syringe adaptor having the syringe attached thereto, to the receptacle port adaptor and pushing the plunger, thus injecting the at least part of the contents of the vial into the receptacle, wherein at least one of the receptacle port adaptor, the syringe adaptor and the vial adaptor is vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form. [0027] There is still further provided in accordance with yet another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, inserting a receptacle port adaptor into a port in a receptacle containing a fluid, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, retracting the plunger, thus drawing at least part of the contents of the vial into the syringe, connecting the syringe adaptor having the syringe attached thereto, to the receptacle port adaptor and pushing the plunger, thus injecting the at least part of the contents of the vial into the receptacle, wherein the syringe adaptor is adapted to be brought into fluid communication and mechanically locked to at least one of the receptacle port adaptor and the vial adaptor in a single step. [0028] There is even further provided in accordance with another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, retracting the plunger, thus drawing at least part of the contents of the, vial into the syringe and pushing the plunger, thus injecting the at least part of the contents of the vial into an infusion line, wherein at least one of the receptacle port adaptor, the syringe adaptor and the vial adaptor is vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form. [0029] There is still further provided in accordance with yet another preferred embodiment of the present invention a drug mixing method including attaching a luer fitted hypodermic syringe having a plunger to a syringe adaptor, connecting the syringe adaptor having the syringe attached thereto, to a vial adaptor assembly, having a drug containing vial attached thereto, retracting the plunger, thus drawing at least part of the contents of the vial into the syringe and pushing the plunger, thus injecting the at least part of the contents of the vial into an infusion line, wherein the syringe adaptor is adapted to be brought into fluid communication and mechanically locked to at least one of the receptacle port adaptor and the vial adaptor in a single step. [0030] Preferably, the connecting the syringe adaptor also includes disconnecting the syringe adaptor from the receptacle adaptor prior to the connecting. Preferably, the connecting the syringe adaptor having the syringe attached thereto to the receptacle port adaptor also includes disconnecting the syringe adaptor from the vial adaptor prior to the connecting. [0031] Additionally or alternatively, the connecting the syringe adaptor includes connecting the drug containing vial to a vial head adaptor and connecting the drug containing vial having the vial head adaptor attached thereto to the vial adaptor assembly, prior to the connecting the syringe to the vial adaptor assembly. Alternatively or additionally, the drug mixing method also includes attaching the syringe adaptor, having the syringe containing at least part of the drug solution attached thereto, to the receptacle port adaptor and injecting contents of the syringe into the receptacle. [0032] There is still further provided in accordance with still another preferred embodiment of the present invention a drug mixing method including inserting a receptacle port adaptor into a port in a receptacle containing a fluid, connecting a drug containing vial to the receptacle port adaptor, transferring at least a portion of the fluid from the receptacle to the drug containing vial, thereby producing a drug solution in the vial and subsequently transferring the drug solution from the vial to the receptacle. [0033] Preferably, the connecting the drug containing vial includes connecting the drug containing vial to a vial head adaptor prior to the connecting the drug containing vial. Additionally or alternatively, the receptacle port adaptor includes at least one of a spike port adaptor and a needle port adaptor. [0034] There is yet further provided in accordance with another preferred embodiment of the present invention a vial adaptor adapted for connection to a vial containing a drug and adapted for connection to other elements of a drug mixing system, the vial adaptor including a spike adapted for penetrating the vial, a mechanical lock for locking the vial adaptor to the vial once the spike penetrates the vial and an element operative to vent the interior of the vial to the atmosphere without permitting potentially harmful contents of the vial to reach the atmosphere. [0035] Preferably, the vial adaptor also includes a membrane vent operative to vent the vial adaptor to the atmosphere. Additionally, the membrane vent includes a filter. Alternatively or additionally, the membrane vent includes a hydrophobic membrane. [0036] Preferably, the vial adaptor also includes a septum equipped syringe port. Additionally or alternatively, the vial adaptor includes at least one locking element, operative to irreversibly lock the vial adaptor to the vial. Preferably, the at least one locking element includes at least one radially extending portion and at least one transversely extending portion. [0037] There is further provided in accordance with yet another preferred embodiment of the present invention a vial adaptor adapted for connection to a vial containing a drug and being adapted for connection to other elements of a drug mixing system, the vial adaptor including at least one locking element, operative to irreversibly lock the vial adaptor to the vial. [0038] Preferably, the at least one locking element includes at least one radially extending portion and at least one transversely extending portion. [0039] There is still further provided in accordance with another preferred embodiment of the present invention a vial adaptor adapted for connection to a vial containing a drug and being adapted for connection to a fluid transfer device, the vial adaptor being vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form. [0040] Preferably, the vial adaptor also includes a membrane vent operative to vent the vial adaptor to the atmosphere. Additionally, the membrane vent includes a filter. Alternatively or additionally, the membrane vent includes a hydrophobic membrane. [0041] There is yet further provided in accordance with still another preferred embodiment of the present invention a syringe adaptor adapted for connection to a syringe and adapted for connection to at least one other element of a drug mixing system, the syringe adaptor including a septa housing, at least two septa enclosed in the septa housing defining a space therebetween and a needle, including a tip located in the space when the syringe adaptor is not connected to the at least one other element. [0042] Preferably, the septa housing is movable relative to the needle, thereby to expose the tip. Additionally or alternatively, at least a portion of the needle is protected by a needle protector. Additionally, the needle protector includes an elastomeric tubing element. [0043] There is still further provided in accordance with yet a further preferred embodiment of the present invention a vial head adaptor for use in connecting a vial with a first head circumference to a vial adaptor adapted for use with a vial with a second head circumference, the second head circumference being greater than the first head circumference, the vial head adaptor including at least one locking element. [0044] Preferably, the at least one locking element includes four locking elements arranged generally at right angles to each other. Additionally, the at least one locking element includes a locking tooth. [0045] There is even further provided in accordance with still another preferred embodiment of the present invention a receptacle port adaptor for use in a drug mixing system including a housing, a needle located within the housing and adapted to be inserted into a port of a fluid receptacle, a septum located in the housing and a locking mechanism to fix the receptacle port adaptor to the port. [0046] Preferably, the needle is protected by a needle protector. Additionally, the needle protector includes a latex needle cover. Alternatively or additionally, the needle moves between a protected position and a piercing position. [0047] There is also provided in accordance with yet another preferred embodiment of the present invention a protective vial housing for use with a drug mixing system including a fluid flow passageway adapted to connect a vial containing a drug to the drug mixing system, the protective vial housing being operative to prevent release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form in the event of breakage of the vial. BRIEF DESCRIPTION OF THE DRAWINGS [0048] The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: [0049] FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L and 1M are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with a preferred embodiment of the present invention; [0050] FIG. 2 is a simplified pictorial illustration of a vial head adaptor element which forms part of the drug mixing system of FIGS. 1A-1M ; [0051] FIG. 3 is a sectional illustration taken along section lines III-III in FIG. 2 ; [0052] FIG. 4 is a simplified exploded view illustration of a vial adaptor assembly which forms part of the drug mixing system of FIGS. 1A-1M ; [0053] FIG. 5 is a simplified assembled pictorial illustration of the vial adaptor assembly of FIG. 4 ; [0054] FIGS. 6A and 6B are sectional illustrations taken along respective section lines VIA-VIA and VIB-VIB in FIG. 5 ; [0055] FIG. 7 is a simplified exploded view illustration of a syringe adaptor element which forms part of the drug mixing system of FIGS. 1A-1M ; [0056] FIG. 8 is a simplified assembled pictorial illustration of the syringe adaptor element of FIG. 7 ; [0057] FIGS. 9A and 9B are sectional illustrations taken along respective section lines IXA-IXA and IXA-IXB in FIG. 8 ; [0058] FIG. 9C is a sectional illustration of an alternative embodiment of the syringe adaptor element of FIG. 8 , taken along section lines IXA-IXA in FIG. 8 . [0059] FIG. 10 is a simplified pictorial illustration of a spike port adaptor element which forms part of the drug mixing system of FIGS. 1A-1M ; [0060] FIGS. 11A and 11B are sectional illustrations taken along section lines XI-XI in FIG. 10 , of two different inner structures of the spike port adaptor element; [0061] FIGS. 12A and 12B are simplified pictorial illustrations of a needle port adaptor element which forms part of the drug mixing system of FIGS. 1A-1M ; [0062] FIGS. 13A and 13B are sectional illustrations taken along respective section lines XIIIA-XIIIA and XIIIB-XIIIB in FIG. 12A ; [0063] FIG. 14 is a simplified pictorial illustration of a syringe protection cover which fours part of the drug mixing system of FIGS. 1A-1M ; [0064] FIG. 15 is a sectional illustration taken along section lines XV-XV in FIG. 14 ; [0065] FIG. 16 is a simplified pictorial illustration of an injection set adaptor element which forms part of the drug mixing system of FIGS. 1A-1M ; [0066] FIG. 17 is a sectional illustration taken along section lines XVII-XVII in FIG. 16 ; [0067] FIGS. 18A and 18B are, respectively, a simplified planar illustration and a simplified sectional illustration of the drug mixing system of FIG. 1A during attachment of the vial adaptor, the sectional illustration being taken along lines XVIIB-XVIIIB in FIG. 18A ; [0068] FIGS. 19A and 19B are, respectively, a top view simplified planar illustration and a simplified sectional illustration of the drug mixing system of FIG. 1C during attachment of the syringe adaptor, the sectional illustration being taken along lines XIXB-XIXB in FIG. 19A ; [0069] FIGS. 19C and 19D are respectively, a side view simplified planar illustration and a simplified sectional illustration of the drug mixing system of FIG. 1C during attachment of the syringe adaptor, the sectional illustration being taken along lines XIXD-XIXD in FIG. 19C ; [0070] FIG. 20 is a partially pictorial partially sectional illustration of the drug mixing system of FIG. 1D during attachment of the spike port adaptor element; [0071] FIG. 21 is a partially pictorial partially sectional illustration of the drug mixing system of FIG. 1D during attachment of the needle port adaptor element; [0072] FIG. 22 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 20 prior to syringe attachment; [0073] FIG. 23 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 20 following syringe attachment; [0074] FIG. 24 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 21 prior to syringe attachment; [0075] FIG. 25 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 21 following syringe attachment; [0076] FIG. 26 is a sectional illustration of the drug mixing system of FIG. 1G prior to drug dilution; [0077] FIG. 27 is a sectional illustration of the drug mixing system of FIG. 1H following drug dilution; [0078] FIG. 28 is a sectional illustration of the drug mixing system of FIGS. 1K and 1L in a protected, ready for delivery state; [0079] FIG. 29 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1M and 28 when ready for injection; [0080] FIG. 30 is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1M and 20 when ready for injection; [0081] FIGS. 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H, 311, 31J, 31K and 31L are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with another preferred embodiment of the present invention; [0082] FIG. 32 is a simplified pictorial illustration of a vial head adaptor element which forms part of the drug mixing system of FIGS. 31A-31L ; [0083] FIG. 33 is a sectional illustration taken along section lines XXXIII-XXXIII in FIG. 32 ; [0084] FIG. 34 is a simplified pictorial illustration of a spike port adaptor element which forms part of the drug mixing system of FIGS. 31A-31L ; [0085] FIG. 35 is a sectional illustration taken along section lines XXXV-XXXV in FIG. 34 ; [0086] FIG. 36 is a simplified exploded view illustration of an adaptor assembly which forms part of the drug mixing system of FIGS. 31A-31L ; [0087] FIG. 37 is a simplified pictorial illustration of a stopcock element which forms part of the adaptor assembly of FIG. 36 ; [0088] FIGS. 38A and 38B are sectional illustrations taken along respective section lines XXXVIIIA-XXXVIIIA and XXXVIIB-XXXVIIIB in FIG. 37 ; [0089] FIG. 39 is a simplified pictorial illustration of a receptacle adaptor subassembly which forms part of the adaptor assembly of FIG. 36 ; [0090] FIGS. 40A and 40B are sectional illustrations taken along respective section lines XLA-XLA and XLB-XLB in FIG. 39 ; [0091] FIG. 41 is a simplified pictorial illustration of a vial adaptor subassembly which forms part of the adaptor assembly of FIG. 36 ; [0092] FIGS. 42A and 42B are sectional illustrations taken along respective section lines XLIIA-XLIIA and XLIIB-XLIIB in FIG. 41 ; [0093] FIGS. 43A and 43B are simplified pictorial illustrations of a housing element which forms part of the adaptor assembly of FIG. 36 in closed and open orientations, respectively; [0094] FIG. 44 is a simplified assembled pictorial illustration of the adaptor assembly of FIG. 36 ; [0095] FIGS. 45A and 45B are sectional illustrations taken along respective section lines XVA-XVA and XVB-XVB in FIG. 44 ; [0096] FIG. 46 is a sectional illustration of the drug mixing system of FIG. 31C during attachment of a syringe to the adaptor assembly of FIGS. 44-45B ; [0097] FIG. 47 is a sectional illustration of the drug mixing system of FIG. 31D during attachment of the receptacle adaptor element of FIG. 31B to the adaptor assembly of FIG. 46 ; [0098] FIG. 48 is a sectional illustration of the drug mixing system of FIG. 31E during attachment of a vial to the adaptor assembly of FIG. 47 ; [0099] FIG. 49 is a sectional illustration of the drug mixing system of FIGS. 31F and 48 during fluid drawing from a receptacle; [0100] FIG. 50 is a sectional illustration of the drug mixing system of FIGS. 31G and 48 during fluid injection into a vial; [0101] FIG. 51 is a sectional illustration of the drug mixing system of FIGS. 31I and 48 during fluid drawing from a vial; [0102] FIG. 52 is a sectional illustration of the drug mixing system of FIG. 31J and 48 during fluid injection into a receptacle; [0103] FIG. 53 is a sectional illustration of the drug mixing system of FIG. 31L when ready for storage; [0104] FIGS. 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54H are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with yet another preferred embodiment of the present invention; [0105] FIG. 55 is a simplified pictorial illustration of a vial head adaptor element which fauns part of the drug mixing system of FIGS. 54A-54H ; [0106] FIG. 56 is a sectional illustration taken along section lines LVI-LVI in FIG. 55 ; [0107] FIG. 57 is a simplified pictorial illustration of a spike port adaptor element which forms part of the drug mixing system of FIGS. 54A-54H ; [0108] FIG. 58 is a sectional illustration taken along section lines LVIII-LVIII in FIG. 57 ; [0109] FIG. 59 is a simplified exploded view illustration of an adaptor assembly which forms part of the drug mixing system of FIGS. 54A-54H ; [0110] FIG. 60 is a simplified pictorial illustration of ad vial adaptor subassembly which forms part of the adaptor assembly of FIG. 59 ; [0111] FIGS. 61A and 61B are sectional illustrations taken along respective section lines LXIA-LXIA and LXIB-LXIB in FIG. 60 ; [0112] FIG. 62 is a simplified pictorial illustration of a receptacle adaptor subassembly which forms part of the adaptor assembly of FIG. 59 ; [0113] FIGS. 63A and 63B are sectional illustrations taken along respective section lines LXIIIA-LXIIIA and LXIIIB-LXIIIB in FIG. 62 ; [0114] FIGS. 64A and 64B are simplified pictorial illustrations of a housing element which forms part of the adaptor assembly of FIG. 59 in closed and open orientations, respectively; [0115] FIG. 65 is a simplified assembled pictorial illustration of the adaptor assembly of FIG. 59 ; [0116] FIGS. 66A and 66B are sectional illustrations taken along respective section lines LXVIA-LXVIA and LXVIB-LXVIB in FIG. 65 ; [0117] FIGS. 67A and 67B are sectional illustrations of the drug mixing system of FIG. 54C during attachment of a vial to the adaptor assembly of FIG. 65 ; [0118] FIG. 68 is a sectional illustration of the drug mixing system of FIG. 54D-54G during attachment of the receptacle port adaptor element of FIG. 54B to the adaptor assembly of FIG. 67 ; [0119] FIG. 69 is a sectional illustration of the drug mixing system of FIGS. 54H and 68 during disconnection of the receptacle port adaptor element of FIG. 54B from the adaptor assembly of FIG. 67 ; [0120] FIG. 70 is an exploded view illustration of a drug mixing system which is constructed and operative in accordance with a further preferred embodiment of the present invention; [0121] FIG. 71 is a simplified pictorial illustration of a vial support element which forms part of the drug mixing system of FIG. 70 ; [0122] FIGS. 72A and 72B are, respectively, a sectional illustration and a pictorial sectional illustration taken along section lines LXXII-LXXII in FIG. 71 ; [0123] FIG. 73 is a simplified pictorial illustration of the vial support element of FIG. 71 , when containing a vial; [0124] FIG. 74 is a sectional illustration taken along section lines LXXIV-LXXIV in FIG. 73 ; [0125] FIGS. 75A and 75B are simplified pictorial illustrations of a vial puncturing cover element which forms part of the vial adaptor subassembly of FIG. 70 ; [0126] FIG. 76 is a sectional illustration taken along section lines LXXVI-LXXVI in FIG. 75A ; [0127] FIG. 77 is a simplified assembled pictorial illustration of the vial adaptor subassembly of FIG. 70 ; [0128] FIG. 78 is a sectional illustration taken along section lines LXXVIII-LXXVIII in FIG. 77 ; [0129] FIG. 79 is a pictorial illustration of the vial adaptor assembly of FIG. 77 when assembled to an adaptor assembly in accordance with a preferred embodiment of the present invention; [0130] FIG. 80 is a sectional illustration taken along section lines LXXX-LXXX in FIG. 79 ; [0131] FIG. 81 is a pictorial illustration taken of the vial adaptor assembly and adaptor assembly of FIG. 79 when connected to a receptacle port adaptor element and a receptacle in accordance with a preferred embodiment of the present invention; [0132] FIG. 82 is a sectional illustration taken along section lines LXXXII-LXXXII in FIG. 81 ; [0133] FIG. 83 is an exploded view illustration of a drug mixing system which is constructed and operative in accordance with a still further preferred embodiment of the present invention; [0134] FIG. 84 is a simplified pictorial illustration of a receptacle adaptor housing assembly which forms part of the drug mixing system of FIG. 83 ; [0135] FIGS. 85A and 85B are sectional illustrations taken along section lines LXXXVA-LXXXVA and LXXXVB-LXXXVB in FIG. 84 ; [0136] FIG. 86 is a simplified pictorial illustration of a receptacle adaptor needle element which forms part of the drug mixing system of FIG. 83 ; FIGS. 87A and 87B are sectional illustrations taken along section lines LXXXVIIA-LXXXVIIA and LXXXVIIB-LXXXVIIB in FIG. 86 ; [0137] FIG. 88 is a simplified assembled pictorial illustration of the receptacle adaptor subassembly of FIG. 83 ; [0138] FIGS. 89A and 89B are sectional illustrations taken along section lines LXXXIXA-LXXXIXA and LXXXIXB-LXXXIXB in FIG. 88 ; [0139] FIG. 90 is a pictorial illustration of the receptacle adaptor subassembly of FIG. 88 when assembled to a vial adaptor subassembly in accordance with a preferred embodiment of the present invention, prior to connection of a needle to a receptacle port element; [0140] FIG. 91 is a sectional illustration taken along section lines XCI-XCI in FIG. 90 ; [0141] FIG. 92 is a pictorial illustration of the receptacle adaptor subassembly of FIG. 88 when assembled to a vial adaptor subassembly, following connection of a needle to a receptacle port element; and [0142] FIG. 93 is a sectional illustration taken along section lines XCIII-XCIII in FIG. 92 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0143] Reference is now made to FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L and 1M which are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with a preferred embodiment of the present invention. [0144] As seen in FIG. 1A , a conventional vial 10 , including a top portion 12 and a neck portion 13 , is pushed into engagement with a vial adaptor assembly 30 which is described hereinbelow with reference to FIGS. 4-6B . Top portion 12 of vial 10 preferably has a septum 31 sealingly seated therein. FIGS. 18A-18B show a sectional view of the drug mixing system at this stage: [0145] Alternatively, if a small vial 32 is used, small vial 32 is pushed into engagement with a vial head adaptor element 34 which is described hereinbelow with reference to FIGS. 2-3 as shown in FIG. 1B , and is then pushed into engagement with vial adaptor assembly 30 . The vials 10 and 32 typically contain a drug in a soluble powder form, in a solution or in other suitable form. [0146] As shown in FIG. 1C , a luer fitted hypodermic syringe 40 having a plunger 42 and a luer tip 44 is attached to a syringe adaptor element 50 which is described hereinbelow with reference to FIGS. 7-9B . FIGS. 19A-19D show planar and sectional views of the drug mixing system at this stage. [0147] FIG. 1D shows a spike port adaptor element 60 , as described hereinbelow with reference to FIGS. 10-11 , being inserted into a spike port 61 in a receptacle 62 containing a fluid. FIG. 20 shows a partially pictorial partially sectional view of the drug mixing system at this stage. Typically, receptacle 62 comprises a bag, and the fluid contained therein is sterile saline solution, water, or any other suitable sterile solution or pure fluid. [0148] Alternatively, a needle port adaptor element 70 , as described hereinbelow with reference to FIGS. 12A-13B , is inserted into a needle port 64 in receptacle 62 . FIG. 21 shows a sectional view of the drug mixing system at this stage. It will be appreciated by persons skilled in the art that the assembly steps shown in FIGS. 1B-1D may be performed in any suitable sequence. [0149] As seen in FIG. 1E , syringe adaptor element 50 , having syringe 40 attached thereto ( FIG. 1C ), is connected to a connection port in either of spike port adaptor element 60 or needle port adaptor element 70 of FIG. 1D . FIGS. 22-23 and 24-25 , respectively, show partially pictorial partially sectional views of the two alternate orientations of the drug mixing system at this stage. [0150] Typically, plunger 42 of syringe 40 is fully pushed inward into syringe 40 before syringe adaptor element 50 is connected to either of spike port adaptor element 60 and needle port adaptor element 70 . [0151] As seen in FIG. 1F , a user retracts plunger 42 in either of the operative orientations of FIG. 1E , thus at least partially filling syringe 40 with fluid drawn from receptacle 62 . The fluid flows through the spike port adaptor element 60 or through the needle port adaptor element 70 directly into syringe 40 . This flow of fluid ensures that the fluid remains sterile, and that the user is not exposed to the fluid. Subsequently, the syringe 40 and syringe adaptor element 50 are disconnected from the spike port adaptor element 60 or the needle port adaptor element 70 . The drug mixing system of the present invention also ensures that the user is not exposed to the fluid during disconnection thereof, as explained further hereinbelow. [0152] The user then connects syringe adaptor element 50 , which is attached to syringe 40 , to the vial adaptor assembly 30 having the vial 10 attached thereto, as shown in FIG. 1G . FIG. 26 shows a sectional view of the drug mixing system at this stage. [0153] When the syringe 40 and vial 10 are connected and fluid can flow therebetween, the user pushes plunger 42 inward, with the vial positioned upright, thus injecting the fluid contained in syringe 40 into vial 10 and dissolving the drug contained therein. FIG. 27 shows a sectional view of the drug mixing system at this stage. As seen in FIG. 1H , the user then shakes the drug mixing system of FIG. 1G to ensure that the drug in vial 10 is fully dissolved and that the resulting solution is homogenous. [0154] It is appreciated that when vial 10 contains a drug in a pre-dissolved form, the steps described hereinabove with reference to FIGS. 1E-1H may be obviated. As seen in FIG. 1I , the user turns the drug mixing system upside clown and retracts plunger 42 , thus drawing at least part of the solution from the vial 10 into syringe 40 . Subsequently, syringe 40 and syringe adaptor element 50 are disconnected from vial 10 and vial adaptor assembly 30 , as shown in FIG. 1J . At this stage, if some of the drug solution is left in vial 10 , vial 10 and vial adaptor assembly 30 , joined thereto, may be stored in a suitable facility for further use. [0155] At a next stage, the drug solution contained in syringe 40 is prepared for delivery to a hospital ward for infusion into a patient. As shown in FIG. 1K , syringe 40 containing the drug solution is connected to spike port adaptor element 60 for transferring the drug into receptacle 62 . Alternatively, syringe 40 may be connected to needle port adaptor element 70 . [0156] As a further alternative, the user may place a syringe protection cover 80 , which is described hereinbelow with reference to FIGS. 14-15 , onto the syringe adaptor element 50 which is attached to syringe 40 , prior to delivering it to a hospital ward. [0157] As seen in FIG. 1L , the user pushes plunger 42 of syringe 40 inward, thus injecting the drug solution into receptacle 62 and further diluting it prior to infusion into a patient. Alternatively, syringe 40 may be covered by the syringe protection cover 80 and is ready for delivery to the appropriate hospital ward. FIG. 28 is a sectional view of the drug mixing system at this stage. [0158] As seen in FIG. 1M , the receptacle 62 and spike port adaptor element 60 are connected via a standard infusion set 92 such as model IAS which is commercially available from Teva Medical Ltd. of Ashdod, Israel, to a patient's intravenous cannula. The connection to the spike port adaptor element 60 is performed after the removal of a connection element which is placed at the end of the spike port adaptor element 60 . FIG. 30 is a sectional view of the drug mixing system at this stage. [0159] Alternatively, the syringe 40 and syringe adaptor element 50 may be connected via an infusion set adaptor element 90 , which is described hereinbelow with reference to FIGS. 16-17 , to an infusion set 92 including a port 93 and an intravenous cannula 94 which is placed at the injection site. Before syringe adaptor element 50 is attached to the infusion set adaptor element 90 , the syringe protection cover 80 is removed from the end of the syringe adaptor element 50 . FIG. 29 shows a partially pictorial partially sectional view of the drug mixing system at this stage. [0160] The structure of elements of the drug mixing system of FIGS. 1A-1M is described hereinbelow with reference to FIGS. 2-17 . [0161] Reference is now made to FIG. 2 , which is a simplified pictorial illustration of a vial head adaptor element 34 which forms part of the drug mixing system of FIGS. 1A-1M , and to FIG. 3 , which is a sectional illustration taken along section lines III-III in FIG. 2 . [0162] As seen in FIG. 2 , vial head adaptor element 34 is preferably a side-to-side symmetric integrally formed element, which is preferably injection molded of plastic. [0163] Vial head adaptor element 20 preferably includes a generally cylindrical main body portion 200 and has a central axis 201 . An inner cylindrical surface 202 of main body portion 200 preferably has four arms 204 extending therefrom, each arm 204 being arranged at generally right angles with respect to its neighboring arms. [0164] Each of arms 204 terminates at an upper end thereof, in the sense of FIG. 1B , in an inwardly facing generally triangular tooth 206 having a forwardly facing inclined surface 208 and a bottom-facing engagement surface 210 extending generally perpendicular to aim 204 . [0165] At bottom surface of vial head adaptor element 34 , there are formed four inwardly protruding surfaces 212 , extending generally perpendicular to inner surface 202 of main body portion 200 . Each of neighboring surfaces 212 is preferably arranged at a generally right angle with respect to its neighboring surfaces 212 . Surfaces 212 and arms 204 are rotationally offset from one another about axis 201 . [0166] Reference is now made to FIG. 4 , which is a simplified exploded view illustration of a preferred vial adaptor assembly 30 which forms part of the drug mixing system of FIGS. 1A-1M , to FIG. 5 , which is a simplified assembled pictorial illustration of the vial adaptor assembly 30 , and to FIGS. 6A and 6B , which are sectional illustrations taken along respective section lines VIA-VIA and VIB-VIB in FIG. 5 . [0167] As seen in FIGS. 4-6B , vial adaptor assembly 30 comprises a main body element 302 arranged generally about an axis 303 . Main body element 302 is preferably integrally formed and preferably injection molded of plastic. [0168] Main body element 302 is preferably side-to-side symmetric about axis 303 , and preferably includes a rear portion 304 , which is generally cylindrical and terminates in a forward wall 306 . Rear portion 304 comprises a forward base section 308 , rearward of which are preferably foisted four tabs 310 each having a rectangular window 312 . Rearward of rectangular windows 312 and on an inner surface 314 of each of tabs 310 there are preferably formed two radially extending inwardly facing protrusions 316 each having an inclined surface. Protrusions 316 preferably terminate at a forward end thereof in an inwardly facing transversely extending protrusion 318 . Rearward of protrusions 316 , each of tabs 310 preferably includes an outwardly tapered portion 320 . [0169] A hollow vial puncturing spike 322 extends rearwardly from a rearward surface 324 of forward wall 306 , and is surrounded by base section 308 and by tabs 310 . Rearward surface 324 additionally includes a circular cylindrical protrusion 325 , surrounding puncturing spike 322 . Two radially extending bores 326 and 327 extend through vial puncturing spike 322 . [0170] Forward of forward wall 306 of rear portion 304 there is formed an intermediate portion 328 which is generally rectangular, and includes axial hollow tubular portion 330 which is in fluid flow engagement with bore 327 of vial puncturing spike 322 . [0171] At a top surface of intermediate portion 328 and slightly recessed with respect thereto there is formed a plastic membrane support surface 332 , having formed thereon a plurality of generally evenly distributed spherical protrusions 334 , which are adapted to support a hydrophobic membrane 336 and prevent it from excessive inflation and from cracking. Membrane 336 is adapted to allow free passage of air into the main body element 302 , but to prevent passage therethrough of liquid and air-borne particles, microorganisms and aerosol. A preferred membrane 336 is Model Versapor R 0.2 Micron which is commercially available from Pall Corporation of New York, U.S.A. Membrane 336 is in fluid flow engagement with vial puncturing spike 322 via bore 326 and via a recess 337 formed in intermediate portion 328 . [0172] A rim 338 surrounding support surface 332 is adapted to support an optional carbon cloth filter 340 and maintain it in a raised position above and spaced from membrane 336 . Carbon cloth filter 340 is adapted to prevent toxic vapors from escaping from main body element 302 , thus protecting users. A preferred carbon cloth filter 340 is Model No. Zorflex EMI, which is commercially available from Charcoal Cloth International Ltd. of Houghton-le-Spring, England. [0173] Intermediate portion 328 terminates at a forward end thereof in a generally circular wall 342 . Forward of circular wall 342 there is formed a hollow neck portion 344 , which is in fluid flow engagement with hollow tubular portion 330 and with hollow vial puncturing spike 322 . Hollow neck portion 344 terminates at a forward end thereof in a generally circular wall surface 346 . [0174] Forward of neck portion 344 there is formed a forward facing portion 348 , which is adapted to sealingly accommodate a generally circular septum 350 on a seat 352 which is located at a forward end of portion 348 . Forward facing portion 348 defines a central bore 354 which communicates between tubular portion 330 and septum 350 . [0175] Vial adaptor assembly 30 preferably additionally includes a covering element 360 which supports and covers membrane 336 and carbon filter 340 . Covering element 360 is a generally cylindrical, generally side-to-side symmetric, element and is preferably formed with a central opening 362 at a forward end thereof through which forward portion 348 extends. [0176] A pair of outer side surfaces 364 of covering element 360 are each formed with ribbed grip regions 366 . An inner top surface 368 of covering element 360 is preferably flat, and is adapted to support the top surfaces of membrane 336 and carbon filter 340 and to prevent excessive inflation and cracking thereof. [0177] It is appreciated that the functionalities of membrane 336 and carbon cloth filter 340 , to allow free passage of air into the drug mixing system while preventing passage thereinto of liquid and air-borne particles, microorganisms and aerosol and preventing toxic vapors from escaping from the drug mixing system, may be incorporated, using similar elements, into any of syringe adaptor element 50 , spike port adaptor element 60 and needle port adaptor element 70 . [0178] Reference is now made to FIG. 7 , which is a simplified exploded view illustration of syringe adaptor element 50 which forms part of the drug mixing system of FIGS. 1A-1M , to FIG. 8 , which is a simplified assembled pictorial illustration of syringe adaptor element 50 and to FIGS. 9A, 9B and 9C , which are sectional illustrations taken along respective section lines IXA-IXA and IXB-IXB in FIG. 8 . [0179] As seen with particular clarity in FIG. 7 , syringe adaptor element 50 comprises a housing element 500 , which has seated therein a forward septum 502 and a rearward septum 504 . [0180] Housing element 500 is preferably an integrally formed cylindrical hollow element made of plastic and is preferably side-to-side, top-to-bottom and forward-rearward symmetrical. [0181] Preferably, a forward portion 506 of housing element 500 includes a seat 508 for forward septum 502 , and a rear portion 510 of the housing element includes a seat 512 for rearward septum 504 . An intermediate portion 514 of housing element 500 preferably includes on a top and a bottom surface thereof generally rectangular outwardly facing protrusions 516 . [0182] Septa 502 and 504 are preferably formed to have a generally circular portion 518 with a partially spherical protrusion 520 at one side thereof. [0183] Surrounding housing element 500 there is formed a body 522 , which defines a main body portion 523 , which is generally cylindrical, preferably side-to-side and top-to-bottom symmetrical, and preferably formed of plastic, and side surfaces 524 . Extending from a forward portion of each of side surfaces 524 is an outwardly protruding arm 526 , defining at an inner facing forward end thereof a generally triangular tooth 527 having a transversely extending rearward facing surface 528 which is adapted to engage a forward facing surface of intermediate portion 514 of housing element 500 . [0184] Rearward of each of arms 526 there is formed a generally rectangular aperture 529 . Adjacent a rearward portion 530 of housing element 500 there is formed a circumferential protrusion 532 , forward of which is formed an additional circumferential protrusion 534 , having a slightly larger outer circumference than that of protrusion 532 . [0185] A compression spring 536 is seated within housing element 500 , on a shoulder 538 located between intermediate portion 514 and rear portion 510 of housing element 500 . [0186] A generally cylindrical rear sealing element 540 is located rearward of housing element 500 . Rear sealing element 540 is preferably side to side symmetric, and is typically formed of plastic. [0187] Rear sealing element 540 preferably defines a forward cowl 542 terminating at a rearward end thereof in a generally circular wall portion 544 . Forward cowl 542 preferably includes a circumferential recess 546 , which is adapted to engage circumferential protrusion 532 of housing element 500 . A forward facing surface 547 of sealing element 540 is adapted to engage a rearward facing surface of additional circumferential protrusion 534 when the syringe adaptor element 500 is assembled. Wall portion 544 preferably defines a rear spring seat for compression spring 536 . [0188] A tapered inner portion 548 of rear sealing element 540 , which has a smaller circumference than that of housing element 500 , is preferably therewithin at a rear portion thereof. Inner portion 548 is formed forward of and immediately adjacent to wall portion 544 and lies within compression spring 536 . A radially extending bore 549 is preferably formed in inner portion 548 and a hollow needle 550 is sealingly mounted therein. Inner portion 548 is preferably surrounded by a cylindrical portion 552 , which terminates at a rearward end thereof in wall portion 544 and which also has a circumference which is smaller than that of housing element 500 . [0189] Needle 550 preferably extends axially within compression spring 536 and through the center of housing element 500 and rearward septum 504 . A sharpened tip of needle 550 is preferably placed between forward septum 502 and rearward septum 504 , thus maintaining the needle inaccessible to a user and to the atmosphere. [0190] Two generally concave symmetric surfaces 554 forming a nearly complete cylinder, may extend rearwardly of wall portion 544 and preferably surround an inner rearward cylindrical portion 556 , which is adapted to engage the luer tip 44 of luer fitted syringe 40 , defining generally symmetric side-facing tabs 558 at rearward ends thereof. The rear portion of needle 550 preferably extends axially within inner cylindrical portion 556 . [0191] Referring specifically to FIG. 9C , which illustrates an alternative embodiment of the syringe adaptor element of FIG. 8 , it is seen that a needle protector 560 , preferably made of latex, at least partially covers needle 550 , thus protecting it from the surrounding atmosphere. [0192] Reference is now made to FIG. 10 , which is a simplified pictorial illustration of spike port adaptor element 60 which forms part of the drug mixing system of FIGS. 1A-1M and to FIGS. 11A and 11B which are sectional illustrations taken along section lines XI-XI in FIG. 10 . [0193] Spike port adaptor element 60 preferably comprises a hollow flexible plastic tube 602 having associated therewith a standard clamp 604 , which is commercially available from various manufacturers, such as Qosina of Italy. [0194] At a forward end thereof, tube 602 is fitted with a hollow spike element 606 which is preferably side-to-side symmetric and formed of plastic. Spike element 606 is preferably formed of a main body portion 607 which preferably defines at a forward end thereof a spike 608 , having formed therein apertures communicating with two axially extending bores 610 and 612 . Rearward of spike 608 , main body portion 607 defines a generally semi-circular planar protrusion 614 adapted to define the location at which a user grips the spike. [0195] Alternatively, as seen with particular clarity in FIG. 11B , main body portion 607 may have formed therein a single aperture, which communicates with a single axially extending bore 615 . [0196] The interior of tube 602 is in fluid flow communication with bore 612 . A bore 616 formed in a neck portion 618 which preferably extends transversely from main body portion 607 and communicates with bore 610 . Hollow neck portion 618 preferably terminates in a forward facing cylindrical portion 620 , which sealingly accommodates a generally circular septum 622 located on a seat 624 which communicates with bore 616 . [0197] A sealing assembly 630 is preferably attached to a rear end of tube 602 . Sealing assembly 630 preferably includes at a rearwardmost end thereof a selectably removable tapered sealing section 632 , forward of which there is formed a connecting tube portion 634 which is adapted to connect sealing section 632 to tube 602 . Sealing assembly 630 is adapted to seal tube 602 during use of the drug mixing device, and may be removed from tube 602 when receptacle 62 is connected directly to an infusion set spike for infusion of the fluid contained therein to a patient. [0198] It is appreciated that the spike connector of connection assembly 630 of spike port adaptor element 60 may optionally be replaced by a luer connector. [0199] Reference is now made to FIGS. 12A and 12B , which are simplified pictorial illustrations of needle port adaptor element 70 which forms part of the drug mixing system of FIGS. 1A-1M and to FIGS. 13A and 13B , which are sectional illustrations taken along respective section lines XIIIA-XIIIA and XIIIB-XIIIB in FIG. 12A . [0200] Needle port adaptor element 70 preferably comprises a main body element 700 arranged generally about an axis 701 . Main body element 700 is preferably integrally formed and preferably injection molded of plastic. [0201] Main body element 700 is preferably side-to-side symmetric about axis 701 , and preferably includes a rear portion 702 which is generally cylindrical, terminating in a forward wall portion 704 having a bore 706 extending therethrough. Each of side surfaces 708 of rear portion 702 preferably includes a ribbed engagement surface portion 710 . [0202] Four axially extending slots 712 extend along rear portion 702 , each slot 712 being arranged at generally right angles with respect to its neighboring slots. Defined between slots 712 at a rearward facing end of rear portion 702 are four outwardly tapering tabs 714 . Each tab 714 includes an inwardly facing generally triangular tooth 715 and terminates in a transversely extending section 716 . Rear portion 702 preferably surrounds a generally cylindrical portion 718 , which extends rearwardly from forward wall portion 704 . [0203] Forward of wall portion 704 there is formed a neck portion 720 , defining a radially extending bore 722 . A hollow needle 724 is adhesively mounted in bore 722 and extends rearwardly thereof along axis 701 . [0204] Forward of neck portion 720 there is formed a forward facing cylindrical portion 726 , which sealingly supports a generally circular septum 728 on a seat 730 which is located at a forward end of cylindrical portion 726 . A bore 732 preferably extends radially through forward facing cylindrical portion 726 . Bore 732 is preferably in fluid flow engagement with the interior of hollow needle 724 . [0205] A generally conical cover element 740 which is generally side-to-side and top-to-bottom symmetric about axis 701 preferably is axially slidable with respect to main body element 700 for selectably surrounding rear portion 702 of main body element 700 . [0206] A rear portion 742 of cover element 740 is preferably outwardly tapered, and terminates in a transversely extending edge surface 744 . Four outwardly facing radially extending protrusions 746 lie along an outer surface of cover element 740 , each protrusion 746 being arranged at generally right angles with respect to its neighboring protrusions. [0207] Four outwardly facing generally circumferential protrusions 748 are preferably formed on an outer surface 750 of cover element 740 between protrusions 746 thus defining a grip region. [0208] At a forward end thereof, an inner surface 751 of cover element 740 includes an inwardly tapered section 752 , which is adapted to slidably engage ribbed engagement surface portion 710 of rear portion 702 of main body element 700 . Four generally rectangular inwardly facing protrusions 754 extend from section 752 , each protrusion 754 being arranged at generally right angles with respect to its neighboring protrusions. Protrusions 754 are adapted to slidably engage slots 712 of rear portion 702 of main body element 700 . [0209] Reference is now made to FIG. 14 , which is a simplified pictorial illustration of syringe protection cover 80 which forms part of the drug mixing system of FIGS. 1A-1M and to FIG. 15 , which is a sectional illustration taken along section lines XV-XV in FIG. 14 . [0210] Syringe protection cover 80 is preferably integrally formed, and is generally side to side symmetric about an axis 800 . A generally circular locking element 802 is preferably formed at a bottom end of syringe protection cover 80 . [0211] Locking element 802 preferably includes a flat generally circular base surface 804 , preferably extending along a plane which is perpendicular to axis 800 . Surface 804 is integrally formed with a generally cylindrical portion 806 . Cylindrical portion 806 terminates in a generally circular radially outwardly extending wall portion 808 , which lies in a plane parallel to that defined by surface 804 . Wall portion 808 terminates in a generally cylindrical portion 810 , which generally surrounds cylindrical portion 806 . An elongate tab 812 extends from surface 804 along axis 800 . [0212] Reference is now made to FIG. 16 , which is a simplified pictorial illustration of infusion set adaptor element 90 which forms part of the drug mixing system of FIGS. 1A-1M and to FIG. 17 , which is a sectional illustration taken along section lines XVII-XVII in FIG. 16 . [0213] As seen in FIGS. 16 and 17 , infusion set adaptor element 90 is preferably integrally formed, and preferably is side-to-side symmetric along an axis 901 . [0214] Infusion set adaptor element 90 preferably includes a forward facing cylindrical portion 902 , which is adapted to surround a generally circular septum 904 which is sealingly mounted onto a seat 906 which is located at a forward end of cylindrical portion 902 . [0215] A generally cylindrical intermediate portion 908 is formed rearward of cylindrical portion 902 , having an outer circumference which is slightly smaller than that of cylindrical portion 902 . At a rear end thereof, intermediate portion 908 tapers toward a cylindrical neck portion 910 , which has an outer circumference which is smaller than that of intermediate portion 908 . [0216] An axially extending bore 912 extends through neck portion 910 , intermediate portion 908 and cylindrical portion 902 , thus allowing fluid flow through infusion set adaptor element 90 when the septum 904 is suitably pierced. [0217] The assembled structure of the drug mixing system at various stages of use thereof is described hereinbelow with reference to FIGS. 18A-30 . [0218] Reference is now made to FIGS. 18A and 18B which are, respectively, a simplified planar illustration and a simplified sectional illustration of. the drug mixing system of FIG. 1B during attachment of vial adaptor 30 , the sectional illustration being taken along lines XVIIIB-XVIIIB in FIG. 18A . [0219] As seen with particular clarity in FIG. 18B , vial puncturing spike 322 of vial adaptor assembly 30 punctures septum 31 located inside top portion 12 of vial 10 , thus enabling fluid flow between the main body of vial 10 and forward facing portion 348 of main body element 302 of vial adaptor assembly 30 . Preferably, puncturing of septum 31 releases any vacuum in vial 10 by entrance of air into vial 10 through carbon filter 340 ( FIGS. 4 and 6B ) and membrane 336 ( FIGS. 4 and 6B ). [0220] Engagement between vial adaptor assembly 30 and vial 10 is preferably maintained by snap engagement of protrusions 316 and 318 of rear portion 304 of main body element 302 with a neck portion 13 of vial 10 . The engagement of protrusions 316 and 318 with neck portion 13 ensures that vial adaptor assembly 30 is latched onto vial 10 and cannot be removed therefrom. Tabs 310 and outwardly tapered portions 320 generally surround top portion 12 and neck portion 13 of vial 10 . [0221] Reference is now made to FIGS. 19A and 19B and to FIGS. 19C and 19D which are, respectively, a top and a side view simplified planar illustration and a simplified sectional illustration of the drug mixing system of FIG. 1C during attachment of the syringe adaptor element 50 to syringe 40 , the sectional illustrations being taken along lines XIXB-XIXB in FIG. 19A and XIXD-XIXD in FIG. 19C . [0222] As seen in FIGS. 19A-19D , luer 44 of luer fitted hypodermic syringe 40 preferably engages inner rearward cylindrical portion 556 of sealing element 540 of syringe adaptor element 50 and tabs 558 formed thereon, such that needle 550 is in fluid flow engagement with the hollow body of syringe 40 . [0223] At this stage, the sharpened tip of needle 550 is preferably placed between septa 502 and 504 , and compression spring 536 is relaxed. Preferably, when syringe 40 is connected to syringe adaptor assembly 50 , plunger 42 of syringe 40 is pushed fully inward with respect to the syringe. [0224] Reference is now made to FIG. 20 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIG. 1D during attachment of spike port adaptor element 60 . [0225] As seen in FIG. 20 , spike 608 of spike element 606 of spike port adaptor element 60 is preferably inserted into a spike port 61 of receptacle 62 . At this stage, receptacle 62 and tube 602 are in fluid flow engagement. However, clamp 604 is closed and prevents fluid from flowing out of the receptacle through bore 612 into tube 602 . Additionally, bore 610 is in fluid flow communication with cylindrical portion 620 via bore 616 of neck portion 618 . [0226] Reference is now made to FIG. 21 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIG. 1D during attachment of needle port adaptor element 70 . [0227] As seen in FIG. 21 , needle 724 of needle port adaptor element 70 is preferably inserted into needle port 64 of receptacle 62 . Preferably, teeth 715 of tabs 714 engage port 64 when needle 724 is inserted. Additionally, after needle 724 is inserted, cover element 740 is preferably moved with respect to main body element 700 along ribbed engagement surface portion 710 ( FIG. 13B ). [0228] The axial displacement of cover element 740 preferably seals and locks the connection between main body element 700 and port 64 , by pressing on tabs 714 and pushing them inward. Displacement of cover element 740 includes a corresponding axial displacement of protrusions 754 with respect to slots 712 of rear portion 702 of main body element 700 .The axial displacement terminates when sections 716 of tabs 714 engage inner surface 751 of cover element 740 . [0229] At this stage, receptacle 62 is preferably in fluid flow engagement with bore 732 of cylindrical portion 726 via intermediate portion 720 and needle 724 . However, fluid does not flow out of cylindrical portion 726 , as the cylindrical portion is sealed by septum 728 . [0230] Reference is now made to FIG. 22 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 20 prior to the attachment of syringe 40 and syringe adaptor element 50 to spike port adaptor element 60 . [0231] As seen in FIG. 22 , syringe adaptor element 50 and syringe 40 joined thereto are placed in close proximity to cylindrical portion 620 of spike port adaptor element 60 . It is appreciated that at this stage compression spring 536 is relaxed and the sharpened tip of needle 550 is preferably placed between septa 502 and 504 . Preferably, surfaces 528 of teeth 527 of arms 526 engage forward facing surfaces on either side of intermediate portion 514 of housing element 500 . [0232] Throughout the engagement process, septum 622 of spike port adaptor element 60 and septum 502 of syringe adaptor element 50 are pushed into touching engagement by the biasing force of spring 536 , thus preventing exposure of the tip of needle 550 to the environment. [0233] Reference is now made to FIG. 23 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 20 following the attachment of syringe 40 and syringe adaptor element 50 to spike port adaptor element 60 . [0234] As seen in FIG. 23 syringe adaptor element 50 and syringe 40 joined thereto are pushed into engagement with cylindrical portion 620 of spike port adaptor element 60 . [0235] Preferably, surfaces 528 of teeth 527 of arms 526 snap into engagement with wall portion 618 , thus ensuring that the engagement between syringe adaptor element 50 and cylindrical portion 620 is secure. At this stage, spring 536 is in a compressed state, and housing element 500 is pushed rearwardly by the pressure from cylindrical portion 620 . [0236] The rearward motion of housing element 500 causes the sharpened tip of needle 550 to pierce septa 502 and 622 . As a result, needle 550 partially extends through the hollow space in cylindrical portion 620 , and is in fluid flow engagement with receptacle 62 via bore 610 of spike 608 of spiked element 606 and via bore 616 of neck portion 618 . Due to the fluid flow engagement between luer 44 of syringe 40 and needle 550 of syringe adaptor element 50 , the syringe 40 is now in fluid flow engagement with receptacle 62 . It is appreciated that when using the syringe adaptor element described in FIG. 9C , needle protector 560 at least partially collapses, thus exposing the needle 550 . [0237] In order to draw fluid from receptacle 62 into syringe 40 via spiked element 606 , bore 616 of neck portion 618 , cylindrical portion 620 and needle 550 , a user retracts plunger 42 . In order to disengage syringe adaptor element 50 and cylindrical portion 620 , a user pushes slightly on arms 526 extending from side surfaces 524 of housing element 522 , causing teeth 527 to move outward and release a rearward facing surface of cylindrical portion 620 , thus disconnecting the cylindrical portion. [0238] Throughout the disengagement process, septum 622 of spike port adaptor element 60 and septum 502 of syringe adaptor element 50 are pushed into touching engagement by the biasing force of spring 536 , thus preventing exposure of the tip of needle 550 to the environment. [0239] Reference is now made to FIG. 24 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 21 prior to the attachment of syringe 40 and syringe adaptor element 50 to needle port adaptor element 70 .As seen in FIG. 24 , syringe adaptor element 50 and syringe 40 joined thereto are placed in close proximity to cylindrical portion 726 of needle port adaptor element 70 . It is appreciated that at this stage compression spring 536 is relaxed and the sharpened tip of needle 550 is preferably located between septa 502 and 504 . Preferably, surfaces 528 of teeth 527 of arms 526 engage forward facing surfaces on either side of intermediate portion 514 of housing element 500 . [0240] Reference is now made to FIG. 25 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1E and 21 following the attachment of syringe 40 and syringe adaptor element 50 to needle port adaptor element 70 . As seen in FIG. 25 syringe adaptor element 50 and syringe 40 joined thereto are pushed into engagement with cylindrical portion 726 of needle port adaptor element 70 . [0241] Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage a rearward facing wall portion of cylindrical portion 726 , thus ensuring that the engagement between syringe adaptor element 50 and cylindrical portion 726 is secure. At this stage, spring 536 is in a compressed state, and housing element 500 is pushed rearwardly by the pressure from cylindrical portion 726 . [0242] The rearward motion of housing element 500 causes the sharpened tip of needle 550 to pierce septa 502 and 728 . As a result, needle 550 partially extends through bore 732 of cylindrical portion 726 , and is in fluid flow engagement with receptacle 62 via needle 724 of rear portion 702 , neck portion 720 of main body element 700 and bore 732 of cylindrical portion 726 . Due to the fluid flow engagement between luer 44 of syringe 40 and needle 550 of syringe adaptor element 50 , the syringe 40 is now in fluid flow engagement with receptacle 62 . It is appreciated that when using the syringe adaptor element described in FIG. 9C , needle protector 560 at least partially collapses, thus exposing the needle 550 . [0243] In order to draw fluid from receptacle 62 into syringe 40 via needle 724 , bore 732 and needle 550 , a user retracts plunger 42 . In order to disengage syringe adaptor element 50 and cylindrical portion 726 , a user pushes slightly on arms 526 extending from side surfaces 524 of housing element 522 , causing teeth 527 to move outward and release a rearward facing wall portion of cylindrical portion 726 , thus disconnecting cylindrical portion 726 . [0244] Throughout the engagement and disengagement process, septum 728 of needle port adaptor element 70 and septum 502 of syringe adaptor element 50 are pushed into touching engagement by the biasing force of spring 536 , thus preventing exposure of the tip of needle 550 to the environment. [0245] Reference is now made to FIG. 26 , which is a sectional illustration of the drug mixing system of FIG. 1G prior to drug dilution. [0246] As seen in FIG. 26 , syringe adaptor element 50 and syringe 40 joined thereto are placed in close proximity to forward facing portion 348 of vial adaptor element 30 . [0247] It is appreciated that at this stage compression spring 536 is relaxed and the sharpened tip of needle 550 is preferably located between septa 502 and 504 . Preferably, surfaces 528 of teeth 527 of arms 526 engage forward facing surfaces on either side of intermediate portion 514 of housing element 500 . [0248] At this stage, syringe 40 is preferably filled with a fluid drawn from receptacle 62 ( FIGS. 22-25 ) and therefore plunger 42 is at least partially retracted. [0249] Reference is now made to FIG. 27 , which is a sectional illustration of the drug mixing system of FIG. 1H following drug dilution. [0250] As seen in FIG. 27 syringe adaptor element 50 and syringe 40 joined thereto are pushed into engagement with forward facing portion 348 of vial adaptor element 30 . [0251] Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage wall portion 346 of forward facing portion 348 , thus ensuring that the engagement between syringe adaptor element 50 and portion 348 is secure. At this stage, spring 536 is in a compressed state, and housing element 500 is pushed rearwardly by the pressure from forward facing portion 348 . [0252] The rearward motion of housing element 500 causes the sharpened tip of needle 550 to pierce septa 502 and 350 . As a result, needle 550 partially extends through a hollow section of portion 348 , and is in fluid flow engagement with vial 10 via bore 350 of neck portion 344 and vial puncturing spike 322 of main body element 302 . Due to the fluid flow engagement between luer 44 of syringe 40 and needle 550 of syringe adaptor element 50 , the syringe 40 is now in fluid flow engagement with vial 10 . It is appreciated that when using the syringe adaptor element described in FIG. 9C , needle protector 560 at least partially collapses, thus exposing the needle 550 . [0253] At this stage, a user injects the fluid contained in syringe 40 into vial 10 via bore 350 of neck portion 344 and vial puncturing spike 322 by inwardly pushing plunger 42 of syringe 40 . A corresponding volume of air escapes from vial 10 via membrane 336 and optional carbon cloth filter 340 . It is appreciated that any drug containing aerosol is blocked by the membrane and any non-aerosolized drug vapor is adsorbed by the charcoal filter, thus protecting users and the environment from contamination. [0254] Preferably, the user ensures that the drug contained in vial 10 is fully dissolved, and then draws at least part of the drug solution contained in vial 10 into syringe 40 by turning the system upside down and retracting plunger 42 (not shown). At this stage, a corresponding volume of sterile air enters vial 10 via membrane 336 and optional carbon cloth filter 340 . [0255] In order to disengage syringe adaptor element 50 and forward facing portion 348 , a user pushes slightly on arms 526 extending from side surfaces 524 of housing element 522 , causing teeth 527 to move outward and release a wall portion 346 of forward facing portion 348 , thus disconnecting the forward facing portion. [0256] Throughout the engagement and disengagement process, septum 350 of vial adaptor element 30 and septum 502 of syringe adaptor element 50 are pushed into touching engagement by the biasing force of spring 536 , thus preventing exposure of the tip of needle 550 to the environment. [0257] Reference is now made to FIG. 28 , which is a sectional illustration of the drug mixing system of FIGS. 1K and 1L in a protected, ready for delivery state, when syringe adaptor element 50 is covered by syringe protection cover 80 . [0258] As seen in FIG. 28 , syringe adaptor element 50 is preferably covered at a forward end thereof by syringe protection cover 80 . At this stage, plunger 42 is preferably at least partially retracted with respect to syringe 40 , and the syringe contains a drug solution withdrawn from vial 10 ( FIG. 27 ). [0259] The forwardmost circumference of main body portion 523 is preferably seated in the recess formed by wall portions 806 and 810 of syringe protection cover 80 and surface 804 of syringe cover element 80 preferably engages a forward surface of septum 502 . [0260] It is appreciated that at this stage compression spring 536 is relaxed and the sharpened tip of needle 550 is preferably located between septa 502 and 504 . Preferably, surfaces 528 of teeth 527 of arms 526 engage forward facing surfaces on either side of intermediate portion 514 of housing element 500 . [0261] Reference is now made to FIG. 29 , which is a partially pictorial, partially sectional illustration of the drug mixing system of FIGS. 1M and 28 when ready for injection. [0262] As seen in FIG. 29 , syringe protection cover 80 has been removed from syringe adaptor element 50 , and syringe adaptor element 50 and syringe 40 joined thereto are pushed into engagement with cylindrical portion 902 of infusion set adaptor element 90 , while the infusion set adaptor element 90 is connected to a side port of an intravenous cannula located at an injection site. [0263] Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage a rearward facing wall portion of cylindrical portion 902 , thus ensuring that the engagement between syringe adaptor element 50 and cylindrical portion 902 is secure. At this stage, spring 536 is in a compressed state, and housing element 500 is pushed rearwardly by the pressure from cylindrical portion 902 . [0264] The rearward motion of housing element 500 causes the sharpened tip of needle 550 to pierce septa 502 and 904 . As a result, needle 550 partially extends through bore 912 of infusion set adaptor element 90 , and is therefore in fluid flow engagement with the injection site. Due to the fluid flow engagement between luer 44 of syringe 40 and needle 550 of syringe adaptor element 50 , the syringe 40 is now in fluid flow engagement with the injection site. It is appreciated that when using the syringe adaptor element described in FIG. 9C , needle protector 560 at least partially collapses, thus exposing the needle 550 . [0265] In order to disengage syringe adaptor element 50 and cylindrical portion 902 , a user pushes slightly on arms 526 extending from side surfaces 524 of housing element 522 , causing teeth 527 to move outward and release a the rearward facing wall portion of cylindrical portion 902 , thus disconnecting the cylindrical portion. [0266] Reference is now made to FIG. 30 , which is a partially pictorial partially sectional illustration of the drug mixing system of FIGS. 1M and 20 when ready for injection. [0267] Preferably, receptacle 62 is connected via spike port adaptor element 60 to an infusion set 92 . The infusion set then connects to a standard intravenous cannula 94 such as a Venolit model commercially available from Teva Medical Ltd. of Ashdod, Israel which is located in an infusion site. Typically, prior to connection of spike port adaptor element 60 to infusion set 92 , sealing element 630 is removed, and infusion set 92 is connected directly to tube 602 . [0268] Alternatively, infusion set 92 may be connected to a new receptacle, not containing a drug, in which case the drug solution is injected directly into the infusion set. If this option is selected, syringe adaptor 50 having syringe 40 ( FIG. 28 ) joined thereto is connected to port 93 after syringe protector cover 80 is removed, and the drug solution contained therein is injected into the infusion line. [0269] Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage a rearward facing wall portion of port 93 , thus ensuring that the engagement between syringe adaptor element 50 and port 93 is secure. At this stage, spring 536 is in a compressed state, and housing element 500 is pushed rearwardly by the pressure from port 93 . [0270] The rearward motion of housing element 500 causes the sharpened tip of needle 550 to pierce septum 502 and a sealing septum of port 93 . As a result, needle 550 partially extends into infusion set 92 , and is therefore in fluid flow engagement with the injection site. Due to the fluid flow engagement between luer 44 of syringe 40 and needle 550 of syringe adaptor element 50 , the syringe 40 is now in fluid flow engagement with the injection site. [0271] In order to disengage syringe adaptor element 50 and port 93 , a user pushes slightly on arms 526 extending from side surfaces 524 of housing element 522 , causing teeth 527 to move outward and release a rearward facing wall portion of port 93 , thus disconnecting the port. [0272] Reference is now made to FIGS. 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H, 31I, 31J and 31L which are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with another preferred embodiment of the present invention. [0273] FIG. 31A shows a spike port adaptor element 1030 , as described hereinbelow with reference to FIGS. 34-35 , being inserted into a spike port 1031 in a receptacle 1032 containing a fluid. Preferably, a luer connector of spike port adaptor element 1030 is sealed by a luer cover element 1034 . [0274] Typically, receptacle 1032 comprises a bag, and the fluid contained therein is sterile salt solution, water, or any other suitable sterile solution or pure fluid. [0275] As shown in FIG. 31B , a luer-equipped hypodermic syringe 1040 , having a plunger 1042 and a luer tip 1044 , is connected to a syringe port of an adaptor assembly 1050 , which is described hereinbelow with reference to FIGS. 36 and 44-45B . Preferably, the syringe port is defined by a stopcock 1052 which is described hereinbelow with reference to FIGS. 37-38B and includes a removable protection cap 1054 . FIG. 46 shows a sectional view of the drug mixing system at this stage. [0276] Typically, plunger 1042 of syringe 1040 is pushed fully inward before the syringe is connected to the syringe port of stopcock 1052 . [0277] FIG. 31C shows spike port adaptor element 1030 and receptacle 1032 joined thereto being connected to a receptacle adaptor subassembly 1056 of adaptor assembly 1050 . Subassembly 1056 is described hereinbelow with reference to FIGS. 39-40B . Preferably, stopcock 1052 is in an operative orientation which enables fluid flow between receptacle adaptor subassembly 1056 and syringe 1040 . FIG. 47 shows a sectional view of the drug mixing system at this stage. [0278] As seen in FIG. 31D , a vial 1060 , including a top portion 1062 and a neck portion 1063 , is pushed into engagement with a vial adaptor subassembly 1058 of adaptor assembly 1050 . Top portion 1062 of vial 1060 preferably has a septum 1064 sealingly seated therein. Subassembly 1058 is described hereinbelow with reference to FIGS. 41-42B . [0279] Alternatively, if a small vial 1066 is used, small vial 1066 is pushed into engagement with a vial head adaptor element 1068 , which is described hereinbelow with reference to FIGS. 32-33 , as shown in FIG. 31E , and is then pushed into engagement with vial adaptor subassembly 1058 . Vials 1060 and 1066 typically contain a drug in soluble powder form, in a solution or in other suitable four. FIG. 48 shows a sectional view of the drug mixing system at this stage. [0280] It is appreciated that stopcock 1052 , receptacle adaptor subassembly 1056 and vial adaptor subassembly 1058 are preferably enclosed in a housing element 1070 of adaptor assembly 1050 , which is described hereinbelow with reference to FIGS. 43A-43B . [0281] It will be appreciated by persons skilled in the art that the assembly steps shown in FIGS. 31C-31E may be performed in any suitable sequence. [0282] As seen in FIG. 31F , a user retracts plunger 1042 while receptacle 1032 is upright and vial 1060 lies therebelow, thus at least partially filling syringe 1040 with fluid drawn from receptacle 1032 . The operative orientation of stopcock 1052 enables this fluid flow from receptacle 1032 to syringe 1040 via spike port adaptor element 1030 , receptacle adaptor subassembly 1056 and stopcock 1052 in a manner that ensures that the fluid remains sterile, and that the user is not exposed thereto. FIG. 49 shows a sectional view of the drug mixing system at this stage. [0283] The user then rotates a handle 1080 of stopcock 1052 to enable fluid flow between syringe 1040 and vial adaptor subassembly 1058 , having joined thereto vial 1060 , as shown in FIG. 31G . [0284] When the syringe 1040 and vial 1060 are in fluid flow engagement, the user pushes plunger 1042 inward, thus injecting the fluid contained in syringe 1040 into vial 1060 and dissolving the drug contained therein. FIG. 50 shows a sectional view of the drug mixing system at this stage. [0285] As seen in FIG. 31H , the user then shakes the drug mixing system of FIG. 31G to ensure that the drug in vial 1060 is fully dissolved and that the resulting solution is homogenous. [0286] As seen in FIG. 31I , the user turns the system upside down, so that the vial 1060 faces upward, and then retracts plunger 1042 , thus drawing at least part of the solution from vial 1060 into syringe 1040 . FIG. 51 shows a sectional view of the drug mixing system at this stage. [0287] It will be appreciated by those skilled in the art that at this stage the drug mixing system of the present invention is preferably held such that vial 1060 lies above syringe 1040 , to allow smooth flow of the fluid from vial 1060 to syringe 1040 via vial adaptor subassembly 1058 and stopcock 1052 . [0288] As shown in FIG. 31J , handle 1080 of stopcock 1052 is oriented to enable flow of fluid between syringe 1040 and receptacle 1032 . The user then pushes plunger 1042 of syringe 1040 inward, thus injecting the drug solution into receptacle 1032 and further diluting it prior to infusion into a patient. FIG. 52 shows a sectional view of the drug mixing system at this stage. [0289] Subsequently, spike port adaptor element 1030 , having receptacle 1032 joined thereto, is disconnected from adaptor assembly 1050 , which remains connected to vial 1060 as shown in FIG. 31K . [0290] As seen in FIG. 31L , if some of the drug solution is left in vial 1060 , vial 1060 and adaptor assembly 1050 joined thereto may be stored in a suitable facility for further use. It is appreciated that at this stage syringe 1040 remains connected to the syringe port of stopcock 1052 of adaptor assembly 1050 . FIG. 53 is a sectional view of the drug mixing system at this stage. [0291] The structure of elements of the drug mixing system of FIGS. 31A-31L is described hereinbelow with reference to FIGS. 32-43B . [0292] Reference is now made to FIG. 32 , which is a simplified pictorial illustration of a vial head adaptor element 1068 which forms part of the drug mixing system of FIGS. 31A-31L and to FIG. 33 which is a sectional illustration taken along section lines XXXIII-XXXIII in FIG. 32 . [0293] As seen in FIG. 32 , vial head adaptor element 1068 is preferably a side-to-side symmetric integrally formed element which is preferably injection molded of plastic. [0294] Vial head adaptor element 1068 preferably includes a main body portion 1200 which is generally cylindrical and has a central axis 1201 . An inner cylindrical surface 1202 of main body portion 1200 preferably has four arms 1204 extending therefrom, each arm 1204 being arranged at generally right angles with respect to its neighboring arms. [0295] Each of arms 1204 terminates at an upper end thereof, in the sense of FIG. 31A , in an inwardly facing generally triangular tooth 1206 having a upwardly facing inclined surface 1208 and a bottom-facing engagement surface 1210 extending generally perpendicular to arm 1204 . [0296] At the bottom of vial head adaptor element 1068 , there are formed four inwardly protruding surfaces 1212 , extending generally perpendicular to inner surface 1202 of main body portion 1200 . Each of neighboring surfaces 1212 is preferably arranged at a generally right angle with respect to its neighboring surfaces 1212 . Surfaces 1212 and arms 1204 are rotationally offset from one another about axis 1201 . [0297] Reference is now made to FIG. 34 , which is a simplified pictorial illustration of spike port adaptor element 1030 which forms part of the drug mixing system of FIGS. 31A-31L and to FIG. 35 which is a sectional illustration taken along section lines XXXV-XXXV in FIG. 34 . [0298] Spike port adaptor element 1030 preferably comprises a hollow flexible plastic tube 1302 having associated therewith a standard clamp 1304 , which is commercially available from various manufacturers such as Quosina of Italy. At a forward end thereof, tube 1302 is connected to a tube port 1305 of a hollow spike element 1306 which is preferably formed of plastic. Spike element 1306 preferably includes a main body portion 1307 which defines at a forward end thereof a spike 1308 which includes an aperture communicating with an axially extending bore 1310 and an additional bore 1312 which extends partially through main body portion 1307 and communicates with a top portion of bore 1310 , thus facilitating complete priming before drug injection. [0299] Rearward of spike 1308 , main body portion 1307 defines a generally circular planar protrusion 1314 adapted to define the location at which a user grips the spike. [0300] The interior of tube 1302 is in fluid flow communication with bore 1312 via tube port 1305 . Bore 1310 preferably terminates in an aperture located in spike 1308 of main body portion 1307 , and fully extends through the body portion 1307 . [0301] Main body portion 1307 preferably terminates in a connection port 1318 which is adapted to connect spike port adaptor element 1030 to receptacle adaptor subassembly 1056 . Connection port 1318 preferably sealingly accommodates a generally circular septum 1320 on a seat 1322 . Septum 1320 preferably engages the rear end of bore 1310 , thus sealing the rear end of the bore. [0302] Forward of connection port 1318 , there is formed on main body portion 1307 a circumferential protrusion 1324 , forward of which is formed an additional circumferential protrusion 1326 , having an outer circumference which is slightly larger than that of protrusion 1324 . Protrusions 1324 and 1326 are adapted to limit the movement of spike port adaptor element 1030 when it is connected to receptacle adaptor subassembly 1056 . [0303] A luer connector 1330 is preferably attached to a rear end of tube 1302 . Luer connector 1330 preferably includes at a rearwardmost end thereof a narrow hollow port section 1332 , forward of which there is formed a connecting tube portion 1334 and a hollow neck portion 1336 which connects port section 1330 to tube 1302 . Preferably, luer connector 1330 is sealed by luer cover element 1034 . [0304] It is appreciated that spike port adaptor element 1030 may alternatively be identical to spike port adaptor element 630 described hereinabove with reference to FIGS. 10-11B . [0305] Reference is now made to FIG. 36 , which is a simplified exploded view illustration of adaptor assembly 1050 which forms part of the drug mixing system of FIGS. 31A-31L . [0306] As seen with particular clarity in FIG. 36 , adaptor assembly 1050 includes vial adaptor subassembly 1058 , onto which is placed a hydrophobic membrane 1402 , above which is optionally seated a carbon cloth filter 1404 . Vial adaptor subassembly 1058 is connected at a forward portion thereof to a vial port 1082 of stopcock 1052 , which additionally includes a syringe port 1084 adapted for engagement with luer 1044 of syringe 1040 . Stopcock 1052 additionally includes a receptacle port 1086 which is adapted for connection to a rear connection element 1406 of receptacle adaptor subassembly 1056 . [0307] Preferably, when syringe 1040 is not connected to the syringe port of stopcock 1052 , the syringe port 1084 is sealed by protection cap 1054 . [0308] A needle holding element 1408 is preferably seated within rear connection element 1406 and supports a needle 1410 . A forward portion of needle 1410 is preferably protected by a flexible latex needle protection element 1412 . Receptacle adaptor subassembly 1056 connects at a rearward end thereof to rear connection element 1406 , enclosing needle holding element 1408 , needle 1410 and needle protection element 1412 . [0309] The forward portion of vial adaptor subassembly 1058 as well as stopcock 1052 and the rear portion of receptacle adaptor subassembly 1056 are located within housing element 1070 . However, a handle 1080 of stopcock 1052 protrudes from housing element 1070 , thus enabling a user to change the operative orientation of the stopcock 1052 and thereby switch the fluid flow pathway. [0310] Reference is now made to FIG. 37 , which is a simplified pictorial illustration of stopcock 1052 which forms part of the adaptor assembly of FIG. 36 and to FIGS. 38A and 38B , which are sectional illustrations taken along respective section lines XXXVIIIA-XXXVIIIA and XXXVIIIB-XXXVIIIB in FIG. 37 . [0311] Stopcock 1052 , as noted hereinabove, has a vial port 1082 , a syringe port 1084 and a receptacle port 1086 , all of which are defined in a housing portion 1090 . User operable handle 1080 is fixed to a pathway defining element 1092 , which defines a three-way direction pathway, as seen with particularity in FIG. 38B . Selectable rotational orientation of handle 1080 enables any two of ports 1082 , 1084 and 1086 to be placed in mutual fluid communication. Stopcock 1052 is commercially available from Eleam Ltd. of Baram, Israel. [0312] Reference is now made to FIG. 39 , which is a simplified pictorial illustration of receptacle adaptor subassembly 1056 which forms part of the adaptor assembly of FIG. 36 and to FIGS. 40A and 40B , which are sectional illustrations taken along respective section lines XLA-XLA and XLB-XLB in FIG. 39 . [0313] As seen in FIGS. 39-40B , receptacle adaptor subassembly 1056 includes a main body element 1600 which is arranged generally about an axis 1601 . Main body element 1600 is preferably integrally formed of plastic, and is preferably side-to-side symmetric about axis 1601 . Main body element 1600 preferably includes a generally cylindrical base portion 1602 terminating in a rear portion 1604 . [0314] Top and bottom generally concave wall portions 1606 are formed at a forward end of base portion 1602 , each wall portion 1606 defining on an outer surface thereof an outwardly facing axially extending rib 1608 , which extends from a forwardmost end of each of wall portions 1606 and along base portion 1602 . [0315] A connection surface 1610 extending transversely from side surfaces 1612 of base portion 1602 connects an outwardly extending arm 1614 to each side surface 1612 . Each arm 1614 preferably has a generally square rear portion 1616 , formed rearwardly of connection surface 1610 , and has a radially extending outwardly facing protrusion 1618 formed thereon. Protrusion 1618 preferably extends onto an outer surface of a generally rectangular forward portion 1620 of each of arms 1614 , which extends forwardly of connection surface 1610 . [0316] An inwardly facing generally triangular tooth 1622 is formed adjacent a top end of each of forward portions 1620 . Each tooth 1622 preferably includes a forwardly facing inclined surface 1624 and a rearwardly facing engagement surface 1626 . [0317] Rear portion 1604 preferably includes a transversely extending generally circular portion 1630 which forms a base for ribs 1608 and which terminates at a rear end thereof in an axially extending generally cylindrical wall portion 1632 . [0318] Wall portion 1632 preferably defines on a top and bottom surface thereof a small generally rectangular window 1634 , and two forwardly facing slots 1636 which are formed on either side of window 1634 . Two generally symmetric side-facing tabs 1638 are formed on side surfaces 1640 of wall portion 1632 , each tab 1638 being formed forwardly of a generally rectangular forwardly facing slot 1642 . [0319] Rear connection element 1406 preferably includes a forward disk 1652 defining a central bore 1654 . Disk 1652 preferably functions as a terminating wall for a forward facing cylindrical portion 1656 . Rearward of disk 1652 there is preferably formed a rear portion 1658 , having a narrow bore 1660 extend therethrough. Bore 1660 preferably widens toward the rear end of rear portion 1658 , thus enabling rear portion 1658 to connect to an appropriate port. Preferably, two generally symmetric tabs 1662 are formed on top and bottom surfaces of rear portion 1658 . Cylindrical portion 1656 preferably has an outer circumference that is slightly smaller than that of wall portion 1632 , and is located therein. [0320] Needle holding element 1408 preferably supports needle 1410 on a generally circular disk portion 1672 . Needle 1410 extends axially through base portion 1602 of main body element 1600 and through bore 1660 of rear connection element 1650 . Disk portion 1672 is preferably seated in cylindrical portion 1656 , and is locked into cylindrical portion 1656 by portion 1630 . [0321] Reference is now made to FIG. 41 , which is a simplified pictorial illustration of vial adaptor subassembly 1058 which forms part of adaptor assembly 1050 of FIG. 36 and to FIGS. 42A and 42B , which are sectional illustrations taken along respective section lines XLIIA-XLIIA and XLIIB XLIIB in FIG. 41 . [0322] As seen in FIGS. 41-42B , vial adaptor subassembly 1058 comprises a main body element 1702 arranged generally about an axis 1703 . Main body element 1702 is preferably integrally formed and preferably injection molded of plastic. [0323] Main body element 1702 is preferably side-to-side symmetric about axis 1703 , and preferably includes a rear portion 1704 , which is generally cylindrical and terminates in a forward wall 1706 . Rear portion 1704 comprises a forward base section 1708 , preferably having four transversely extending outwardly facing protrusions 1709 extend therefrom, each protrusion being arranged at generally right angles with respect to its neighboring protrusions. [0324] Rearward of base section 1708 there are formed four tabs 1710 each having a rectangular window 1712 . Rearward of rectangular windows 1712 and on an inner surface 1714 of each of tabs 1710 there are preferably formed two radially extending inwardly facing protrusions 1716 each having an inclined surface. Protrusions 1716 preferably terminate at a forward end thereof in an inwardly facing transversely extending protrusion 1718 . Rearward of protrusions 1716 , each of tabs 1710 preferably includes an outwardly tapered portion 1720 . [0325] A hollow vial puncturing spike 1722 extends rearwardly from a rearward surface 1724 of forward wall 1706 , and is surrounded by base section 1708 and by tabs 1710 . Rearward surface 1724 additionally includes a circular cylindrical protrusion 1725 , surrounding puncturing spike 1722 . Two axially extending bores 1726 and 1727 extend through vial puncturing spike 1722 . [0326] Forward of forward wall 1706 of rear portion 1704 there is formed an intermediate portion which is formed of two generally rectangular surfaces 1728 , and which includes an axial tubular portion 1730 having a bore 1731 extend therethrough, bore 1731 being in fluid flow engagement with bore 1726 of hollow vial puncturing spike 1722 . [0327] On the top rectangular surface 1728 and slightly recessed with respect thereto there is formed a plastic membrane support surface 1732 , having formed thereon a plurality of generally evenly distributed spherical protrusions 1734 , which are adapted to support hydrophobic membrane 1402 and prevent it from excessive inflation and from cracking. Membrane 1402 is adapted to allow free passage of air to and from main body element 1702 , but to prevent passage of liquid and air borne particles, microorganisms and aerosol. A preferred membrane 1402 is Model Versapor R 0.2 Micron which is commercially available from Pall Corporation of New York, U.S.A. Membrane 1402 is in fluid flow engagement with vial puncturing spike via bore 1727 and via a recess 1737 formed in top rectangular surface 1728 . [0328] A rim 1738 surrounding support surface 1732 is adapted to support a carbon cloth filter 1404 and maintain it in a raised position above and spaced from membrane 1402 . Carbon filter 1404 is adapted to prevent toxic vapors from escaping from main body element 1702 , thus protecting users. A preferred carbon cloth filter 1404 is Model No. Zorflex EMI which is commercially available from Charcoal Cloth International Ltd. of Houghton-le-Spring, England. [0329] Rectangular surfaces 1728 of the intermediate portion terminate at a forward end thereof in a forward facing cylindrical portion 1748 , having a bore 1750 extend therethrough. Preferably, bore 1750 is a continuation of tubular portion 1730 of the intermediate portion. [0330] It is appreciated that the functionalities of membrane 1402 and carbon cloth filter 1404 , to allow free passage of air into the drug mixing system while preventing passage thereinto of liquid and air-borne particles, microorganisms and aerosol and preventing toxic vapors from escaping from the drug mixing system, may be incorporated, using similar elements, into spike port adaptor element 1030 or receptacle adaptor subassembly 1056 . [0331] Reference is now made to FIGS. 43A and 43B , which are simplified pictorial illustrations of the housing element 1070 which forms part of the adaptor assembly 1050 of FIG. 36 in closed and open orientations, respectively. [0332] As seen in FIGS. 43A and 43B , housing element 1070 is preferably integrally formed about an axis 1800 and includes a top housing portion 1801 and a bottom housing portion 1802 . Preferably, housing portions 1801 and 1802 are side-to-side symmetric about axis 1800 . Preferably, each of housing portions 1801 and 1802 includes a semi-cylindrical forward portion 1804 and a semi-cylindrical rearward portion 1806 . [0333] Top housing portion 1801 includes an inwardly recessed portion 1808 including a generally round aperture 1810 which extends forwardly into an elongate aperture 1812 . Rearward of aperture 1810 there is preferably formed an elongate protrusion 1814 . Preferably, apertures 1810 and 1812 lie below handle 1080 of stopcock 1052 when adaptor assembly 1050 is assembled. [0334] Bottom housing portion 1802 includes an inwardly recessed portion 1816 which is generally symmetrical to recessed portion 1808 of top housing portion 1801 , and which includes a central generally round aperture 1818 . Two elongate protrusions 1820 are formed on either side of aperture 1818 , such that rearward protrusion 1820 is generally symmetrical to protrusion 1814 of top housing portion 1801 . Preferably, a bottom portion of pathway defining element 1090 of stopcock 1052 extends through aperture 1818 when adaptor assembly 1050 is assembled. [0335] Top housing portion 1801 includes at forward and rearward ends thereof outwardly extending fingers 1822 terminating in a generally triangular teeth 1824 which include inclined outwardly facing surfaces 1826 and engagement surfaces 1828 . Bottom housing portion 1802 preferably includes at forward and rearward ends thereof two generally rectangular windows 1830 which are placed generally below fingers 1822 and are adapted to engage engagement surfaces 1828 of fingers 1822 when housing element 1070 is assembled. [0336] An inner surface 1834 of housing element 1070 preferably includes at a rearward end thereof a circumferential recess 1836 which is adapted to engage protrusions 1709 of rear portion 1704 of vial adaptor subassembly 1058 . An outer surface of housing element 1070 which lies above recess 1836 preferably includes an outwardly facing protrusion 1840 which protrudes out of cylindrical forward portion 1804 . [0337] Preferably, side surfaces of top housing portion 1801 and bottom housing portion 1802 include generally parallel generally rectangular slots 1842 , through which syringe port 1084 of stopcock 1052 extends when adaptor assembly 1050 is assembled. [0338] Reference is now made to FIG. 44 , which is a simplified assembled pictorial illustration of the adaptor assembly of FIG. 36 and to FIGS. 45A and 45B , which are sectional illustrations taken along respective section lines XLVA-XLVA and XLVB XLVB in FIG. 44 . [0339] As seen in FIGS. 44-45B , rear portion 1704 of vial adaptor subassembly 1058 extends from a rear portion of housing element 1070 . Vial puncturing spike 1722 preferably extends out of housing element 1070 , and is accessible for connection of vial 1060 or of vial 1066 ( FIG. 31E ) thereto. [0340] Preferably, circumferential recess 1836 of inner surface 1834 of housing element 1070 engages protrusions 1709 of rear portion 1704 of vial adaptor subassembly 1058 . Preferably, forward facing cylindrical portion 1748 engages vial port 1082 of stopcock 1052 . [0341] A forward portion of main body element 1600 of receptacle adaptor subassembly 1056 preferably extends from a forward portion of housing element 1070 of adaptor assembly 1050 , and surrounds needle 1410 enclosed in needle protection element 1412 . Main body element including needle 1410 and needle protection cover 1412 is preferably accessible for connection of spike port adaptor element 1030 ( FIGS. 34-35 ) thereto. [0342] Preferably, rear portion 1658 of rear connection element 1406 engages receptacle port 1086 of stopcock 1052 . A rear end of needle 1410 at least partially extends through bore 1660 such that needle 1410 is in fluid flow communication with receptacle port 1086 . [0343] Syringe port 1084 of stopcock 1052 preferably extends from housing element 1070 through slots 1842 formed in side surfaces thereof. Preferably, pathway defining element 1092 extends from apertures 1810 and 1812 of top housing portion 1801 , and a bottom portion of stopcock 1052 extends through aperture 1818 of bottom housing element. [0344] Housing element 1070 is preferably assembled such that top housing portion 1801 and bottom housing portion 1802 are connected by engagement of engagement surfaces 1828 of teeth 1824 of top housing portion 1801 and windows 1830 of bottom housing portion 1802 . [0345] Reference is now made to FIG. 46 , which is a sectional illustration of the drug mixing system of FIG. 31B during attachment of syringe 1040 to the adaptor assembly 1050 of FIGS. 44-45B . [0346] As seen in FIG. 46 , luer tip 1044 of syringe 1040 is attached to syringe port 1084 of stopcock 1052 . At this stage, handle 1080 of stopcock 1052 is positioned such that fluid can flow from receptacle port 1086 to syringe 1040 thereof. It is appreciated that at this stage plunger 1042 of syringe 1040 is preferably pushed fully inward in the syringe. [0347] Reference is now made to FIG. 47 , which is a sectional illustration of the drug mixing system of FIG. 31C during attachment of spike port adaptor element 1030 and receptacle 1032 of FIG. 31A to the receptacle adaptor subassembly 1056 of the adaptor assembly 1050 of FIG. 46 . [0348] As seen in FIG. 47 , spike port adaptor element 1030 , having receptacle 1032 joined thereto, is connected to receptacle adaptor subassembly 1056 of adaptor assembly 1050 . [0349] Spike 1308 is preferably previously inserted into spike port 1031 of receptacle 1032 , such that bore 1310 of spike element 1306 engages fluid content of receptacle 1032 . Connection port 1318 of spike port adaptor element 1030 engages wall portions 1606 and base portion 1602 of main body element 1600 of receptacle adaptor subassembly 1056 . [0350] Connection port 1318 is preferably locked into connection with receptacle adaptor subassembly 1056 by engagement of engagement surfaces 1626 of forward portions 1620 of arms 1614 ( FIG. 40B ) and a rearward facing wall portion of connection port 1318 . [0351] Preferably, needle 1410 punctures needle protection cover 1412 and septum 1320 , resulting in a change to the structure of the needle protection cover. At this stage, receptacle 1032 is in fluid flow communication with syringe 1040 via bore 1310 of spike 1308 of spike port adaptor element 1030 , needle 1410 , bore 1660 and receptacle port and syringe port 1084 of stopcock 1052 . [0352] Reference is now made to FIG. 48 , which is a sectional illustration of the drug mixing system of FIG. 31 D during attachment of vial 1060 to vial adaptor subassembly 1058 of the adaptor assembly 1050 of FIG. 47 . [0353] Vial 1066 and vial head adaptor element 1068 joined thereto ( FIG. 31E ) or vial 1060 is preferably pushed into engagement with vial puncturing spike 1722 of vial adaptor subassembly 1058 . [0354] Typically, vial puncturing spike 1722 of vial adaptor subassembly 1058 punctures septum 1064 located inside top portion 1062 of vial 1060 , thus enabling fluid flow between the main body of vial 1060 and cylindrical portion 1748 of main body element 1702 of vial adaptor subassembly 1058 . Preferably, puncturing of septum 1064 releases any vacuum in vial 1060 by entrance of air into vial 1060 through carbon filter 1404 ( FIG. 42B ) and membrane 1402 ( FIG. 42B ). [0355] Engagement between vial adaptor subassembly 1058 and vial 1060 is preferably maintained by snap engagement of protrusions 1716 and 1718 ( FIGS. 42A and 42B ) of rear portion 1704 of main body element 1702 with a neck portion 1063 of vial 1060 . The engagement of protrusions 1716 and 1718 with neck portion 1063 ensures that vial adaptor subassembly 1058 is latched onto vial 1060 and cannot be removed therefrom. Tabs 1710 and outwardly tapered portions 1720 generally surround top portion 1062 and neck portion 1063 of vial 1060 . [0356] At this stage, the main body of vial 1060 is in fluid flow communication with syringe port 1084 via vial puncturing spike 1722 , bore 1750 of cylindrical portion 1748 and vial port 1082 of stopcock 1052 . [0357] Reference is now made to FIG. 49 , which is a sectional illustration of the drug mixing system of FIGS. 31F and 48 during fluid drawing from receptacle 1032 into syringe 1040 . [0358] At this stage, plunger 1042 of syringe 1040 is preferably retracted, thus drawing fluid from receptacle 1032 into syringe 1040 . Fluid drawn from receptacle 1032 reaches syringe 1040 via bore 1310 of spike 1308 of spike port adaptor element 1030 , needle 1410 , bore 1660 of receptacle adaptor subassembly 1056 , receptacle port 1086 , pathway defining element 1092 , syringe port 1084 and luer tip 1044 . [0359] Reference is now made to FIG. 50 , which is a sectional illustration of the drug mixing system of FIGS. 31G and 48 during injection of fluid from syringe 1040 into vial 1060 . [0360] Initially, the user rotates handle 1080 of stopcock 1052 , thus bringing syringe port 1084 into fluid flow engagement with vial port 1082 . [0361] Preferably, the user pushes plunger 1042 of syringe 1040 inwardly with respect to syringe 1040 , resulting in injection of fluid from syringe 1040 to vial 1060 , thus dissolving the drug contained in the vial. The fluid injected from syringe 1040 flows to vial 1060 via luer tip 1044 of syringe 1040 , syringe port 1084 , pathway defining element 1092 , vial port 1082 , bore 1750 of cylindrical portion 1748 and vial puncturing spike 1722 . [0362] The user preferably shakes the drug mixing system of FIG. 50 as shown in FIG. 31H , in order to ensure that the drug contained in vial 1060 is fully dissolved, and that the drug solution is homogenous. [0363] Reference is now made to FIG. 51 , which is a sectional illustration of the drug mixing system of FIGS. 31I and 48 during drawing of fluid from vial 1060 into syringe 1040 . [0364] At this stage, the user positions the system such that vial 1060 is on top, and preferably draws at least part of the drug solution contained in vial 1060 , by at least partially retracting plunger 1042 of syringe 1040 . The fluid drawn from vial 1060 flows into syringe 1040 via vial puncturing spike 1722 , bore 1750 of cylindrical portion 1748 , vial port 1082 , pathway defining element 1092 and syringe port 1084 of stopcock 1052 and luer tip 1044 of syringe 1040 . [0365] Reference is now made to FIG. 52 , which is a sectional illustration of the drug mixing system of FIGS. 31J and 48 during injection of fluid from syringe 1040 into receptacle 1032 . [0366] At a first stage, the user rotates handle 1080 of stopcock 1052 , resulting in syringe port 1084 being in fluid flow engagement with vial port 1082 . [0367] Subsequently, plunger 1042 of syringe 1040 is preferably pushed inward with respect to the main body portion of the syringe. The inward displacement of plunger 1042 causes injection of fluid from syringe 1040 into receptacle 1032 . Fluid drawn from syringe 1040 reaches receptacle 1032 via liter tip 1044 , syringe port 1084 , pathway defining element 1092 , receptacle port 1086 of stopcock 1052 , bore 1660 of receptacle adaptor subassembly 1056 , needle 1410 and bore 1310 of spike 1308 of spike port adaptor element 1030 . [0368] Reference is now made to FIG. 53 , which is a sectional illustration of the drug mixing system of FIG. 31L when ready for storage. [0369] As shown in FIG. 53 , spike port adaptor element 1030 ( FIGS. 34-35 ) and receptacle 1032 joined thereto are disconnected from receptacle adaptor subassembly 1056 of adaptor assembly 1050 . Typically, spike port adaptor element 1030 is disconnected from receptacle adaptor subassembly 1056 by slightly pushing arms 1614 extending from side surfaces 1612 ( FIGS. 39-40B ) of base portion 1602 , causing teeth 1620 to move outward and release the rearward facing wall portion of connection port 1318 ( FIGS. 34-35 ), thus disconnecting the connection port. Typically, needle 1410 is released from connection port 1318 , and needle protection cover 1412 is deployed and once again fully encloses needle 1410 , thus preventing liquid spill and aerosol spray. [0370] Adaptor assembly 1050 , including vial adaptor subassembly 1058 , stopcock 1052 , receptacle adaptor subassembly 1056 and housing element 1070 , is preferably stored in a suitable cooling facility. During cooling thereof, adaptor assembly is preferably connected to syringe 1040 , having plunger 1042 fully pushed inward, and to vial 1060 containing a drug solution therein. Typically, pathway defining element 1092 of stopcock 1052 connects receptacle port 1086 to syringe port 1084 at this stage. Reference is now made to FIGS. 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54H which are simplified pictorial illustrations of various stages of assembly and typical use of a drug mixing system constructed and operative in accordance with yet another preferred embodiment of the present invention. [0371] FIG. 54A shows a spike port adaptor element 2010 , as described hereinbelow with reference to FIGS. 57-58 , being inserted into a spike port 2011 in a receptacle 2012 containing a fluid. Preferably, a luer connector of spike port adaptor element 2010 is sealed by a luer cover element 2014 . [0372] Typically, receptacle 2012 comprises a bag, and the fluid contained therein is sterile salt solution, water, or any other suitable sterile solution or pure fluid. [0373] As seen in FIG. 54B , a vial 2020 , including a top portion 2022 and a neck portion 2023 , is pushed into engagement with a vial adaptor subassembly 2044 of adaptor assembly 2040 . Top portion 2022 of vial 2020 preferably has a septum 2024 sealingly seated therein. Subassembly 2044 is described hereinbelow with reference to FIGS. 60-61B . [0374] Alternatively, if a small vial 2026 is used, small vial 2026 is pushed into engagement with a vial head adaptor element 2030 which is described hereinbelow with reference to FIGS. 55-56 as shown in FIG. 54C , and is then pushed into engagement with vial adaptor subassembly 2044 . Vials 2020 and 2026 typically contain a drug in soluble powder form, in a solution or in other suitable form. FIGS. 67A and 67B show a sectional view of the drug mixing system at this stage. [0375] FIG. 54D shows spike port adaptor element 2010 and receptacle 2012 joined thereto, being connected to a receptacle adaptor subassembly 2046 of adaptor assembly 2040 , which is described hereinbelow with reference to FIGS. 62-63B . [0376] It is appreciated that receptacle adaptor subassembly 2046 and vial adaptor subassembly 2044 are preferably enclosed in a housing element 2050 of adaptor assembly 2040 , which is described hereinbelow with reference to FIGS. 64A-64B . [0377] it is appreciated by persons skilled in the art that the assembly steps shown in FIGS. 54A-54D may be performed in any suitable sequence. [0378] As seen in FIG. 54E , a user holds receptacle 2012 upright and squeezes the receptacle, thus at least partially filling vial 2020 with fluid squeezed out of receptacle 2012 . This flow of fluid ensures that the fluid remains sterile, and that the user is not exposed thereto. [0379] As seen in FIG. 54F , the user then shakes the drug mixing system of FIG. 54E to ensure that the drug in vial 2020 is fully dissolved and that the resulting solution is homogenous. [0380] As seen in FIG. 54G , the user reverses the direction of the receptacle 2012 , such that it is now facing downward, and then squeezes the receptacle. Squeezing of the receptacle 2012 causes the drug solution contained in vial 2020 to be drawn into the receptacle, thus further diluting the solution. The user preferably repeats this action until vial 2020 is empty, thus diluting the entire content of the vial in a single receptacle. [0381] As shown in FIG. 54H , spiked receptacle adaptor element 2010 having receptacle 2012 joined thereto is disconnected from adaptor assembly 2040 , which remains connected to vial 2020 . It is appreciated that at this stage adaptor assembly 2040 and vial 2020 may be disposed of. [0382] The structure of elements of the drug mixing system of FIGS. 54A-54H is described hereinbelow with reference to FIGS. 55-64B . [0383] Reference is now made to FIG. 55 , which is a simplified pictorial illustration of a vial head adaptor element 2030 which forms part of the drug mixing system of FIGS. 54A-54H and to FIG. 56 which is a sectional illustration taken along section lines LVI-LVI in FIG. 55 . [0384] As seen in FIG. 55 , vial head adaptor element 2030 is preferably a side-to-side symmetric integrally formed element which is preferably injection molded of plastic. [0385] Vial head adaptor element 2030 preferably includes a main body portion 2200 which is generally cylindrical and has a central axis 2201 . An inner cylindrical surface 2202 of main body portion 2200 preferably has four arms 2204 extending therefrom, each arm 2204 being arranged at generally right angles with respect to its neighboring arms. [0386] Each of arms 2204 terminates at an upper end thereof, in the sense of FIG. 54C , in an inwardly facing generally triangular tooth 2206 having a forwardly facing inclined surface 2208 and a bottom-facing engagement surface 2210 extending generally perpendicular to arm 2204 . [0387] At bottom surface of vial head adaptor element 2030 , there are formed four inwardly protruding surfaces 2212 , extending generally perpendicular to inner surface 2202 of main body portion 2200 . Each of neighboring surfaces 2212 is preferably arranged at a generally right angle with respect to its neighboring surfaces 2212 . Surfaces 2212 and arms 2204 are rotationally offset from one another about axis 2201 . [0388] Reference is now made to FIG. 57 , which is a simplified pictorial illustration of spike port adaptor element 2030 which forms part of the drug mixing system of FIGS. 54A-54H and to FIG. 58 which is a sectional illustration taken along section lines LVIII-LVIII in FIG. 57 . [0389] Spike port adaptor element 2010 preferably comprises a hollow flexible plastic tube 2302 having associated therewith a standard clamp 2304 , which is commercially available from various manufacturers, such as Qosina of Italy. [0390] At a forward end thereof, tube 2302 is connected to a tube port 2305 of a hollow spike element 2306 which is preferably formed of plastic. Spike element 2306 is preferably formed of a main body portion 2307 which preferably defines at a forward end thereof a spike 2308 , having formed therein an aperture communicating with an axially extending bore 2310 and an additional bore 2312 which extends partially through main body portion 2307 and communicates with a top portion of bore 2310 . [0391] Rearward of spike 2308 , main body portion 2307 defines a generally circular planar protrusion 2314 adapted to define the location at which a user grips the spike. [0392] The interior of tube 2302 is in fluid flow communication with bore 2312 via tube port 2305 . Bore 2310 preferably terminates in an aperture located in spike 2308 of main body portion 2307 and fully extends through the main body portion. [0393] Main body portion 2307 preferably terminates in a connection port 2318 which is adapted to connect spike port adaptor element 2010 to receptacle adaptor subassembly 2046 . Connection port 2318 preferably sealingly accommodates a generally circular septum 2320 on a seat 2322 . Septum 2320 preferably engages the rear end of bore 2310 , thus sealing the rear end of the bore. [0394] Forward of connection port 2318 , there is formed on main body portion 2307 a circumferential protrusion 2324 , forward of which is formed an additional circumferential protrusion 2326 , having an outer circumference which is slightly larger than that of protrusion 2324 . Protrusions 2324 and 2326 are adapted to limit the movement of spike port adaptor element 2010 when it is connected to receptacle adaptor subassembly 2044 . [0395] A luer connector 2330 is preferably attached to a rear end of tube 2302 . Luer connector 2330 preferably includes at a rearwardmost end thereof a narrow hollow port section 2332 , forward of which there is formed a connecting tube portion 2334 and a hollow neck portion 2336 which is adapted to connect luer connector 2330 to tube 2302 . Preferably, luer connector 2330 is sealed by luer cover element 2014 . [0396] It is appreciated that spike port adaptor element 2010 may alternatively be identical to spike port adaptor element 630 described hereinabove with reference to FIGS. 10-11B . [0397] Reference is now made to FIG. 59 , which is a simplified exploded view illustration of adaptor assembly 2040 which forms part of the drug mixing system of FIGS. 54A-54H . [0398] As seen with particular clarity in FIG. 59 , adaptor assembly 2040 comprises vial adaptor subassembly 2044 , onto which are placed a hydrophobic membrane 2402 , above which is optionally seated a carbon cloth filter 2404 . Vial adaptor subassembly 2044 is connected at a forward portion thereof to a rear connection element 2406 of receptacle adaptor subassembly 2046 . [0399] A needle holding element 2408 is preferably seated within rear connection element 2406 and supports a needle 2410 . A forward portion of needle 2410 is preferably protected by a flexible latex needle protection element 2412 . Receptacle adaptor subassembly 2046 connects at a rearward end thereof to rear connection element 2406 , enclosing needle holding element 2408 and needle protection element 2412 . [0400] The forward portion of vial adaptor subassembly 2044 as well as the rear portion of receptacle adaptor subassembly 2046 are located within housing element 2050 . [0401] Reference is now made to FIG. 60 , which is a simplified pictorial illustration of vial adaptor subassembly 2044 which forms part of adaptor assembly 2040 of FIG. 59 and to FIGS. 61A and 61B , which are sectional illustrations taken along respective section lines LXIA-LXIA and LXIB-LXIB in FIG. 60 . [0402] As seen in FIGS. 60-61B , vial adaptor subassembly 2044 comprises a main body element 2502 arranged generally about an axis 2503 . Main body element 2502 is preferably integrally formed and preferably injection molded of plastic. [0403] Main body element 2502 is preferably side-to-side symmetric about axis 2503 , and preferably includes a rear portion 2504 , which is generally cylindrical and terminates in a forward wall 2506 . Rear portion 2504 comprises a forward base section 2508 , preferably having four transversely extending outwardly facing protrusions 2509 extend therefrom, each protrusion being arranged at generally right angles with respect to its neighboring protrusions. [0404] Rearward of base section 2508 there are formed a plurality of tabs 2510 each having a rectangular window 2512 . Rearward of rectangular windows 2512 and on an inner surface 2514 of each of tabs 2510 there are preferably formed two radially extending inwardly facing protrusions 2516 each having an inclined surface. Protrusions 2516 preferably terminate at a forward end thereof in an inwardly facing transversely extending protrusion 2518 . Rearward of protrusions 2516 , each of tabs 2510 preferably includes an outwardly tapered portion 2520 . [0405] A hollow vial puncturing spike 2522 extends rearwardly from a rearward surface 2524 of forward wall 2506 , and is surrounded by base section 2508 and by tabs 2510 . Rearward surface 2524 additionally includes a circular cylindrical protrusion 2525 , surrounding puncturing spike 2522 . Two axially extending bores 2526 and 2527 extend through vial puncturing spike 2522 . [0406] Forward of forward wall 2506 of rear portion 2504 there is formed an intermediate portion which formed of two generally rectangular surfaces 2528 , and includes an axial tubular portion 2530 having a bore 2531 extend therethrough, bore 2531 being in fluid flow engagement with bore 2526 of hollow vial puncturing spike 2522 . [0407] On the top rectangular surface 2528 and slightly recessed with respect thereto there is formed a plastic membrane support surface 2532 , having formed thereon a plurality of generally evenly distributed spherical protrusions 2534 , which are adapted to support hydrophobic membrane 2402 and prevent it from excessive inflation and from cracking. Membrane 2402 is adapted to allow free passage of air to and from main body element 2502 , but to prevent passage of liquid and air borne particles, microorganisms and aerosol. A preferred membrane 2402 is Model Versapor R 0.2 Micron which is commercially available from Pall Corporation of New York, U.S.A. [0408] A narrow bore 2537 connects membrane 2402 to bore 2531 , thus allowing pressure equalization in an evacuated drug vial 2020 upon connection of vial 2020 to the vial adaptor subassembly 2044 . When fluid first passes through the system during drug dilution, bore 2537 irreversibly fills with liquid, thus preventing air from escaping the system. [0409] Prevention of the escape of air from the system is necessary for the reversible transfer of liquid from the receptacle 2012 to the vial 2020 and vice versa. Air movement between vial 2020 and receptacle 2012 causes changes in pressure in the vial, thereby pushing liquid from the vial into the receptacle. [0410] A rim 2538 surrounding support surface 2532 is adapted to support an optional carbon cloth filter 2404 and maintain it in a raised position above and spaced from membrane 2402 . Carbon filter 2404 is adapted to prevent toxic vapors from escaping from main body element 2502 , thus protecting users. A preferred carbon cloth filter 2404 is Model No. Zorflex EMI which is commercially available from Charcoal Cloth International Ltd. of Houghton-le-Spring, England. [0411] Rectangular surfaces 2528 of the intermediate portion terminate at a forward end thereof in a forward facing cylindrical portion 2548 , having a bore 2550 extend therethrough. Preferably, bore 2550 is a continuation of tubular portion 2530 of the intermediate portion. [0412] It is appreciated that the functionalities of membrane 2402 and carbon cloth filter 2404 , to allow free passage of air into the drug mixing system while preventing passage thereinto of liquid and air-borne particles, microorganisms and aerosol and preventing toxic vapors from escaping from the drug mixing system, may be incorporated, using similar elements, into any receptacle adaptor subassembly 2046 . [0413] Reference is now made to FIG. 62 , which is a simplified pictorial illustration of receptacle adaptor subassembly 2046 which forms part of the adaptor assembly 2040 of FIG. 59 and to FIGS. 63A and 63B , which are sectional illustrations taken along respective section lines LXIIIA-LXIIIA and LXIIIB-LXIIIB in FIG. 62 . [0414] As seen in FIGS. 62-63B , receptacle adaptor subassembly 2046 includes a main body element 2600 which is arranged generally about an axis 2601 . Main body element 2600 is preferably integrally formed of plastic, and is preferably side-to-side symmetric about axis 2601 . Main body element 2600 preferably includes a generally cylindrical base portion 2602 terminating in a rear portion 2604 . [0415] Top and bottom generally concave wall portions 2606 are formed at a forward end of base portion 2602 , each wall portion 2606 defining on an outer surface thereof an outwardly facing axially extending rib 2608 , which extends from a forwardmost end of each of wall portions 2606 and along base portion 2602 . [0416] A connection surface 2610 extending transversely from side surfaces 2612 of base portion 2602 connects an outwardly extending arm 2614 to each side surface 2612 . Each arm 2614 preferably has a generally square rear portion 2616 , formed rearwardly of connection surface 2610 , and has a radially extending outwardly facing protrusion 2618 formed thereon. Protrusion 2618 preferably extends onto an outer surface of a generally rectangular forward portion 2620 of each of arms 2614 , which extends forwardly of connection surface 2610 . [0417] An inwardly facing generally triangular tooth 2622 is formed adjacent a top end of each of forward portions 2620 . Each tooth 2622 preferably includes a forwardly facing inclined surface 2624 and a rearwardly facing engagement surface 2626 . [0418] Rear portion 2604 preferably includes a transversely extending generally circular portion 2630 which forms a base for ribs 2608 and which terminates at a rear end thereof in an axially extending generally cylindrical wall portion 2632 . [0419] Wall portion 2632 preferably defines on a top and bottom surface thereof a small generally rectangular window 2634 , and two forwardly facing slots 2636 which are formed on either side of window 2634 . Two generally symmetric side-facing tabs 2638 are formed on side surfaces 2640 of wall portion 2632 , each tab 2638 being formed forwardly of a generally rectangular forwardly facing slot 2642 . [0420] Rear connection element 2406 preferably includes a forward disk 2652 defining a central bore 2654 . Disk 2652 preferably functions as a terminating wall for a forward facing cylindrical portion 2656 . Rearward of disk 2652 there is preferably formed a rear portion 2658 , having a narrow bore 2660 extend therethrough. Bore 2660 preferably widens toward the rear end of rear portion 2658 , thus enabling rear portion 2658 to connect to an appropriate port. Preferably, two generally symmetric tabs 2662 are formed on top and bottom surfaces of rear portion 2658 . Cylindrical portion 2656 preferably has an outer circumference that is slightly smaller than that of wall portion 2632 , and is located therein. [0421] Needle holding element 2408 preferably supports needle 2410 on a generally circular disk portion 2672 . Needle 2410 extends axially through base portion 2602 of main body element 2600 and through bore 2660 of rear connection element 2650 . Disk portion 2672 is preferably seated in cylindrical portion 2656 , and is locked into cylindrical portion 2656 by portion 2630 . [0422] Reference is now made to FIGS. 64A and 64B , which are simplified pictorial illustrations of the housing element 2050 which forms part of the adaptor assembly 2040 of FIG. 59 in closed and open orientations, respectively. [0423] As seen in FIGS. 64A and 64B , housing element 2050 is preferably integrally formed about an axis 2700 and includes a top housing portion 2701 and a bottom housing portion 2702 . Preferably, housing portions 2701 and 2702 are side-to-side symmetric about axis 2700 . Preferably, each of housing portions 2701 and 2702 includes a semi-cylindrical forward portion 2704 and a semi-cylindrical rearward portion 2706 . [0424] Top and bottom housing portions 2701 and 2702 each include an inwardly recessed portion 2708 including a generally central elongate protrusion 2710 . [0425] Top housing portion 2701 includes at forward and rearward ends thereof outwardly extending fingers 2722 terminating in a generally triangular teeth 2724 which include inclined outwardly facing surfaces 2726 and engagement surfaces 2728 . Bottom housing portion 2702 preferably includes at forward and rearward ends thereof two generally rectangular windows 2730 which are placed generally below fingers 2722 and are adapted to engage engagement surfaces 2728 of fingers 2722 when housing element 2050 is assembled. [0426] An inner surface 2734 of housing element 2050 preferably includes at a rearward end thereof a circumferential recess 2736 which is adapted to engage protrusions 2509 of rear portion 2504 of vial adaptor subassembly 2044 . An outer surface of housing element 2050 which lies above recess 2736 preferably includes an outwardly facing protrusion 2740 which protrudes out of cylindrical rearward portion 2706 . [0427] Reference is now made to FIG. 65 , which is a simplified assembled pictorial illustration of the adaptor assembly 2040 of FIG. 59 and to FIGS. 66A and 66B , which are sectional illustrations taken along respective section lines LXVIA-LXVIA and LXVIB-LXVIB in FIG. 65 . [0428] As seen in FIGS. 65-66B , rear portion 2504 of vial adaptor subassembly 2044 extends from a rear portion of housing element 2050 . Vial puncturing spike 2522 preferably extends out of housing element 2050 , and is accessible for connection of vial 2020 or of vial 2026 ( FIG. 54B ) thereto. [0429] Preferably, circumferential recess 2736 of inner surface 2734 of housing element 2050 engages protrusions 2509 of rear portion 2504 of vial adaptor subassembly 2044 . Preferably, forward facing cylindrical portion 2548 engages rear portion 2658 of rear connection element 2406 . A rear end of needle 2410 at least partially extends through bore 2660 and through bore 2550 such that bore 2550 is in fluid flow communication with needle 2410 of receptacle adaptor subassembly 2046 . [0430] A forward portion of main body element 2600 of receptacle adaptor subassembly 2046 preferably extends from a forward portion of housing element 2050 of adaptor assembly 2040 , and surrounds needle 2410 enclosed in needle protection element 2412 . Main body element 2600 including needle 2410 and needle protection cover 2412 is preferably accessible for connection of spike port adaptor element 2010 ( FIGS. 57-58 ) thereto. [0431] Housing element 2050 is preferably assembled, such that top housing portion 2701 and bottom housing portion 2702 are connected by engagement of engagement surfaces 2728 of teeth 2724 of top housing portion 2701 and windows 2730 of bottom housing portion 2702 . [0432] Reference is now made to FIGS. 67A and 67B , which are sectional illustrations of the drug mixing system of FIG. 54B during attachment of vial 2020 to the vial adaptor subassembly 2044 of adaptor assembly 2040 of FIG. 65 . [0433] Vial 2026 and vial head adaptor element 2030 joined thereto ( FIG. 54C ) or vial 2020 is preferably pushed into engagement with vial puncturing spike 2522 of vial adaptor subassembly 2044 . [0434] Typically, vial puncturing spike 2522 of vial adaptor subassembly 2044 punctures septum 2024 located inside top portion 2022 of vial 2020 , thus enabling fluid flow between the main body of vial 2020 and bore 2550 of cylindrical portion 2548 of main body element 2502 of vial adaptor subassembly 2044 . Preferably, puncturing of septum 2024 releases any vacuum in vial 2020 by entrance of air into vial 2020 through optional carbon cloth filter 2404 ( FIG. 61A ) and membrane 2402 ( FIG. 61A ). Engagement between vial adaptor subassembly 2044 and vial 2010 is preferably maintained by snap engagement of protrusions 2516 and 2518 of rear portion 2504 of main body element 2600 with neck portion 2023 of vial 2020 . The engagement of protrusions 2516 and 2518 with neck portion 2023 ensures that vial adaptor subassembly 2044 is latched onto vial 2020 and cannot be removed therefrom. Tabs 2510 and outwardly tapered portions 2520 generally surround top portion 2022 and neck portion 2023 of vial 2020 . [0435] At this stage, the main body of vial 2020 is in fluid flow communication with needle 2410 via vial puncturing spike 2522 , bore 2550 of cylindrical portion 2548 and bore 2660 of cylindrical portion 2658 . [0436] Reference is now made to FIG. 68 , which is a sectional illustration of the drug mixing system of FIG. 54D-54G during attachment of the receptacle port adaptor element 2010 and receptacle 2012 of FIG. 54A to the receptacle adaptor subassembly 2046 of adaptor assembly 2040 of FIG. 67 , having vial 2020 attached thereto. [0437] As seen in FIG. 68 , spike port adaptor element 2010 , having receptacle 2012 joined thereto, is connected to receptacle adaptor subassembly 2046 of adaptor assembly 2040 . [0438] Spike 2308 is preferably previously inserted into spike port 2011 of receptacle 2012 , such that bore 2310 of spike element 2306 engages fluid content of receptacle 2012 . Connection port 2318 of spike port adaptor element 2010 engages wall portions 2606 and base portion 2602 of main body element 2600 of receptacle adaptor subassembly 2046 . [0439] Connection port 2318 is preferably locked into connection with receptacle adaptor subassembly 2046 by engagement of engagement surfaces 2626 of forward portions 2620 of awls 2614 and a rearward facing wall portion of connection port 2318 . [0440] Preferably, needle 2410 punctures needle protection cover 2412 and septum 2320 , resulting in partial collapse of the needle protection cover. At this stage, receptacle 2012 is in fluid flow communication with the main body of vial 2020 via bore 2310 of spike 2308 of spike port adaptor element 2010 , needle 2410 , bore 2660 , bore 2550 of cylindrical portion 2548 , bore 2531 of tubular portion 2530 and vial puncturing spike 2522 . [0441] Reference is now made to FIG. 69 , which is a sectional illustration of the drug mixing system of FIGS. 54H and 68 during disconnection of the spike port adaptor element 2010 and receptacle 2012 from the receptacle adaptor subassembly 2046 of adaptor assembly 2040 of FIG. 67 . [0442] As shown in FIG. 69 , spike port adaptor element 2010 and receptacle 2012 joined thereto are disconnected from receptacle adaptor subassembly 2046 of adaptor assembly 2040 . Typically, spike port adaptor element 2010 is disconnected from receptacle adaptor subassembly 2046 by slightly pushing arms 2614 extending from side surfaces 2612 of base portion 2602 , causing teeth 2620 to move outward and release the rearward facing wall portion of connection port 2318 , thus disconnecting the connection port. Typically, needle 2410 is released from connection port 2318 , and needle protection cover 2412 is deployed and once again fully encloses needle 2410 , thus sealing it to prevent leakage. [0443] Reference is now made to FIG. 70 which is a simplified exploded view illustration of a drug mixing system constructed and operative in accordance with a further preferred embodiment of the present invention. The embodiment of FIG. 70 is a modification of the embodiments of FIGS. 31A-53 and 54A-69 . Accordingly, for the sake of conciseness, it is described hereinbelow in somewhat abbreviated faun with reference to FIGS. 71-78 . [0444] In this embodiment the drug vial is enclosed in a protective housing used during storage and dilution, thereby preventing spills in case of breakage. [0445] As seen with particular clarity in FIG. 70 , the drug mixing system comprises a vial adaptor subassembly 3000 , which preferably comprises an externally threaded vial support element 3010 , into which is placed a vial 3020 . [0446] A vial puncturing cover assembly 3030 comprises an internally threaded covering element 3032 , which connects at a forward end thereof to the externally threaded portion of vial support element 3010 . At a top end thereof, covering element 3032 engages a vial puncturing spike element 3034 , which supports a hydrophobic membrane 3036 . [0447] Vial puncturing cover assembly 3030 connects at a forward end thereof to a connection port of a receptacle adaptor subassembly 3040 , which is adapted to engage a spike port receptacle adaptor element 3050 . Spike port receptacle adaptor element 3050 is preferably inserted into a receptacle port 3051 of a receptacle 3052 . [0448] Alternatively, vial puncturing cover assembly 3030 may connect at a forward end thereof to a vial port 3080 of a stopcock 3082 , and the connection port of receptacle port adaptor assembly 3040 connects to a receptacle port 3084 of stopcock 3082 . When this option is used, a syringe port 3086 of stopcock 3082 preferably engages a luer fitted syringe. [0449] It is appreciated that vial 3020 may be identical to either of vials 2020 and 2026 , and that receptacle 3052 may be identical to receptacle 2012 , described hereinabove with reference to FIGS. 54A-54C . [0450] Receptacle adaptor subassembly 3040 may be identical to receptacle adaptor subassembly 2046 , described hereinabove with reference to FIGS. 62-63B . [0451] Spike port adaptor element 3050 may be identical to spike port adaptor element 2010 , described hereinabove with reference to FIGS. 57-58 . [0452] Reference is now made to FIG. 71 which is a simplified pictorial illustration of a vial support element 3010 which forms part of vial adaptor subassembly 3000 of the drug mixing system of FIG. 70 and to FIGS. 72A and 72B which are, respectively, a sectional illustration and a pictorial sectional illustration taken along section lines LXXII-LXXII in FIG. 71 . [0453] Vial support element 3010 comprises a generally cylindrical body element 3100 arranged generally about an axis 3101 . Body element 3100 is preferably integrally formed and preferably is generally side-to-side symmetric about axis 3101 . [0454] Body element 3100 preferably includes a top portion 3102 , which is externally threaded and which is separated from a bottom portion 3104 by an outwardly facing circumferential protrusion 3106 . Four axially extending outwardly facing protrusions 3108 are preferably formed on bottom portion 3104 , each protrusion 3108 being arranged at generally right angles with respect to its neighboring protrusions. [0455] Body element 3100 preferably terminates in a transversely extending base wall portion 3110 , which includes a central spherical protrusion 3112 which is adapted to center vial 3020 in vial support element 3010 . [0456] As seen with particular clarity in FIG. 72B , an inner surface 3114 of body element 3100 may optionally include a plurality of axially extending inwardly facing generally rectangular protrusions 3116 , which are operative to adapt vial support element 3010 to support a smaller vial. Different body elements 3100 , molded with protrusions 3116 of different sizes, may be used for different vial sizes. Similarly, base wall portion 3110 may optionally be molded at various heights with respect to bottom portion 3104 , thus enabling different vial support elements 3010 to support vials of different heights. [0457] Reference is now made to FIG. 73 , which is a simplified pictorial illustration of vial support element 3010 of FIGS. 71-72B containing a vial 3020 and to FIG. 74 , which is a sectional illustration taken along section lines LXXIV-LXXIV in FIG. 73 . [0458] As seen in FIGS. 73 and 74 , vial 3020 is placed within vial support element 3010 , such that top portion 3022 , septum 3024 and at least part of neck portion 3023 extend above the vial support element and are accessible to a user. [0459] A base of vial 3020 is preferably seated on base wall portion 3110 and engages spherical protrusion 3112 . [0460] Reference is now made to FIGS. 75A and 75B , which are simplified pictorial illustrations of vial puncturing cover assembly 3030 which forms part of the vial adaptor subassembly 3000 of FIG. 70 and to FIG. 76 which is a sectional illustration taken along section lines LXXVI-LXXVI in FIG. 75A . [0461] Vial puncturing cover assembly 3030 includes covering element 3032 , which comprises a generally cylindrical main body portion 3202 arranged generally about an axis 3203 . [0462] Main body portion 3202 is preferably internally threaded and is adapted to engage the externally threaded top portion 3102 of vial support element 3010 . Four axially extending outwardly facing protrusions 3204 are preferably formed on an outer surface 3205 of main body portion 3202 , each protrusion 3204 being arranged at generally right angles with respect to its neighboring protrusions. An outwardly facing radially extending wall portion 3206 extends from a bottom end of main body portion 3202 . [0463] Main body portion 3202 terminates in a wall portion 3208 , which preferably extends transversely with respect to axis 3203 and includes a generally round aperture 3210 . An inner surface 3212 of wall portion 3208 preferably includes two semi-circular tracks 3214 . [0464] Vial puncturing spike element 3034 preferably includes a vial puncturing spike 3220 extending through aperture 3210 of wall portion 3208 . Vial puncturing spike 3220 preferably has two axial bores 3222 and 3224 extending therethrough. [0465] Preferably membrane 3036 is in fluid flow engagement with cover element 3032 via bore 3224 of vial puncturing spike 3220 . [0466] Spike 3220 preferably extends forwardly from a generally circular wall portion 3226 , which engages a top surface of wall portion 3208 . Four generally rectangular wall portions 3228 extend radially from spike 3220 , each wall portion 3228 being arranged at generally right angles with respect to its neighboring wall portions. [0467] Wall portions 3228 preferably define at top surfaces thereof four spherical protrusions 3230 , which engage tracks 3214 and are adapted to lock vial puncturing spike element 3034 with respect to covering element 3032 . [0468] A generally cylindrical portion 3232 , including an axial bore 3234 , preferably extends rearwardly from wall portion 3226 . Cylindrical portion 3232 is preferably adapted to engage rear portion 3658 of receptacle adaptor subassembly 3040 . [0469] A second generally cylindrical portion 3236 preferably extends rearwardly of wall portion 3226 and adjacent cylindrical portion 3232 . Portion 3236 preferably defines a seat 3238 which is adapted to support unidirectional breathing membrane 3036 and prevent it from excessive inflation and from cracking. Membrane 3036 is adapted to allow free passage of air into the main body element 3032 , but prevent passage therethrough of liquid and air-borne particles, microorganisms and aerosol. A preferred membrane 3036 is Model Versapor R 0.2 Micron which is commercially available from Pall Corporation of New York, U.S.A. [0470] Reference is now made to FIG. 77 , which is a simplified assembled pictorial illustration of the vial adaptor subassembly 3000 of FIG. 70 and to FIG. 78 , which is a sectional illustration taken along section lines LXXVIII-LXXVIII in FIG. 77 . [0471] As seen in FIGS. 77 and 78 , vial puncturing cover assembly 3030 threadably engages vial support element 3010 , thus enclosing therein vial 3020 . [0472] The threaded engagement between vial support element 3010 and vial puncturing cover element 3032 causes puncturing spike 3220 to be pushed into engagement with vial 3020 . [0473] Typically, vial puncturing spike 3220 of vial puncturing cover element 3030 punctures septum 3024 located inside top portion 3022 of vial 3020 , thus enabling fluid flow between the main body of vial 3020 and bore 3234 of cylindrical portion 3232 via bore 3222 of puncturing spike 3220 . Preferably, puncturing of septum 3024 releases any vacuum in vial 3020 . [0474] Reference is now made to FIG. 79 , which is a pictorial illustration of the vial adaptor subassembly 3000 of FIG. 77 when assembled to receptacle adaptor subassembly 3040 thus forming an adaptor assembly in accordance with a preferred embodiment of the present invention, and to FIG. 80 , which is a sectional illustration taken along section lines LXXX-LXXX in FIG. 79 . [0475] As seen in FIGS. 79 and 80 , cylindrical portion 3232 of vial cover element 3030 engages rear portion 3658 of receptacle adaptor subassembly 3040 . A rear end of needle 3410 at least partially extends through bore 3660 and through bore 3234 such that bore 3234 is in fluid flow communication with needle 3410 of receptacle adaptor subassembly 3040 . Due to fluid flow communication between bore 3234 and the main body of vial 3020 , needle 3410 is in fluid flow communication with vial 3020 . [0476] A forward portion of main body element 3414 of receptacle adaptor subassembly 3040 preferably surrounds needle 3410 enclosed in needle protection element 3412 . Main body element 3600 including needle 3410 and needle protection cover 3412 is preferably accessible for connection of spike port adaptor element 3050 thereto. [0477] It is appreciated that cylindrical portion 3232 of vial cover element 3030 may alternatively engage a stopcock 3052 , which additionally engages receptacle adaptor subassembly 3040 and a syringe as described hereinabove with reference to FIGS. 31A-53 . In such a case, the method of use of the system would be similar to that described in FIGS. 31A-31L . [0478] Reference is now made to FIG. 81 , which is a pictorial illustration of vial adaptor subassembly 3000 connected to receptacle adaptor subassembly 3040 of FIG. 79 when connected to a spike port adaptor element 3050 and receptacle 3052 and to FIG. 82 , which is a sectional illustration taken along section lines DOM-DOOM in FIG. 81 . [0479] As seen in FIGS. 81 and 82 , spike port adaptor element 3050 , having receptacle 3052 joined thereto, is connected to receptacle adaptor subassembly 3040 . [0480] A spike 3308 is preferably previously inserted into spike port 3051 of receptacle 3052 , such that a bore 3310 of a spike element 3306 engages fluid content of receptacle 3052 . A connection port 3318 of spike port adaptor element 3050 engages wall portions 3606 and base portion 3602 of main body element 3414 of receptacle adaptor subassembly 3040 . [0481] Connection port 3318 is preferably locked into connection with receptacle adaptor subassembly 3040 by engagement of engagement surfaces 3626 of forward portions 3620 of arms 3614 and a rearward facing wall portion of connection port 3318 . [0482] Preferably, needle 3410 punctures needle protection cover 3412 and septum 3320 , resulting in partial collapse of the needle protection cover. At this stage, receptacle 3052 is in fluid flow communication with the main body of vial 3020 via bore 3310 of spike 3308 of spike port adaptor element 3050 , needle 3410 , bore 3660 , bore 3234 of cylindrical portion 3232 and vial puncturing spike 3220 . [0483] Reference is now made to FIG. 83 , which is a simplified exploded view illustration of a drug mixing system constructed and operative in accordance with a still further preferred embodiment of the present invention. The embodiment of FIG. 83 is a modification of the embodiment of FIGS. 54A-69 . Accordingly, for the sake of conciseness, it is described hereinbelow in somewhat abbreviated form with reference to FIGS. 84-92 . [0484] As seen with particular clarity in FIG. 83 , the drug mixing system comprises a receptacle adaptor subassembly 4000 which preferably comprises a receptacle adaptor housing element 4010 . Receptacle adaptor housing element 4010 preferably engages a receptacle adaptor needle assembly 4020 . Receptacle adaptor subassembly 4000 preferably engages a port such as a receptacle port 4031 of a receptacle 4032 . [0485] Receptacle adaptor needle assembly 4020 connects at a rearward end thereof to a connection port of a vial adaptor subassembly 4040 , which is adapted to engage a vial 4050 . [0486] It is appreciated that vial 4050 may be identical to either of vials 2020 and 2026 , and receptacle 4032 may be identical to receptacle 2032 , described hereinabove with reference to FIGS. 54A-54C . [0487] Vial adaptor subassembly 4040 may be identical to vial adaptor subassembly 2046 , described hereinabove with reference to FIGS. 60-61B . [0488] Receptacle port 4031 may be identical receptacle port 2031 , described hereinabove. It is appreciated that receptacle adaptor subassembly 4000 may engage a spike port adaptor element such as spike port adaptor element 2030 described hereinabove with reference to FIGS. 57-58 . [0489] Reference is now made to FIG. 84 , which is a simplified pictorial illustration of receptacle adaptor housing element 4010 which fauns part of the drug mixing system of FIG. 83 and to FIGS. 85A and 85B , which are sectional illustrations taken along section lines LXXXVA-LXXXVA and LXXXVB-LXXXVB in FIG. 84 . [0490] Receptacle adaptor housing element 4010 comprises a body element 4100 , arranged generally about an axis 4101 . Body element 4100 comprises a tube of generally rectangular cross-section, is preferably integrally formed and preferably is generally side-to-side symmetric about axis 4101 . [0491] Body element 4100 preferably includes a rear portion 4102 which is formed with ribbed grip regions 4104 on an outer surface 4106 . Two elongate windows 4108 are preferably formed on top and bottom surfaces of rear portion 4102 . [0492] A forward portion 4110 of body element 4100 has a slightly smaller outer circumference than that of rear portion 4102 , and includes a generally rectangular window 4112 on each of the surfaces thereof. Forward portion 4110 preferably sealingly accommodates a septum 4114 in a seat 4116 . [0493] Four axially extending tabs 4118 extend forwardly of forward portion 4110 , each tab 4118 being arranged at generally right angles with respect to its neighboring tabs. Each tab 4118 preferably includes and an inwardly facing tooth 4120 and preferably terminates in an outwardly tapered portion 4122 . [0494] Reference is now made to FIG. 86 , which is a simplified pictorial illustration of receptacle adaptor needle assembly 4020 which forms part of the drug mixing system of FIG. 83 and to FIGS. 87A and 87B , which are sectional illustrations taken along section lines LXXXVIIA-LXXXVIIA and LXXXVIIB-LXXXVIIB in FIG. 86 . [0495] Receptacle adaptor needle assembly 4020 comprises a generally cylindrical body element 4200 , arranged generally about an axis 4201 . Body element 4200 is preferably integrally formed and preferably is generally side-to-side symmetric about axis 4201 . [0496] Body element 4200 preferably includes a rear connection port 4202 which is separated from a forward portion 4204 by a circumferential outwardly extending protrusion 4206 . Protrusion 4206 is adapted to limit the extent to which receptacle adaptor needle assembly 4020 is inserted into receptacle adaptor housing element 4010 . [0497] Forward portion 4204 preferably terminates in a forward wall portion 4205 from which extends a cylindrical portion 4210 having an outer circumference which is slightly larger than that of forward portion 4204 . Cylindrical portion 4210 preferably has formed thereon four axially extending protrusions 4212 , each protrusion 4212 being arranged at generally right angles with respect to its neighboring protrusions. [0498] Two outwardly extending arms 4214 are formed at a forward end of cylindrical portion 4210 , each aim 4214 being generally across from the other arm. Protrusions 4212 and arms 4214 are preferably rotationally offset from one another about axis 4201 . Each arm 4214 preferably defines at a forward most end thereof a generally triangular tooth 4216 including an engagement surface 4218 . [0499] A hollow needle 4220 is preferably sealingly mounted in a cylindrical portion 4222 which is formed within cylindrical portion 4210 of receptacle adaptor needle assembly 4020 . [0500] Reference is now made to FIG. 88 , which is a simplified assembled pictorial illustration of the receptacle adaptor subassembly 4000 of FIG. 83 and to FIGS. 89A and 89B ,which are sectional illustrations taken along section lines LXXXIXA-LXXXIXA and LXXXIXB-LXXXIXB in FIG. 88 . [0501] As seen in FIG. 88-89B , cylindrical portion 4210 of receptacle adaptor needle assembly 4020 preferably engages a rearwardmost portion of rear portion 4102 of receptacle adaptor housing element 4010 . Teeth 4216 of arms 4214 of cylindrical portion 4210 preferably extend through windows 4108 and maintain receptacle adaptor needle assembly 4020 locked in receptacle adaptor housing element 4010 . [0502] It is appreciated that a user may push receptacle adaptor needle assembly 4020 inward with respect to receptacle adaptor housing element 4010 . Such inward motion of receptacle adaptor needle assembly 4020 is limited by protrusion 4206 . [0503] Reference is now made to FIG. 90 , which is a pictorial illustration of the receptacle adaptor subassembly 4000 of FIG. 88 when assembled to a vial adaptor subassembly 4040 and to port 4031 of receptacle 4032 , prior to insertion of needle 4220 into the receptacle port 4031 and to FIG. 91 , which is a sectional illustration taken along section lines XCI-XCI in FIG. 90 . [0504] Vial 4050 is preferably pushed into engagement with a vial puncturing spike 4522 of vial adaptor subassembly 4040 . [0505] Typically, vial puncturing spike 4522 of vial adaptor subassembly 4050 punctures a septum 4014 located inside a top portion 4012 of vial 4050 , thus enabling fluid flow between the main body of vial 4050 and a bore 4550 of a cylindrical portion 4548 of main body element 4502 of vial adaptor subassembly 4050 . Preferably, puncturing of septum 4014 releases any vacuum in vial 4050 by entrance of air into vial 4050 through a carbon filter 4404 and a membrane 4402 . [0506] Engagement between vial adaptor subassembly 4040 and vial 4050 is preferably maintained by snap engagement of protrusions 4516 and 4518 of rear portion 4504 of main body element 4502 with neck portion 4013 of vial 4050 . The engagement of protrusions 4516 and 4518 with neck portion 4013 ensures that vial adaptor subassembly 4040 is latched onto vial 4050 and cannot be removed therefrom. Tabs 4510 and outwardly tapered portions 4520 generally surround top portion 4012 and neck portion 4013 of vial 4050 . [0507] Cylindrical portion 4548 preferably engages connection port 4202 of receptacle adaptor needle assembly 4020 , such that needle 4220 is in fluid flow communication with vial 4050 via forward portion 4204 , bore 4550 of cylindrical portion 4548 and vial puncturing spike 4522 . The sharpened tip of needle 4220 preferably partially extends through septum 4114 . [0508] Teeth 4120 of arms 4118 preferably engage receptacle port 4031 of receptacle 4032 , or may alternatively engage any other suitable port such as a spike port adaptor element 4030 as described hereinabove. [0509] Reference is now made to FIG. 92 , which is a pictorial illustration of the receptacle adaptor subassembly 4000 of FIG. 88 when assembled to a vial adaptor subassembly 4040 and to port 4031 of receptacle 4032 , following insertion of needle 4220 into receptacle port 4031 and to FIG. 93 , which is a sectional illustration taken along section lines XCIII-XCIII in FIG. 92 . [0510] As seen in FIGS. 92 and 93 , a user preferably pushes receptacle adaptor needle assembly 4020 inward, such that needle 4220 pierces septum 4114 , resulting in fluid flow communication between receptacle 4032 and vial 4050 . [0511] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as modifications thereof which would occur to persons skilled in the art upon reading the foregoing specification and which are not in the prior art.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to U.S. Provisional Ser. No. 61/508,282, filed on Jul. 15, 2011. BACKGROUND This disclosure relates to golf clubs and more particularly to a golf shaft or shafts having interchangeable heads. Golfing can be difficult to play not just for the skill required but because the golf equipment necessary to play is difficult to lug around a golf course. One who may want to walk the course may not be able to because the fourteen clubs allowed to be carried along with other golf paraphernalia like balls, tees, etc. are simply too heavy to carry. The golfer may then be forced to rent a golf cart and give up the opportunity to walk the course while significantly increasing the cost of the round by renting the cart. Some modular club systems exist in which the club heads are detachable from a shaft. However, the existing systems are difficult to assemble and take apart quickly. SUMMARY According to an embodiment disclosed herein, a golf club system includes a club head and a shaft. The club head has a column extending upwardly therefrom, the column having a tooth extending radially outwardly therefrom, the tooth having a first magnet attaching thereto. The shaft has a wall defining a hollow portion that receives the column, the wall having a slot therein the slot having an insertion portion through which the tooth may slide axially and an attachment portion in which the tooth may rotate circumferentially after passing through the insertion portion and a second magnet that engages the first magnet in the tooth after the tooth rotates circumferentially away from the slot. According to a further embodiment disclosed herein, a method of attaching and detaching a shaft from a club head, includes the steps of providing a first club head having a column extending upwardly therefrom, the column having a tooth extending radially outwardly therefrom, the tooth having a first magnet attaching thereto, providing a shaft, the shaft having a slot therein, rotating the tooth circumferentially within the slot about the shaft, and engaging the first magnet of the tooth with the second magnet. Although the different examples have the specific components shown in the illustrations, embodiments of this invention are not limited to those particular combinations. It is possible to use some of the components or features from one of the examples in combination with features or components from another one of the examples. BRIEF DESCRIPTION OF THE DRAWINGS This disclosure can be further understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: FIG. 1 is a perspective view of a modular golf system described herein. FIG. 2 is a an exploded perspective view of a disassembled golf club taken along the line 2 - 2 of FIG. 1 . FIG. 3 is a view of a tooth used in FIG. 2 . FIG. 4 is a perspective view of a golf bag for use with the modular golf system of FIG. 1 . DETAILED DESCRIPTION FIGS. 1 and 4 illustrate a modular golf system 10 . The golf system 10 includes a shaft 15 and a plurality of club heads 20 including driving iron club head 25 , 3 iron club head 30 , 7 iron club head 35 , 9 iron club head 40 , pitching wedge club head 45 and putter club head 50 . The club heads 20 are each attached to the shaft 15 by a joint 55 . The club heads 20 and the shaft 15 are stored in a lightweight golf bag 60 as will be discussed infra. Other clubs heads such a wedge(s), a driver, a chipper, a hybrid, a wood or other heads used in golfing may be used by utilizing the teachings provided herein. In fact, a utility head such as a ball retriever club head 65 may also be used. A second (or more) upper shaft 70 that may be shorter, longer or extending for use with a belly putter or for the ball retriever club head 65 , or the like, incorporating a joint 55 , may also be included. Each club head 20 includes a club head 20 , a lower shaft 75 and a hosel 80 that connects the lower shaft 75 to the club head 20 . The lower shaft 75 has a flared portion 85 at an end distal from the hosel 80 . The flared portion 85 creates a shoulder 90 that interacts with the upper shaft 15 as will be discussed infra. A keyed portion 95 extends beyond the flared portion 85 and is coaxial with the lower shaft 75 . Each upper shaft 15 includes a grip 100 and an elongated portion 105 that also terminates at the joint 55 as will be discussed infra. The lower shaft 75 of each club head 20 may be longer or shorter than the other club heads given the requirements of the game. For instance, the club heads 20 for the lower numbered clubs are generally longer than the club heads 20 for the higher numbered club heads. So the club head 45 for a wedge has a lower shaft 75 that is shorter than the lower shaft 75 for the nine iron club head 40 which is shorter than the 7 iron club head 35 etc. This is not to say that the lower shafts 75 , as in some golfing systems, cannot be equal in length or different in length in other ways. Referring now to FIGS. 2 and 3 , the joint 55 is described. The upper shaft 15 terminates in a wider portion 110 than the width of the upper shaft 15 . A hollowed portion 115 in which the keyed portion 95 extends forms a mild interference fit therein such that the keyed portion may be inserted, rotated coaxially and removed. The interference fit can be defined as one in which the key portion may not move if undisturbed in the hollowed portion 115 but will move if force beyond the force gravity is added. An end 120 of the keyed portion 95 may have a chamfer 117 to allow easier insertion into the hollowed portion 115 . The keyed portion 95 includes a column 125 that extends beyond and coaxially with the shoulder 90 . A tooth 130 extends radially outwardly from the column 125 that fits in the hollowed portion 115 . The tooth has a width W 1 , a height H 1 and a length L 1 . A first magnet 135 , which may be permanent and made of a durable alloyed rare earth material including neodymium, or the like, is attached by cementing or the like, into place in an indentation 140 in a side 145 of the tooth 130 . As shown in FIG. 3A , the first magnet 135 is recessed into the indentation 140 to minimize a force of a golf club swing on the first magnet 135 . Such force would be carried by the tooth 130 to wall 170 in the wider portion 110 . The first magnet 135 may also be cemented to the side 145 and not be placed in an indentation 140 . Referring back to FIG. 3 , the wider portion 110 of the elongated portion 105 has a slot 150 . The slot has a width W 2 that is roughly equal to the width W 1 , and a height H 2 that is equal or greater than the height H 2 so that if the tooth is inserted in the slot 150 , the tooth height H 1 is equal to a the height H 2 of the surface 155 of the wider portion 110 or extends there beyond such that a mild interference fit as defined above exists. The slot 150 is defined by an insertion portion 160 extending through the wider portion 110 and an open attachment portion 165 that extends circumferentially around and through the wider portion 110 from the insertion portion 160 . The insertion portion 160 has a length L 2 that forms a mild interference fit, as above, with the length L 1 of the tooth 130 . The slot attachment portion 165 terminates in a wall 170 of the wider portion 110 . A second magnet 175 , which may also be permanent, is attached within a recess 180 in the wall 170 . As above, the second magnet 175 may be recessed in the recess 180 or attached to the wall 170 . One of the first magnet 135 and the second magnet is arranged so that its positive pole faces away from the wall 170 and the other of the first magnet 135 and the second magnet is arranged so that its negative pole faces away from the side 145 of the tooth 130 . The first and second magnets 135 , 175 will then attract each other during operation because positive pole and a negative pole attract one another. The joint 55 is defined by: the hollowed portion 115 of the wider portion 110 , the slot 150 , and the second magnet 175 in the wall 170 in the shaft 15 ; and by the tooth 130 , the first magnet 135 , the column 125 , the shoulder 90 , and the flared portion 85 of the club head 20 . To mount a club head 20 to a shaft 15 , a golfer chooses a club head 20 for a required shot or other particular use. For instance, if the required shot is under one hundred yards, the golfer may choose a wedge club head 45 and if the ball is on a green (not shown), the golfer may choose a putter club head 50 . The golfer grasps the putter club head 50 , inserts the column 125 within the hollowed portion 115 , aligns the tooth 130 with the insertion portion 160 of the slot 150 , slides the tooth through the insertion portion 160 until the tooth contacts the wider portion and until the shoulder 90 contacts the wider portion 110 (which happens simulataneously), and rotates either the club head 50 or the shaft 15 so that the tooth moves circumferentially in the attachment portion 165 of the slot 150 until the side 145 of the tooth 130 engages the wall 170 in the wider portion 110 . At this point the first and second magnets 135 , 175 ensure that the tooth 130 does not disengage from the wall 170 . In the instant example, the tooth 130 rotates counter-clockwise relative to the shaft 15 , so that impact with a golf ball (or turf or sand or a ball washer—not shown) by a club head 20 does not cause a club head 20 to disengage the magnets 135 , 170 for a right-handed golfer. As one of ordinary skill in the art can appreciate, if a golfer is left-handed, the slot 150 would be arranged so that clockwise rotation of the tooth 130 is required. Once a shot is completed and another club head 20 is desired, e.g., the golfer is done putting and is ready to select another club head 20 , the process is reversed. The right-handed golfer, the club head 50 is rotated clockwise relative to the shaft 15 so that the tooth 130 moves thereby disengaging the magnets 135 , 175 and the tooth engages wide portion wall 185 . The tooth 130 is then slid through the insertion portion 160 and the column 125 disengages the hollowed portion 115 . Another club head, such as driving iron club head 25 may be coupled to the shaft 15 . Referring now to FIG. 4 , golf bag 60 is shown. The bag 60 has a shoulder strap 200 attached at either end to a body 205 . Though the body 205 is shown as cylindrical, other shapes are contemplated herein. The bag 60 has a plurality of holster-shaped outer pockets 210 attached to an outer surface 215 of the bag 60 . The interior 220 of the bag 60 is hollow so that the shaft 15 or other shafts may be carried therein. The bag is lighter because the golfer does not have to carry fourteen shafts due to the unique nature of the joint 55 described herein, only one shaft 15 is necessary for a golfer to carry. The bag 60 may have other pockets 230 to carry balls, tees, markers, divot tools, distance lens, etc. (not shown) as may be necessary. The pockets 210 , which may be holster-shaped, have an elongated section 235 for fitting the lower shafts 75 therein and a wider portion 240 extending above the elongated section 235 for fitting the club head 20 therein. To protect the club heads 20 from the elements, the wider portion may be capped by a cover 245 that attaches to the outside surface 250 of the pocket 210 by a zipper 255 . Indicia 260 may be placed on each pocket 210 to enable a golfer to properly store and select each club head 20 . The elongated sections 235 are sized to accommodate a length of each lower shaft 75 . In other words, the elongated sections 235 are longer for a 3 iron club head 30 than for a 9 iron club head 40 . The pockets may be aligned (e.g., for pockets with club heads for a 2, 3, 7 and 9 iron) in such a way that the lengths of the lower shafts 75 for each column of pockets equal the lengths of the lower shafts 75 for other aligned pockets (as for the club heads for a driver “D”, 4, 6, pitching wedge “PW” that may equal the club heads for the 2, 3, 7 and 9 iron) to maximize space on the surface 250 of the bag 60 . The pockets 210 may also interleave such that pockets 210 aligned in a first column 260 may have each pocket with the wider portion 240 extending to the right (as seen in FIG. 4 ) and the second column 270 may have pockets 210 with their wider portions 275 extending to the left and below the wider portions 240 of the first column 260 to create a staggering of the pockets 210 in the first column 260 and the second column 270 . This staggering allows for the placement of more club heads 20 on the bag 60 . The applicants have discovered that the prior art systems have mechanical connections that tend to wear over time creating tolerances (slop) in the joints. This slop may cause the joints to loosen thereby lessening the feel a golfer expects when hitting the ball because of relative motion in the joints. The golfer may also lose power because of energy absorbed in the joint due to relative motion therein. The joints may also cause noise. Because the embodiments shown herein use first and second magnets, which may be permanent, even if the mild interference fits are loosened by wear, the first and second magnets 135 , 175 will keep the tooth 130 in contact with the wider portion 110 so that there is minimal or no movement in the joint 55 to enhance feel, minimize noise, maximize power and maximize the golfing experience over time. Although an example embodiment has disclosed, a worker of ordinary skill in the art would recognize that certain modifications would come within the scope of the claims. For example, any feature of the various examples described above may be used with any other feature of a different example. For that reason, the following claims should be studied to determine their true scope and content.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention relates to package or parcel delivery boxes and specifically to package or parcel delivery boxes with self-locking mechanisms that allow the package or parcel delivery box to remain open and unlocked when empty but automatically lock after a package or parcel is placed inside and the lid is closed. [0003] 2. Description of Related Art [0004] There are other self-locking package or parcel delivery boxes in the prior art however none disclose a self-locking mechanism as described below. BRIEF SUMMARY OF THE INVENTION [0005] Self-locking parcel delivery box is a container with a special locking mechanism that allows a hinged lid to remain unlocked and openable while the container is empty but then automatically lock shut after a package or parcel has been placed inside the container and the hinged lid is closed. Special locking mechanism comprises, among other things, a rotating striker plate that remains in a closed position while container is empty but then rotates to an open position when a package or parcel is placed inside container. With rotating striker plate in the closed position, a spring loaded latch cannot extend outward to latch or lock into a latch window when the hinged lid 86 is closed, thereby keeping hinged lid unlocked and openable. With rotating striker plate is in the open position, the spring loaded latch will latch and lock into latch window when the hinged lid is closed, thereby locking hinged lid shut. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1 is a top perspective view of self-locking parcel delivery box. [0007] FIG. 2 is a top perspective view of self-locking parcel delivery box with hidden view of self-locking mechanism. [0008] FIG. 3 is a front elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism. [0009] FIG. 4 is a side elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism. [0010] FIG. 5 is a front elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism just before a package or parcel is placed inside self-locking parcel delivery box. [0011] FIG. 6 is a side elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism just before a package or parcel is placed inside self-locking parcel delivery box. [0012] FIG. 7 is a blowup view of the inner surface of striker plate window just before a package or parcel is placed inside self-locking parcel delivery box. [0013] FIG. 8 is a front elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism just after a package or parcel was placed inside self-locking parcel delivery box. [0014] FIG. 9 is a side elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism just after a package or parcel was placed inside self-locking parcel delivery box. [0015] FIG. 10 is a blowup view of the inner surface of striker plate window just after a package or parcel was placed inside self-locking parcel delivery box. [0016] FIG. 11 is a front elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism after a package or parcel was placed inside self-locking parcel delivery box and hinged lid has been closed to lock hinged lid shut. [0017] FIG. 12 is a side elevation view of self-locking parcel delivery box with hidden view of self-locking mechanism after a package or parcel was placed inside self-locking parcel delivery box and hinged lid has been closed to lock hinged lid shut. DEFINITION LIST [0018] [0000] Term Definition 5 Self-Locking Parcel Delivery Box 10 Vertical Support Plate 12 Floating Base Plate Window 14 Spring Attachment Point on Vertical Support Plate 16 Rotating Striker Plate Pivotal Attachment Means 18 Striker Plate Window 20 Floating Base Plate 22 Spring Attachment Point on Floating Base Plate 30 Floating Stanchion 32 Slideable Attachment Means 40 Spring 50 Swing Arm 52 Lower Pivotal Attachment Means 54 Upper Pivotal Attachment Means 60 Rotating Strike Plate 62 Vertical Support Plate Pivotal Attachment Point on Rotating Striker Plate 63 Swing Arm Pivotal Attachment Point on Rotating Striker Plate 64 Striker Plate Protrusion 70 Latch Assembly 72 Spring Loaded Latch 74 Key 76 Keyhole 80 Container 82 Container Bottom 84 Container Side 86 Hinged Lid 88 Hinge 100 Package or Parcel DETAILED DESCRIPTION OF THE INVENTION [0019] Self-locking parcel delivery box 5 comprises: a vertical support plate 10 , a floating base plate 20 , a floating stanchion 30 , at least one spring 40 , a swing arm 50 , a striker plate 60 , a latch assembly 70 , and a container 80 . [0020] Container 80 comprises: a container bottom 82 , at least one container side 84 , a hinged lid 86 , and a hinge 88 . Container 80 is a secure hollow container in the shape of a rectangular cuboid, a cube, or a cylinder with an interior and an exterior. Container 80 is impervious to water. In the cases of a rectangular cuboid shaped container 80 and a cube shaped container 80 , container 80 comprises four container sides 84 that are each rigid planar members that are impervious to water with a width, a height, an inner surface, an outer surface, an upper end, and a lower end. In the case of a cylindrical shaped container 80 , container 80 comprises one container side 84 that is a rigid cylindrical shaped member that is impervious to water with a circumference, a height, an inner surface, an outer surface, an upper end, and a lower end. Container bottom 82 is a rigid planar member that is impervious to water with an upper surface and a lower surface. Inner surfaces of container sides 84 face the interior of container 80 . Exterior surfaces of container sides 84 face the exterior of container 80 . In the case of a rectangular cuboid shaped container 80 , container bottom 82 is rectangular shaped or square shaped. In the case of a cube shaped container 80 , container bottom 82 is square shaped. In the case of a cylindrical shaped container 80 , container bottom 82 is circular shaped. All outer edges of container bottom 82 are rigidly attached to container side(s) 84 to form a watertight connection or seam there between. Watertight connection or seam must be sturdy, waterproof, weatherproof, and able to withstand attempts to pry the seam open in order to prevent someone from breaking into the container 80 . Container bottom 82 and container side(s) 84 form an open-topped watertight receptacle. Hinged lid 86 is a rigid planar member that is impervious to water with an outer edge, an upper surface, and a lower surface. In the case of a rectangular cuboid shaped container 80 , hinged lid 86 is rectangular shaped or square shaped. In the case of a cube shaped container 80 , hinged lid 86 is square shaped. In the case of a cylindrical shaped container 80 , hinged lid 86 is circular shaped. Hinge 88 is a hinge or bearing member that pivotally attaches or connects hinged lid 88 to a container side 84 . Hinge 88 is positioned vertically so that its axis of rotation is positioned horizontally. Hinge 88 has an upper end and a lower end. The lower end of hinge 88 is rigidly attached to the upper end of a container side 84 . The upper end of hinge 88 is rigidly attached to the outer edge of hinged lid 86 . Hinge 88 functions to allow the pivotal attachment of hinge 88 to a side 84 of container 80 to allow for the rotation of hinged lid 82 about hinge 88 . Hinged lid 86 rotates upwards to open hinged lid 86 and rotates downwards to close hinged lid 86 . When hinged lid 86 is closed, it is positioned horizontally and forms a waterproof and weatherproof connection with the upper end(s) of all container side(s) 84 . When hinged lid 86 is closed and locked shut, it forms sturdy connection with the upper end(s) of all container side(s) 84 that is able to withstand attempts to pry hinged lid 86 open in order to prevent someone from breaking into container 80 when it is locked shut. In best mode, there are two hinges 88 . [0021] Vertical support plate 10 is a rigid oblong planar member with an overall width, an overall height, a lower end, an upper end, an inner surface, and an outer surface. Vertical support plate 10 is positioned vertically inside the interior of container 80 with its lower end rigidly affixed to the upper surface container bottom 82 with the longitudinal axis of vertical support plate 20 perpendicular to container bottom 80 . The inner surface of vertical support plate 10 faces the interior of container 80 . The outer surface of vertical support plate 10 faces the exterior of container 80 . Vertical support plate 10 is positioned adjacent to a container side 84 so that there is about 0.125 to 2.0 inches of space between the outer surface of vertical support plate 10 and the inner surface of the adjacent container side 84 . Floating stanchion 30 , at least one spring 40 , swing arm 50 , and rotating striker plate 6 are located and housed between the outer surface of vertical support plate 10 and the inner surface of the adjacent container side 84 as depicted. Vertical support plate 10 is a sturdy vertical support member that solely supports floating base plate 20 , floating stanchion 30 , at least one spring 40 , swing arm 50 , rotating striker plate 60 , and the weight of a package or parcel 100 placed inside self-locking parcel delivery box 5 . Floating base plate 20 , floating stanchion 30 , at least one spring 40 , swing arm 50 , rotating striker plate 60 , and package or parcel 100 move or float upwards and downwards relative to vertical support plate 10 , which is stationary and rigidly affixed to container bottom 82 . Vertical support plate 10 also functions as a housing, firewall, or divider plate to separate floating stanchion 30 , at least one spring 40 , swing arm 50 , and rotating striker plate 6 , which are moving parts, from the interior of container 80 where a package or parcel 100 is placed, in order to all keep moving parts from physically contacting or touching package or parcel 100 . Overall width of vertical support plate 10 must be less than the width or circumference of container side 84 and height of vertical support plate 10 must be less than that of container side 84 to allow vertical support plate 10 to fit inside container 80 . Any know attachment means may be used to attach lower end of vertical support plate 10 to upper surface of container bottom 82 such as weld, glue, epoxy, bolts, screws, rivets, clips, or snaps. In best mode, vertical support plate 10 is rectangular. Vertical support plate 10 further comprises a floating base plate window 12 . Floating base plate window 12 is a rectangular shaped void or notch in the lower end of vertical support plate 10 as depicted. Floating base plate window 12 has a width, a height, a left end, a right end and an upper end. Floating base plate window 12 functions to provide clearance for floating base plate 20 to freely float or move vertically upwards and downwards. The width of floating base plate window 12 is slightly large than the width of floating base plate 20 . The height of floating base plate window 12 must be large enough to allow for sufficient vertical movement of floating base plate 20 to yield sufficient rotation of rotating striker plate 60 to allow successful locking and unlocking of latch assembly 70 . This mechanism is described in more detail below. Vertical support plate 10 further comprises at least one spring attachment point 14 on its outer surface at its upper end. Typically, there is one spring attachment point 14 for each spring 40 . Spring attachment point 14 is a means to reversibly attach the upper end of a spring 40 thereto. Spring attachment means could be any known means such as a hook, a ring, an eye, a hole, a connector, a fitting, fastener, screw, bolt, staple, nail, or any other known means. Vertical support plate 10 further comprises a rotating striker plate pivotal attachment means 16 on its outer surface at its upper end. Rotating striker plate pivotal attachment means 16 functions to pivotally attach rotating striker plate 60 to the outer surface of vertical support member 10 at a location just below rotating striker plate window 18 as depicted. Rotating striker plate pivotal attachment means 16 is a means to pivotally attached rotating striker plate 60 to vertical support plate 10 , which could be accomplished by a hinge, a bearing, an axle, a hub, a spindle, a pin, a rivet, a screw, a bolt, or any other know means of pivotal attachment. Vertical support plate 10 further comprises a striker plate window 18 . Striker plate window 18 is a rectangular shaped or semi-rectangular shaped void or hole in the upper end of vertical support plate 10 that functions to receive a spring loaded latch 72 when hinged lid 86 is locked shut. Striker plate window 18 must be sized slight larger than spring loaded latch 72 so that spring loaded latch 72 may penetrate through striker plate window in order to lock latch assembly 70 to striker plate window 18 . One end of rotating striker plate 60 , called the striker plate protrusion 66 , is inserted through striker plate window 18 as depicted. Rotating striker plate 60 rotates back and forth within striker plate window 18 in order to either disallow hinged lid 86 from locking shut or to allow hinged lid to lock shut. As discussed below, rotating striker plate 60 rotates back and forth to block striker plate window 18 so that spring loaded latch 72 cannot penetrate into striker plate window 18 or to unblock striker plate window 18 to allow spring loaded latch 72 to penetrate striker plate window 18 and lock hinged lid 86 shut. [0022] Floating base plate 20 is a rigid horizontal planar member with an upper surface and a lower surface. In the case of a rectangular cuboid shaped container 80 , floating base plate 20 is rectangular shaped or square shaped. In the case of a cube shaped container 80 , floating base plate 20 is square shaped. In the case of a cylindrical shaped container 80 , floating base plate 20 is circular shaped. The outer dimensions of floating base plate 20 are slightly smaller than the inner dimensions of container 80 so that floating base plate may freely slide upwards and downwards without its edges touching the inner surface of container side(s) 84 but also without leaving too much clearance to allow for a package or parcel 100 to fall there between. The upper surface of floating base plate 20 is rigidly attached to the lower end of floating stanchion 30 . Floating base plate 20 further comprises at least one spring attachment point 22 on its upper surface. Typically, there is one spring attachment point 22 for each spring 40 . Spring attachment point 22 is a means to reversibly attached the lower end of spring 40 thereto. Spring attachment means could be accomplished any known means such as a hook, a ring, an eye, a hole, a connector, a fitting, fastener, screw, bolt, staple, nail, or any other known means. [0023] Floating stanchion 30 is a rigid oblong planar member with an overall width, an overall height, a lower end, an upper end, an inner surface, and an outer surface. Floating stanchion 30 is a sturdy vertical support member. Floating stanchion 30 is positioned vertically between the outer surface of vertical support plate 10 and the inner surface of the adjacent container side 84 as depicted. The lower end of floating stanchion 30 is rigidly affixed to the upper surface of floating base plate 20 with the longitudinal axis of floating stanchion 30 perpendicular to floating base plate 20 . Floating stanchion 30 further comprises a slideable attachment means 32 . Slideable attachment means 32 is a means to slideably attach floating stanchion 30 to the outer surface of vertical support plate 10 so that floating stanchion 30 may slide vertically upwards and downwards, but is prevented from movement in all other directions. Slideable attachment means 32 may be accomplished by any know means such as: wheel and track, tongue and groove, guide, bearing, loop, collar, or any other known means. In best mode, slideable attachment means 32 is two horizontal collars or loops rigidly attached to the inner surface of vertical support member 10 , one at the upper end of floating stanchion 30 , one at the lower end of floating stanchion 30 , with floating stanchion 30 running vertically and inserted through each as depicted. With this mode the two collars or loops each have an inner dimension that is sized to make a slip fit with the outer dimension of the horizontal cross section of floating stanchion 30 so that floating stanchion 30 may freely slide upwards and downwards but is retained from moving in all other directions. [0024] At least one spring 40 is a vertical spring member with an upper end and a lower end. At least one spring 40 is a coil spring, flat spring, machined spring, compression spring, cantilever spring, leaf spring, v-spring, gas spring, torsion spring, hairspring, rubber band, elastic band, or any other type of spring. Best mode at least one spring 40 is a coil spring. The upper end of at least one spring 40 is connected to spring attachment point 14 on vertical base plate 10 . The lower end of at least one spring 40 is connected to spring attachment point 22 on floating base plate 20 . At least one spring 40 must be of the proper length and tension to apply continuous upward tension on floating base plate 20 to pull the floating base plate 20 all the way upwards to contact and rest against upper end of floating base plate window 12 when there is no package or parcel 100 sitting on the upper surface of floating base plate 20 , but still allow the floating base plate 20 fall all the way downwards to rest on the upper surface of container bottom 82 when a package or parcel 100 sitting on the upper surface of floating base plate 20 . In best mode, there are two springs 40 , where one is positioned on each side of floating stanchion 30 to provide equal or balanced upward tension on each side of floating stanchion 30 . [0025] Swing arm 50 is a rigid oblong member with an upper end and a lower end. Swing arm 50 has a lower pivotal attachment means 52 at its lower end and an upper pivotal attachment means 54 at its upper end. Lower pivotal attachment means 52 is a means to pivotally attach the lower end of swing arm 50 to the upper end of floating stanchion 30 . Pivotal attachment is such that swing arm 50 may freely rotate around the point of pivotal attachment and remains connected to the upper end of floating stanchion 30 . Pivotal attachment could be accomplished by a hinge, a bearing, an axle, a hub, a spindle, a pin, a rivet, a screw, a bolt, or any other know means of pivotal attachment. Upper pivotal attachment means 54 is a means to pivotally attach the upper end of swing arm 50 to swing arm pivotal attachment point 63 on rotating striker plate 60 . Pivotal attachment is such that swing arm 50 may freely rotate around the point of pivotal attachment and remains connected to the pivotal attachment point 63 on rotating striker plate 60 . Pivotal attachment could be accomplished by a hinge, a bearing, an axle, a hub, a spindle, a pin, a rivet, a screw, a bolt, or any other know means of pivotal attachment. [0026] Rotating striker plate 60 is a rigid tri-planar member wherein two parallel planar members are rigidly connected together by a third planar member perpendicular thereto. Rotating striker plate 60 comprises a plane one, a plane two, and a plane three, each with a first and second end. Planes one and two are parallel to each other and plane three is perpendicular to planes one and two. The first end of plane three rigidly attached to second end of plane one and the second end of plane three rigidly attached to first end of plane two to yield a rigid step-shaped structure with two steps. Rotating striker plate 60 is positioned within rotating striker plate window 18 so that: plane one is adjacent to and parallel with the outer surface of vertical support plate 10 , plane two is adjacent to and parallel with the inner surface of vertical support plate 10 , and plane three is perpendicular to vertical support plate 10 and straddles rotating striker plate window 18 with its first end adjacent to the outer surface of vertical support plate 10 and its second end adjacent to the inner surface of vertical support plate 10 , as depicted. Rotating striker plate 60 further comprises a swing arm pivotal attachment point 62 located on the first end of plane one. Rotating striker plate 60 is pivotally attached to swing arm 50 by rotating striker plate pivotal attachment means 16 . As stated, pivotal attachment could be accomplished by a hinge, a bearing, an axle, a hub, a spindle, a pin, a rivet, a screw, a bolt, or any other known means of pivotal attachment. Rotating striker plate 60 further comprises a swing arm pivotal attachment point 63 also located on plane one, at a location that is above vertical support plate pivotal attachment point 62 . As stated, rotating striker plate 60 is pivotally attached to the upper end of swing arm 50 by upper pivotal attachment means 52 . Rotating striker plate 60 further comprises a striker plate protrusion 64 . Striker plate protrusion 64 is plane two of striker plate 60 . Striker plate protrusion 64 functions to either: block striker plate window 18 to prevent spring loaded latch 72 from penetrating through striker plate window 18 in order to keep hinged lid 86 from locking shut or unblock striker plate window 18 to allow spring loaded latch 72 to penetrate through striker plate window 18 in order to lock hinged lid 86 shut. As a result of its mechanical connection or linkage to floating base plate 20 , rotating striker plate 60 blocks striker plate window 10 when floating base plate 20 is in its upper most position and unblocks striker plate window 10 when floating base plate 20 is in its lower most position. [0027] Latch assembly 70 comprises a housing, an internal lock mechanism (not depicted), a spring loaded latch 72 , a key 74 , and a keyhole 76 . Internal lock mechanism is a lock mechanism that functions to retract spring loaded latch 72 in response to the turning of key 74 when positioned in keyhole 76 . Internal lock mechanism is a standard lock mechanism that allows the user to retract spring loaded latch 72 with the rotation of key 74 when properly inserted into keyhole 76 . Spring loaded latch 72 is a standard latch with bias pressure forcing the latch to extend outward, which can be overcome by pressing the spring loaded latch 72 inward with about 0.25-10 pounds of force. [0028] To use self-locking parcel delivery box 5 , self-locking parcel delivery box 5 is placed in empty unlocked condition at a location where packages or parcels are normally delivered. At the time of package or parcel 100 delivery, hinged lid 86 is lifted or opened, the package or parcel 100 is placed inside, where the weight of the package or parcel 100 pushes or forces floating base plate 20 downwards so that rotating striker plate 60 rotates downwards to unblock striker plate window 18 . Hinged lid 86 is then closed and pushed shut so that spring loaded latch 72 penetrates through striker plate window 18 to effectuate the locking shut of hinged lid 86 on container 80 . At the time of package or parcel 100 retrieval from self-locking parcel delivery box 5 , key 74 is placed in keyhole 76 and rotated therein to cause spring loaded latch 72 to retract from penetrating through striker plate window 18 to allow for hinged lid 86 to unlock. Hinged lid 86 is then lifted or opened and package or parcel 100 is lifted off of floating base plate 20 and retrieved from container 80 . The lifting of package or parcel 100 off of floating base plate 20 causes the floating base plate 20 to rise upwards to cause rotating striker plate 60 to rotate back upwards to block striker plate window 18 to allow for hinged lid to remain openable and unlocked until another package or parcel 100 is placed inside container 80 .

1a

BACKGROUND AND SUMMARY OF THE INVENTION This invention relates to novel substituted pyrazolo-rings fused to nitrogen containing heterocyclic rings having the following formula: ##STR2## in which at least one of Y, Z or W is N or N-O and the remainder of Y, Z or W is C-R wherein R is hydrogen; halogen; nitro; cyano; alkyl; alkoxyalkyl acetoxymethyl; hydroxymethyl; haloalkyl; formyl; alkylcarbonyl; carboxy and its salts; COO alkyl; azido (N 3 ); amino; substituted amino wherein the substituents are alkyl, alkoxy, hydroxy, formyl, alkylcarbonyl, alkoxycarbonylalkyloxy, alkoxycarbonylalkylthio, alkoxycarbonylalkylidenecarbonyl, hydroxycarbonylalkoxy, hydroxycarbonylthio, cyanoalkoxy, hydroxycarbonylalkyledinecarbonyl, alkylsulfonyl, haloalkylsulfonyl, aminocarbonyl, (di)alkylaminocarbonyl, alkoxycarbonyl, alkoxyalkyl, hydroxycarbonylalkyl, alkoxycarbonylalkyl, and amino; carboxyamido; substituted carboxyamido wherein said substituents can be selected from alkyl, alkylsulfonyl, and haloalkylsulfonyl; sulfonamido wherein the N is substituted with hydrogen and/or alkyl; VR 6 wherein V is O and S(O) m and R 6 is selected from the group hydrogen, alkyl, haloalkyl, cyanoalkyl, alkoxycarbonylalkyl, hydroxycarbonylalkyl and aminocarbonylalkyl wherein the N is substituted with hydrogen and/or alkyl; m is 0 to 2; R 1 is hydrogen and halogen; R 2 is hydrogen, nitro, halogen, cyano, alkylthio, alkylsulfinyl, alkylsulfonyl, and alkoxy; R 3 is halogen, haloalkyl, cyano, alkylthio, alkylsulfinyl, and alkylsulfonyl; R 4 is hydrogen and halogen; X is N or C-R 5 ; wherein R 5 is hydrogen, haloalkyl, halogen, cyano, nitro, alkythio, alkylsulfinyl, alkylsulfonyl, and alkoxy; and agriculturally acceptable salts thereof. DESCRIPTION OF THE INVENTION Within the scope of the above invention, certain embodiments are preferred as follows: R is preferably halogen, nitro, cyano, lower alkyl, lower haloalkyl, alkoxy, alkoxyalkyl, alkylsulfonyl, alkoxycarbonylalkylthio, and alkythio. More particularly preferred groups are chloro, bromo, methyl, ethyl, trifluoromethyl, cyano, ethylthio, ethyl sulfonyl and alkoxycarbonylalkylthio. R 1 is hydrogen. R 2 is halogen. Particularly preferred is chloro or fluoro. R 3 is halo or haloalkyl. Particularly preferred is trifluoromethyl. R 4 is hydrogen. X is preferably N or C-halogen particularly C-chloro. The term "alkyl" and all groups containing alkyl portions are intended to include straight-chain, branched-chain and cyclic groups. Examples are methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl and t-butyl. Each alkyl member may contain one to six carbon atoms. For example (C 1 -C 6 )alkoxy(C 1 -C 6 )alkoxy. In the above definitions the term "halogen" includes fluoro, chloro, bromo and iodo groups. In polyhalogenated groups the halogens may be the same or different. The term haloalkyl refers to the alkyl group substituted by one or more halogen atoms. The compounds of the present invention, have been found to be active herbicides, possessing utility as pre-emergence and post-emergence herbicides and useful against a wide range of plant species including broadleaf and grassy species. This invention therefore also relates to a method for controlling undesirable vegetation comprising applying to a locus where control of such vegetation is desired, either prior or subsequent to the emergence of such vegetation, a herbicidally effective amount of a compound as described herein, together with an inert diluent or carrier suitable for use with herbicides. The terms "herbicide" and "herbicidal" are used herein to denote the inhibitive control or modification of undesired plant growth. Inhibitive control and modification include all deviations from natural development such as, for example, total killing, growth retardation, defoliation, desiccation, regulation, stunting, tillering, stimulation, leaf burn and dwarfing. The term "herbicidally effective amount" is used to denote any amount which achieves such control or modification when applied to the undesired plants themselves or to the area in which these plants are growing. The term "plants" is intended to include germinated seeds, emerging seedlings and established vegetation, including both roots and above-ground portions. The term "agriculturally acceptable" salt includes sodium, potassium, calcium, ammonium and magnesium salts. The process for making the compounds of this invention will be more fully understood by reference to the following examples: EXAMPLE 1 PYRAZOLO [4.3-b]PYRIDINES Preparation of 5, 6-dimethyl-1-[2,6-dichloro-4-trifluoromethylphenyl]-1-H-pyrazolo [4,3-b] pyridine (Compound 1 in Table I) ##STR3## To 200 milliliters (mL) of 20% fuming sulfuric acid, cooled to 0° C., was slowly added 21.20 grams (g) of 2,3,6-trimethylpyridine. An excess (25%) of solid potassium nitrate was added and the mixture was heated at 100° C. for 8 hours and at 125°-130° C. for 8 hours. The cooled reaction mixture was poured into 2 liters of ice. Solid sodium carbonate was slowly added to the mixture until an organic solid appeared. An additional 20 g of sodium carbonate was added and the solution was extracted twice with ether. The ether extracts were dried and concentrated to give 22.94 g of solid 5-nitro-2,3,6-trimethylpyridine, m.p.=53° C. ##STR4## An 18.7 g sample of 5-nitro-2,3,6-trimethylpyridine was dissolved in 200 mL of methanol and 100 mg of 5% palladium on carbon was added. Hydrogenation was performed at 45 lb. and yielded the crude amino compound after 45 minutes. The compound was filtered through diatomaceous earth, concentrated under vacuum, dissolved in 50 mL of methylene chloride, and then 20 mL of acetic anhydride was added. The mixture was heated for 1 hour on a steam bath and poured onto 300 mL of freshly prepared 5% aqueous sodium carbonate. The aqueous solution was extracted with methylene chloride, dried, concentrated under vacuum, and the resulting solid tritiated with pentane to give 18.3 g of 5-(acetylamino) - 2,3,6-trimethylpyridine, m.p. 89°-92° C. ##STR5## The reaction was run similar to that described by D. Chapman and J. Durst, J. Chem. Soc. Perkin I, 2398 (I980). A 12.40 g sample of the 5-(acetylamino)-2,3,6-trimethylpyridine was combined with 22 mL of acetic anhydride, 22 mL of acetic acid, and 13 g of potassium acetate in 200 mL of benzene. The mixture was brought to relux. A solution of an excess of amyl nitrite, (11 g) in benzene (40 mL), was added to the refluxing solution over a period of 2 hours and refluxing was continued an additional 12 hours. The reaction was cooled and stirred, with 200 mL of 5% aqueous sodium carbonate, for 3 hours. The organic phase was separated, dried with anhydrous sodium sulfate, concentrated under vacuum and chromatographed (silica gel: methylene chloride/ether) to give 4.94 g of 1-acetyl-5,6-dimethylpyrazolo [4,3-b] pyridine. ##STR6## A 3.80 g sample of 1-acetyl-5,6-dimethylpyrazolo [4,3-b] pyridine was heated with 25 mL of 20% aqueous hydrochloric acid for 11/2 hours on a steam bath. The aqueous solution was cooled, neutralized and extracted with methylene chloride. The methylene chloride extracts were dried and concentrated to 3.1 g of crude, deacylated pyrazolopyridine. This crude product was dissolved in 40 mL of dimethylformamide and 6 g of powdered potassium carbonate was added along with the addition of 5.4 g 3,5-dichloro-4-fluorobenzotrifluoride. After stirring for 2-72 hours, the reaction was poured into 250 mL of ice water and 150 mL of ether was added. The organic phase was separated, washed twice with water and dried. Chromatography gave 0.891 g of a pure solid, insoluble in pentane. The product, 5,6-dimethyl-1-[2,6-dichlor-4-trifluoromethylphenyl]-1 H-pyrazolo [4,3-b] pyridine (Compound No. 1 in Table 1) had m.p.=135°- 136° C. EXAMPLE 2 PYRAZOLO [4,3-c]PYRIDINES PREPARATION OF VARIOUS 1-ARYL-4-METHYL-PYRAZOLO [4,3-c]PYRIDINES ##STR7## A sample of 175 mL of 30% hydrogen peroxide was added slowly to 100 g 2,3-dimethylpyridine in 1.0 L AcOH. The temperature was kept below 85° C. After the addition was complete, the mixture was gradually heated to 90° C. and after 3 hours stirred at 60° C. for 18 hours. The volume was reduced under vacuum. Yield 130 g N-oxide as a light oil (contaminated by acetic acid). This crude product was used in the next step without further purification. 4-nitro-2.3-dimethylpyridine N-oxide To 400 mL of concentrated H 2 SO 4 was added slowly 130 g of impure 2,3-dimethylpyridine N-oxide. Fuming HNO 3 (330 mL) was slowly added at a rate to keep the temperature between 120° C. and 170° C. After addition was complete, the temperature was held at 103° C. for 3 hours and then the reaction was cooled. The crude reaction was added to 1 kg ice in a large pan, then, with stirring, 1.1 kg Na 2 CO 3 was added. After cooling to room temperature, the solids were removed by suction filtration from the solution. The filtrate was extracted with chloroform. The solids were washed with hot chloroform (3 times). The combined reduced organic extracts yielded 110 g of the crude desired nitropyridine N-oxide as an orange solid. ##STR8## 4-acetylamino-2,3-dimethylpyridine A flask was charged with 50 g of the nitropyridine N-oxide, 200 mL ethanol, 50 mL H 2 O and 10 mL concentrate HCl. The solution was heated to near reflux. Iron powder (100 g) was added in portions to the refluxing mixture. The crude product was filtered and washed with hot methanol. The solution was reduced under vacuum to yield 40 g of crude amino pyridine as a dark oil. The above was stirred in excess acetic anhydride overnight at room temperature, then reduced under vacuum. The product was dissolved in 500 mL chloroform and 200 g of solid K 2 CO 3 added and stirred for 3 hours, filtered and reduced. Product was filtered through silica. Yield, 40 g of the title compound as a tan solid. ##STR9## 4-methylpyrazolo[4,3-c]pyridines A sample of the acetylaminopyridine can be converted to the 4-(substituted) methyl pyrazolo [4,3-c]pyridines by the conditions described in Example 1. (Compounds 13, 15, 16, 18 and 27) The aryl group may be a substituted phenyl or substituted pyridyl ring wherein the substituents are as heretofore defined as R 2 , R 3 , R 4 and R 5 . ##STR10## 5-oxo-4-methylpyrazolo [4,3-c]pyridine To a solution of 0.5 g 1-[3-chloro-5-trifluoromethyl-2-pyridyl]-4-methylpyrazolo-[4,3-c]pyridine (Compound No. 13) in methylene chloride at 0° C. was added 0.6 g 50% metachloroperoxybenzoic acid. The solution was stirred for 18 hours at room temperature, then was washed with 1 mL sodium hydroxide, dried with (MgSO 4 ) and reduced under vacuum to yield 0.6 g 1-[3-chloro-5-trifluoro-methyl-2-pyridyl]-4-methylpyrazolo [4,3-c]pyridine-5-(N)-oxide as a tan solid; m.p. 186°-187° C. (Compound No. 16). ##STR11## 4-acetylamino-2,3-dimethylpyridine N-oxide 200 mL 30% peracetic acid in acetic acid was slowly added to a solution of 50 g 4-acetylamino-2,3-dimethylpyridine in 100 mL glacial acetic acid at 60° C. The solution was held at 70° C. for 12 hours then reduced under vacuum heated by a 50° C. water bath. Yield, 58 g N-oxide. 2-cyano-4-acetylamino-4,5-dimethylpyridine A solution of 10 g 4-acetylamino-2,3-dimethylpyridine N-oxide in 25 g dimethylsulfate was cautiously heated to and maintained at 80° C. for 90 minutes. Reduced under vacuum, dissolved in acetonitrile and added to an ice cold solution of excess potassium cyanide in water. The solution was saturated with sodium chloride and, after stirring 18 hours at room temperature, extracted with chloroform (2 times). The organic extracts were dried (MgSO 4 ) and reduced to 3 g of a mixture. Purified by column chromatography (CH 2 Cl 2 /pentane) to yield 1.3 g of the titled cyano-pyridine. ##STR12## 6-cyano-4-methylpyrazolo [4,3-c]pyridines Using methods previously described in Example 1, 0.6 g 4-acetylamino-2-cyano-5,6-dimethylpyride was converted to the pyrazolopyridine then to the N-arylated pyrazolopyridine. Yield 0.12 g 1-[3-chloro-5-trifluoro-methyl-2-pyridyl]-6-cyano-4-methylpyrazolo [4,3-c]pyridine (Compound No. 14) as a solid; m.p. 144°-145° C. and 0.08 g by product 2-[3-chloro-5-trifluoro-methyl-2-pyridyl]-6-cyano-4-methylpyrazolo [4,3-c]-pyridine as a solid; m.p. 180°-185° C. ##STR13## 4-acetylamino-2-ethanethio-5,6-dimethylpyridine To 15 g 4-acetylamino-2,3-dimethylpyridine N-oxide in methylene chloride was added 5 g dimethylcarbamyl chloride and the reacton was stirred for 30 minutes. Dropwise 4.6 g ethanethiol was added and stirred for 3 days at room temperature. The organic layer was washed with 10% NaHCO 3 , dried (MgSO 4 ) and reduced under vacuum. Purification by column chromatography gave 2.6 g of the ethanethio substituted pyridine. ##STR14## 6-ethanethio-4-methylpyrazolo [4.3-c]pyridines Using methods previously described in Example 1, 1.7 g 4-acetylamino-2-ethanethio-4,5-dimethylpyridine was converted to 0.15 g 1-H-pyrazolapyridine. This was arylated and purified to yield 0.06 g 1-[3-chloro-5-trifluoromethyl-2-pyridyl]-6-ethanethio-4-methylpyrazolo-[4,3-c]pyridine (Compound No. 17). ##STR15## 4-ethanesulfonylpyrazolo [4,3-c]pyridine Meta-chloroperoxybenzoic acid (2.1 eq) was added to the corresponding 6-ethanethio compound (Compound 8) in ice cold methylene chloride and stirred pyernight at room temperature. The solution was washed with 1N sodium hydroxide and water; dried and reduced under vacuum to give 1-[3-chloro-5-trifluoromethyl-2-pyridyl]-4-ethanesulfonyl pyrazolo [4,3-c]pyridine (Compound No. 9). 4-hydroxymethyl-1[3-chloro, 5-trifluoromethyl-2-pyridyl] pyrazolo [4,3-c]pyridine (Compound 27 in Table II) ##STR16## 2-acetoxymethyl-4-acetylamino-3-methyl-pyridine A solution of 8 g (58 mmole) 4-amino-2,3-dimethylpyridine N-oxide in 100 mL acetic anhydride was heated to reflux for 20 minutes; reduced under vacuum to an oil and purified by column chromatography. Yield was 5 g of the title compound as an oil ##STR17## 1H-4-hydroxymethyl pyrazolo [4,3-c]pyridine hydrochloride A flask was charged with 5 g of the above described compound, 2.2 g (1 eq) potassium acetate, 4.6 g (2 eq) acetic anhydride and 0.2 g 18-crown-6 in anhydrous benzene. Heated to reflux and added, over 15 minutes, 4.5 g (2 eq) isoamyl nitrite. The solution was allowed to reflux for 5 hours, cooled, washed with saturated NaCl, dried (MgSO 4 ) and purified by column chromatography. Yield was 1.5 g 1-acetyl-4-acetoxymethyl pyrazolo [4,3-c]pyride as a solid. The above pyrazolopyridine in 20 mL 2 M HCl was refluxed, then reduced under vacuum. Yield was 2 g of the title compound as a soft solid. ##STR18## 1-[3-chloro-5-trifluoromethyl-2-pyridyl]-4-hydroxymethyl pyrazolo [4,3-c]pyridine Two grams of the above described pyrazolopyridine hydrochloride, 5.0 g potassium carbonate and 5.0 g 2,3-dichloro-5-trifluoromethylpyridine in 20 mL dimethyl formamide was heated to 85° C. for 2 hours. The solution was cooled and diethyl ether was added. Then the solution was washed with saturated NaCl, dried, reduced under vacuum, and purified by column chromatography. Yield was 0.6 g of the title compound as a solid (Compound 27). EXAMPLE 3 PYRAZOLO [3,4-c]PYRIDINES Many pyrazolo [3,4-c]pyridines can be prepared from the appropriate pyridines as described in Example 1. In this example Aryl is an optionally substituted phenyl or pyridyl as heretofore described. Preparation of various 1-Aryl-pyrazolo [3,4-c]pyridines: A. Preparation of 1-aryl-5-bromopyrazolo [3,4-c]pyridine ##STR19## The nitration of 2-amino-4-methylpyridine was carried out as described by B. A. Fox, T. C. Threhall, Org. Syn Coll Vol. 5, p 346. This yielded a mixture of isomers in 75% yield. ##STR20## The bromide exchange of the above nitro-aminopyridine was carried out as described by C. F. H. Allen, John R. Thirtle, Org. Syn. Coll. Vol. 3, p 136, 1955. This gave a mixture of isomers in 40% yield. The 3 and 5-nitro isomers were separated by column chromatography to a corresponding yield ratio of 1:3. ##STR21## 3-(or 5)-amino-2-bromo-4-methylpyridines The corresponding nitropyridines were reduced as previously described using aqueous ethanol, iron powder and hydrochloric acid to give the amino pyridines in 80% yield. ##STR22## 5-amino-2-bromo-4-methylpyridine was acylated and reacted as in Example 1. Similarly described is the synthesis of the 1-aryl-5-bromopyrazolo [3,4-c]pyridines (Compound No. 24). B. Preparation of 5-ethanethio (or sulfonyl) - pyrazolo [3,4-c]pyridine ##STR23## A solution of 8 g 2-bromo-4-methyl-5-nitropyridine 6.7 g potassium carbonate and 3.4 g ethanethiol in dimethyl formamide was heated to 70° C. for 6 hours. The solution was washed, dried and reduced under vacuum. Yield, 8 g of ethanethiopyridine as an oil. This was reduced under standard conditions using iron powder, aqueous ethanol and hydrochloric acid to yield 7.0 g 5-amino-2-ethanethio-4-methylpyridine. ##STR24## 5-ethanethio (or sulfonyl)-pyrazolo [3,4-c]pyridine The above 5-amino pyridine was reacted as in Example 1 to give the pyrazolo [3,4-c]pyridine, then the 1-N-arylpyrazolo [3,4-c]pyridine (Compound No. 25). The 1-aryl-5-ethanethiopyrazolo [3,4-c]pyridine can be oxidized in cold (0° C.) methylene chloride with 2.1 g meta-chloroperoxybenzoic acid, as previously described. This yielded the 5-ethanesulfonyl product (Compound No. 26). C. Preparation of 1-aryl-pyrazolo [3,4-c]pyridine ##STR25## 3-amino-4-methylpyridine A solution of 2-bromo-3-nitro-4-methylpyridine in ethanol was reduced under 60 psi hydrogen using a 5% Pd. on carbon catalyst. This yields the 3-amino-4-methylpyridine quantitatively Pyrazolo [3,4-c]pyridine Using the precedures described in Example 2, the corresponding amino-pyridine was reacted to form the pyrazolo [3,4-c]pyridine and the 1-aryl-pyrazolo [3,4-c]pyridine (Compound No. 23). EXAMPLE 4 Preparation of pyrazolo [4,3-c]pyridazine The preparation of the intermediate 3,6-dimethy,4-nitro-1-oxo pyridazine can be found in the following two references. Takanobu et al., Chem. Pharm. Bull. 9, 194 (1961) and Overberger et al., J. Am. Chem. Soc. 78, 1961 (1956); ##STR26## 4-amino-3,6-dimethylpyridazine-N-oxide 3,6-dimethyl-4-nitropyridazine-N-oxide (1.0 g), 0.5 mL water, 5 mL ethanol, 0.025 mL conc HCl and 1.0 g Fe powder were stirred together and heated under reflux. After 30 minutes an additional 1.0 g of Fe and 2 drops conc HCl was added to the mixture. After 2 hours an additional 1 g Fe and 2 drops of conc HCl were added and heating continued for another 5 hours, whereupon 5 mL EtoH, 1 g Fe and 2 drops conc HCl were added. Reflux was continued for 20 hours. The reaction was cooled filtered through celite, the celite washed with CH 3 OH and the filtrate was evaporated to give an orange oil which crystallized on standing (0.88 g yield). Used without further purification. ##STR27## 1 -acetyl-6-methyl-5-oxapyrazolo-(4,3-c)pyridazine 4-amino-3,6-dimethylpyridazine-N-oxide (3 g, 16.5 mmol) and 3.5 mL acetic anhydride were dissolved in 35 mL benzene and heated to reflux. t-Butylnitrite (1.6 g, 16.5 mmol) was dissolved in 10 mL benzene and added over about 1 hour. Heating was continued for 3 hours. The solution was cooled and poured into water. Ethyl acetate was added and the organic extract was dried with MgSO 4 and evaporated to give a brown oil (one spot by TLC silica 5% CH 3 OH/CH 2 Cl 2 ) which solidified upon addition of ether. The solid was collected via vacuum filtration and used without further purification. (2.0 g) 1-H-6 methyl-5-oxapyrazolo (4,3-c)pyridazine 1.1 g of 1-acetyl-6-methyl-5-oxapyrazolo (4,3-c)pyridazine was heated in 10 mL 10% HCl for 30 minutes. The resulting dark red solution was neutralized by addition of NaHCO 3 . The resulting solid was extracted with ethyl acetate, dried with MgSO 4 and evaporated to give 1.1 g of a brown solid which was used without further purification. 1-(2,6 dichloro-4 trifluoromethylphenyl)-6-methyl-5-oxopyrazolo [4,3-c]pyridazine ##STR28## 1 H-6-methyl-5-oxopyrazolo (4,5-c)pyridazine (1.0 g, 6.6 mmol), 3,5-dichloro-4-fluorobenzotrifluoride (1.46 g, 6.6 mmol) and freshly ground potassium carbonate (1.0 g, 7.2 mmol) were added to 18 g DMF and the resulting suspension stirred. A catalytic amount (about 0.05 g) of 18-crown-6 was added and the mixture heated to 60° C. for 30 minutes. The reaction mixture was cooled, poured into 2x volume of water and extracted with 50 mL ethyl acetate and then 50 mL CH 2 Cl 2 . The combined organic extracts were dried with MgSO 4 and evaporated to dryness. Ether (5 mL) was added to the resulting orange oil which then crystallized on standing. The solution was filtered to obtain 540 mg (24%) of an orange brown solid. (MP 201°-204°) (Compound No. 28) EXAMPLE 5 PYRAZOLO [3,4-d]PYRIDAZINE 1-[ 2,4,6-trichlorophenyl]-4-hydroxypyrazolo [3,4-d]pyridazine In general, the intermediate ethyl 4,4 diethoxy-2-ethoxymethylene-3-oxobutanoate can be prepared by known methods described in Bisagni et al., Tetrahedron, 29, 429 (1973) and the target pyridazines can be made by a method similar to that described in J. P. Marquet et al., Tetrahedron, 29, 435 (1973) with slight modifications within the preview of one skilled in the art. Ethyl 4,4 diethoxy-2-ethoxymethylene-3-oxobutanoate (14.4 g, 0.052 mole) was added to a slight excess of 2,4,6-trichlorophenyl hydrazine (11.85 g, 0.056 mole) in 240 mL of dioxane and refluxed for 6 hours with removal of dioxane. The solution was cooled to 20° C. HCl was added and stirred for 16 hours. The organic phase was separated, dried and purified by chromatography. The resulting acetal was eluted with methylene chloride/ether. ##STR29## The acetal (11.8 g) was dissolved in acetic acid (220 mL) and refluxed. A solution of 4.8 g of hydrazine hydrate, in 30 mL of glacial acetic, was added and refluxing was continued. After 6 hours, no starting material was detected by gas chromatography. The cooled mixture was poured into 600 mL of ice-water. The solid formed was filtered off and recrystallized from dichloroethane to give 0.912 g pure product which can exist in either the keto form or enol form. (Compound 29) When produced, the compounds of this invention are of a basic nature. The compounds can be reacted with strong acids to produce agriculturally acceptable salts. Therefore, any reference to the compound in the specification and claims is intended to encompass the agriculturally acceptable salts thereof within its purview. These and other compounds made by the foregoing processes are set forth in Tables I, II and III which follows werein the various substitutent groups are indicated. TABLE I__________________________________________________________________________ ##STR30##Compound Physical ConstantNo. R R.sup.1 R.sup.2 R.sup.3 R.sup.4 X R.sup.5 M.P. °C. or n.sub.D.sup.3°__________________________________________________________________________1 5,6-dimethyl H Cl CF.sub.3 H CR.sup.5 Cl 135.0-136.02 5,6-dimethyl H Cl CF.sub.3 H N 114.0-115.03 5-CH.sub.3 H Cl CF.sub.3 H CR.sup.5 Cl 94.0-98.04 7-CH.sub.3 H Cl CF.sub.3 H N Oil5 5,7-dimethyl H Cl CF.sub.3 H N Oil__________________________________________________________________________ TABLE II______________________________________ ##STR31##CompoundNo. R R.sup.1 R.sup.2 R.sup.3 R.sup.4 X R.sup.5______________________________________ 6 4,6-CF.sub.3 H Cl CF.sub.3 H N 7 4,6-CH.sub.3 H Cl CF.sub.3 H N 8 4-SC.sub.2 H.sub.5 H Cl CF.sub.3 H N 9 4-SO.sub.2 C.sub.2 H.sub.5 H Cl CF.sub.3 H N10 6-SC.sub.2 H.sub.5 H Cl CF.sub.3 H N11 4-CN H Cl CF.sub.3 H N12 H H Cl CF.sub.3 H N13 4-CH.sub.3 H Cl CF.sub.3 H N14 4-CH.sub.3, 6-CN H Cl CF.sub.3 H N15 4-CH.sub.3 H Cl CF.sub.3 H CR.sup.5 Cl16 4-CH.sub.3, 5-O H Cl CF.sub.3 H CR.sup.5 Cl17 4-CH.sub.3, 6-SC.sub.2 H.sub.5 H Cl CF.sub.3 H N18 4-CH.sub.3, 5-O H Cl CF.sub.3 H N19 4,6-CF.sub.3 H Cl CF.sub.3 H CR.sup.5 Cl27 4-CH.sub.2 O H Cl CF.sub.3 H N______________________________________ TABLE III______________________________________ ##STR32##CompoundNo. R R.sup.1 R.sup.2 R.sup.3 R.sup.4 X R.sup.5______________________________________20 5-CH.sub.3 H Cl CF.sub.3 H N21 5-CH.sub.3 H Cl CF.sub.3 H CR.sup.5 H22 7-Cl H Cl CF.sub.3 H N23 H H Cl CF.sub.3 H N24 5-Br H Cl CF.sub.3 H N25 5-SC.sub.2 H.sub.5 H Cl CF.sub.3 H N26 5-SO.sub.2 C.sub.2 H.sub.5 H Cl CF.sub.3 H N______________________________________ TABLE IV__________________________________________________________________________ ##STR33##Compound Physical ConstantNo. Y W Z R.sup.1 R.sup.2 R.sup.3 R.sup.4 X R.sup.5 M.P. °C. or n.sub.D.sup.3°__________________________________________________________________________28 N CCH.sub.3 NO H Cl CF.sub.3 H CR.sup.5 Cl 201-204°29 COH N N H Cl Cl H CR.sup.5 Cl --__________________________________________________________________________ Other compounds included in the inventions are: 4-hydroxyl-1-[2,4,6-trichlorophenyl]pyrazolo [3,4-d]pyridazine, 1-(2,6-dichloro-4-trifluoromethylphenyl) -5-oxopyrazolo [4,3-c]pyridazine, and 4-hydroxy-1-[2,6-dichloro-4-trifluoromethyphenyl]pyrazolo [3,4-d]pyridazine. This list of compounds is in no way intended to limit the invention. HERBICIDAL SCREENING TESTS The compounds listed in the foregoing tables were tested for herbicidal activity by various methods and at various rates of application. The results of some of these tests are given below. As one skilled in the art is aware, the results obtained in herbicidal screening tests are affected by a number of factors that are not readily controllable. Environmental conditions, such as amount of sunlight and water, soil type, soil pH, temperature and humidity, are examples of such factors. Other factors which can affect test results are the depth of planting and the application rate of the herbicide, as well as the nature of the crops being tested. Results will also vary from crop to crop and within the crop varieties. PRE-EMERGENCE HERBICIDAL SCREENING TEST On the day preceding treatment, seeds of several different weed species were planted in sandy loam soil in individual rows using one species per row across the width of a flat. The grassy weeds planted were green foxtail [SETVI] (Setaria viridis), wild oat [AVEFA] (Avena fatua), and watergrass [ECHCG] (Echinochloa crusgalli). Broadleaf weeds utilized were wild mustard [SINAR] (Brassica kaber), velvet-leaf [ABUTH] (Abutilon theophrasti), and annual morningglory (PHBPU) (Ipomoea purpurea). Ample seeds were planted to give about 20 to 40 seedlings per row, after emergence, depending upon the size of the plants. Solutions of the test compounds were made by weighing out 400 (mg) of the test compound into a 60 mL widemouth bottle, then dissolving the compound in 25 mL acetone containing 1% Tween 20 (polyoxyethylene sorbitan monolaurate emulsifier). Additional solvents, not exceeding 5 mL, were used if needed to dissolve the compound. A 20.5 mL aliquot was then taken from the solution and diluted with 25 mL of an acetone:water mixture (19:1) containing 1% Tween 20 to form a sprayable solution. The flats were placed in a greenhouse at 21°-29.5° C., and watered by sprinkling. One day after planting, the flats were sprayed with the spray solution calibrated to deliver 400 L/ha. The application rate was 4.0 kg/ha. The flats were then returned to the greenhouse and water daily by sprinkling. The degree of weed control was estimated and recorded 3 weeks after treatment, as percentage control compared to the growth of the same species in an untreated check flat of the same age. The percent control is the total injury to the plants due to all factors, including inhibited germination, killing of the plant tissue after emergence, stunting, malformation, chlorosis and other types of injury. The control ratings vary from 0 to 100 percent, where 0 represents no effect with growth equal to the untreated control, and 100 represents complete kill; a dash indicates that no test was performed at that level of application. POST-EMERGENCE HERBICIDAL EVALUATION The soil was prepared and seeded with the same varieties as described for the pre-emergence test. The flats were placed in the greenhouse at 21°-29° C. and watered by sprinkling. The seeds of the weed species were planted 10-12 days before treatment. The flats were sprayed with solution at a rate of 4 kg/ha, using a spray solution as prepared in the pre-emergence test. The flats were returned to the greenhouse after spraying and watered daily without wetting the foliage. Three weeks after treatment the degree of weed control was estimated and recorded as percentage control compared to the growth of the same species in an untreated check flat of the same age. The percent control ratings were assigned on the basis as for the pre-emergence evaluation. The results are listed in Table V below. TABLE V__________________________________________________________________________GREENHOUSE HERBICIDAL TEST RESULTSAPPLICATION WEED SPECIESCompound Rate PERCENT INJURYNo. kg/ha Method AVEFA ECHCG SETVI ABUTH PHBPU SINAR__________________________________________________________________________ 1 4.0 PES 90 100 100 100 100 100 4.0 POS 95 100 100 100 100 100 2 4.0 PES 90 100 100 100 100 100 4.0 POS 95 100 100 100 100 100 3 4.0 PES 70 100 100 100 90 100 4.0 POS 20 100 95 100 100 100 4 4.0 PES 0 0 0 0 0 0 4.0 POS 20 50 90 100 100 15 5 4.0 PES 0 0 0 0 0 0 4.0 POS 0 5 5 60 60 30 8 4.0 PES 15 95 100 100 98 98 4.0 POS 5 100 100 100 100 100 9 4.0 PES 10 70 90 70 10 15 4.0 POS 5 40 70 100 100 2010 4.0 PES 90 100 100 100 100 100 4.0 POS 100 100 100 100 100 10011 4.0 PES 95 100 100 100 100 100 4.0 POS 100 100 100 100 100 10012 4.0 PES 10 15 100 100 30 0 4.0 POS 30 30 100 100 100 5013 4.0 PES 25 98 100 100 100 100 4.0 POS 50 85 100 100 100 10014 4.0 PES 0 0 100 100 80 100 4.0 POS 5 15 40 100 100 10020 4.0 PES 20 100 100 70 10 60 4.0 POS 80 100 100 100 100 10021 4.0 PES 30 80 100 100 0 100 4.0 POS 40 95 100 100 100 9522 4.0 PES 0 5 75 90 0 0 4.0 POS 0 0 15 100 90 1528 4.0 PES 100 100 100 100 100 100 4.0 POS 100 100 100 100 100 10029 4.0 PES 85 100 100 100 95 100 4.0 POS 10 100 70 100 100 85__________________________________________________________________________ Another series of tests was undertaken in accordance with the procedure described above, except that differing quantities of herbicide were used. Those quantities were achieved by dilution of the original spray solution. The weed species were as follows: ______________________________________Common Name Scientific Name ABR______________________________________ ALOMYWild oat Avena fatua AVEFABroadleaf signalgrass Brachiaria platyphylla BRAPPWatergrass Echinochloa crusgalli ECHCGGreen foxtail Setaria viridis SETFAVelvetleaf Abutilon theophrasti ABUTHPigweed AMARE CASOBMorningglory Ipomoea IPOSS MATCHHemp sesbania Sebania exaltata SEBEX STEME______________________________________ In addition to the foregoing weed species, the herbicides were also tested against various crop species. The crop species were as follows: ______________________________________ WISoybean Glycine max SOYCotton Gossypium hirsutum COTSugarbeet Beta vulgaris SBWheat Triticum aestivum WHRice Oryzae Sativa RCMilo Sorghum bicolor MLCorn Zea mays CN______________________________________ The results of these tests are set forth in Table VI and Table VII below. TABLE VI APPLICATION WEED SPECIES Cmpd. Rate PERCENT INJURY No. kg/ha Method ALOMY AVEFA BRAPP ECHCG SETVI ABUTH AMARE CASOB IPOSS MATCH SEBEX STEME XANPE 1 2.00 PES 90 5 90 100 100 100 100 35 95 100 100 100 0 POS 15 40 0 85 25 100 100 10 100 40 100 100 0 1.00 PES 20 0 85 100 100 100 100 15 100 100 100 50 0 POS 20 45 0 65 0 100 100 0 100 0 100 100 0 0.50 PES 10 0 75 80 100 100 100 0 80 50 95 50 0 POS 30 20 0 15 0 100 100 0 90 10 95 20 0 0.25 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 2 2.00 PES 85 65 100 95 100 50 100 0 75 100 100 0 0 POS 55 75 50 80 90 60 60 15 100 0 95 0 0 1.00 PES 50 15 60 90 100 50 100 0 70 70 95 0 0 POS 40 35 20 55 15 20 20 0 75 0 80 0 0 0.50 PES 5 5 10 0 100 0 75 0 20 0 0 0 0 POS 25 20 0 30 5 0 0 0 75 0 60 0 0 0.25 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 3 2.00 PES 10 0 50 10 85 45 75 80 5 90 100 90 5 POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 0 0 0 0 50 15 40 0 0 50 25 50 0 POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.50 PES 0 0 0 0 0 0 0 0 0 0 10 -- 0 POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 0 0 20 20 100 30 10 0 100 0 15 -- 20 POS 0 0 5 45 20 60 100 30 100 0 100 0 15 6 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 0 0 0 0 40 -- 100 -- 10 100 -- 45 -- POS 5 0 -- 25 30 100 95 100 88 100 -- 100 -- 0.50 PES 0 0 -- -- 30 -- -- 0 -- 100 -- 20 -- POS 5 0 -- 20 20 100 100 100 90 90 -- 85 -- 0.25 PES 0 0 -- 0 0 0 -- -- 0 0 -- 5 -- POS 0 0 10 -- 20 100 95 75 100 60 -- 50 -- 7 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS 10 50 10 10 55 100 100 50 100 90 -- 70 -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS 10 40 0 0 5 30 100 15 100 60 -- 45 -- 8 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 10 40 65 95 100 100 100 40 45 100 -- 98 -- POS 10 20 10 30 45 85 100 30 100 100 -- 20 -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 0 10 30 20 65 20 98 0 0 100 -- 0 -- POS 10 20 10 20 30 80 90 30 90 100 -- 20 -- 9 2.00 PES 10 0 45 15 35 50 100 20 0 100 -- 0 -- POS 10 15 5 5 25 30 98 30 65 20 -- 10 -- 1.00 PES 0 0 0 0 0 35 100 40 0 95 -- 0 -- POS 0 0 5 10 15 25 95 30 65 0 -- 0 -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 10 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 0 30 0 5 65 0 70 0 0 50 -- 0 -- POS 20 30 15 15 30 99 100 5 100 50 -- 50 -- 11 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 80 55 100 100 100 100 100 60 98 100 -- 100 -- POS 98 100 98 98 100 100 100 100 100 100 -- 100 -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 30 20 35 60 100 100 100 20 70 100 -- 100 -- POS 65 65 15 50 75 100 100 65 100 100 -- 20 -- 12 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 0 0 45 0 30 40 65 10 1595 -- 0 -- POS 15 20 5 1025 98 100 25 100 -- -- 0 -- 0.50 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 0 0 0 0 0 0 15 0 10 0 -- 0 -- POS 5 10 0 0 5 98 70 10 95 -- -- 0 -- 19 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 70 10 95 95 100 100 100 100 100 100 -- 65 -- POS 0 5 0 5 55 100 100 95 100 100 -- 0 -- 0.50 PES 30 10 95 98 100 100 100 100 50 100 -- 60 -- POS 0 5 5 5 35 100 95 100 100 100 -- 0 -- 0.25 PES 0 0 95 30 95 100 100 100 0 100 -- 20 -- POS 0 5 5 5 20 100 100 40 95 100 -- 0 -- 20 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 0 20 0 0 0 10 0 10 50 100 -- 0 -- POS 5 5 15 20 55 100 100 100 100 80 -- 0 -- 0.50 PES 0 0 0 0 0 0 0 0 20 0 -- 0 -- POS 5 5 0 10 50 100 100 30 95 65 -- 0 -- 0.25 PES 0 0 0 0 0 0 0 0 0 0 -- 0 -- POS 5 10 0 10 35 100 35 10 100 10 -- 0 -- 21 2.00 PES -- -- -- -- -- -- -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- -- -- -- -- -- -- 1.00 PES 20 25 10 10 98 100 100 0 0 0 -- 0 -- POS 0 20 0 0 70 100 100 15 95 0 -- 0 -- 0.50 PES 0 10 0 10 30 15 0 0 0 0 -- 0 -- POS 0 10 0 0 55 100 100 0 85 0 -- 0 -- 0.25 PES 0 0 0 0 0 10 0 0 0 0 -- 0 -- POS 0 0 0 0 30 100 70 0 70 0 -- 0 -- 28 0.5 PES 65 75 98 100 100 100 100 -- 60 100 -- -- 70 -- -- -- -- -- -- -- -- -- -- -- -- -- 0.25 PES 20 60 75 100 100 98 100 -- 45 100 -- -- 45 POS 30 45 35 90 55 100 100 -- 100 55 -- -- -- TABLE VII__________________________________________________________________________APPLICATION CROP SPECIESCmpd. Rate PERCENT INJURYNo. kg/ha Method CN ML RC WH COT SB SOY__________________________________________________________________________1 2.00 PES 50 95 20 30 25 100 20 POS 30 20 10 90 70 85 45 1.00 PES 15 55 20 20 0 100 15 POS 20 5 10 80 70 75 20 0.50 PES 0 5 0 5 0 95 0 POS 30 5 0 45 85 45 10 0.25 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- --2 2.00 PES 35 75 10 25 0 95 0 POS 60 15 20 70 40 40 25 1.00 PES 0 0 0 10 0 90 0 POS 40 5 0 60 20 40 10 0.50 PES 0 0 0 0 0 50 0 POS 20 0 0 40 10 15 10 0.25 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- --3 2.00 PES 10 10 75 0 5 10 20 POS -- -- -- -- -- -- -- 1.00 PES 0 0 15 0 5 0 0 POS 5 80 10 20 -- 100 85 0.50 PES 0 0 0 0 0 0 0 POS 5 40 10 10 -- 100 40 0.25 PES -- -- -- -- -- -- -- POS 0 10 5 5 -- 100 156 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 0 -- 0 0 -- 0 -- POS 0 -- 10 10 -- 100 70 0.50 PES -- -- 0 0 -- 0 0 POS 0 -- 10 5 -- 100 70 0.25 PES 0 -- 0 0 -- 0 0 POS 0 -- 10 5 -- 100 407 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES -- -- -- -- -- -- -- POS 20 -- 10 5 -- 100 60 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES -- -- -- -- -- -- -- POS 15 -- 10 5 -- 60 458 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 15 -- 5 25 -- 65 0 POS 15 -- 20 15 -- 100 40 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES 0 -- 0 0 -- 10 0 POS 15 -- 10 10 -- 100 309 2.00 PES 15 -- 25 0 -- 10 30 POS 10 -- 5 10 -- 50 50 1.00 PES 10 -- 15 0 -- 10 0 POS 5 -- 5 0 -- 30 55 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- --10 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES 5 -- 0 0 -- 100 0 POS 20 -- 10 10 -- 40 3011 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 35 -- 25 45 -- 100 35 POS 50 -- 70 98 -- 100 100 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES 10 -- 10 10 -- 100 10 POS 30 -- 30 35 -- 100 9012 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 10 -- 20 0 -- 10 0 POS 25 -- 5 25 -- 60 60 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES 0 -- 0 0 -- 0 0 POS 15 -- 5 15 -- 45 2013 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 0 -- 10 0 -- 0 12 POS 12 -- 20 10 -- 58 35 0.50 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 0.25 PES 0 -- 0 0 -- 0 0 POS 15 -- 12 10 -- 15 2020 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 0 -- 0 10 -- 0 30 POS 10 -- 10 10 -- 100 35 0.50 PES 0 -- 0 0 -- 0 10 POS 0 -- 10 10 -- 95 40 0.25 PES 0 -- 0 0 -- 0 0 POS 0 -- 10 10 -- 80 1521 2.00 PES -- -- -- -- -- -- -- POS -- -- -- -- -- -- -- 1.00 PES 10 -- 0 10 -- 40 0 POS 5 -- 0 0 -- 100 40 0.50 PES 0 -- 0 0 -- 0 0 POS 5 -- 0 0 -- 40 15 0.25 PES 0 -- 0 0 -- 0 0 POS 0 -- 0 0 -- 10 35__________________________________________________________________________ METHOD OF APPLICATION The compounds of the present invention are useful as herbicides and can be applied in a variety of ways known to those skilled in the art, at various concentrations. The compounds are useful in controlling the growth of undesirable vegetation by pre-emergence or post-emergence application to the locus where control is desired. In practice, the compounds are applied as formulations containing the various adjuvants and carriers known to or used in the industry for facilitating dispersion. The choice of formulation and mode of application for any given compound may affect its activity, and selection will be made accordingly. The compounds of the invention may thus be formulated as granules, as wettable powders, as emulsifiable concentrates, as powders or dusts, as flowables, as solutions, suspensions or emulsions, or in controlled-release forms such as microcapsules. These formulations may contain as little as about 0.5% to as much as amount 95% or more by weight of active ingredient. The optimum amount for any given compound will depend upon the nature of the seeds or plants to be controlled. The rate of application will generally vary from about 0.01 to about 10 pounds per acre, preferably from about 0.02 to about 4 pounds per acre. Wettable powders are in the form of finely divided particles which disperse readily in water or other liquid carriers. The particles contain the active ingredient retained in a solid matrix. Typical solid matrices include fuller's earth, kaolin clays, silicas and other readily wet organic or inorganic solids. Wettable powders normally contain about 5% to about 95% of the active ingredient plus a small amount of wetting, dispersing, or emulsifying agent. Emulsifiable concentrates are homogeneous liquid compositions dispersible in water or other liquid, and may consist entirely of the active compound with a liquid or solid emulsifying agent, or may also contain a liquid carrier, such as xylene, heavy aromatic naphthas, isophorone and other nonvolatile organic solvents. In use, these concentrates are dispersed in water or other liquid and normally applied as a spray to the area to be treated. The amount of active ingredient may range from about 0.5% to about 95% of the concentrate. Granular formulations include both extrudates and relatively coarse particles, and are usually applied without dilution to the area in which suppression of vegetation is desired. Typical carriers for granular formulations include sand, fuller's earth, attapulgite clay, bentonite clays, montmorillonite clay, vermiculite, perlite and other organic or inorganic materials which absorb or which can be coated with the active compound. Granular formulations normally contain about 5% to about 25% active ingredients which may include surface-active agents such as heavy aromatic naphthas, kerosene and other petroleum fractions, or vegetable oils; and/or stickers such as dextrins, glue or synthetic resins. Dusts are free-flowing admixtures of the active ingredient with finely divided solids such as talc, clays, flours and other organic and inorganic solids which act as dispersants and carriers. Microcapsules are typically droplets or granules of the active material enclosed in an inert porous shell which allows escape of the enclosed material to the surroundings at controlled rates. Encapsulated droplet are typically about 1 to 50 microns in diameter. The enclosed liquid typically constitutes about 50 to 95% of the weight of the capsule, and may include solvent in addition to the active compound. Encapsulated granules are generally porous granules with porous membranes sealing the granule pore openings, retaining the active species in liquid form inside the granule pores. Granules typically range from 1 millimeter to 1 centimeter, preferably 1 to 2 millimeters in diameter. Granules are formed by extrusion, agglomeration or prilling, or are naturally occurring. Examples of such materials are vermiculite, sintered clay, kaolin, attapulgite clay, sawdust and granular carbon. Shell or membrane materials include natural and synthetic rubbers, cellulosic materials, styrene-butadiene copolymers:, polyacrylonitriles, polyacrylates, polyesters, polyamides, polyureas, polyurethanes and starch xanthates. Other useful formulations for herbicidal applications include simple solutions of the active ingredient in a solvent in which it is completely soluble at the desired concentration, such as acetone, alkylated naphthalenes, xylene and other organic solvents. Pressurized sprayers, wherein the active ingredient is dispersed in finely-divided form as a result of vaporization of a low boiling dispersant solvent carrier, such as the Freons, may also be used. Many of these formulations include wetting, dispersing or emulsifying agents. Examples are alkyl and alkylaryl sulfonates and sulfates and their salts; polyhydric alcohols; polyethoxylated alcohols; esters and fatty amines. These agents when used normally comprise from 0.1% to 15% by weight of the formulation. Each of the above formulations can be prepared as a package containing the herbicide together with other ingredients of the formulation (diluents, emulsifiers, surfactants etc.). The formulations can also be prepared by a tank mix method, in which the ingredients are obtained separately and combined at the grower site. The compounds of the present invention are also useful when combined with other herbicides and/or defoliants, dessicants, growth inhibitors, and the like. These other materials can comprise from about 5% to about 95% of the active ingredients in the formulations. These combinations frequently provided a higher level of effectiveness in controlling weeds and often provide results unattainable with separate formulations of the individual herbicides. Examples of other herbicides, defoliants, dessicants and plant growth inhibitors with which the compounds of this invention can be combined are: acetanilide herbicides such as alachlor, 2-chloro-2',6'-diethyl-N-(methoxymethyl) acetanilide; acetochlor, 2-chloro-2'-methyl-6'ethyl-N-ethoxymethyl acetanilide; metolachlor, 2-chloro-2'-methyl-6'ethyl-N-methoxy-isopropyl-2-acetanilide; chlorophenoxy herbicides such as 2,4-D, 2,4,5-T, MCPA, MCPB, 2,4-DB, 2,4-DEB, 4-CPA, 2,4,5-TB, and silvex; carbamate herbicides such as propham, chlorpropham, swep, and barban; thiocarbamate and dithiocarbamate herbicides such as CDEC, metham-sodium, EPTC, diallate, PEBC, and vernolate; substituted urea herbicides such as norea, dichloral, urea, chloroxuron, cycluron, fenuron, monuron, monuron TCA, diuron, linuron, monolinuron neburon, buturon and trimeturon; substituted triazine herbicides such as simazine, chlorazine, desmetryne, norazine, ipazine, prometryn, atrazine, trietazine, simetone, prometone, propazine and ametryne; chlorinated aliphatic acid herbicides such as TCA and dalapon; chlorinated benzoic acid and phenylacetic acid herbicides such as 2,3,6-TBA, dicamba, tricamba, chloramben, fenac, PBA, 2-methoxy-3,6-dichlorophenyl acetic acid, 3-methoxy-2,6-dichlorophenyl acetic acid, 2-methoxy-3,5,6-trichlorophenyl acetic acid, and 2,4-dichloro-3-nitro benzoic acid; sulfonylurea herbicides such as chlorosulfuron, chlorimuron, chlorimuron ethyl and bensulfuron ethyl; imidazoline herbicides such as imazapyr, imazaquin, and imazethapyr; aryloxyphenoxy herbicides such as fluazifop-p-butyl, fenoxaprop, and quizalofop-p; diphenyl ether herbicides such as fomesafen, chlomethyoxyfen and bifenox; oxime herbicides such as sethoxydim and clethodim; pyrazole and pyridine derivatives; substituted 1,3-cyclohexanedione compounds, including 2-(2-substituted benzoyl)-1,3 cyclohexanediones; and such compounds as aminotriazole, maleic hydrazide, phenylmercury acetate, endothal, technical chlordane, CDCPA, diquat, erbon, DNC, DNBP, dichlobenil, DPA, diphenamide, dipropalin, trifluralin, solan, dicryl, merphos, DMPA, DSMA, MSMA, potassium azide, acrolein, benefin, bensulide, AMS, bromacil, 2-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxazolidine-3,5-dione, bromoxynil, cacodylic acid, CMA, CPMF, cypromid, DCB, DCPA, dichlone, diphenatril, DMTT, DNAP, EBEP, EXD, HCA, ioxynil, IPX, isocil, potassium cyanate, MAA, MAMA, MCPES, MCPP, MH, molinate, NPA, OCH, paraquat, PCP, picloram, DPA, PCA, sesone, terbacil, terbutol, TCBA, nitralin, sodium tetraborate, calcium cyanamide, S,S,S-tributylphosphorotrithioate and propanil, isopropyl amine salt of N-phosphonomethyl glycine, trimethylsulfonium salts of N-phosphonomethyl glycine. GENERAL These formulations can be applied to the areas where control is desired by conventional methods. Dust and liquid compositions, for example, can be applied by the use of powerdusters, boom and hand sprayers and spray dusters. The formulations can also be applied from airplanes as a dust or a spray or by rope wick applications. To modify or control growth of germinating seeds or emerging seedlings, dust and liquid formulations can be distributed in the soil to a depth of at least one-half inch below the soil surface or applied to the soil surface only, by spraying or sprinkling. The formulations can also be applied by addition to irrigation water. This permits penetration of the formulations into the soil together with the irrigation water. Dust compositions, granular compositions or liquid formulations applied to the surface of the soil can be distributed below the surface of the soil by conventional means such as discing, dragging or mixing operations. The following are examples of typical formulations. ______________________________________5% dust: 5 parts active compound 95 parts talc2% dust: 2 parts active compound 1 part highly dispersed silicic acid 97 parts talc______________________________________ These dusts are formed by mixing the components then grinding the mixture to the desired particle size. ______________________________________5% granules: 5 parts active compound 0.25 part epichlorohydrin 0.25 part cetyl polyglycol ether 3.5 parts polyethylene glycol 91 part kaolin (particle size 0.3-0.8 mm)______________________________________ Granules are formed by mixing the active compound with epichlorohydrin and dissolving the mixture in 6 parts of acetone. The polyethylene glycol and cetyl polyglycol ether are then added. The resultant solution is sprayed on the kaolin and the acetone evaporated in vacuo. ______________________________________Wettable powders:______________________________________70%: 70 parts active compound 5 parts sodium dibutylnaphthylsulfonate 3 parts naphthalenesulfonic acid/phenolsulfonic acid/formaldehyde condensate (3:2:1) 10 parts kaolin 12 parts Champagne chalk40%: 40 parts active compound 5 parts sodium lignin sulfonate 1 part sodium dibutylnaphthalene sulfonic acid 54 parts silicic acid25%: 25 parts active compound 4.5 parts calcium lignin sulfate 1.9 parts Champagne chalk/hydroxyethyl cellulose (1:1) 1.5 parts sodium dibutylnaphthalene sulfonate 19.5 silicic acid 19.5 parts Champagne chalk 28.1 parts kaolin25%: 25 parts active compound 2.5 parts isooctylphenoxy-polyethylene- ethanol 1.7 parts Champagne chalk/hydroxyethyl cellulose (1:1) 8.3 parts sodium aluminum silicate 16.5 parts kieselguhr 46 parts kaolin10%: 10 parts active compound 3 parts of a mixture of sodium salts of saturated fatty alcohol sulfates 5 parts naphthalenesulfonic acid/ formaldehyde condensate 82 parts kaolin______________________________________ These wettable powders are prepared by intimately mixing the active compounds with the additives in suitable mixers, and grinding the resulting mixture in mills or rollers. ______________________________________Emulsifiable concentrate:______________________________________25%: 25 parts active substance 2.5 parts epoxidized vegetable oil 10 parts of an alkylarylsulfonate/fatty alcohol polyglycol ether mixture 5 parts dimethylformamide 57.5 parts xylene______________________________________ The amount of the present compositions which constitute a herbicidally effective amount depends upon the nature of the seeds or plants to be controlled. The rate of application of active ingredients varies from about 0.01 to about 25 pounds per acre, preferably about 0.10 to about 10 pounds per acre with the actual amount depending on the overall costs and the desired results. It will be readily apparent to one skilled in the art that compositions exhibiting lower herbicidal activity will require a higher dosage than more active compounds for the same degree of control.

1a

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] This application is a Continuation of U.S. application Ser. No. 12/969,999, filed Dec. 16, 2010, which is a Continuation of U.S. application Ser. No. 12/621,845, filed Nov. 19, 2009, which is a Continuation of U.S. application Ser. No. 11/716,014, filed Mar. 9, 2007, now U.S. Pat. No. 7,723,910, which is a Continuation of U.S. application Ser. No. 10/755,318, filed Jan. 13, 2004, now U.S. Pat. No. 7,190,109, which is a Divisional of U.S. application Ser. No. 09/774,084, filed Jan. 31, 2001, now U.S. Pat. No. 6,709,446, which is a Divisional of U.S. application Ser. No. 09/070,772, filed May 1, 1998, now U.S. Pat. No. 6,223,071, the entire contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention is directed to photodynamic therapy using an illuminator that provides a uniform distribution of visible light. In particular, the present invention is directed to an apparatus and method for photodynamic treatment (PDT) or diagnosis (PD) of actinic keratosis of the scalp or facial areas of a patient. The present invention is also directed to an apparatus and method for PDT and PD of other indications (e.g., acne) and other areas of the patient (e.g., arms, legs, etc.). [0004] As they are used here, the term “visible light” refers to radiant energy in the visible range of the electromagnetic radiation spectrum, and the term “light” refers to radiant energy including the ultraviolet (UV), infrared (IR) and visible ranges of the electromagnetic radiation spectrum. [0005] 2. Description of Related Art [0006] Photodynamic therapy or photochemotherapy is currently being proposed to treat several types of ailments in or near the skin or other tissues, such as those in a body cavity. For example, PDT is being proposed to treat different types of skin cancer and pre-cancerous conditions. In PDT, a patient is administered a photoactivatable agent or precursor of a photoactivatable agent which accumulates in the tissue being diagnosed or treated. An area of the patient which includes the tissue being diagnosed or treated is then exposed to visible light. The visible light causes chemical and/or biological changes in the photoactivatable agent which in turn selectively locate, destroy or alter the target tissue while at the same time causing only mild and reversible damage to other tissues in the treatment area. [0007] General background information on PDT using 5-aminolevulinic acid (“ALA”) as the precursor of a photoactivatable agent can be found in U.S. Patent No. 5,079,262, entitled “Method of Detection and Treatment of Malignant and Non-Malignant Lesions Utilizing 5-Aminolevulinic Acid,” issued to James C. Kennedy et al. on Jan. 7, 1992, and U.S. Pat. No. 5,211,938, entitled “Method of Detection of Malignant and Non-Malignant Lesions by Photochemotherapy of Protoporphyrin IX Precursors,” issued to James C. Kennedy et al. on May 18, 1993. The contents of these patents are incorporated herein by reference. The publication of James C. Kennedy et al. in the Journal of Clinical Laser Medicine and Surgery on Nov. 5, 1996, entitled “Photodynamic Therapy (PDT) and Photodiagnosis (PD) Using Endogenous Photosensitization Induced by 5-Aminolevulinic Acid (ALA): Mechanisms and Clinical Results,” is also incorporated herein by reference. The “First Phase III” 1996 Annual Report by DUSA Pharmaceuticals, Inc. (Tarrytown, N.Y.) contains pictures and examples of use of the invention, and is also incorporated herein by reference. [0008] As they are used here, the terms ALA or 5-aminolevulinic acid refer to ALA itself, precursors thereof and pharmaceutically acceptable salts of the same. [0009] Most conventional, non-laser light sources are comprised of just three basic functional blocks: an emission source to generate photons (e.g., a light bulb); coupling elements to direct, filter or otherwise conduct the emitted light so that it arrives at the intended target in a usable form; and a control system to start and stop the production of light when necessary. The common office fluorescent lighting fixture is a good example of such a system. In these fixtures, white visible light is produced by a controlled mercury arc discharge which excites inorganic phosphor materials inside a glass tube. Energy transfer from the arc causes visible white light emission from the tube. The emitted visible light is directed toward the work space by reflectors in the lamp housing; the distribution of visible light to the target is often further increased by using a diffusing system. In the typical office setting, visible light production is controlled by a simple snap switch which interrupts the flow of power to the lamp. [0010] For therapeutic reasons it is desirable to have a power output which is uniform in intensity and color. In particular, it is highly desirable to have an illuminator with a spectral output that overlaps to a large extent with the optical activation spectrum of the target photosensitizer. According to one preferred embodiment of the present invention, blue light having wavelengths exceeding 400 nm (nanometers) is particularly advantageous for certain diagnostic purposes and treatments, especially when ALA is the photoactivatable agent used for PD and PDT of actinic keratosis. However, visible light in other ranges of the spectrum, particularly in the green and red ranges between 400 and 700 nm, may also be used. [0011] Conventional illuminators do not produce visible light that is sufficiently uniform in intensity over a contoured surface. SUMMARY OF THE INVENTION [0012] It is an object of the present invention, therefore, to provide an improved illuminator for PDT and/or PD. [0013] Another object of the invention is to provide an illuminator for PDT that produces visible light of consistent uniformity in terms of both spectral characteristics and intensity over a diversely contoured surface. As it is used here, the term contoured surface refers to a non-planar surface. [0014] Yet another object of the invention is to provide an illuminator for PDT or PD which produces visible light almost entirely in a selected wavelength range. [0015] A further object of the present invention is to provide an illuminator for irradiating the face or scalp of a patient. [0016] Yet a further object of the present invention is to provide a cooling system for improving the irradiance uniformity of an illuminator. [0017] An additional object of the present invention is to provide an illuminator comprising a finite emitter that approximates the uniform output of an infinite plane emitter by varying the spacing of individual light sources within the illuminator. [0018] Yet an additional object of the present invention is to provide a monitoring system for an illuminator comprising a single visible light sensor monitoring the visible light output of a plurality of light sources and outputting a signal to adjust the visible light output from the plurality light sources. [0019] In accomplishing the foregoing objects, there has been provided according to the present invention an illuminator for PDT or PD of a contoured surface. The illuminator comprises a plurality of light sources generally conforming to the contoured surface and irradiating the contoured surface with substantially uniform intensity visible light, and a housing supporting the plurality of light sources with respect to the contoured surface. [0020] In accomplishing the foregoing objects, there is also provided according to the present invention a method of PDT or PD of a contoured surface. The method comprises topically applying 5-aminolevulinic acid to the contoured surface, and irradiating the contoured surface with substantially uniform intensity visible light from a plurality of light sources generally conforming to the contoured surface. [0021] In accomplishing the foregoing objects, there is also provided according to the present invention a cooling system for an illuminator including an elongated light source having a generally arcuate segment connected to a generally straight segment. The cooling system comprises a plenum enclosing the light source; an intake vent to the plenum receiving ambient air, the intake vent being positioned proximate a free end of the generally straight segment; and an exhaust vent from the plenum discharging heated ambient air, the exhaust vent being positioned proximate a connection between the generally arcuate and straight segments. The generally straight segment and a connection between the generally arcuate and straight segments receives greater cooling relative to the generally arcuate segment. [0022] In accomplishing the foregoing objects, there is also provided according to the present invention a method of providing substantially uniform intensity light from an elongated light source having a generally arcuate segment connected to a generally straight segment. The method comprises providing greater cooling to the generally straight segment relative to the generally arcuate segment. [0023] In accomplishing the foregoing objects, there is also provided according to the present invention an illuminator for emulating an infinite plane emitter. The illuminator comprises an emitting area having a perimeter, and a plurality of light sources being generally parallel to one another, said plurality of light sources being adapted for irradiating substantially uniform intensity light from said emitting area. Lateral spacing between adjacent ones of said plurality of light sources varies with respect to said perimeter. [0024] In accomplishing the foregoing objects, there is also provided according to the present invention a monitoring system for an illuminator irradiating a surface. The monitoring system comprises a plurality of adjustable light sources adapted for irradiating the surface with substantially uniform intensity light; a light sensor being supported with respect to the plurality of light sources; a partition interposed between the light sensor and the plurality of light sources; a first aperture in the partition adapted for admitting light from a first one of the plurality of light sources to the light sensor, the first aperture being spaced from the light sensor a first distance and having a first cross-sectional area; and a second aperture in the partition adapted for admitting light from a second one of the plurality of light sources to the light sensor, the second aperture being spaced from the light sensor a second distance and having a second cross-sectional area. A ratio of the first and second cross-sectional areas is proportional to inverse squares of the first and second distances; and the light sensor is adapted for monitoring light output from the first and second ones of the plurality of light sources and outputting a signal to adjust light output from the plurality of light sources so as to provide the substantially uniform intensity light irradiating the surface. [0025] In accomplishing the foregoing objects, there is also provided according to the present invention light for photodynamically diagnosing or treating a contoured surface, the light coming from a plurality of sources generally conforming to the contoured surface and irradiating the contoured surface with uniform intensity. [0026] The present invention relies on similar fundamentals to that of the office fluorescent lighting system described above. According to an embodiment of the present invention: visible light is produced by contour surface conforming fluorescent tubes and their associated control electronics; visible light output from these tubes is directed toward the diagnosis or treatment area by the contour surface conforming shape of the tubes and other elements such as a reflector; and activation of the fluorescent tubes and visible light exposure on the contoured surface is controlled by the electronic circuitry. [0027] The present invention differs from conventional light sources because of the biological requirements imposed on a PDT light source. A much higher degree of precision and integration is required for the components of the present invention. Output spectrum, irradiance, and irradiance uniformity all must be controlled to assure that the properties of the device are suitable to deliver light to the target lesions and drive the photodynamic reaction. To achieve this, each functional block within the present invention comprises carefully selected and engineered components. The principles of operation of each are described in detail below. [0028] The inverse square law of optics states that the intensity of light from a point source received by an object is inversely proportional to the square of the distance from the source. Because of this behavior, distance from the source is an important variable in all optical systems. Thus, in order to achieve uniform facial or scalp irradiation, variations in output irradiance with distance must be minimized. A flat emitting surface would not deliver a uniform light dose to all contours of the face simultaneously because the non-planar facial and scalp surfaces could not be placed at a constant distance from the emitting surface. To ameliorate this problem, the present invention uses a U-shaped emitting surface that more closely follows the contours of the human face and scalp, and minimizes lamp to target distance variations which in turn minimizes irradiance variations at the target. [0029] Since the output of tubular light sources may vary with temperature, temperature distribution also plays a key role in irradiance uniformity. Further, since the tube output may vary over its length, modulation of the temperature distribution may be used to control irradiance uniformity of the illuminator. [0030] Additional objects, features and advantages of the invention will be set forth in the description which follows, and in part will be clear from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0031] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description of the preferred embodiments given below, serve to explain the principles of the invention. [0032] FIG. 1 is a partial cross-section, front elevation view of an illuminator according to the present invention. [0033] FIG. 2 is a partial cross-section, side elevation view of the illuminator shown in FIG. 1 . [0034] FIG. 3 is a partial cross-section, plan view of the illuminator shown in FIG. 1 . [0035] FIGS. 4A and 4B are detailed views of the fluorescent tube light source shown in FIG. 1 . [0036] FIGS. 5A and 5B are detailed views of the reflector shown in FIG. 1 . [0037] FIG. 6 is a detail view of the shield shown in FIG. 1 . [0038] FIG. 7 is a schematic illustration of a wiring circuit for the illuminator shown in FIG. 1 . [0039] FIG. 8 is a schematic illustration of a ballast wiring circuit for the illuminator shown in FIG. 1 . [0040] FIG. 9A is a schematic illustration of a modified wiring circuit of an illuminator according to the present invention. [0041] FIGS. 9B-9E are schematic illustrations showing details of the wiring circuit shown in FIG. 9A . [0042] FIG. 10 is an illustration of a typical fluorescence emission spectrum of the fluorescent tube light source shown in FIG. 4 . [0043] FIG. 11 is a depiction of a monitoring system according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Overview [0044] According to one preferred embodiment illustrated in FIGS. 1-8 , seven U-shaped fluorescent tubes 10 ( 1 )- 10 ( 7 ) are driven by three electronic ballasts 20 . Adjusting the ballast voltage controls the output power of the tubes. The tubes 10 ( 1 )- 10 ( 7 ) are supported by a housing 30 and are covered by a polycarbonate shield 40 which directs cooling airflow within the unit and prevents glass-patient contact in the event of tube breakage. An aluminum reflector 50 located behind the tubes increases both the output irradiance and the uniformity of the output distribution. The overall dimensions of the unit are approximately 38 cm H×45 cm W×44.5 cm D. FIG. 1 shows the position of the patient's head and nose. Exemplary Light Sources [0045] According to a preferred embodiment of the present invention, seven 36″ U-shaped F34T8 Ultra Blue fluorescent tubes 10 ( 1 )- 10 ( 7 ) provide a maximum visible light-emitting area 36 cm high by 46 cm wide (approximately 2850 cm 2 ), with a minimum therapeutically active area 30 cm high by 46 cm wide (approximately 1350 cm 2 ). As shown in FIG. 1 , the tubes have a generally arcuate central region 10 A and arms 10 B extending from respective ends of the central region. [0046] Fluorescent tubes are a type of gas discharge lamp. They utilize an electric discharge through a low pressure gas to create a plasma which interacts with a fluorescing phosphor to convert electrical energy into light. A typical fluorescent tube consists of a sealed glass tube with electrodes, or cathodes, at both ends. The tube is internally coated with a uniform luminescent inorganic crystalline phosphor. The tube is filled with a low pressure inert gas, usually argon, to which a small amount of liquid mercury is added prior to sealing. The low internal pressure causes some of the liquid mercury to evaporate resulting in an argon/mercury atmosphere within the tube. Application of a sufficiently high voltage potential across the cathodes causes the emission of electrons from the cathode, which diffuse along the length of the tube and ionize the argon/mercury vapor. Once ionized, the gas mixture within the tube becomes conductive which permits an electrical current to flow and continue to excite the mercury atoms. The magnitude of the tube current controls the number of excited atoms and hence the light output from the tube. As the excited mercury atoms return to a lower energy state, they emit ultraviolet (UV) radiation. This UV radiation is absorbed by the phosphor on the tube wall causing the phosphor to fluoresce, efficiently converting the energy of the principle resonant line of mercury to a longer wavelength. The chemistry of the phosphor material determines the characteristic spectral emission of the light output from the lamp. This can be utilized to tune the wavelength output of the light source to suit the requirements of the application, as is the case in the present invention. [0047] The output from a fluorescent tube is not inherently uniform. The output measured in the immediate vicinity of the cathode is typically much lower than the output over the rest of the tube. This occurs because ionized gas in the area near the cathode does not emit as much UV to excite the phosphor. This area of reduced emission is known as the Faraday dark space. To avoid uniformity problems, one embodiment of the present invention utilizes a plurality of U-shaped tubes 10 ( 1 )- 10 ( 7 ). This arrangement allows the cathodes and their low output area to be located outside the active emitting area (effectively behind the patient's ears). Only the more uniform center portion of the tube output is used for patient treatment. Another advantage of the arrangement is that uniformity can also be adjusted by varying the lateral spacing of the tubes (relative horizontal spacing as shown in FIG. 2 ). This is important since it is necessary to compensate for the fact that the output from a flat plane emitting light source drops near the edges. Varying the lateral spacing of the tubes creates the same effect as folding the edges of a larger illuminator in on itself, thus emulating an infinite plane emitter with a compact unit. [0048] The U-shape minimizes the variations in distance between the emitter and the target, providing a uniform visible light distribution to the face or scalp of the patient; the tube dimensions were chosen based on the average dimensions of the adult human head. The mounting of the tubes minimizes the impact of the non-emitting area at their ends. This allows the present invention to be more compact and permits easier centering of the patient's head within the visible light sources. Moreover, the “U” shape provides the desired irradiance and irradiance uniformity for scalp and facial irradiation, and thus ensures that the proper visible light dosage is applied to all target areas during PDT. [0049] The number of tubes used and the spacing between them were chosen to achieve desired uniformity and power output specifications. Optimum output distribution has been found to occur when seven tubes 10 ( 1 )- 10 ( 7 ) are placed in the chassis in a symmetric pattern with respect to opposite edges of the unit with the following approximate lateral spacing: 7 cm between the center tube 10 ( 4 ) and each of the two tubes 10 ( 3 ), 10 ( 5 ) adjacent to the center tube 10 ( 4 ); 5 cm between the tubes 10 ( 3 ), 10 ( 2 ) and 10 ( 5 ), 10 ( 6 ), i.e., the next pairs of tubes out from the center; and 3.5 cm between tubes 10 ( 2 ), 10 ( 1 ) and 10 ( 6 ), 10 ( 7 ), i.e., the outermost pairs of tubes at the sides of the unit. The outermost tubes 10 ( 1 ), 10 ( 7 ) are approximately 2.5 cm from the edges of the housing. The present invention provides a highly uniform output irradiance without the use of an additional diffusing element. However, it is also envisioned that a diffusing element could also be incorporated into the shield 40 . [0050] The fluorescent tubes according to preferred embodiments of the present invention utilize a commercially available phosphor —Sr 2 P 2 O 7 :Eu—that is used in the diazo blueprinting process. When this phosphor absorbs the UV radiation emitted from the mercury it produces an emission spectrum of blue light with a bandwidth having a range of 30 nm at a peak wavelength of 417 nm (nominal). A typical fluorescence emission spectrum of the tubes according to the present invention is shown in FIG. 10 . According to a preferred embodiment of the present invention, the spectral output is selected to match the absorption spectrum of protoporphyrin IX, the photosensitizing species thought to be formed from ALA in target tissue. Other visible spectral outputs may be provided when utilizing a different phosphor within the tubes. Other visible spectral outputs may also be provided when utilizing other light source technologies. Electrical Features [0051] Achieving satisfactory performance from a fluorescent tube requires the application of a voltage to the tube cathodes to initiate tube conduction and subsequently control the tube current. Fluorescent tubes, being gas discharge devices, are particularly sensitive to the electrical voltages and currents used to drive them. Higher tube currents will increase the electron yield causing the output irradiance to increase. But higher currents result in higher cathode temperatures, potentially increasing the erosion of the cathode emitting material and contamination of the tube atmosphere by material removed from the cathodes; this ultimately results in decreased tube life. Tube currents that are too low can result in low tube wall temperatures that may cause condensation of the mercury vapor, adversely affecting the uniformity of the lamp output. Furthermore, for most tube designs it is necessary to heat the cathodes to achieve proper tube starting. Control of the voltage and/or tube current characteristics, as well as heating of the cathodes is accomplished with external electronic circuitry which is usually engineered and packaged into a single device commonly referred to as a “ballast.” There are many such ballast designs possible; they range from simple electromagnetic inductors to sophisticated electronic circuits that optimize and control many aspects of tube operation. [0052] According to a preferred embodiment of the present invention, each ballast 20 comprises three main functional sections: an input filtering circuit, a power oscillator circuit, and a high frequency output transformer. [0053] The input filter circuit rectifies the 120 VAC line voltage into an internal DC voltage that can be utilized by the power oscillator. The filter also prevents disturbances on the AC line from adversely affecting the operation of the ballast and prevents oscillator switching transients from feeding back into the AC line. Lastly, this circuit provides power factor correction so that the peak AC line current drawn by the ballasts is lower than that for a simple rectifier. It is also possible to operate preferred embodiments of the present invention using DC input voltage. [0054] The power oscillator provides the mechanism for electrical energy transfer in each ballast unit 20 ; it consists of a pair of switching transistors coupled to a resonant circuit which includes the output transformer. A small signal from the output transformer is fed back to the input of the switching transistors causing them to oscillate when the DC voltage is applied. Energy from this oscillation is coupled through the transformer to the tubes. For this ballast design, the magnitude of the oscillation is proportional to the DC voltage which in turn is proportional to the AC line voltage. Because the transformer is also connected to the tube cathodes, the magnitude of the tube current is proportional to the AC line voltage. This is known as a non-constant wattage design and it was chosen to allow adjustment of the output irradiance of the present invention. [0055] The high frequency transformer couples energy to the tube, as well as performing several other important functions. It provides electrical transformation of voltage levels and a current limiting impedance in order to supply the correct voltage and current to the tubes to ensure proper and safe operation. It also provides feedback to the oscillator to help stabilize its operation and to supply a mechanism to generate an initial high voltage starting pulse. [0056] Additional windings of the transformer also provide a current to heat the tube cathodes. This lowers the starting voltage requirements and reduces damage to the cathodes from the initial starting current surge. [0057] Because of manufacturing variations in the production of the tubes, the output irradiance must be adjusted to meet the requirements for the specific PDT indication. Furthermore, the output must be adjusted as the tubes age to compensate for degradation within the tubes themselves. In a preferred embodiment of the present invention, ballasts 20 are non-constant wattage ballasts, thus allowing the tube output to be adjusted by changing the input voltage to the ballasts. According to a preferred embodiment of the present invention, a 40% variation is possible through the use of two buck/boost auto-transformers 60 on the AC line. [0058] The ballast voltage may be adjusted manually or automatically. According to embodiments of the present invention having manual voltage adjustment, the appropriate ballast voltage is set by a technician manually selecting the taps on two buck/boost auto transformers 60 . Since variations in input AC line voltage affect the ballast voltage, external voltage stabilization may be used to improve the stability of the output. Another preferred embodiment of the present invention has automatic voltage adjustment including an “active” system of microcontroller-activated electronic switches to eliminate the need for external voltage stabilization and the need for technician-adjustment of the ballast voltage as the tube output decreases with use. The microcontroller accepts input signals from optical and voltage sensors and then activates the appropriate electronic switch to maintain output irradiance within specified parameters. The active switching system is also able to correct for changes in power output due to line voltage and temperature variation during treatment; thus external line voltage stabilization is not required in a preferred embodiment of the present invention having the active switching system. Automatic voltage adjustment according to a preferred embodiment of the present invention is be described more fully below. [0059] According to one preferred embodiment of the present invention, three rapid-start electronic ballasts 20 are utilized to drive seven fluorescent tubes 10 ( 1 )- 10 ( 7 ). Two of the ballasts 20 ( 1 ) and 20 ( 3 ) drive two tubes 10 ( 1 ), 10 ( 7 ) and 10 ( 2 ), 10 ( 6 ), respectively, and one ballast 20 ( 2 ) drives three tubes 10 ( 3 )- 10 ( 5 ). These ballasts convert 120 VAC line voltage available from a standard wall outlet into a high frequency (˜25 kHz) sinusoidal current suitable for driving the fluorescent tubes. High frequency operation is desirable to reduce the optical output ripple which is present in all fluorescent tubes and to increase the overall output. Output ripple is a small variation in the tube output related to the sinusoidal alternating tube current used to sustain the plasma arc. Visible Light Transmission Features [0060] In order to utilize the visible light emitted from the back of the tubes, and to increase the uniformity of the output distribution, a reflector 50 is positioned approximately 10 mm from the rear surface of the tubes. The reflector 50 is made of polished aluminum sheet which is bent to approximately conform to the configuration of the tubes. [0061] The emitting area of the present invention is covered with a low UV transmission plastic shield 40 . In a preferred embodiment of the present invention, plastic shield 40 is made from polycarbonate. When fluorescent tube technology is utilized, there is a small quantity of UV emission present in the output. Polycarbonate has very low transmission in the UV region of the spectrum and it effectively filters out any residual UV emission from the visible light output of the unit. The shield 40 also protects the patient from injury in the event of tube breakage. Cooling Features [0062] Since cathode and tube wall temperatures strongly affect the output distribution, a cooling system is provided to ensure proper bulb operation. According to an embodiment of the present invention, the cooling system comprises vents in the polycarbonate shield 40 , the reflector 50 and the housing 30 , as well as fans 70 to displace cooling air. [0063] Ambient air enters the present invention through intake vents 42 in the polycarbonate shield 40 . The space between the shield 40 and the reflector 50 creates a first zone (i.e., a plenum) in which the ambient air passes over the tubes 10 ( 1 )- 10 ( 7 ). The ambient air is heated by the tubes, and is transferred from the first zone to a second zone between the reflector 50 and the housing 30 through vents in the reflector 52 . The reflector vents 52 are located at ±45° to provide the proper temperature distribution at the tube walls. Heated air is exhausted by four fans 70 through exhaust vents 32 in the housing 30 . [0064] According to a preferred embodiment of the present invention, a plurality of intake vents 42 (thirty-six are illustrated) in the polycarbonate shield 40 are evenly spaced along each edge directly over the cathode area of the tubes. The vents 52 in the reflector 50 are pairs of slots machined in columns from its top to its bottom; the reflector vents 52 are directly in front of the fans 70 which are located at ±45° from the center of the unit. [0065] The straight section of the tube between the cathode area and curved section of the “U” tubes produces slightly more output than the center portion of the curved section. This has been attributed to differences in the phosphor coating thickness caused by the bending process. To further increase irradiance uniformity, the reflector vents 52 are located in the reflector 50 so that cooling air flows primarily over the straight section and the end portions of the curved section. Less cooling air flows over the middle of the tubes between the sets of reflector vents 52 , causing the tube wall temperature to be higher in this region. Since the output irradiance for this tube increases (to a point) with tube wall temperature, the hotter central region of the tube produces higher output irradiances than the rest of the tube and compensates for the lower emission efficiency of the central region. Basic Control Features [0066] The user controls according an embodiment of the present invention include a main power switch 80 located on the back of the housing 30 , and an on/off key switch 90 and a timer 100 , located on a side of the housing 30 . The timer 100 includes an exposure time indicator 102 that displays the remaining treatment time. [0067] The main power switch 80 is part of a fused power entry module consisting of a two position rocker switch and an International Electrotechnical Commission (IEC) standard power cord connector. Pushing the rocker switch to the “1” position supplies power to the system. The fans 70 will operate but the tubes 10 ( 1 )- 10 ( 7 ) will not light until the key switch 90 is turned on and the timer 100 is set and activated. When the main power switch 80 is in the “0” position all electrical components within the present invention are disconnected from the AC line. The fused power entry module provides over-current protection to the present invention and current limiting in the event of a power surge; the main power switch 80 will not apply power to the unit if either fuse in this module has blown. [0068] The key switch 90 provides a means by which use of the present invention can be restricted to authorized personnel. According to an embodiment of the present invention, operation of the timer 100 and tubes 10 ( 1 )- 10 ( 7 ) requires inserting the key and rotating it clockwise ¼ turn to the “ON” position. This activates the timer 100 so that the prescribed exposure time can be entered. [0069] According to an embodiment of the present invention, the system timer 100 directly controls the operation of the fluorescent tubes 10 ( 1 )- 10 ( 7 ). It contains three adjustment/control buttons 104 : one start/stop and two time select buttons, as well as the exposure time indicator 102 . The timer 100 is used to set the required exposure time and to initiate visible light exposure. It automatically turns off the present invention tubes after the set exposure time has elapsed. [0070] The two time select buttons 104 are preferably membrane switches that enable the user to set the exposure time. Depressing the button 104 with the “up” arrow increases time and depressing the button 104 with the “down” arrow decreases time. When first depressed, these buttons will change the display reading slowly. If they remain depressed, the display will begin to scroll more rapidly. Small adjustments to the displayed time can be made by quickly depressing and releasing these buttons. In this manner, the prescribed treatment time may set by the user. [0071] The start/stop button 104 is a membrane switch that controls the tube operation; it toggles between the running and stopped states of the tubes and timer. After the exposure time has been set, depressing this button 104 activates the tubes and initiates the timer countdown sequence. Depressing it a second time turns off the tubes and stops the timer, thus providing a means for interrupting treatment if required. If the start/stop button 104 is not pressed a second time, the timer automatically turns off the tubes at the completion of the timer countdown. Treatment may also be terminated, if necessary, by rotating the key to the OFF position or by pushing the main power switch 80 to the “0” position. [0072] The exposure time indicator 102 on the timer 100 is preferably a four digit LED display which reads in minutes and seconds. Prior to pushing the start/stop button 104 to begin light exposure, the display 102 indicates the exposure time that has been set. When the start/stop button 104 is depressed to initiate treatment, the exposure time indicator 102 will count down and display the amount of exposure time remaining. The tubes will automatically turn off when the display reads “00:00.” [0073] Power is supplied via a three conductor hospital grade electrical cord. The power requirements according to an embodiment of the present invention are 120 VAC, 2.5 amps, 60 Hz AC line voltage input that is stabilized using an external commercial voltage regulator (e.g., a SOLA MCR1000 constant voltage transformer). Automatic Control Features [0074] According to a preferred embodiment of the present invention, the need for technician-adjustment of the ballast voltage as the tube output decreases with use is eliminated by providing automatic self-adjustment of the ballast voltage. This has been accomplished by replacing the manual tap selection jumpers with an “active” system of microcontroller-activated electronic switches ( FIGS. 9A-9E ). The microcontroller accepts input signals from optical and voltage sensors and then activates the appropriate electronic switch to maintain output irradiance within specified parameters. The active switching system is able to correct for changes in power output due to line voltage and temperature variation during treatment; thus external line voltage stabilization is not required according to preferred embodiments of the present invention having automatic adjustment of the ballast voltage. All other components of the automatic ballast voltage adjusting embodiments of the present invention, including the tubes 10 ( 1 )- 10 ( 7 ), ballasts 20 , reflector 50 , and polycarbonate shield 40 , are the same as for the manually adjusted embodiments. [0075] According to a preferred embodiment of the present invention, an electronic control system 110 consists of six functional blocks. A microcontroller 200 is the central processing unit; it contains firmware which reads the system sensors, determines the system status, controls the ballast voltage (and tube output), and provides user information by way of a system status LED 112 (the firmware is described in detail below). To achieve output irradiance in the specified range, the microcontroller 200 monitors the tube output via a visible light sensor 120 which is located behind the tube reflector 50 . Referring to FIG. 11 , diffuse visible light is provided to the visible light sensor 120 by machining slots 122 ( 3 )- 122 ( 5 ) behind each of the center three tubes 10 ( 3 )- 10 ( 5 ) on the reflector panel 50 just left of the center. A voltage detection circuit 210 tells the microcontroller 200 when the timer 100 has initiated its countdown sequence and also when the maximum allowable ballast voltage has been reached. Using input from these sensors, the microcontroller 200 compares the current system status with the values stored during calibration and determines whether ballast voltage adjustment is required. Ballast voltage adjustment is accomplished with an electronic switch array interfaced with zero-crossing opto-isolators 222 to the microcontroller output lines. Finally, if the system is not functioning properly, or cannot produce output power in the specified operating range, the microprocessor 200 activates the system status LED 112 to inform the user. The functional blocks of the electronic control system will now be described in greater detail. [0076] According to a preferred embodiment of the present invention, a fully programmable embedded microcontroller 200 (e.g., Microchip PIC16F84) is provided that incorporates an arithmetic logic unit, system RAM, non-volatile storage RAM, ROM and interface circuitry into a single monolithic integrated circuit. The microcontroller 200 also contains an electronically independent “watch-dog” timer circuit which is programmed to reset the CPU in the event of a microcontroller hardware failure or a firmware execution error. The microcontroller 200 interfaces. with the system sensors, the system status LED 112 and the electronic switch array via twelve programmable digital I/O lines. System calibration parameters are stored in the on-chip non-volatile RAM and all system firmware for controlling regulator functions is contained within the on-chip ROM storage. Firmware is programmed into ROM and verified using external programming hardware. [0077] According to a preferred embodiment of the present invention, the visible light sensor 120 (e.g., a Texas Instruments TSL230B photosensor) is used to detect the tube output, and the output of the visible light sensor 120 is used as the regulation criterion. In the case of the TSL230B photosensor, a large area photodiode and an integrated current-to-frequency converter provide an output signal to the microcontroller as a series of digital pulses. The direct conversion of the optical signal to a digital format reduces circuit complexity and eliminates calibration and drift problems associated with analog circuitry. [0078] The visible light sensor 120 is located behind the central tube 10 ( 4 ) and the reflector panel 50 just to the left of center. In order to monitor the visible light contribution from multiple tubes, three slots 122 ( 3 )- 122 ( 5 ) are machined into the reflector 50 behind the central three tubes 10 ( 3 )- 10 ( 5 ). The cross sectional area and position of these slots 122 ( 3 )- 122 ( 5 ) are such that the visible light sensor 120 receives equally weighted inputs from the three bulbs 10 ( 3 )- 10 ( 5 ). According to a preferred embodiment of the present invention, the ratio of the cross-sectional areas for any two selected slots is proportional to the inverse squares of the selected slots' distances from the visible light sensor 120 . The visible light sensor 120 is covered with a filter to match its spectral responsivity to that of the optometer which was used as the metering standard for calibration. Additionally, the visible light sensor 120 is covered with a glass-diffuser to further minimize the positional dependence of the detector relative to the reflector slots 122 ( 3 )- 122 ( 5 ). [0079] The voltage detection circuit 210 performs a dual function: it coordinates microcontroller operation with the system timer 100 and informs the microcontroller 200 when the maximum permissible ballast voltage has been reached. In a preferred embodiment of the present invention (referring to FIG. 9B ), the voltage detection circuit 210 comprises a CD4046 CMOS phase lock loop (PLL) 214 used as a voltage controlled oscillator (VCO). A sample of the line voltage present on the ballast is rectified and used both to provide power to the CD4046 and to drive the VCO input. This arrangement enables the circuit to produce a digital pulse train whose frequency is proportional to ballast voltage. The pulse train is coupled via an opto-isolator 212 to the microcontroller 200 which determines the ballast voltage by measuring the pulse period. [0080] Detection of system timer state is accomplished by placing the timer relay contacts in series with the ballast supply leads. When the timer 100 is off (e.g., no treatment), no voltage is present to drive either the voltage detection circuit 210 or the ballasts 20 . Upon detecting this condition, the microcontroller 200 resets the system variables and loops until a pulse train (voltage) is present. Upon initiation of the timer countdown sequence, the timer relay contacts close, supplying voltage to the voltage detection circuit 210 and ballasts 20 . When the presence of a pulse train is detected by the microcontroller 200 , it commences regulation (see below). Although the regulator circuit can adjust the ballast voltage, treatment duration is hardware-controlled by the timer 100 through the series wiring of the relay contacts. [0081] Once the visible light treatment has been initiated, the microcontroller 200 monitors the VCO pulse train and compares it with a value stored in memory during unit setup and calibration. If the measured value exceeds the stored value, further increases in ballast voltage are inhibited. The value stored in the microcontroller memory corresponds to the ballast voltage at one transformer tap setting less than its maximum rated operating voltage, preventing selection of a transformer tap setting that would exceed the maximum ballast voltage. This technique minimizes unnecessary switching and ensures that the ballast voltage does not exceed its maximum rated operating voltage (133 VAC in a preferred embodiment of the present invention) at any time. [0082] Referring to FIGS. 9D and 9E , the electronic switch array for transformer tap selection comprises six thyristor electronic switches 220 which connect the ballast input lines and the voltage selection taps on the buck/boost auto-transformers 60 . The thyristor switches 220 control gates electro-optically coupled to the microcontroller 200 . The microcontroller 200 thus increases or decreases the voltage applied to the ballasts 20 (increasing or decreasing the tube output) by energizing the appropriate control gates to select the appropriate taps. [0083] According to preferred embodiments of the present invention, the system status indicator 112 shows when the output irradiance is not within specifications or when a control system failure has occurred. Inspection with a separate power meter is not necessary. [0084] In one preferred embodiment of the present invention, the system status indicator 112 comprises a single LED which indicates the functional status of the system using a coded flash rate. [0085] Immediately after the key is first turned to the “ON” position, the LED flashes three times to indicate that the system function is normal and is ready for use. If this fails to occur, either the LED or microcontroller is not functioning correctly, or the, key switch 90 has been turned on, off, and on again too quickly for the microcontroller 200 to reset the LED control. If the LED does not flash three times after shutting off the power for several seconds and restarting it, the unit should not be used. [0086] Rapid flashing immediately after the key switch 90 is turned on indicates there is a checksum error in the microcontroller 200 . This occurs when a problem exists with the values stored in the microcontroller memory for the optical regulation and ballast voltage limits. In this instance, the unit is not operational and will not light. [0087] If slow flashing occurs after timed treatment has been initiated, and the regulator attempts and fails 10 times to reduce the tube output to within the specified range, this indicates that the output may be too high and the ballast voltage cannot be further reduced. This may result from a microcontroller or component failure. If the LED slowly flashes during treatment, the treatment should be discontinued because the output power may be higher than the specified maximum. [0088] If a steady glow occurs after timed treatment has been initiated, and the regulator attempts and fails 10 times to increase the tube output to within the specified range, this indicates that the output power may be too low and the ballast voltage cannot be further increased. If the LED glows steadily during treatment, but does not flash, the treatment may be continued, although the efficacy may be reduced as a result of low tube output. The LED will turn off if the output irradiance subsequently increases to above the minimum specified limit. [0089] The microcontroller firmware has three main executable firmware modules: power-on setup, calibration and regulation. Only the power-on setup and the regulation modules execute during patient treatments. [0090] The power-on setup module runs only at microcontroller power up when the key switch 90 is inserted and turned to “ON.” At this time, the system variables are reset and calibration values stored in non-volatile RAM are retrieved. Additionally, a checksum calculation is performed and compared against a stored checksum. Any mismatch causes the firmware to shut down the system and initiate the LED rapid flashing code. Once successful startup has been achieved, control is transferred to the regulation module. [0091] Upon entering the regulation module, the microcontroller 200 enters a voltage detection loop until it detects either a pulse train from the voltage circuit or contact closure on one of the technician-accessible service buttons/jumpers. The internal clock and the error flags are reset in this loop. If contact service closure is detected, control is transferred to the calibration module (see below). After the exposure time has been set on the timer 100 and the “START” button 104 has been pressed, the microcontroller 200 detects the pulse train produced by the VCO, and enters the main regulation loop. This starts the internal clock (independent of the timer). The main regulation loop reads the output of the VCO, the visible light sensor 120 , and the internal clock; selects a new tap switch (if required); and displays any system errors every three seconds according to the algorithm described below. Loop execution continues until the timer terminates the treatment and the VCO pulse train. [0092] When the timer countdown sequence is first initiated, the microcontroller 200 sets up the switch array to apply line voltage to the ballasts 20 . During the first 2.5 minutes of the treatment (as determined from the internal clock), the visible light sensor 120 measures the tube output, and appropriate transformer taps are selected to keep the output irradiance between half the stored minimum and maximum regulation limits (9.3 and 10.7 mW/cm 2 according to a preferred embodiment of the present invention). This is done to provide optimum tube warm-up while maintaining output irradiance within the specified limits. [0093] To allow sufficient time for the output to be within the required range at five minutes after any ballast voltage adjustment, the microcontroller 200 switches the minimum regulation limit to the stored value (9.3 mW/cm 2 in a preferred embodiment of the present invention) after the first two and a half minutes of operation; the maximum limit remains unchanged. Since the regulation limits are not modified beyond this point, the output irradiance will remain within these limits until treatment is terminated. [0094] If the output cannot be maintained between the regulation limits, the system error flags activate the system status LED. A system error is not reported until the regulator has made ten attempts to correct the condition. This allows time for the tubes to respond to adjustment and to prevent “nuisance” error indications. [0095] During each loop, the microcontroller 200 measures the ballast voltage via the VCO and sets an inhibit flag if the voltage is at maximum. While this action does not directly cause an error, one may be indicated if the system output is too low but cannot be raised due to the inhibit flag. If the timer 100 has terminated the treatment, the VCO pulse train is no longer present, and the microcontroller 200 returns to the voltage detection loop until a new treatment is initiated. [0096] Data for the calibration module is established prior to clinical installation. The maximum allowable ballast voltage for the voltage detection circuit 210 and the visible light sensor 120 signals corresponding to the minimum and maximum regulation limits are programmed into the microcontroller memory using a setup/calibration algorithm. [0097] To set the maximum ballast voltage, a voltage calibration jumper on the printed circuit board is shorted, causing the microcontroller 200 to enter the voltage calibration mode. A variac is used to adjust the ballast voltage to one transformer tap setting below the maximum allowable ballast voltage (127 VAC in a preferred embodiment of the present invention). Shorting the voltage calibration jumper a second time stores both this voltage value and a checksum in the microcontroller non-volatile memory. Each time the voltage calibration jumper is shorted, the system status LED flashes to indicate that the action has been completed. [0098] Next, the maximum and minimum regulation limits are stored in the microcontroller memory by switching to the optical calibration mode. A reference UDT optometer (e.g., a UDT S370 power meter with a 247 detector/cosine diffuser assembly), is placed at a reference point. According to a preferred embodiment of the present invention, the reference point is 3″ from the polycarbonate shield 40 at the center of the therapeutically active area. The ballast voltage is adjusted with a variac to obtain the desired maximum irradiance on the optometer. The corresponding output signal from the visible light sensor 120 is input to microcontroller memory as the maximum output limit. This procedure is repeated, adjusting the output to obtain the desired minimum irradiance on the optometer and setting the minimum limit of the regulator. Finally, a checksum is stored and the microcontroller 200 returns to the power-on setup module, commencing normal operation. As with the voltage calibration, the system status LED flashes each time calibration data has been stored. [0099] It has been found that, according to a preferred embodiment of the present invention, the measured output over the active emitting area is within 70% of the measured maximum when measured with a cosine response detector at distances of 4″ and 2″, and within 60% of the measured maximum over all operation distances. Exemplary Diagnosis and Treatment Methods [0100] One example of a treatment method for precancerous lesions, such as actinic keratosis, by PDT utilizing an illuminator described above in conjunction with 5-aminolevulinic acid (ALA) will now be described. [0101] Essentially anhydrous ALA is admixed with a liquid diluent just prior to its use. The ALA admixture is topically applied to the lesions using a point applicator to control dispersion of the ALA admixture. A suitable applicator is described in U.S. patent application Ser. No. 08/962,294 (filed Oct. 31, 1997), and ALA is generally discussed further in U.S. patent application Ser. No. 08/921,664 (filed Sep. 2, 1997). The entire contents of these applications are incorporated herein by reference. [0102] After the initial application of the ALA admixture has dried, one or more subsequent applications may be similarly applied. Approximately 2 mg/cm 2 of ALA is administered. Formation of photosensitive porphyrin and photosensitization of the treated lesions occurs over the next 14-18 hours, during which time exposure to direct sunlight or other bright light sources should be minimized. Between 14 and 18 hours after administration of the ALA, the lesions are irradiated by an illuminator according to the present invention. The illuminator irradiates the lesions with a uniform blue light for a prescribed period. According to a preferred treatment, the visible light has a nominal wavelength of 417 nm. [0103] The invention thus provides a method for photodynamically diagnosing or treating a contoured surface of a patient which includes providing the illuminator described above, placing the patient in the illuminator, and illuminating the patient to diagnose or treat the patient. As described in the documents referred to above, the patient may be illuminated to treat actinic keratoses, acne, photo damaged skin, cancer, warts, or psoriasis. The method can also be used to remove hair and diagnose cancer. [0104] Since total light Dose (J/cm 2 )=Irradiance (W/cm 2 )×Time (sec), the only additional parameter that needs to be controlled for delivery of the correct treatment light dose is exposure time. This is accomplished in a preferred embodiment of the present invention by the timer which controls electrical power to the ballasts and which can be set by the physician. Data has shown that 10 J/cm 2 delivered from a source with an irradiance density of 10 mW/cm 2 produces clinically acceptable results. From the equation above, this light dose will require an exposure time of 1000 seconds (16 min. 40 sec). A selected light dose may also be administered by additionally or alternatively varying the irradiance density. [0105] Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, and representative devices, shown and described herein. [0106] Accordingly, various modifications may be made without departing from the spirit and scope of the general inventive concept as defined by the appended claims and their equivalents.

1a

TECHNICAL FIELD [0001] This invention relates to new dehydrated food products in the form of flakes, and also to a process for producing these products. In particular, the invention relates to flakes that can dissolve rapidly, essentially instantaneously, in hot or cold water. BACKGROUND [0002] Dehydrated food products generally have the serious disadvantage of being difficult to dissolve in hot and cold water, so that particular precautions have to be taken to prevent the formation of lumps in the reconstituted product or to remove lumps once formed by, for example, sieving or using an electric mixer [0003] Typical products are in the form of fine powders, granules or compressed tablets. However, in addition to being difficult to dissolve in water without lump formation, such products tend to have an appearance of having been highly processed or manufactured which can seem artificial or non-natural to a user. Cooks may be put off using such products, particularly when there is a widespread wish from cooks and consumers to be preparing and eating foods that are as natural as possible. [0004] In many kitchens there are now fewer qualified and experienced staff. Often there is little time or patience to wait until water, to which a powdered dehydrated food product is to be added, has reached the optimum temperature for dissolution without lump formation. It is therefore commonplace for the powder to be added at any time while the water is being heated, even on boiling. There is therefore a need for a dehydrated food product to work well at a variety of water temperatures. [0005] There is also a demand for dehydrated food products to be easy to use in the kitchen. For example, many existing products are available in the form of a compressed block or tablet. The cook must use the entire block when preparing the food, or break the block and use only the amount of product the cook wishes to use. This can be a cumbersome step and can often lead to too much or too little product used in the food preparation. Those dehydrated food products available in the form of a loose powder are also not user-friendly in the kitchen. They may need to be weighed or measured in small amounts, spillages are common, and some powdered products suffer from lump formation before use in high humidity locations. [0006] An example of a non-homogeneous powdered dehydrated sauce is described in EP 1 709 876. The sauce is prepared from of a mixture of ingredients where some are powdered, some may be in the form of flakes, and yet others may be chips or granules. This non-homogenous appearance can be displeasing to the cook. Further, there is the problem of segregation where fine particle size ingredients tend to separate out from the larger particle size ingredients in the packaging during storage and transport. This can lead to inconsistency of ingredients and flavours from one food preparation to the next. There is therefore a need for dehydrated food products that have an homogeneous composition such that segregation based on particle size does not matter. [0007] Granulation of dehydrated food products is known. However, granulated products too have drawbacks. Some granulated products do not dissolve rapidly or well in water. This may be due to low porosity of the granules or low surface area available for contact with water compared to powders. Additionally, granulated products tend to have a highly manufactured non-natural appearance which may not be appealing to the user. U.S. Pat. No. 4,060,645 describes an example of an homogeneous dehydrated sauce product in the form of grains. [0008] An object of the present invention is to provide a new homogeneous dehydrated food product which at least goes part way to overcoming one or more of the above disadvantages of existing dehydrated food products. SUMMARY OF THE INVENTION [0009] In a first aspect of the invention there is provided a dehydrated food product of homogeneous composition in the form of flakes, which flakes have a porosity of 30 to 70%, preferably 40 to 60%. The shape and size of the flakes may be irregular or regular. [0010] The dehydrated food product may dissolve and/or disperse more or less instantaneously in water at a temperature greater than 20° C., preferably greater than 50° C., and more preferably greater than 80° C. [0011] Typical flakes of the invention each have an average thickness of about 0.8 mm to about 2.3 mm, and top and bottom surface areas in the range of about 10 mm 2 to about 400 mm 2 . The flakes of a given volume may all be of varying size or may be of a similar size. They may have irregular of regular shapes. Further, the flakes preferably have a bulk density of about 100 g/L to about 300 g/L. [0012] The flakes of the invention may be formed by any suitable means, but are preferably formed by the extrusion of a thermoplastic material through an extruder followed by cutting of the extruded material. The extrusion die of the extruder can influence the physical appearance of the flakes. The die preferably has a cross-sectional shape having multiple slits which may be linked or intersecting slits. [0013] The thermoplastic material used to prepare the flakes will typically contain at least some of flour, starch, fat, salt, sugar, flavours, and maltodextrins, but it will be appreciated that any suitable extrudable material may be used depending on the nature of flake product desired. [0014] The thermoplastic material may be extruded at any suitable temperature and pressure, but usually in the ranges of 60° C. to 125° C. and 15 to 150 bar. [0015] The food product that may be prepared using the flakes of the invention is not restricted to any particular type of food product, but would typically be a sauce, soup, fond, gravy, stock, or consommé. [0016] In a second aspect of the invention there is provided a process for preparing the dehydrated food product flakes of the invention, including the steps of extruding a thermoplastic material through an extrusion die to form an extrudate strand and cutting the strand into pieces to form the flakes. [0017] The process is preferably carried out where the thermoplastic material is formed under sub-atmospheric pressure and at a temperature of at least 60° C. BRIEF DESCRIPTION OF THE FIGURES [0018] FIG. 1 shows a dehydrated food product in the form of flakes of the invention. [0019] FIG. 2 shows a longitudinal cut (6 mm×4.7 mm) of a flake of the invention. [0020] FIG. 3 shows a transversal cut (6 mm×2 mm) of the flake of FIG. 2 . [0021] FIG. 4 shows a vertical cut (4.7 mm×2 mm) of the flake of FIG. 2 . [0022] FIG. 5 shows the dissolution kinetics of flakes and granules. DETAILED DESCRIPTION [0023] The present invention provides a dehydrated food product of homogeneous composition in the form of flakes, where the flakes dissolve and/or disperse rapidly in water. The dissolution and dispersion characteristics of the flakes are due in large part to the flakes having a porosity of 30 to 70%, preferably 40 to 60%. [0024] According to this invention, a “flake” is a piece of the food product that is generally thin, such that its thickness is less than its width or length (or diameter in the case of a circular shaped piece), and has opposed surfaces that may be regarded as top and bottom surfaces (depending on the orientation of the piece relative to the horizontal). Flakes may generally be, although not necessarily, flat or curved or have smooth/regular surfaces or irregular surfaces. The circumferential shape of such flakes may also be smooth/regular or irregular. [0025] The term “irregular”, when referring to flakes of irregular shape and size, means non-uniform, uneven and variable such that the individual flakes in a volume of flakes each may have a different shape and/or size compared to other flakes in the volume. [0026] The term “homogenous composition” as used in the claims means a composition having substantially uniformly or evenly dispersed ingredients and may comprise one or more types of particle depending on the number and nature of the ingredients used for formation of the flakes. [0027] The term “dehydrated”, when referring to the food product of this invention, means having a total moisture content of less than 5% by weight. The dehydrated food product may or may not have been prepared by a process that includes a specific step where the moisture content is reduced, i.e. a dehydration step. For example, the reduction in moisture content of the food product may occur during a vacuum extrusion process where the extrudate expands into a reduced pressure environment with concomitant evaporation of water. [0028] The term “rapidly”, when referring to flakes substantially dissolving in water, means rapidly compared with other types of food particulates, such as grains having low porosity, and typically less than 2-3 minutes and more often less than 30 seconds depending on the temperature of the water and the respective volumes of flakes and water. [0029] The term “porosity” means the relative proportion of the volume of voids in a volume of flakes. For example, a flake having a porosity of 20% means that 20% of the flake volume comprises voids (e.g. spaces, holes, gaps etc.). [0030] In the context of this invention, “dissolving” in water means dissolving in the sense of forming a solution in water as well as dispersing in water, so that the resultant liquid is a combination or mixture of solubilised particles and particles in suspension in the water. [0031] According to the invention, the dehydrated food product is in the form of flakes. This provides the desirable characteristic of a natural appearance. The flakes have an homogeneous composition which means that all the flakes have the same composition and also that the internal composition of each flake is homogeneous. In essence, the flakes are all made from the same material. One example of flakes of the invention is shown in FIG. 1 . [0032] The flakes of the invention are porous. The porosity of the flakes is in the range 30 to 70%, but preferably 40 to 60%. This enables the flakes to dissolve and/or disperse rapidly in water. The flakes also preferably have a bulk density between 100 and 300 g/L. [0033] Generally the flakes of the invention have an average top and/or bottom surface area of at least 2 mm 2 , but less than about 400 mm 2 . Typical flakes have an average top and/or bottom surface area in the range of about 8 to 100 mm 2 . [0034] According to a preferred embodiment of the present invention, the dehydrated food product is a dehydrated sauce, soup, fond, gravy, stock, or consommé. The dehydrated food product may be based on extracts or powders of meat, vegetables, fruits, spices, and aroma carrier products. [0035] The dehydrated sauce product according to the invention usually has a water content of up to 5% by weight. [0036] When the dehydrated food product according to the invention is a sauce, it preferably comprises at least meat and/or vegetable based components, flavouring compounds, salt, sugar, hydrocolloids (such as maltodextrin, starch, or flour), and fat or vegetable oil. [0037] The products of the present invention have the advantage that they dissolve well in water, in contrast to dehydrated food products in the form of powders or grains which have a lower porosity and therefore do not dissolve so well. Dissolution of the flakes of the invention occurs readily and with no lump formation even in boiling water. [0038] The invention also provides a process for the production of such a product which comprises extruding a thermoplastic material in powder or paste form at a temperature in the range of 60 to 125° C. and under a pressure in the range of 15 to 150 bar into a chamber having a sub-atmospheric pressure from 0.015 to 0.40 bar, preferably 0.015 to 0.25, and most preferably 0.015 to 0.15, and cutting the extruded product into fragments. [0039] In the context of the invention, the “thermoplastic material” is in the form of a powder or paste material which is either thermoplastic in itself or which contains enough thermoplastic constituents to be capable of softening under the effect of heat, and optionally pressure, and hardening when cooled. The notion of thermoplasticity is easily realised in the case of a paste. In the case of a powder, thermoplasticity signifies that the constituent particles of the powder are capable, under the effect of heat, and optionally pressure, of melting into one another to form a soft, more or less malleable mass. [0040] The thermoplasticity of the material is preferably provided by the presence of fat or oil. This enables the paste to soften on application of heat or the powder to melt thereby forming a soft and malleable mass. The amount of fat or oil in the food product of the invention is usually not more than 50% by weight, preferably 1 to 30% by weight, typically 5 to 15% by weight. [0041] This starting material may be selected from a wide range of food-grade materials used individually or in combination which, more specifically, may be grouped into two categories: materials based on polysaccharides and materials based on proteins. One or the other of these two categories covers, for example, vegetables, seeds, starches, more especially modified starches and dextrins, gums, alginates, meat and fish extracts, proteins of microbiological origin, especially yeast extracts and autolysates, protein hydrolysates and gelatins. The starting material may also contain other ingredients such as spices, flavourings, colorants, fats, sugars, and salts. [0042] In general, preferred starting materials are extracts of vegetables, dextrins, gums, low fat or fat free instant stocks in powder form or mixtures for preparing such stocks, such as mixtures which normally contain, aside from vegetable extracts, yeast autolysates, meat extracts, protein hydrolysates, flavourings, spices, sugar, salt and sodium glutamate. [0043] The thermoplastic starting material in powder or paste form can contain from 1.5 to 20% water by weight. The water content of the starting material is an important factor, but is not critical insofar as it may vary within a wide range, amounting to as much as 20% based on the dry weight of the flakes. It has a direct influence upon the characteristics of the end product and, to prepare a given end product, it may be necessary to modify the water content of the starting material. [0044] The temperature of the starting material in the extruder is important to ensure the plasticity of the starting material and to enable it to pass suitably through the extrusion nozzles. The temperature should be high enough to ensure this plasticity, namely 60° C., but should not cause any deterioration of the treated extract. A temperature of 125° C. may be regarded as an upper limit, but it is normally best not to exceed 105° C. However, the temperature in the vicinity of the nozzles may be above that limit because the residence time of the starting material there is very short. In the absence of special controlling, this temperature is effectively above the temperature prevailing in the actual extruder because the compression forces which act on the starting material, at least when it has to pass through the small orifices constituting the nozzles, cause an increase in temperature and the establishment upstream thereof of a pressure normally amounting to between 15 and 150 bar (approximately 1 to 15 atmospheres) during regular operation. Nevertheless, it is preferred to avoid excessive heating in the vicinity of the nozzles. [0045] In order to provide the end product with a particular shape, it is preferred to use nozzles of non-circular cross-section. In addition, the surface finish of the extruded product, i.e. of the flakes obtained, may be influenced by using cooled or gently heated nozzles or nozzles of which the outer part is cooled or gently heated. [0046] The sub-atmospheric pressure or vacuum prevailing in the chamber downstream of the nozzles is also important. In the absence of this vacuum, the product obtained by extruding a starting material heated to fairly moderate temperatures for operations of this kind would not be able to acquire the expanded texture required. In contrast, the presence of the vacuum downstream of the nozzles causes, on the one hand, a sudden elimination of at least part of the water in the form of steam and the gases initially present in the extract and, on the other hand, a sudden reduction in temperature, leaving the extruded product with the desired texture and rigidity. In practice, the sub-atmospheric pressure is typically 0.015 to 0.400 bar (approximately 0.015 to 0.400 atmospheres). [0047] In preferred embodiments of the invention, the starting material in powder or paste form is introduced by delivery means of any kind, at atmospheric pressure, under pressure or in vacuo and, if necessary, under an inert gas into an extruder. The barrel of the extruder is at a temperature of from 60 to 100° C. The material is then conveyed towards the extrusion nozzle(s) by such means as a piston (for batch operation) or a single or double screw (for continuous operation), at a fixed or variable pitch, and gradually plasticises under the effect of the heat and pressure applied. The heated material then passes through the extrusion nozzles and arrives in the chamber where the vacuum prevails. The chamber may be referred to as an expansion chamber. Under the effect of sudden decompression, some water (up to 50%) and some of the gases present are expelled. At the same time, the temperature of the hot extract falls by several tens of degrees. An expanded product in the form of a porous, relatively rigid strand is thus obtained. [0048] In a first variant, the strand is left to expand completely and is then cut in a regular sequence, for example by means of a rotary blade, to give uniformly dimensioned flat irregular flakes. [0049] In a second preferred variant, the strand is cut in close proximity to the extrusion nozzles and in vacuo, before having completed its expansion. The pellets obtained continue to expand, ultimately giving flakes of comparable size. [0050] In one preferred embodiment of the invention, the starting material used for extrusion is in paste or powder form with any granulometry and with a water content of from 1.5 to 20%. The extruder used is a heated screw extruder kept at 60 to 100° C. and equipped with nozzles. The pressure in the expansion chamber is 0.015 to 0.150 bar. The expanded strand is cut in vacuo immediately it issues from the extrusion nozzles. The portions obtained then drop onto a tray and, having completed their expansion, may be carried outside the expansion chamber through an airlock. These portions generally have an apparent density of from 100 to 300 g/L. [0051] Typical product examples may constitute instant fruit and vegetable extracts or instant lean stocks. They may also be treated with various substances. In particular, the flakes may be impregnated or coated with fats, preferably in a quantity of from 8 to 18% by weight, which dissolve readily in hot or cold water. It is also possible to add other ingredients such as flavourings and colourants. [0052] The process of the present invention has the advantage of providing a dehydrated food product having a colour very similar to the colour of the food which will be obtained after rehydration compared to a food product in the form of a powder. The cook is therefore more likely to feel confident with the preparation of foods from the product of the invention. It has been observed too that the products of the present invention usually present an aroma nearer to the aroma of the rehydrated food compared with those products in the form of a powder known in the art. EXAMPLES [0053] The invention is further described with reference to the following examples. It will be appreciated that the invention as claimed is not intended to be limited in any way by these examples. Example 1 [0054] The following example describes a method for producing flakes of the invention. Ingredients in powder form were mixed, providing an homogeneous dry mix having the following composition: [0000] Maltodextrin 23% Flavours 18% Starches 30% Meat powder 12% Salt 11% Seasoning  2% Yeast extract  4% [0055] The mix was processed in an extruder at a temperature of up to 80° C. with continuous integration of 8% fat and 3% water in extruder. Pressure was increased to 55-75 bar. The resulting thermoplastic material was forced through a specially shaped die and subsequently cut into flakes of the desired dimensions. [0056] Dehydration of the flakes and porosity of the flakes is achieved through abrupt pressure release of product at exit of the extruder. [0057] Tap density of the flakes was measured to give a desired bulk density of 150-185 g/L. Dissolution in water was measured by dissolving 50 g of flakes in 1 litre of water at 3 temperatures: 100° C., 60° C., 35° C., while agitating constantly with a hand whisk. Dissolution was measured as the time until dissolution of last flake. [0058] Results: 100° C.=6 sec 60° C.=6 sec 35° C.=8 sec Example 2 [0062] This example compares the porosity and dissolution rates of dehydrated food products in the form of flakes with the same products in the form of granules. Two recipe types are compared, one using flour as a binder and one having no flour. [0000] Recipe A Starches  33% Meat powder 6.3% Flavours 16.2%  Vegetables 5.8% Salt 10.8%  Seasoning 2.6% Yeast Extract   5% Flour 3.9% Maltodextrin 7.4% Thickener   2% Sugar   0% Vegetable oil   7% Recipe B Starches  31% Meat powder 2.2% Flavours 12.6%  Vegetables 2.9% Salt 13.5%  Seasoning 0.8% Yeast Extract   9% Maltodextrin 12.4%  Plant extract 4.2% Sugar 1.2% Liquid fat   9% [0063] X-ray tomography scans and 3D image analyses were performed on flakes prepared from each recipe. FIGS. 2 to 4 show the structure of a flake prepared using recipe A. The porosity of each flake was calculated as the ratio of the volume of voids in the flake of the volume of the flake. [0064] The porosity of flakes from Recipe A was determined to be 39.8%. [0065] The porosity of flakes from Recipe B was determined to be 52.6%. [0066] The dissolution kinetics of flakes was performed using a conductivimeter Meterlab (Artsoft, Radiometer Analytical SAS). Flakes (7 g) were dissolved in deionized water (400 mL) at 70° C. The flakes were added to the water instantaneously using a delivery tool. Conductivity frequency measurements were taken using a 12 mm sensor operating at 0.75 Hz. During the measurement, the flakes were stirred using a magnetic stirrer at 500 rpm and a helix stirrer at 100 rpm. FIG. 5 shows the dissolution kinetics of flakes and granules prepared from both Recipes A and B. The graph shows the percentage of solubilised product by weight versus time. It can be seen clearly that in both cases (Recipe A and Recipe B) flakes dissolve more quickly than granules. Example 3 [0067] This example compares the degree of lump formation when flakes and granules are reconstituted in water to form the fully hydrated food product. The same two recipes from Example 2 were tested. [0068] Dehydrated granules or flakes (50 g) were added to boiling water (1 L). A mechanical whisk operating at 120 rpm was used to reconstitute product. After stirred for 3 min at a temperature above 80° C., the product was sieved through a sieve (1 mm mesh size). Remaining lumps were washed under cold water for ten seconds. The lumps were then dehydrated in an oven at 105° C. at 20 mBar for four hours before being weighed. The results are indicated in the following table. [0000] Residue Residue Average weight percentage Percentage Sample [g] % % Granule A 3.39 6.78 4.85 0.32 0.64 3.56 7.12 Granule B — 0.00 0.00 — 0.00 Flakes A — 0.00 0.00 — 0.00 Flakes B — 0.00 0.00 — 0.00 [0069] Flakes made from Recipe A clearly perform better than granules made from Recipe A, i.e. no lumps were formed when flakes were reconstituted in water. Flakes and granules made from Recipe B (which has no flour as a binder) performed equally. [0070] It is to be appreciated that although the invention has been described with reference to specific embodiments, variations and modifications may be made without departing from the scope of the invention as defined in the claims. Furthermore, where known equivalents exist to specific features, such equivalents are incorporated as if specifically referred to in this specification.

1a

BACKGROUND OF THE INVENTION The present invention relates to an exerciser, and in particular to a low impact, full body exerciser. Various exercisers have been designed in response to the modern emphasize on fitness. However, many of the devices do not provide for balanced exercising of one's whole body. Further, even with devices designed to pace the user, it is possible to `fool` the device or become lazy such that the workout is less beneficial than desired. Many devices which do offer a full body aerobic workout are inflexible and difficult to use, particularly for older or heavier individuals. In sports there is also a need for improved ways to condition athletes. For example, it is common for athletes to repeatedly ascend and descend stadium bleachers as a way of conditioning. However, such practices can be dangerous since the athletes are subject to falling and hurting themselves on the hard and irregular surfaces of the bleachers. Further, when the weather does not cooperate, indoor bleachers are not always available. Thus an exerciser which provides a balanced and complete aerobic workout of one's entire body, but which is flexible and easy to use is desired. SUMMARY OF THE INVENTION The present invention solves the aforementioned problems by providing a first and second mechanism for exercising the upper and lower body of an operator, respectively. The first mechanism includes handle means which move and simulate a hand-over-hand motion, while the second mechanism includes platform means which move and simulate a stair-like climbing motion. In one form, the first and second mechanisms are angled and positioned to optimize an operator's comfort during use. This includes providing clearance for the knees of the operator during use. Further, the speed of the first and second mechanisms can be varied to control the amount of exercise that will be obtained from using the exerciser. In a narrower form, the exerciser includes a control that is programmable so that multiple speeds and time durations of each speed can be preset for a pre-programmed exercise routine. The control may include a photocell for increased safety. In yet another narrower form, the lower mechanism includes a sheet of flexible material fastened to the rear of and between the multiple platforms for safety and aesthetics. In still another form, the upper and lower mechanisms are pivotally interconnected for ease of setup between a folded position for shipping and an upright position for use. The present invention includes several advantages over known art. The invention provides a balanced, low-impact, full body aerobic exercise for both the upper and lower body of an operator. During this exercise, the operator's body is in total suspension, the body being actively supported only by the operators moving arms and legs thereby reducing the ability of an operator to "cheat" or become lazy. The upper and lower mechanisms are specially adapted for the operator's upper and lower body, respectively, thereby increasing functional use and safety. The ease and flexibility of use make the exerciser useable by persons who are somewhat less agile such as older or heavier persons, as well as athletes who desire a challenging and extensive workout. These and other features, objects and advantages of the present invention will become apparent upon reading the following description thereof together with reference to the accompanying drawings in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an apparatus embodying the present invention; FIG. 2 is a front view of the apparatus in FIG. 1; FIG. 3 is a sectional taken along the lines III--III in FIG. 1 and showing the position of an operator; FIG. 4 is a side elevation of the apparatus in FIG. 1 with the side guard removed to schematically show the endless chains and the powering mechanism; FIG. 5 is a rear elevational view of the apparatus in FIG. 1 with a portion of the guards removed to show the endless chains and powering mechanism; FIG. 6 is an enlarged side elevational view of the platforms and attachment thereof to the endless chains; FIG. 7 is an enlarged perspective view of a bracket which attaches to the endless chain; FIG. 8 is a schematic of the electrical circuit for the invention; FIG. 9 is a perspective view of an alternative embodiment of the present invention; and FIG. 10 is a side elevational view of yet another embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings and the embodiments illustrated therein, an exerciser or apparatus embodying the present invention is shown in the attached figures and is generally referred to as numeral 20 (FIG. 1). Exerciser 20 includes an upright frame 22 upon which upper and lower mechanisms 24 and 26, respectively, are supported. A motor 28 operates primary endless drive chain 30 and secondary endless drive chain 32 to drive mechanisms 24 and 26 at a coordinated and variable speed (FIG. 4). Upright frame 22 (FIGS. 1 and 4) is a rigid framework constructed of tubular beams for strength. Frame 22 includes a planar base 34 made of two side members 36 and front and rear cross members 40, 42 which are interconnected to form a rigid support structure. Side members 36 have protruding portions 44 that extend forward of front cross member 40. Primary side upright members 48, 50 attach to the forward end of protruding portions 44 and extend diagonally upwardly and rearwardly a vertical distance above the height of a typical person and at a angle which promotes the comfortable operation of exerciser 20, as discussed below. A pair of support beams 52 extend between side members 36 of base 34 and upright members 48, 50 to rigidly fix the angular position of upright members 48, 50. A rearwardly offset middle cross member 56 and a top cross member 58 rigidly interconnect upright members 48, 50 to complete the rigid frame. Upper mechanism 24 includes upper and lower axles 60 and 62 which extend horizontally between upright members 48, 50 and attach to upright members 48, 50 for rotational movement within bearings 64, 66, 68 and 70. Bearings 64, 66, 68 and 70 may attach to the front of upright members 48, 50 to facilitate assembly and to establish a proper angle for mechanism 24, but alternative designs are possible. Upper bearings 64 and 66 are slideably adjustable by adjustment mechanisms 65 and 67 on upright members 48, 50 so that endless chains 72, 74 which extend between axles 60, 62 on sprockets 76, 78, 80 and 82 can be properly tightened. Lower axle 62 further includes a secondary drive chain 32 (FIG. 4) for powering upper mechanism 24. A safety shield 92 is positioned between upright members 48, 50 and between axles 60 and 62 (FIG. 1). It is contemplated that shield 92 will include upper and lower portions 93 that cover axles 60, 62, although several alternative arrangements are possible. For example, lower axle 62 could be constructed with a split shaft so that the central area is entirely open (i.e. similar to axles 98 and 100 of lower mechanism 26). Side shields 94 (FIG. 1) are positioned around the front of endless chains 72, 74 as they extend along the useful segment of the path of rungs 88 to protect against accidental rubbing or contacting of chains 72, 74. These shields increase both the safety and aesthetics of upper mechanism 24. Hand supports or rungs 88 attach between endless chains 72, 74 by use of brackets 90 (FIG. 7). Rungs 88 have a diameter which is conducive for grasping by the hands of an operator. Sprockets 76, 78, 80 and 82 are properly sized so that endless chains 72, 74 and specifically rungs 88 have a clearance for an operator's fingers between them and shield 92 as rungs 88 traverse downwardly in front of shield 92. Rungs 88 establish a path as they travel in an oblong pattern diagonally downwardly from axle 60 to axle 62 in front of shield 92 during a useful segment, around lower axle 62, upwardly behind shield 92, and around upper axle 60. In the preferred embodiment, six to eight round rungs are used, although it is contemplated that various numbers and shapes of rungs can be used. Lower mechanism 26 is adapted for use with an operator's lower body. Lower mechanism 26 includes an upper axle 96 and right and left lower axles 98 and 100. Upper axle 96 extends horizontally between and is rotationally mounted within bearings 102, 104, which are adjustably mounted on the backside of upright members 48, 50 as shown. Bearings 102 and 104 are slideably adjustable by adjustment mechanisms 103 and 105. Lower axles 98 and 100 are axially aligned and rotationally mounted within bearings 103, 105 which are mounted on upright members 48, 50 near a lower end thereof. By mounting upper axle 96 on the backside of upright members 48, 50 and lower axles 98, 100 on the front side thereof, lower mechanism 26 is oriented at a smaller angle from horizontal than upper mechanism 24. Thus, lower mechanism 24 is better adapted for use by the operator's lower body, as discussed below. It is contemplated that lower axles 98 and 100 will be foreshortened to leave an open area between them to eliminate an area that may serve to bruise the operators ankles. Endless chains 106 and 108 extend around sprockets 110, 112, 114 and 116 located on axles 96, 98 and 100, and can be tightened by movement of slideably adjustable bearings 102, 104 on upright members 48, 50. Sprockets 110, 112, 114, and 116 of lower mechanism 26 are larger than sprockets 76, 78, 80, and 82 of upper mechanism 24 to facilitate movement of platforms 118 around lower mechanism 26. Foot supports or platforms 118 extend horizontally between and attach to endless chains 106, 108 by use of brackets 90. An angle iron 122 extends between brackets 90 and attaches under platforms 118 to properly horizontally orient the upper surface 124 of platforms 118 during its useful segment of movement 123. Platforms 118 establish a path as they travel in an oblong pattern diagonally downwardly from upper axle 96, around aligned lower axles 98 and 100, upwardly toward upper axle 96, and around axle 96. It is contemplated that platforms 118 can be made of several different materials, but in the preferred embodiment will be made of a reinforced plastic material. Flexible sheets 126 are attached to the bottom 125 of and between platforms 118 to form a barrier to the operators feet and legs to prevent them from entering the area between and behind platforms 118 during their movement through the useful segment 123 of their path (FIG. 6). Sheets 126 also improve aesthetics by closing off the area behind lower mechanism 24. Sheets 126 flexes and folds as needed as platforms 118 move around lower mechanism 24. During the diagonal downward movement of platforms 118, sheets 126 are stretched tightly enough to reduce the chance of objects being put into and between platforms, but loosely enough to prevent binding of endless chains 106, 108. It is contemplated that sheets 126 could be replaced with a hinged configuration such as is often used in escalators. Inner side shields 128 (FIG. 1) cover endless chains 106, 108 along the forward edge of upright members 48, 50 to protect against rubbing or contacting of chains 106, 108. These shields increase both safety and aesthetics. Lower mechanism 26 is positioned at a smaller angle to horizontal than upper mechanism 24 so that lower mechanism 26 provides clearance for the knees of a user during the useful segment of travel by platforms 118 along their respective path. In the preferred embodiment, this angle is between about 45° and 60°, which is similar to the rise of steps in bleachers and the like. The angle of upper mechanism 22 to horizontal is between about 60 and 75°, which is similar to the angle of a ladder propped against a wall. It is contemplated that various angles can be used, and also that exerciser 20 can be made to allow adjustment of the angles as desired, by adjusting the angle of the base relative to the floor, or support surface, or by shimming any of the bearings inwardly or outwardly such as is shown by arrows A and B in FIG. 4. A powering mechanism includes a motor 28 fastened to base 34. In the embodiment shown, motor 28 is a DC motor which drives a worm-gear speed reduction device 13 which rotates a drive sprocket 134. Motor 28 is a variable speed 1/3 HP DC motor operating at 1750 RPM. Speed reduction device 132 is a worm-gear reducer operating at 30:1 reduction rate, while sprockets 134, 138, 140 and other sprockets on upper and lower mechanisms 24, 26 are matched and sized to achieve the speed desired. A one-way friction clutch 133 attached to device 132 prevents the weight of a person on the exerciser from driving the platforms 118 and motor 28 at a speed faster than is desired. An endless primary drive chain 30 extends from sprocket 134 to sprocket 138 and drives axle 96. Motor 28 is adjustably positionable to tighten chain 30. In addition to driving lower mechanism 24, axle 96 supports a drive sprocket 140 and endless secondary drive chain 32 operably connected to drive axle 62. A tensioning device 144 attached to upright member 50 maintains the necessary tension on endless chain 32. Similar tensioning devices could be used on the other endless chains as may be required. A control panel 146 is mounted to one side of upper mechanism 22 on brackets 148 at a convenient height for use by an operator positioned on exerciser 20. The control panel 146 shown, houses a control circuit 147 (FIG. 8) including an on/off switch 150, a variable speed control 152, and a timer 154. Speed control 152 is a rheostat which cooperates with DC motor 28 to controllably vary the speed of rungs 88 and platforms 118. Timer 154 allows a person using exerciser 20 to time their workout. It is contemplated that control panel 146 could include various readouts and mechanisms (not shown) such for measuring speed, pulse rate, calories burned, and the like. It is also contemplated that a programmable device 156 could be used to preset an exercise routine such as a warm-up speed for a few minutes, a faster intermediate speed for several minutes, and a warm-down speed. Having described the components and parts of the preferred embodiment of the exerciser, its use and operation should be obvious to one skilled in the art. Briefly, exerciser 20 is positioned in a convenient location and is plugged into an electrical outlet. An operator desiring to use exerciser 20 first makes sure the unit is turned off, the variable speed is turned to a slow speed, and the rungs 88 and platforms 118 are not moving. The operator then steps onto a platform 118 and grasps a rung 88. The on/off switch 150 is flipped to the "on" position, and variable speed control 152 is rotated until rungs 88 and platforms 118 begin to move. The operator begins to grasp successive rungs 88 in a hand-over-hand motion as the rungs are presented in front of the operator, and simultaneously begins to step on successive platforms 118 also presented in below the operator. Since both the arms and legs of the operator are active, the operator's body is in "total suspension" such that the operator cannot become lazy or "cheat" by supporting part of their weight on a safety rail or other devices. At the same time, the operator is in control and need not fear falling since both the hands and feet can be actively used to stay in a balanced position. Further, since the operator's arms and legs are used, the exercise provided is a full body exercise which is aerobically balanced. If the operator desires a more vigorous pace, the speed of rungs 88 and platforms 118 are increased by use of variable speed control 152. Also, timer 154 indicates the length of time remaining in the workout. If an operator should stumble or not keep up, shields 92, 94, 128 and flexible sheets 126 help reduce the risk of undesirable entanglement with rungs 88 and platforms 118. Additionally, shield 92 is designed with a blunted lower end 93 (FIG. 1) which tends to gently force an operator's wrist off of rungs 88 as rungs 88 move around axle 62 from the front to the rear, thus causing the operator to release their grasp of rungs 88 during this movement. Platforms 118 also tend to tip as they round lower axle 98, which deposits the operator onto the floor is the operator does not move to the next platform in time. In a first alternative embodiment, an exerciser 20' includes one or more photocells 156 (FIG. 9). Photocells 156 could be positioned at the lower end of upper or lower mechanisms 24, 26 to sense if the operator is falling behind and is therefore lower on exerciser 20 than is desired. Photocell 156 could be electrically connected to slow down or turn off the exerciser depending upon safety devices utilized or deemed necessary. It is contemplated that photocells 156 could also be placed in other positions. In a second alternative embodiment, an exerciser 20" includes a pair of hinges 158 (FIG. 10) between upper 10 and lower portions of upright members 48, 50. Hinges 158 would be positioned on the front side of upright members 48, 50 so that upper mechanism 22 could be folded forwardly onto lower mechanism 24 in a compact arrangement for shipping. When ready for use, lower mechanism 24 would be tipped upwardly into position and locked rigidly in place by latches 162 on the backside of upright members 48, 50. Endless chain 32 would then be installed between drive sprocket 140 and axle 62 to ready exerciser 20 for use. Changes and modifications in the specifically described embodiment can be carried out without departing from the principals of the invention, which is intended to be limited only by the scope of the appended claims, as interpreted according to the principals of patent law including the doctrine of equivalents.

1a

FIELD OF THE INVENTION [0001] The present invention relates to an aqueous formulation useful for selective targeting and delivering gene to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. [0002] More particularly, the present invention relates to an aqueous formulation useful for enhanced, non-viral delivery of genetic products to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. BACKGROUND AND PRIOR ART OF THE INVENTION [0003] Chemotherapy and radiation therapies are two current clinical modalities commonly used for the treatment of cancer. Mostly these techniques are effective to block the growth of tumor; however, there is often a recurrence of the disease, possibly because of incomplete cell killing or cells acquiring drug resistance. [0004] Glucocorticoid receptor is a nuclear hormone receptor residing in various cells including both cancerous and non-cancerous cells. It has two subtypes alpha and beta. This receptor, a ligand activated transcription factor, upon activation translocates itself into the nucleus. As a homodimer it binds to specific DNA sequences called glucocorticoid response elements (GRE) and positively or negatively regulates transcription of target genes. [0005] Dexamethasone (dex), a potent glucocorticoid acts on intracellular glucocorticoid receptor and regulates transcription of several genes. Several of the glucocorticoids including dex exhibit antiproliferative effect on several tissues of different origin (Corroyer et. al. 1997; Ramalingam et. al. 1997; Rider et. al. 1996; Goya et. al. 1993; Wattenberg and Estensen 1996). These molecules also regulate and control metabolism, development, inflammation, cell growth, proliferation and differentiation (Yamamoto et. al. 1985; Cole et. al. 1995; Rogatsky et al. 1997). In various cancer cells such as in non-small cell lung carcinoma Dex mediates suppression of cellular proliferation through the accumulation of cells in G1/G0 stage of the cell cycle and by hypophosphorylation of retinoblastoma protein (Greenberg et. al. 2002). Glucocorticoid-signaling through glucocorticoid receptors potentiate a possible hypoxia related pathway leading to inflammation. As an anti-inflammatory agent, dex also possesses an important role in inhibiting hypoxia inducible factor (HIF-1), which has direct role in mediating angiogenesis through up-regulation of VEGF (Leonard et. al 2005). Hence, glucocorticoids such as dexamethasone (dex) are a very important and inexpensive drug-like substitute used in various pathological conditions. [0006] There is an example of dexamethasone being structurally modified into a cationic entity by conjugating spermine into it. The cationic dexamethsone-spermine compound is used to complex and transfer genes to airway epithelial with concurrent reduction of inflammation (Gruneich et. al. 2004). [0007] The viral based gene delivery is quite well known and is extensively investigated utilizing their phenomenally efficient process of delivering genes to wide variety of cells. A number of problems including host toxicity, immunogenic responses and non-specific genomic integration of transferred gene make viral delivery a risky option for delivering genes. In comparison, non-viral gene delivery is a much more robust and clinically safe option compared to viral counterparts. The patented cationic lipid, DODEAC (Banerjee et. al. U.S. Pat. Nos. 6,503,945 and 6,436,516), whose structure is N,N-dihydroxyethyl, N,N-dioctadecyl, ammonium chloride forms cationic liposome using co-lipid cholesterol in membrane filtered water. This product has been used for the transfection of DNA into cultured eukaryotic cells of various origins. However, the formulation in spite of exhibiting moderate transfection of genes to all cells irrespective of origin shows no specific targeting of genes to cancer cells expressing glucocorticoid receptor. Towards this end, the present invention relates to development of a new dexamethasone carrying cationic lipid based formulation, which targets and deliver genes to glucocorticoid receptor expressing cancer cells. [0008] Therefore, keeping in view the hitherto known prior art, the inventors of the present invention realized that there exists a need to develop an aqueous formulation useful for selective targeting and delivering gene to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. [0009] The present invention deals with targeted gene delivery which is specific to glucocorticoid receptors of cancer cells only and not of normal cells. The normal cells may be having glucocorticoid receptors but the formulation of the present invention will not target the gene to those normal cells. OBJECTS OF THE INVENTION [0010] The main object of the present invention is to provide an aqueous formulation useful for selective targeting and delivering gene to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. [0011] More particularly, the object of the present invention is to provide an aqueous formulation useful for enhanced, non-viral delivery of genetic products to cancer cells comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. [0012] Yet another object of the present invention is to provide a process for the preparation of the said aqueous formulation by formation of small uni-lamellar liposome. [0013] Still another object of the present invention is to provide a pharmaceutical composition comprising the said cationic lipid based formulation complexed with therapeutic amount of biologically active molecules. SUMMARY OF THE INVENTION [0014] The present invention provides an aqueous formulation useful for selective targeting and delivering gene to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. [0015] Accordingly, the present invention provides an aqueous formulation useful for enhanced, non-viral delivery of genetic products to cancer cells comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. [0016] In still another embodiment of the present invention, the said cationic lipid used is selected from the group comprising DODEAC (N,N-dihydroxyethyl, N,N-dioctadecyl ammonium chloride), DOTAP (1,2-dioleoyloxypropyl)-N,N,N-trimethylammonium chloride and DMRIE (1,2-dimyristyloxy-propyl-3-dimethyl-hydroxy ethyl ammonium bromide). [0017] In still another embodiment of the present invention, the cationic lipid used is preferably DODEAC (N,N-dihydroxyethyl, N,N-dioctadecyl ammonium chloride) [0018] Further in an embodiment of the present invention, the said steroid is selected form the group comprising dexamethasone, predinisolone, fluprednisolone, betamethasone, methylpredinisolone, triamcinolone and hydrocorticosone. [0019] In yet another embodiment of the present invention, the steroid used is more preferably dexamethasone. [0020] In yet another embodiment of the present invention, the said neutral co-lipid used is preferably cholesterol and is capable of enhancing the transfection efficiency of the said formulation up to 4 folds. [0021] In still another embodiment of the present invention, the selective targeting and delivery of gene is achieved by using non-viral mode. [0022] In yet another embodiment of the present invention, the non viral mode includes biologically active molecules selected from the group comprising ribosomal RNA, antisense poly nucleotide RNA, antisense poly nucleotide DNA, genomic polynucleotide DNA, cDNA, mRNA encoding anti cancer gene. [0023] In still another embodiment of the present invention, the gene used for selective targeting and delivery is selected from the group consisting of cytotoxic, anti-cancer and anti-metastatic genes. [0024] In yet another embodiment of the present invention, the gene used for selective targeting and delivery is selected from the group comprising p53, tumor necrosis factor Alpha, thymidine kinase, cytosine deaminase, 5 E1A and Tumor growth factor Beta. [0025] In still another embodiment of the present invention, the cancer is selected from the group comprising breast, lung, colon and prostate cancer. [0026] In yet another embodiment of the present invention, the cancer cell lines used are selected from the group comprising A549 (lung), MCF-7 (breast), HT-29 (colon) and PC-3 (prostate). [0027] Further in another embodiment of the present invention, the process for the preparation of an aqueous formulation comprises the following steps of: (a) preparing liposome by dissolving cationic lipid, a steroid and neutral co-lipid in a mole ratio of 0.75:0.5:1 to 1:2:1 preferably 0.75:1.0:1.0-1:2:1 in a mixture of methanol and chloroform in a glass vial; (b) removing the solvent from the mixture obtained from step (a) using a thin flow of moisture free nitrogen gas; (c) keeping the lipid film as obtained from step (b) under vacuum for 6-10 hours after drying the film; (d) hydrating the dried lipid film as obtained from step (c) using sterile deionized water to obtain liposome having total volume of 1 mL for a time period of 10-15 hours; (e) vortexing the liposome as obtained from step (d) for 1-2 minutes to remove adhering lipid film followed by sonicating in a bath sonicator for 2-3 minutes at room temperature to prepare multi-lamellar vesicles; (f) sonicating the multi-lamellar vesicles with a Titanium probe for 1-2 minutes to prepare desired small uni-lamellar vesicles, which is indicated by formation of clear translucent solution; (g) storing the obtained formulation as obtained from step (f) at 0-4° C. until complexed with biologically active molecule. [0035] Further in another embodiment of the present invention, the mole concentration of the steroid and the neutral co-lipid is varied in the range of 0.1-5 mole equivalents separately at a fixed mole concentration of cationic lipid. [0036] In still another embodiment of the present invention, freezing and thawing cycles can cause loss of efficiency of the said formulation. [0037] In yet another embodiment of the present invention, a pharmaceutical composition comprising effective therapeutic amount of the said formulation complexed with therapeutically acceptable amount of biologically active molecule. [0038] In still another embodiment of the present invention, the pharmaceutical composition can be administered in to a subject, wherein the subject is mammal including human. [0039] In yet another embodiment of the present invention, the route of administering the said pharmaceutical composition is selected from the group comprising intra-venous, intra-muscular and intra-peritoneal. [0040] In still another embodiment of the present invention, the said pharmaceutical composition can be alternatively administered into the cancer cells at a ratio of 0.1-0.5 μg of DNA per 50,000 cells in an in vitro system. [0041] In yet another embodiment of the present invention, the ratio of cationic lipid to biological molecule in the pharmaceutical composition is in the range of 1:1 to 8:1. [0042] Further in another embodiment of the present invention, the plasmid used could be of any construction. BRIEF DESCRIPTION OF DRAWINGS [0043] FIG. 1 is a bar graph showing the influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in A549 human metastatic lung cancer cells. A549 cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 h post transfection. Each value represents the mean±SEM for three identically treated samples. [0044] FIG. 2 is a bar graph showing the GR-mediated facilitation of gene delivery to A549 human lung cancer cells. The A549 cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and * indicates the significant difference between the β-galactosidase value obtained from cells pretreated and untreated with RU-486. (p<0.01) [0045] FIG. 3 is a bar graph showing the influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in MCF-7 human primary breast cancer cells. MCF-7 cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 hr post transfection. Each value represents the mean±SEM for three identically treated samples. [0046] FIG. 4 is a bar graph showing the GR-mediated facilitation of gene delivery to MCF-7 human breast cancer cells. The MCF-7 cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed as β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and * indicates the significant difference between the β-galactosidase value obtained from cells pretreated and untreated with RU-486. [0047] (* p<0.01 and + p=0.0109). [0048] FIG. 5 is a bar graph showing that there is no influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in CHO (chinese hamster ovarian) transformed cells, which is in originality not a cancer cell line. CHO cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 hr post transfection. Each value represents the mean±SEM for three identically treated samples. [0049] FIG. 6 is a bar graph showing that there is no GR-mediated facilitation of gene delivery to CHO (chinese hamster ovarian) transformed cells, which is in originality not a cancer cell line. The CHO cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed as β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and, indicates that there is no significant difference between the β-galactosidase values obtained from cells pretreated and untreated with RU-486. (p>0.1). [0050] FIG. 7 is a plot of size against time as determined in Example 6. [0051] FIG. 8 is a bar graphic showing the effect of cholesterol on the efficiency of transgene expressions as determined in Example 7. DETAILED DESCRIPTION OF THE INVENTION [0052] In the present invention, it has been determined that using an glucocorticoid pharmacologic agent in combination with a gene of interest provides a distinct improvement in the efficiency of gene delivery to cells which express glucocorticoid receptors as well as increasing the number of cells receiving the gene. In particular, dexamethasone, one of the most potent synthetic glucocorticoid, at mole ratios up to 3 compared to the cationic lipid, has been shown to facilitate the non-viral gene delivery of a variety of genetic constructs capable of performing their function (including apoptotic cell death) in human cancer cells. [0053] Therefore the present invention provides an aqueous formulation useful for selective targeting and delivery of genes to cancer cells, comprising: (a) a cationic lipid, (b) a steroid and (c) a neutral co-lipid characterized in enhancing the transfection efficiency and stability of the formulation, wherein the said cationic lipid, steroid and neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. [0057] In a preferred embodiment of the invention, genes which can induce cell death are delivered via a non-viral route in combination with glucocorticoid pharmacological compounds in order to provide more complete tumor remission and more effective prevention of tumor recurrence, thus leading to improved patient survival. The glucocorticoid pharmacological agent (e.g., dexamethasone) is to be administered via the same route of gene delivery, by incorporating it with the non-viral gene carrier (e.g., cationic lipid coat). In this embodiment, four classes of genes may be used. First, cytotoxic genes such a tumor necrosis factor alpha or the tumor suppressor gene p53, which promotes apoptosis, can be provided. Second, genes which sensitize cells by enzymatically activating pro-drugs can be provided. For example, thymidine kinase or cytosine deaminase which respectively activates the cytotoxic pro-drugs gancylclovir and 5-fluorocytosine could be provided. Third, genes which promote immune surveillance could be provided. For example, tumor growth factor-beta 1 could be provided in combination with interleukin-2 and interferon-gamma. Fourth, antimetastatic genes, such as 5 E1A, could be provided. [0058] The idea of making this formulation stems from the fact that dexamethasone, a glucocorticoid, has close structural resemblance with cholesterol, a commonly used co-lipid present in many of the cationic lipids used for non-viral based gene delivery. [0059] The present invention provides a method for delivering genetic constructs via a non-viral mode with enhanced efficiency by co-formulating cationic lipid based gene delivery formulation carrying a glucocorticoid based pharmacologic agent along with common co-lipids cholesterol. [0060] Cholesterol as a co-lipid has long been used in liposomal formulations. It is known that cholesterol-containing liposomes have greater stability and lower ion-permeability than when cholesterol is not used [Straubinger et al 1983, Cell, 32, 1069-1079]. In the event of lysosomal entrapment during cellular delivery the liposomal cargo is expected to be chewed up by the lysosomal degradative enzymes, such as nucleases, that work at pH<6. It is very much conceivable from the above known facts that cholesterol-associated liposomes not only provide a concrete integrity to the lipid-DNA complex in cytosol but also prevent diffusion of lower pH solution containing lysosomal nucleases inside the lipid-DNA core. The use of cholesterol increasing the stability of the genetic cargo and transfection efficiency is documented previously [Templeton et al. 1997, Nature Biotechnology, 15, 647-652; Xu and Szoka 1996, Biochemistry, 35, 5616-5623]. [0061] In the context the present invention stands with complete patentability because the formulation uses our own patented cationic lipid along side a secondary co-lipid in the name of dexamethasone, a common, generic, glucocorticoid. The dexamethasone is not modified at all and is used as such. The concentration at which the dexamethasone is used did not induce any toxicity to non-cancer cells. The use of dexamethasone for the targeted gene delivery to cancer is not documented in any of these papers. Moreover, we for the first time showed that upon associating dexamethasone into cationic lipid formulation, the cancer cells are alone targeted leaving non-cancer cells untouched, even though the glucocorticoid receptors, through which dexamethasone works in cells, are ubiquitously present in all cells. [0062] The following examples are given by the way of illustration of the present invention and should not be construed to limit the scope of the present invention. Example 1 Glucocorticoid Receptor Expressing Cell-Specific Gene Delivery Properties of the Dexamethasone-Cationic Liposomal Formulation: [0063] The in vitro transfection efficacies of DX liposome containing dexamethasone in combination with DODEAC as cationic lipid and cholesterol as co-lipid at a mole ratio of 0.75:1:1 were evaluated by reporter gene expression assay using pCMV-SPORT-β-gal plasmid as the reporter gene in A549, MCF-7 and CHO cells across the cationic lipid to DNA having charge ratios 8:1 to 1:1. Dexamethasone containing liposome DX has been found to be nearly 2-30 folds more efficient in transfecting A549 and MCF-7 cells (human cancer cells expressing glucocorticoid receptor) ( FIGS. 1 and 3 ) than CHO cell line. DX was most efficient in transfecting lung cancer cells A549 at cationic lipid:DNA charge ratios of 8:1 and 4:1 ( FIG. 1 ). Transfection efficiency of DX in A549 at 2:1 and 1:1 was at least 10-20 fold less than that of other charge ratios. However, DX was most efficient in transfecting breast cancer cells MCF-7 at cationic lipid:DNA charge ratios of 4:1, 2:1 and 1:1 ( FIG. 3 ). Both in A549 and MCF-7 cells, Lipofectamine™ mediate comparatively much less transfection in comparison to DX ( FIGS. 1 & 3 ). [0064] Significantly low levels of reporter gene expression were observed for DX in the otherwise highly transfectable, non-cancerous, transformed cell CHO across all the charge ratios studied with 8:1 and 4:1 gave highest transfection efficiencies ( FIG. 5 ). Transfection efficiencies of other charge ratios are not shown. Lipofectamine™ as expected did show up very high transfection efficiency in CHO with respect to DX ( FIG. 5 ). The contrastingly enhanced β-galactosidase reporter gene expression level observed in both A549 and MCF-7 cells ( FIGS. 1 and 3 ) strongly indicate that transfection of glucocorticoid receptor expressing cancer cells, A549 and MCF-7 by DX is likely to be mediated by the glucocorticoid receptor-binding dexamethasone as present in formulation DX. Example 2 [0065] The transfection efficiencies of the DX formulation in transfecting glucocorticoid receptor expressing lung and breast cancer cells were significantly reduced when the gene transfer experiments were carried out by pretreating the cells with the RU-38486, the commercially available glucocorticoid receptor antagonists ( FIGS. 2 and 4 ) (p<0.01). Similar RU-38486 pretreatment studies in CHO cells yielded no significant change in transfection efficiencies ( FIG. 6 ) (p>0.1). Thus, the results summarized in FIGS. 1-6 provided strong evidence for the involvement of glucocorticoid receptors expression in breast and lung cancer cells for the present class of dexamethasone associated gene delivery reagents. Example 3 [0066] Materials used—Dulbecco's Modified Eagle medium (DMEM), fetal bovine serum was obtained from Sigma-Aldrich. Lipofectamine™ was obtained from Invitrogen. p-CMV-.beta.-galactosidase was a generous gift from Dr N. M. Rao, CCMB, India. Dexamethasone, RU-38486 were purchased from (sigma chemical co., St. Louis, Mo.) [0067] Cell-Culture—MCF-7, CHO, A549 cells were purchased from National Center for Cell Sciences (Pune, India) and were mycoplasma free. Cells were cultured in DMEM medium (Sigma Chemical Co., St. Louis, Mo.) containing 10% fetal bovine serum (Sigma Chemical Co., St. Louis, Mo.) and 1% penicillin-streptomycin at 370 C in a humidified atmosphere of 5% CO2 in air. Cultures of 85-90% confluency were used for all of the experiments. The cells were trypsinized, counted, subcultured in 96-well plates for transfection and viability studies. The cells were allowed to adhere overnight before they were used for experiments. Example 4 Liposome Preparation: [0068] All the necessary compounds (for e.g. DODEAC, Cholesterol, DOPE, Dexamethasone) were taken as stock solutions and mixed in a sample vial in appropriate amounts. It was dried as a thin film in gentle nitrogen flow and further dried in high vacuum for 6 hrs. Then it was hydrated for overnight. After that it was subjected to bath sonication for 10-15 min and then probe sonicated at room temperature using a Ti-probe sonicator for 3-4 min to get SUV liposome. The liposomes were kept at 4° C. [0069] Plasmid complexation & Gene Transfection—For a typical gene transfection study in vitro, cells were first seeded at a density of 12,000-15,000 cells/well in a 96 well plate usually 18-24 h before transfection. Plasmid DNA was complexed with cationic liposome typically in the following manner: 0.30 μg of pCMV-SPORT-β-gal DNA, a negatively charged entity (diluted to 50 μl with plain DMEM) was electrostatically complexed with varying amount of cationic liposomes (a positively charged entity, diluted to 50 μl with plain DMEM) for 30 min. The molar ratios (lipid:DNA) were 8:1, 4:1, 2:1 and 1:1. After the complexation of plasmid DNA and cationic liposome was completed, 200 μl of DMEM containing 10% FBS (CM1×) were added to the resulting lipoplexes for triplicate experiments. Thus the final concentration of serum became 6.7%. Cells were washed with phosphate-buffered saline (PBS), pH 7.4 (1×200 μl) and then with lipoplex (100 μl). After incubation of the cell plates at a humidified atmosphere containing 5% CO 2 at 37° C. for 4 hr, 100 μl of DMEM containing 10% FBS (CM1×) were added to cells. The reporter gene activity was assayed after 48 hr. The media were removed completely from the wells and cells were lysed with 50 μl of 1× lysis buffer (NP-40) for 30 min. The beta-galactosidase activity per well was estimated by adding 50 μl of 2× substrate (1.33 mg/ml of ONPG, 0.2 M sodium phosphate, pH 7.3 and 2 mM magnesium chloride) to the cell-lysate in the 96 well plate. Absorption of the product ortho-nitrophenol at 405 nm was converted to absolute μ-galactosidase units using a calibration curve constructed with commercial μ-galactosidase enzyme. Example 5 RU 38486 Pretreatment: [0070] RU 38486 was dissolved in DMSO at a concentration of 10 mM. 1 μl of it were added to each well plate where cells were plated previously in 100 μl of DMEM+10% FBS. After 2 hr media were removed and cells were washed with PBS (1×100 μl) and treated with lipoplexes. [0071] Statistical Analysis—All experiments were repeated at least once. Data were expressed as mean±standard derivation and statistically analyzed by the two-tailed unpaired Student t-test using the Microsoft Excel software program (Microsoft, Seattle, Wash.). Data were primarily considered significant if p<0.01. Example 6 Effect of Cholesterol to the Stability of Liposome: [0072] An experiment has been conducted to prove that indeed the cholesterol inclusion increases the stability of the liposomal formulation. The optimal formulation concentration that we used in our examples was 1:0.75:1 for DODEAC:DEX:Chol. We made a formulation devoid of cholesterol but having the same ratio of cationic lipid and dexamethasone. The new formulation is hence DODEAC:DEX, 1:0.75. The formulations were made 1 mM in concentration with respect to cationic lipid. 50 μl of each formulation was dispersed in 2 ml of phosphate buffer saline (PBS). PBS contains similar ionic strength and pH that prevails in a cellular environment. Then we proceeded to measure the size in Zetasizer (Malvern Instruments, U.K.) over the period of time as indicated in FIG. 7 . [0073] The data here indeed proves that the absence of cholesterol in cationic lipid formulation is detrimental for the size-stability of the liposome. The cholesterol-less formulation tends to increase in its size which might render it precipitate out in due course. In fact after 20 h it is noticed that the DODEAC:DEX (1:0.75) formulation indeed precipitated out, while the cholesterol containing formulation [DODEAC:DEX:Cholesterol:1:0.75:1] remained intact and showed no signs of precipitation. The wide range of literature related with cationic lipid mediated gene transfection shows that the optimal size of the liposome showing efficient transfection should be in submicron level primarily because the lipid formulations with more than micron sizes will tend to precipitate out in long run rendering them incapable of carrying any bioactive molecules such as DNA in a near-soluble form. Moreover, a very big particulate matter will not be compatible in fusing with cellular membrane and hence will not be able to penetrate the membrane. In the same scenario, our cholesterol-formulated liposome does not change its size showing tremendous amount of stability and structural integrity of the formulation. Example 7 Effect of Cholesterol to the Efficiency of Transgene Expressions: [0074] Two dexamethasone (DEX) associated cationic liposome formulations comprising with or without cholesterol (Chol) were made and proceeded to check their gene transfection efficiencies. The formulations were DODEAC:DEX:Chol (1:0.75:1) and DODEAC:DEX (1:0.75). The said formulations were respectively complexed with plasmid encoding β-galactosidase gene and fed to the cells. Following 4 h of lipid/DNA complex treatment the cells were washed and kept at normal cell culture conditions for 48 h, on completion of which the cells were washed, lysed and assayed for the β-galactosidase gene using o-nitrophenol-b-D-galactopyrano side (ONPG) substrate. The formation of o-nitrophenol is measured by measuring absorbance at 405 nm. The efficiency of transfection is directly proportional to the expression of transgene (here, β-galactosidase enzyme) that produces o-nitrophenol upon exposure with ONPG substrate. The results are shown in FIG. 8 . [0075] As the result shows that the cholesterol formulated cationic liposome could induce more transfection (2-4 folds) than cholesterol-less formulation. Advantages: [0076] The process of the present invention can be exploited for preparing cationic lipid based gene transfer reagents containing glucocorticoid receptor binding dexamethasone in the formulation. The invention of this dexamethsone associated cationic lipid based gene delivery vehicle is useful for delivering polyanions, polypeptides or nucleopolymers into cells via glucocorticoid receptors. The formulation disclosed herein can be used to deliver an expression vector into a cell for manufacturing or therapeutic use. The expression vectors can be used in gene therapy protocols to deliver a therapeutically useful protein to a cell or for delivering nucleic acids encoding therapeutically useful protein molecules. The dexamethasone associated lipid based formulation can be formulated with anionic, zwitterionic and lipophilic therapeutic agents including anticancer agents such as doxorubicin hydrochloride, a hydrophilic compound, or taxol™, a lipophilic compound to obtain complexes comprising the invented dexamethasone-associated formulation and a therapeutic agent(s). In the invented dexamethasone-associated cationic lipid based formulation, two classes of genes may be used. First, cytotoxic genes such a tumor necrosis factor alpha or the tumor suppressor gene p53, which promotes apoptosis, can be provided. Second, those genes can be provided which sensitize cells by enzymatically activating pro-drugs. For example, thymidine kinase or cytosine deaminase, which respectively activates the cytotoxic pro-drugs gancylclovir and 5-fluorocytosine. Third, genes that promote immune surveillance could also be provided. For example, tumor growth factor-beta 1 could be provided in combination with interleukin-2 and interferon-gamma. Fourth, antimetastatic genes, such as 5 E1A, could also be provided for killing metastatic cells.

1a

This application is the national phase under 35 U.S.C. §371 of PCT International Application No. PCT/AU01/00854 which has an International filing date of Jul. 13, 2001, which designated the United States of America and which claims priority to Australian Provisional Application No. PQ8786, filed Jul. 13, 2000. This invention relates to compositions and methods for treating and preventing skin damage. The present invention also relates to compositions and methods for improving the cosmetic appearance of skin. INTRODUCTION All references, including any patents or patent applications, cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinency of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art, in Australia or in any other country. The steady deterioration of the appearance and function of skin with age can be attributed to a combination of genetically determined ageing and the cumulative damage to the skin caused by various environmental factors. A distinction can be drawn between intrinsic ageing (or normal biological ageing), and accelerated or premature ageing as a result of damage induced by environmental factors. The deterioration of the appearance and function of skin is often associated with skin damage caused by environmental factors such as ultra-violet irradiation resulting from sun exposure, exposure to other environmental pollutants or toxins and dermatological disorders. Damage to the skin by environmental factors serves to aggravate the effects of normal biological ageing, producing more detrimental effects on the function and appearance of the skin. The reduction in the youthful appearance of the skin can also be attributed to the functional and structural deterioration of skin as a result of normal biological ageing, exclusive of environmental factors. Such deterioration can manifest visibly as localised furrows (wrinkles), blemishes, a loss of elasticity of the skin leading to sagging, hyperpigmentation, changes to skin thickness and a dry and rough appearance making the skin more susceptible to mechanical trauma or disease processes leading to blister formation. The deterioration of the appearance and function of skin is attributed to a number of physiological changes in the cellular and molecular processes of the epidermal and dermal tissue (reviewed by Gilchrest 1996). As skin ages, genetically determined factors and various environmental elements reduce skin epidermal cell (keratinocytes) and dermal cell (fibroblast) proliferation and viability as the cells become senescent reducing the total dermal cellularity. This results in skin having a dull and aged appearance and a marked decrease in the dermal thickness. In addition, the activity of metalloprotease enzymes, including matrix metalloprotease 1, that degrade collagen and other dermal matrix proteins is increased. This further results in the fragmentation of the supportive collagenous framework of the dermal tissue as the rate of collagen (type I and type III) degradation exceeds the rate of collagen production. This leads to a loss of structural support as indicated by wrinkles and sagging, and contributes to enhanced dermal thinning. A number of agents have been used to prevent and treat intrinsic and environmental damage to skin. These include alpha-hydroxy acids, retinoids (vitamin A and its derivatives such as retinoic acid), copper-peptide complexes, and vitamin C. Two of the most commonly used agents include retinoic acid and alpha-hydroxy acid. Retinoic acid has been used as an active ingredient in cosmetic formulations claiming anti-ageing effects by reducing the appearance of fine lines, wrinkles and mottled darkened spots and roughness of facial skin. A problem with the use of retinoic acid is that the positive effects of retinoids on skin damage are reversed during long term therapy. This results in the beneficial histological parameters returning to near pre-therapy levels. Furthermore, retinoic acid has been found to be deficient in eliminating wrinkles, repairing sun induced skin damage and restoring skin to its healthier structure. The use of compositions containing retinoids for the long-term treatment of skin damage can also present significant side effects. A further difficulty is that the incorporation of these agents into suitable carriers is problematic. Retinoic acid has been shown to cause erythema, burning and mild scalding, irritation, and increased sun-sensitivity. It also has been identified as a teratogen, which prevents its use by pregnant women (Gilchrest 1996). Alpha-hydroxy acids have been reported to also increase skin thickness as well as collagen and elastin synthesis (reviewed by Bergfeld 1997). The changes in the skin reportedly due to the alpha-hydroxy acids however are associated with the corrosive or exfoliative action of these preparations, which induces acute skin damage and results in a primary healing response. Hence these agents create apparent, short-term benefits by stimulating skin renewal due to the damage they cause. Consequently the application of alpha-hydroxy acid to skin can result in significant skin irritation and side effects that mirror those described for retinoic acid (including sun sensitivity). Glycolic acid, perhaps the most commonly used alpha-hydroxy acid, is absorbed through the skin and is potentially toxic to the kidneys and, to a lesser degree, the liver. More recently, naturally occurring growth factors or cytokines, which are the physiological regulators of intrinsic tissue repair, have been proposed as agents capable of treating wounded skin. Importantly, the processes for healing wounded skin which has lost its structural and functional integrity (including lacerations, penetrations, ulcers and burns) proceeds as a fibroproliferative response leading to the formation of a fibrotic scar. Wound repair is an intricate, temporal process that is dependent on the well described physiological processes of haemostasis, inflammation, wound contraction and re-epithelialisation (Mast 1992). Thus in wound healing, the organ is patched rather than restored (Clark 1995). However, the repair of skin damage which is substantially intact or non-wounded is attributed to a regeneration process and distinct from the processes of wound healing. This can only occur in tissue having its structural and functional integrity maintained, thereby including skin damaged by environmental factors and skin which has lost its youthful appearance. Hence it is an aspect of the present invention to provide a therapeutic and preventative treatment for skin damage and the aged appearance of skin comprising the administration of basic milk factors. The milk factors can directly increase keratinocyte and fibroblast cell proliferation and viability, increase dermal cellularity whilst stimulating dermal collagen production further resulting in the formation of new loose connective tissue in the dermis. Accordingly, it is an object of the present invention to overcome or alleviate some of the problems of the prior art, and to provide such treatment. SUMMARY OF THE INVENTION In a first aspect, the present invention provides a composition for treating or preventing skin damage, the composition comprising an effective amount of basic milk factors or variants thereof, said basic milk factors comprising a plurality of cell growth stimulating factors having basic to approximately neutral isoelectric points. The term “treating or preventing” as used herein is intended to include either therapeutic treatment of skin damage, or preventive or prophylactic procedures performed before the occurrence of skin damage. Thus the patient to be treated may already have skin damage, or may be at risk of having skin damage. The term “treating or preventing” is also intended to include either cosmetic treatment to reduce the aged appearance of skin, or preventive cosmetic treatment performed before the occurrence of the aged appearance of skin. Thus the patient to be treated may already have skin with an aged appearance, or may be at risk of having skin with an aged appearance. The term “treating or preventing” also includes; 1) the regeneration of new epithelial, epidermal and dermal tissue, including the regeneration of keratinocyte and fibroblast cells and the regeneration of collagenous tissue, which adds to the existing epidermal and dermal tissue, and which may serve to replace the epidermal and dermal tissue lost prior to the onset of treatment; 2) the preservation of existing epithelial, epidermal and dermal tissue, including the preservation of keratinocyte and fibroblast cells and the preservation of collagenous tissue, which encompasses epidermal and dermal tissue existing at the onset of treatment and any newly formed epidermal and dermal tissue following onset of treatment; 3) improving the function of the skin; 4) enhancing the youthful appearance of skin, including the enhancement of skin flexibility, firmness, smoothness, suppleness and/or elasticity; 5) reducing wrinkles; and/or 6) reducing blemishes. It will be appreciated that in the method of the invention, the mammal to be treated may be a human, a domestic animal, a companion animal or a zoo animal. The term “skin damage” as used herein includes any resultant adverse effect on the skin by way of normal biological ageing, environmental factors, dermatological disorders, medical or surgical treatments, or a combination of any of the above. Adverse effects on the skin may manifest visibly as localised furrows (wrinkles), blemishes, a loss of elasticity of the skin leading to sagging, hyperpigmentation, changes to skin thickness and a dry and rough appearance making the skin more susceptible to mechanical trauma or disease processes leading to blister formation. Also included are adverse effects which are not apparent to the eye. For example deleterious metabolic changes in the skin cells, and changes to skin vascularisation. Such changes include reduced skin epithelial cell, epidermal cell (keratinocyte) and dermal cell (fibroblast) proliferation and viability. Such changes may reduce the total dermal cellularity and cause the fragmentation of the collagenous framework as the rate of collagen (type I and type III) degradation exceeds the rate of collagen production. The term “basic milk factors” as used herein means a mixture of growth factors concentrated from a milk product having cell proliferating properties, in which the proportions of the salt and/or main protein constituents thereof are altered and the growth factors have approximately neutral to basic isoelectric points. Basic milk factors may be derived from cheese whey, colostral whey, skim milk or acid whey. Examples of basic milk factors include concentrates of milk products subject to organic solvent extraction, ultrafiltrates of milk products or milk products subjected to adsorption and to elution from chromatography matrices. Methods for the preparation of basic milk factors from milk products are well known in the art and can be addressed with no more than routine experimentation. Importantly, since the inventors have surprisingly demonstrated that a growth factor composition having basic to approximately neutral isoelectric points, obtained from a milk product has the capacity to effectively pass through the uppermost layers of the skin as shown by the translocation of insulin-like growth factor I (IGF-I) and transforming growth factor beta 2 (TGFβ2), resulting in the growth factors exerting their biological effects on competent cells leading to metabolic changes in those cells, persons skilled in the art will readily be able to use other alternative and suitable growth factor compositions obtained from milk products to obtain the said affect requiring no more than mere routine experimentation. In a second aspect the present invention provides a composition for cosmetically treating or preventing the aged appearance of skin, the composition comprising an effective amount of basic milk factors or variants thereof, said basic milk factors comprising a plurality of cell growth stimulating factors having basic to approximately neutral isoelectric points. The term “effective amount” as used herein means that amount necessary to at least partially attain the desired effect, or to delay the onset of, inhibit the progression of, or halt altogether, the onset or progression of skin damage. Such amounts may depend, of course, on the particular condition being treated, the severity of the condition and individual parameters, including age, physical condition, size, weight and other concurrent treatments. These factors are well known to those of ordinary skill in the art, and can be addressed with no more than routine experimentation. It is generally preferred that a minimum effective dose be determined according to sound medical or therapeutic judgement. It will be understood by those of ordinary skill in the art, however, that a higher dose may be administered for medical or other reasons. The term “effective amount” as used herein also means that amount necessary to at least partially attain a desired cosmetic effect, or to delay the onset of, or inhibit the progression of the appearance of aged skin. Such amounts may depend, of course, on the particular condition being treated, the severity of the condition and individual parameters, including age, physical condition, size, weight and other concurrent treatments. These factors are well known to those of ordinary skill in the art, and may be addressed with no more than routine experimentation. It is generally preferred that a minimum effective dose be determined according to cosmetic judgment. Preferably, the skin to be treated is substantially intact. The term “substantially intact” as used herein refers to skin which has maintained structural and functional integrity and barrier function. Examples of intact skin include skin showing (or having the potential to show) signs of normal biological ageing, or skin damaged (or having the potential to be damaged) by environmental exposure whereby the skin repairs by regeneration processes. Also included is skin which has been subjected to medical or surgical treatment, where the skin is left substantially intact. Intact skin does not include wounded skin, thereby excluding lacerations, penetrations, ulcers and burns. The repair of damaged intact or non-wounded skin is attributed to a regeneration process. This can only occur in tissue having structural and functional integrity maintained, thereby including skin damaged by environmental factors and ageing. This situation is distinguished from the healing of wounded skin, which has lost its structural and functional integrity (including lacerations, penetrations, ulcers and burns) that proceeds as a fibroproliferative response which develops into a fibrotic scar. Thus in wound healing, the organ is patched rather than restored. However, the processes of wound healing are distinct from those of repair of damaged intact skin, which repairs by a regeneration process. In a preferred form of the invention the basic milk factors are capable of stimulating proliferation of rat L6 myoblasts. Preferably the basic milk factors are prepared by subjecting a milk product to cationic exchange chromatography. The cationic exchange resin may be suitable for adsorbing basic proteins such that the more basic components of the milk product are adsorbed thereon. Proteins may be eluted, from the cationic exchange resin with a suitable buffer solution of a sufficiently high ionic strength (e.g. a molarity above 0.2M). The eluate may be filtered to remove salt or any other low molecular weight contaminants. The cation exchange resin may be a cationic exchange resin suitable for adsorbing a plurality of cell growth stimulating factors. Unsuitable cationic exchange resins include resins with a pore size too small to permit the binding of basic milk proteins. For example the DOWEX AG 50W 2X 50-100 mesh resin would be unsuitable to adsorb a plurality of basic milk factors. A suitable cationic exchange resin used in accordance to the invention includes an agarose-based cationic exchange resin. The term “milk product” as used herein refers to a derivative from human or animal milk in which the proportions of fat and/or protein constitutes thereof are altered. Examples of milk products include milk whey, skim milk, colostral whey, cheese whey and acid (casein) whey. Preferably the milk product is selected from the group comprising milk whey, skim milk, colostral whey, cheese whey and acid whey. The basic milk factors may be obtained from cheese whey wherein the proportions of the main protein constituents thereof are altered. More preferably the milk product is derived from an ungulate mammal. Importantly, epidermal growth factor (EGF) has not been shown to be present in milk of an ungulate mammal. In a preferred form of the invention the basic milk factors are BMF-1 and/or BMF-2. A method for preparing BMF-1 is described in Australian Patent 645589, the entire disclosure of which is incorporated herein by reference. A method for preparing BMF-2 is described in Australian Patent 702002, the entire disclosure of which is incorporated herein by reference. In this process the basic milk factors may be modified to enhance activity, by transient acidification and/or purification under acidic conditions, for example using molecular sieve chromatography or controlled pore ultrafiltration. Accordingly, BMF-2 may include a plurality of modified milk growth factors having isoelectric points above approximately 6.0 and molecular weights in the range of approximately 5000 to 30,000, the basic milk factors being modified by transient acidification. Preferably, the basic milk factors include growth stimulating factors selected from the group comprising insulin-like growth factor I (IGF-I), insulin-like growth factor II (IGF-II), platelet derived growth factor (PDGF), fibroblast growth factor (FGF) and Transforming Growth Factor Beta (TGFβ). These growth factors have basic to approximately neutral isolelectric points ie between approximately 6.0 and approximately 10.5. Preferably, the growth factors present in the composition are deficient in EGF. Preferably the concentration of the basic milk factors is from 1 μg/mg to 500 mg/g. More preferably the concentration of the basic milk factors is from 0.01 mg/g to 200 mg/g. The preparations contemplated by the present invention include any formulations suitable for the cutaneous application of basic milk factors. Suitable carriers and/or diluents are known to those skilled in the art and include conventional solvents, dispersion media, fillers, aqueous solutions, sunscreens, antibacterial and antifungal agents, or absorption-promoting agents, either alone or in combination. Supplementary active ingredients may also be incorporated into the compositions, such as additional growth factors, Vitamin A, C and E, dimethylsulfoxide, retinoic acid, copper-peptide complexes, alpha-keto acids, lanolin, vaseline, aloe vera, methyl or propyl paraben, either alone or in combination. The additional growth factors may be added to enhance activity of the composition. The growth factors may be selected from the group comprising IGF-I, IGF-II, PDGF, FGF, TGFβ and keratinocyte growth factor (KGF). Preferably the composition comprises an effective amount of basic milk factors effective to alleviate or prevent the signs and/or symptoms of skin damage. Preferably, the composition comprises an effective amount of basic milk factors effective to inhibit the progression of, or halt altogether, the onset or progression of the skin damage. In a preferred form, the skin to be treated is substantially intact. The composition may be in a form selected from the group comprising cosmetically acceptable liquids, creams, oils, lotions, ointments, gels, roll-on liquids, skin patches, sprays, glass bead dressings, synthetic polymer dressings impregnated with basic milk factors, solids, conventional cosmetic night creams, foundation creams, suntan lotions, hand lotions, insect repellents, make-up, make-up bases and masks. Except insofar as any conventional medium or agent is incompatible with the active ingredient, use thereof in the cosmetic compositions of the present invention is contemplated. Methods and carriers for the preparation of pharmaceutical and cosmetic compositions are well known in the art, as set out in textbooks such as Remington's Pharmaceutical Sciences, 18 th Edition, Mack Publishing Company, Easton, Pa., USA, the contents of which is incorporated herein. Preferably the composition comprises a cosmetically effective amount of basic milk factors. More preferably the composition comprises an effective amount of basic milk factors effective to alleviate or prevent the signs and/or symptoms of the aged appearance of skin. Most preferably the composition comprises an effective amount of basic milk factors effective to inhibit the progression of, or halt altogether, the onset or progression of the aged appearance of skin. In a preferred form of the invention the skin to be treated is substantially intact. In another aspect the present invention provides the use of basic milk factors comprising a plurality of cell growth stimulating factors having basic to approximately neutral isoelectric points for the manufacture of a composition for the treatment or prevention of skin damage. Preferably the treatment alleviates or prevents the signs and/or symptoms of the skin damage. More preferably the treatment inhibits the progression of, or halts altogether, the onset or progression of the skin damage. In a preferred form, the skin to be treated is substantially intact. The use may incorporate the compositions as described herein. In another aspect the present invention provides the use of basic milk factors comprising a plurality of cell growth stimulating factors having basic to approximately neutral isoelectric points for the manufacture of a composition for cosmetic treatment or prevention of the aged appearance of skin. Preferably the treatment alleviates or prevents the signs and/or symptoms of the aged appearance of skin. More preferably the treatment inhibits the progression of, or halts altogether, the onset or progression of the aged appearance of skin. The use may incorporate the compositions as described herein. In a preferred form the skin to be treated is substantially intact. In another aspect the present invention provides a method for treating or preventing skin damage comprising administering to the skin the compositions as described herein. The treating or preventing may alleviate or prevent the signs and/or symptoms of the skin damage. The treating or preventing may also inhibit the progression of, or halt altogether, the onset or progression of the skin damage. Preferably the skin to be treated is substantially intact. Preferably the skin damage is the result of normal biological ageing, an environmental factor, a dermatological disorder, medical treatment, surgical treatment or a medical condition, either alone or in combination. The normal biological ageing may be predetermined by genetic factors. The environmental factor may be poor food hygiene, exposure to a toxin, exposure to a pollutant, sun exposure, ionizing radiation, X-rays, UV-rays, tobacco use, alcohol or stress. The dermatological disorder may arise from acneic conditions, acne vulgaris, acne rosacea, actinic keratoses, actinodermatoses, angiomas, argyia, chloasma, Darier's disease, dyschromias, lentigines, melasma, nevi, radiodermatitis, rhinophyma, rhytes and rhytides, sebaceous adenomas, sebaceous cysts, seborrheic keratoses, superficial basal cell carcinoma, telangiectasis and/or trichoepitheliomas (Orentreich et al., 2001). Skin damage may also result from the administration of medications for the management of medical conditions. Preferably the medical treatment is topical glucocorticoid treatment or hemodialysis treatment. Skin damage may also result from a medical condition including congenital ectodermal dysplasia, diabetes, HIV infection, an infection associated with AIDS, a nutritional deficiency, renal disease, menopause, recessive dystrophic epidermolysis bullosa, Ehlers Danlos syndrome, generalised cutaneous atrophy, localised cutaneous atrophy, scarring alopaecia, pyoderma gangrenosum, or a hormonal alteration, either alone or in combination. Skin damage may also result from surgical treatments such as liposuction, subscision, electrodesiccation and laser therapy. While these treatments are surgical in nature, such procedures leave the surface of the skin substantially intact, though the dermal structures underneath the intact skin may still be damaged and require treatment. Preferably the composition is administered topically. More preferably the composition is administered topically at a rate of 0.1 mg/cm 2 of skin to 2 g/cm 2 of skin. It is contemplated that the composition may be administered topically by any means which delivers an amount of basic milk factors at the skin tissue to attain the desired therapeutic or cosmetic affect. The composition may be applied to the affected area of the skin of the patient. The frequency of application will depend on the individual circumstances. For example, the composition may be applied daily, or twice daily, or even more frequently. In another aspect the present invention provides a method for cosmetically treating the aged appearance of skin comprising administering a composition as described herein. The method may alleviate or prevent the signs and/or symptoms of the aged appearance of skin. The method may also inhibit the progression of, or halt altogether, the onset or progression of the aged appearance of skin. Preferably, the skin to be treated is substantially intact. In a preferred form of the invention the aged appearance of skin is the result of a wrinkle, a blemish, hyperpigmentation, a change in skin thickness, dryness, or a rough appearance, either alone or in combination. Preferably the mammal requires the enhancement of the youthful appearance of their skin. Preferably the composition is administered topically. More preferably the composition is administered topically at a rate of 0.1 mg/cm 2 of skin to 2 g/cm 2 of skin. In another aspect the present invention provides a kit for the treatment or prevention of skin damage comprising a composition as described herein in; and instructions for use of the composition in a method as described herein. In another aspect the present invention provides a kit for cosmetic treatment of the aged appearance of skin, comprising a composition as described herein; and instructions for use of the composition in a method as described herein. For the purposes of this specification it will be clearly understood that the word “comprising” means “including but not limited to”, and that the word “comprises” has a corresponding meaning. DESCRIPTION OF FIGURES All data presented is represented as the mean±standard error of the mean. FIG. 1 shows a graph demonstrating the in vitro stimulation of human keratinocyte (HaCat) cells using increasing concentrations of BMF-1 and BMF-2. Cell growth was monitored by measuring the optical density (OD) at a wavelength of 630 nm. The dotted line represents a response that was obtained when cells were treated with 10% foetal bovine serum. FIG. 2 shows a histogram demonstrating the increase in collagen production in human skin fibroblasts with increasing concentrations of BMF-1. After starving overnight, cells were exposed to BMF-1 for 48 hours. Cells were harvested and the amount of hydroxyproline per cell measured in four replicate samples. FIG. 3A shows micrographs of porcine skin in cross-section. Topically formulated 20 mg/g BMF-1 or control formulation (vehicle only) was applied to porcine skin, with biopsies being taken after 30 minutes exposure. Sections were prepared and probed using antibodies specific for TGFβ2 or IGF-I. Bound antibody was visualised using fluorescent detection. Panels A and B represent biopsy material stained for the presence of IGF-I (control and treated), while panels C and D represent biopsy material stained for TGFβ2 (control and treated). FIG. 3B shows the graphical representation of the measurement of IGF-1 and TGFβ2 immunofluoresence (represented as integrated optical density, IOD) of samples described in 3A with additional samples collected after 90 minutes also analysed. The average intensity of the IGF-I and TGFβ2 immunofluorescence in both the epidermis (3Bi) and dermis (3Bii) of control (open bars) and BMF-1 treated skin samples (closed bars) was obtained by capturing three fields of view from each of two sections from each sample. The results from two topically formulated emulsions containing BMF-1 (A and B) are shown. FIG. 4 shows a graphical representation of the dermal cellularity in a skin sample collected after the topical application of 2 mg/g or 20 mg/g of BMF-1. Porcine skin was repeatedly treated for 4 weeks with BMF-1 (high dose or low dose), or control formulation (vehicle only). Biopsies were taken which were analysed microscopically and scored according to the number of fibroblasts. A higher score correlates to higher cellularity. FIG. 5 shows a graphical representation of the production of type III collagen in porcine skin after repeated topical application of 2 mg/g or 20 mg/g of BMF-1 for 2 weeks. Porcine skin was treated with a topical BMF-1 formulation (high dose or low dose), or control formulation (vehicle only). Biopsies were taken and sections stained with an antibody specific for type III collagen. Bound antibody was detected using a fluorescent-tagged secondary antibody, with the fluorescence intensity being quantitated using image analysis software represented by IOD (integrated optical density). FIG. 6A shows representative autoradiographs of RNA extracted from skin fibroblast cells and probed using Northern blot analysis for collagen I, III, MMP-1 and the control gene GapDH. Cells were cultured for 48 hours in basal media alone (B) or basal media containing 0.2 or 2.0 mg/ml BMF-1. FIG. 6B shows the graphical representation of 4 replicate experiments described in part 6A. Band intensity was measured after exposing probed filters to a phosphorimage plate and the data presented as the fold change of gene expression in RNA from cells treated with 0.2 or 2.0 mg/ml BMF-1 compared to cells cultured under basal conditions. The intensity of each band was normalised to the respective GapDH signal for each sample. FIG. 7A shows representative autoradiographs of RNA extracted from skin fibroblast cells and probed using Northern blot analysis for collagen I, III and the control gene GapDH. Cells were cultured for 48 hours in basal media alone (B) or basal media containing 0.1 mg/ml BMF-1 or BMF-2. FIG. 7B shows the graphical representation of the combined data from 4-7 replicate experiments described in part A. Band intensity was measured after exposing probed filters to a phosphorimage plate and the data presented as the fold change of gene expression in RNA from cells treated with 0.1 mg/ml BMF-1 or BMF-2 compared to cells cultured under basal conditions. The intensity of each band was normalised to the respective GapDH signal for each sample. DETAILED DESCRIPTION OF THE INVENTION The present invention will now be more fully described with reference to the accompanying non-limiting examples. It should be understood that the following description is illustrative only, and should not be taken in any way as a restriction on the generality of the invention. EXAMPLE 1 Production of BMF-1 Suitable for the Cosmetic and Therapeutic Treatment of Skin Damage and the Aged Appearance of Skin BMF-1 was prepared as in Australian Patent Number 645589. The process involves the microfiltration of pasteurised whey to remove solids, adsorption of growth-promoting material to a column of S-Sepharose Fast Flow S™ cation exchange resin (Pharmacia) that had been equilibrated with 50 mM sodium citrate buffer to remove unadsorbed material, elution of BMF-1 with 0.4M NaCl added to 10 mM sodium citrate pH 6.5, diafiltration against water and concentration. The composition can be left in liquid form or freeze dried for further formulation. EXAMPLE 2 Production of BMF-2 Suitable for the Cosmetic and Therapeutic Treatment of Skin Damage and the Aged Appearance of Skin BMF-2 was prepared as in Australian Patent Number 702002. A 10 g sample of BMF-1 prepared as in Example 1 was dissolved in 150 mM PBS and added to 250 mls of 10 mM HCl containing 0.2M NaCl, and the pH adjusted to 2.5 with NaOH. A 2 liter Cellufine GL 1000™ (Amicon) column was equilibrated with a 10 mM solution of HCl containing 0.2M NaCl adjusted to pH 2.5 with NaOH and 125 ml of the dissolved BMF-1 was applied to the column and eluted at 6.8 ml/min with the same solution. 675 ml was collected from when the absorbance profile at 280 nm fell below 0.4 A. This pool was diafiltered against 0.1M ammonium bicarbonate. The composition can be left in liquid form or freeze dried for further formulation. EXAMPLE 3 Formulations Suitable for Applying Basic Milk Factors to Skin All units for ingredients of the compositions are measured in “parts”. Basic milk factors quantity specified hereby referred to as “qs”. (i) Cetomacrogol Cream Basic milk factors qs Cetomacrogol emulsifying wax 15 Liquid paraffin (by weight) 10 Chlorocresol 0.1 Propylene glycol 5 Distilled water to 100 Cetomacrogol emulsifying wax was melted with paraffin at about 70° C. Chlorocresol and propylene glycol were dissolved in about 50 parts of the distilled water warmed to about the same temperature. After mixing, the composition was adjusted to weight and stirred until cool. Basic milk factors are then added to an appropriate concentration, and mixed thoroughly. (ii) Aqueous Cream APF Basic milk factors qs Emulsifying ointment 30 Glycerol 5 Phenoxyethanol 1 Distilled water to 100 The emulsifying ointment was melted at about 70° C. The phenoxyethanol was dissolved in the distilled water, warmed to about the same temperature. The composition was mixed, adjusted to weight and stirred until cool. The basic milk factors are then added while stirring thoroughly. (iii) Buffered Cream BPC 73 Basic milk factors qs Citric acid 5 Sodium phosphate 25 Chlorocresol 1 Emulsifying ointment 300 Distilled water 669 Emulsifying ointment was melted with the aid of gentle heat, followed by addition of sodium phosphate, citric acid and chlorocresol, previously dissolved in the distilled water at the same temperature. The composition was stirred gently until cold. The basic milk factors are then added and mixed thoroughly. (iv) Emulsifying Ointment APF Basic milk factors qs Emulsifying wax 30 White soft paraffin 50 Liquid paraffin (by weight) 20 The waxes and paraffins were melted together and stirred until cool. Basic milk factors are then added to an appropriate concentration in a portion of the base, gradually incorporating the remainder, followed by thorough mixing. (v) Peptide Ointment (as in Neomycin and Bacitracin Ointment BPC 73) Basic milk factors qs Liquid paraffin  10 White soft paraffin to 100 White soft paraffin was melted, and the liquid paraffin incorporated. The mixture was stirred until cold. The basic milk factors are titrated with a portion of the base and gradually incorporated into the remainder of the base. (vi) Gel (as used in Lignocaine and Chlorhexidine Gel APF) Basic milk factors qs Tragacanth 2.5 Glycerol 25 Distilled water to 100 The tragacanth was mixed with glycerol and most of the distilled water. After bringing to the boil, the mixture was cooled, and the basic milk factors are added. The composition was adjusted to weight and mixed well. The finished product was protected from light. (vii) Spray (as used in Adrenaline and Atropine Spray BPC 73) Basic milk factors qs Sodium metabisulphite 1 Chlorbutol 5 Prophylene glycol 50 Distilled water to 1000 (viii) Spray (as used in Indospray) Basic milk factors qs Alcohol 95% (ix) Lotions (as used in Aminobenzoic Acid Lotion BPC 73) Basic milk factors qs Glycerol  20 Alcohol 95%  60 Distilled water to 100 (x) Cetomacrogol Lotion APF Basic milk factors qs Cetomacrogol emulsifying wax 3 Liquid paraffin 10 Glycerol 10 Chlorhexidine gluconate solution 0.1 Distilled water to 100 Cetomacrogol emulsifying wax was melted with the liquid paraffin at about 60° C. To this mixture, the chlorhexidine solution previously diluted to 50 parts was added, with rapid stirring, with distilled water at the same temperature. After mixing, the composition was adjusted to volume and stirred until cold. EXAMPLE 4 BMF-1 Increases Proliferation and Viability of Animal Fibroblast Cells Balb C3T3 mouse fibroblasts were plated into 24-place multiwells 24 hours before treatment to give a monolayer close to confluence. Performed in triplicate, cells were incubated at least overnight in complete growth medium, rinsed with serum-free media then exposed to concentrations of BMF-1 product (1.0 mg/ml) in basal medium (DMEM containing 0.1% FBS) for between 48 and 72 hours. Cell monolayers were treated with trypsin/EDTA (0.125%/0.5 mM) to disperse individual cells. Cells were pelleted, washed in Hanks balanced salt solution (HBSS) and to assess cell number, cells were suspended in 450 μl of HBSS and 50 μl trypan blue and counted manually using a haemocytometer. To assess viability, cells were treated with both annexin V/FITC (1 μg/ml) and propidium iodide (PI, 5 μg/ml) in a total volume of 500 μl at 4° C. for 15 minutes (method modified from Van Engeland et al, 1996). Flow cytometry was then used to analyse cell viability. Table 1 shows the viability of cultured fibroblasts treated with BMF-1 or basal medium treated with annexin/PI were segregated into the following categories; viable cells (negative annexin V staining and negative PI staining), apoptotic cells (positive annexin staining but negative PI staining) and necrotic cells (positive annexin V staining and positive PI staining). Table 1 demonstrates that compared to basal DMEM media, BMF-1 (1 mg/ml) stimulated the growth of cultured fibroblasts by approximately 3.0 fold. The percentage of viable cells was increased by 26% in cultures treated with BMF-1 compared with basal medium. BMF-1 also reduced the number of apoptotic and necrotic cells by 73% and 21% respectively compared to basal medium. Thus BMF-1 stimulates the growth and survival of fibroblast cells in culture. TABLE 1 Effect of BMF-1 (1 mg/ml) on cell growth and survival of cultured fibroblasts (n = 3) Annexin/PI (cell viability) Cell Growth Viable Apoptotic Necrotic Treatment (cells/well × 10 4 ) (%) (%) (%) Basal  5.5 ± 0.4 68.8 ± 1.8 21.7 ± 1.0 7.0 ± 1.1 Medium BMF-1 16.3 ± 1.9 86.6 ± 2.2  5.9 ± 1.0 5.5 ± 1.4 EXAMPLE 5 BMF Product Increases Proliferation and Viability of Human Keratinocyte Cells To assess the effect of BMF-1 and BMF-2 on the growth of human keratinocyte cells (HaCat), cells were plated into 96-well plates to give a monolayer close to confluence. Performed in triplicate, the cells were incubated at least overnight in complete growth medium, starved for at least two hours and then exposed to concentrations of BMF-1 or BMF-2 (0-1.0 mg/ml) dissolved in DMEM for up to 4 days. Replicate wells were exposed to concentrations of 10% FBS to serve as a positive control. Plates were rinsed and methanol fixed for 30 minutes, then methylene blue stained for 30 minutes (Oliver et al, 1989). Excess stain was washed off with borate buffer and the remaining stain solubilised with acidified ethanol (100 μl/well). The optical density of the wells was read at 630 nm and the results presented in FIG. 1 with the growth response obtained with 10% FBS shown by the dashed line To assess the effect of BMF-1 on cell viability, human keratinocyte cells (HaCat) were plated into 24-place multiwells to give a monolayer close to confluence and incubated for up to 3 days in complete growth medium. Performed in triplicate, cells were then starved for up to 48 hours and then exposed to concentrations bf BMF-1 (1.0 mg/ml) dissolved in basal medium for between 48 and 72 hours. Cell monolayers were treated with 4 mM EDTA for 10 minutes and then with trypsin/EDTA (0.125%/0.5 mM) to disperse individual cells. Cells were pelleted, washed in HBSS and to assess cell number, cells were suspended in 450 μl of HBSS and 50 μl trypan blue and counted manually using a haemocytometer. To assess viability, cells were treated with both annexin V/FITC (1 μg/ml) and propidium iodide (PI, 5 μg/ml) in a total volume of 500 μl at 4° C. for 15 minutes (method modified from Van Engeland et al). Flow cytometry was then used to analyse cells (see Table 2). Cells incubated with annexin/PI were segregated into the following categories; viable cells (negative annexin V staining and negative PI staining), apoptotic cells (positive annexin staining but negative PI staining) and necrotic cells (positive annexin V staining and positive PI staining). TABLE 2 Effect of BMF-1 (1 mg/ml) on cell growth and survival of cultured keratinocytes (n = 3) Annexin/PI (cell viability) Cell Growth Viable Apoptotic Necrotic Treatment (cells/well × 10 4 ) (%) (%) (%) Basal 11.0 ± 1.8 68.2 ± 2.8 21.8 ± 2.5 7.4 ± 0.2 Medium BMF-1 18.0 ± 1.8 76.6 ± 2.0 12.5 ± 1.3 8.2 ± 0.7 Both BMF-1 and BMF-2 stimulated the growth of HaCat cells as shown in FIG. 1 . The maximum responses obtained with BMF-1 and BMF-2 were at least comparable to the growth response observed in cells treated with 10% FBS in the same assay (dashed line, FIG. 1 ). As shown in Table 2, a greater percentage of cells treated with BMF-1 (1 mg/ml) were found to be viable (approximately 12% increase compared to basal medium) and less identified as apoptotic (approximately 43% decrease compared to basal medium). Thus, BMF-1 product stimulates the growth and promotes the survival of cultured human keratinocytes. EXAMPLE 6 BMF-1 Product Stimulates Collagen Production by Human Skin Fibroblast Cells Human skin fibroblasts were plated into 6-well plates at a density of about 1×10 5 cells/well and grown until almost confluent before being starved overnight in basal medium (DMEM and 0.1% FBS). Cells were then exposed to concentrations of BMF-1 (0-2.0 mg/ml) in basal medium for 48 hours. Cell pellets were harvested for hydroxyproline determination as a measurement of collagen content ( FIG. 2 ). BMF-1 stimulated collagen production by human skin fibroblasts in a dose dependent manner ( FIG. 2 ). The amount of collagen deposited by the cells as extra-cellular matrix was measured in the cell pellets and was found to have increased by up to 3 fold when cells were incubated with BMF-1 compared to basal medium ( FIG. 2 ). Thus BMF-1 stimulates both collagen secretion by human fibroblast cells and deposition of this collagen into the extra-cellular matrix. EXAMPLE 7 Topically Formulated BMF-1 Penetrates Living Skin BMF-1 was formulated into four representative topical emulsions on a weight for weight basis with incorporation of up to approximately 20 mg BMF-1 protein per gram of emulsion. Both control emulsion and topically formulated BMF-1 was applied to prepared porcine skin (washed and shaved) at an application rate of approximately 0.05 g/cm 2 . Material was applied by measured syringe (250 μl/5.0 cm 2 marked area) and rubbed into the skin with a cotton bud until minimal residue was evident on the surface of the skin. After 30 or 90 minutes full thickness 6 mm punch biopsies were harvested from both control and treated areas and snap frozen in Tissue-Tek OCT (optical cutting temperature) compound. Tissue samples collected in OCT were cut at between 5 and 7 μm using a cryostat and sections fixed in acetone for 20 minutes before being assessed for growth factor staining by immunohistochemistry. Two sections were cut from each section at least 10 μm apart and were rehydrated with phosphate buffered saline (PBS), blocked with 10% skimmed milk powder for 30 minutes at room temperature and washed 2-3 times with PBS. One hundred microliters of the diluted primary antibodies (rabbit anti-TGFβ2 polyclonal antibody 1:200, rabbit anti-IGF-1 polyclonal antibody 1:200) was added to each porcine skin section and left for 1 hour at room temperature before being washed 2-3 times with PBS. One hundred microliters of the diluted secondary antibody (biotinylated anti-rabbit IgG) 1:500 was added to each section and left for a further 1 hour at room temperature before being washed off with 2-3 times PBS and streptavidin-CY3 (1:300) was added to the sections for 40 minutes at room temperature. Finally the sections were washed with PBS and mounted in immu-mount and examined using a fluorescent microscope. Quantitation was performed by capturing 3 complete fields of view of the skin from each of the two sections from each sample. Using SigmaScan software (Jandel Scientific Software), the average intensity of the fluorescence in the epidermis and dermis in each field was determined together with the average background intensity. The final intensity measurement (represented as integrated optical density, IOD) reflects the average intensity in the measured area (epidermis or dermis) minus the background for each field, with up to 6 fields combined to provide the IOD for each sample. IGF-I and TGFβ2 are components of BMF-1 and can be detected in skin using immunohistochemical detection ( FIG. 3A ). After 30 minutes, the immunohistochemical detection of both IGF-I and TGFβ2 was increased in skin treated with topically formulated BMF-1 preparations ( FIG. 3A panels B and D respectively) compared to control skin treated with emulsion only ( FIG. 3A panels A and C). FIG. 3B shows the results of the quantitation of the IGF-I and TGFβ2 immunofluorescence observed in the epidermis and dermis of skin treated with two emulsions (A and B) containing 20 mg/g BMF-1 (closed bars) compared to emulsion alone (open bars). Quantitation of IGF-I immunofluorescence was performed on samples taken 30 minutes after the skin was treated with topically formulated BMF-1 whereas quantitation of TGFβ2 immunofluorescence was performed on samples taken 90 minutes after treatment. FIG. 3B confirms the observations shown in FIG. 3A (panels A and B) and demonstrates that IGF-I immunofluorescence was increased in both the epidermis and dermis 30 minutes after the skin was treated with topically formulated BMF-1 preparations. Although TGFβ2 immunofluorescence was found to increase 30 minutes after the skin was treated with topically formulated BMF-1 ( FIG. 3A , panels C and D), maximal changes were found to have occurred after 90 minutes. FIG. 3B demonstrates that TGFβ2 immunofluorescence was increased in both the epidermis and dermis after the skin was treated with topically formulated BMF-1. These results indicate that both IGF-I and TGFβ2 have penetrated the skin from the formulation. These studies demonstrate that growth factors contained within the BMF-1 preparations translocate into the skin and are detected in both the epidermal and dermal layers thus confirming the cutaneous availability of formulated BMF-1. EXAMPLE 8 Topically Formulated BMF-1 Increases Dermal Cellularity in Living Skin BMF-1 was formulated into 5 base topical emulsions on a weight for weight basis with incorporation of approximately 2 mg and 20 mg BMF-1 per gram of emulsion. Both control emulsion and topically formulated BMF-1 (2 and 20 mg/g) was applied to prepared porcine skin (washed and shaved) at an application rate of approximately 0.05 g/cm 2 . Material was applied by measured syringe (250 μl/5.0 cm 2 marked area) and rubbed into the skin with a cotton bud until minimal residue was evident on the surface of the skin. Repeated applications were performed at 3 or 4 day intervals for four weeks. Four weeks after the first application, and three days after the last application of topically formulated material, full thickness 6 mm punch biopsies were harvested from both control and treated areas, fixed in 10% formalin and processed for histology. Wax embedded sections from each biopsy were stained with haematoxylin and eosin and assessed in a blinded fashion by scoring the relative degree of dermal cellularity. Following repeated application over four weeks, skin treated with topically formulated BMF-1 (20 mg/g) was observed to have increased dermal cellularity scores compared to controls ( FIG. 4 ), reflecting an increase in the number of fibroblasts in treated skin. As loose connective tissue is more cellular and contains more reticular collagen (type III) than dense connective tissue, an increase in the cellularity score and a increase in type III collagen (Example 9) demonstrates an increase in the deposition of new loose connective tissue in the dermis. EXAMPLE 9 Topically Formulated BMF-1 Stimulates Collagen Production in Living Skin BMF-1 was formulated into sorbolene cream on a weight for weight basis with incorporation of approximately 2 and 20 mg BMF-1 per gram of emulsion. Both control cream and topically formulated BMF-1 (2 and 20 mg/g) was applied to prepared porcine skin (washed and shaved) at an application rate of approximately 0.05 g/cm 2 . Material was applied by measured syringe (250 μl/5.0 cm 2 marked area) and rubbed into the skin of 2 pigs with a cotton bud until minimal residue was evident on the surface of the skin. Repeated applications were performed at 3 or 4 day intervals for two weeks. Two weeks after the first application, and three days after the last application of topically formulated material, full thickness 6 mm punch biopsies were harvested from both control and treated areas and snap frozen in Tissue-Tek OCT compound. Two 10 μm sections from each tissue sample collected in OCT were cut using a cryostat and sections were fixed in acetone for 25 minutes before being assessed for collagen type III staining by immunohistochemistry. The sections were rehydrated with phosphate buffered saline (PBS), blocked with 10% skimmed milk powder for 40 minutes at room temperature and washed 2-3 times with PBS. One hundred microliters of the diluted primary antibodies (rabbit anti-collagen III polyclonal antibody 1:200) was added to each porcine skin section and left for 1 hour at room temperature before being washed 2-3 times with PBS. One hundred microliters of the diluted secondary antibody (biotinylated anti-rabbit IgG 1:200) was added to each section and left for a further 1 hour at room temperature before being washed off with 2-3 times PBS. Streptavidin-CY3 (1:200) was added to the sections for 40 minutes at room temperature. Finally the sections were washed with PBS and mounted in immu-mount and examined using a fluorescent microscope. Two sections from each tissue sample were analysed using an Olympus-Vanox Photomicroscope and image analysis software. The fluorescence intensity (integrated optical density) was measured in the dermis of each section and normalised using the fluorescence value from a negative control ( FIG. 5 ). Four fields of view were captured from each of the papillary and reticular areas of the dermis. The average intensity values per sample were then combined to provide comparative results. Following repeated application over two weeks, topically formulated BMF-1 increased the dermal content of collagen type III as shown in FIG. 5 . Compared to skin treated with sorbolene cream only, twice weekly exposure to topically formulated BMF (2 and 20 mg/g) increased dermal collagen III immunofluorescence ( FIG. 5 ). These results demonstrate that topically formulated BMF-1 stimulates new collagen deposition (type III collagen) by dermal fibroblasts in skin. EXAMPLE 10 BMF-1 Product Stimulates Collagen mRNA Synthesis and Inhibits Matrix-metalloproteinase 1 (MMP-1) mRNA Synthesis by Human Skin Fibroblast Cells Human skin fibroblasts were seeded into T75 tissue culture bottles (Cellstar, Greiner GmbH, Frickenhausen) and grown until confluent before being starved overnight in complete growth medium containing 0.1% FBS (basal medium). Cells were then exposed to concentrations of BMF-1 (0-2.0 mg/ml) in basal medium for 48 hours. Cell pellets were harvested for total RNA extraction using a Quickprep RNA extraction kit according to the manufacturers instructions (Amersham Pharmacia Biotech, Piscataway N.J.). The RNA extracted from each bottle was used as a single replicate and gene expression analysed by standard Northern blot procedures of 4 replicate experiments. Briefly, RNA was quantitated spectrophotometrically and 10 micrograms from each sample was size fractionated by electrophoresis on a 1% agarose-formaldehyde gel, then transferred to a Hybond-N nylon membrane (Amersham, Buckinghamshire, England) and fixed by UV cross-linking (UV Stratalinker 1800, Stratagene, La Jolla, USA). Membranes were probed with antisense riboprobes to human pro-collagen III, pro-collagen I, matrix-metalloproteinase 1 (MMP-1) and GapDH (a constitutively expressed control gene). For the MMP-1 and GapDH hybridisations, pre-hybridisation was carried out at 65° C. for 4 hours in 50% formamide, 5×SSPE, 5× Denhardts, 0.1% SDS and 100 μg/ml sheared salmon sperm DNA. For the collagen hybridisations, ULTRAhyb (Ambion, Austin, Tex.) was used as the hybridisation solution. Riboprobes were generated using either a T7 or SP6 transcription kit (Promega, Madison, USA) and [α-32P]UTP (GeneWorks, Thebarton, Australia), and were used at a final concentration of 10 6 incorporated counts/ml hybridisation solution. Hybridisation was performed for 16 hours using the conditions described for the prehybridisation. Membranes were washed under high stringency conditions; three times with 3×SSC-0.1% SDS at room temperature, three times with 2×SSC-0.1% SDS at 68° C., followed by two washes with 0.5×SSC-0.1% SDS and 0.1×SSC-0.1% SDS at 68° C. The membranes were exposed to film (Hyperfilm, Amersham, Buckinghamshire, England) at −80° C. for up to 24 hours. For quantitation, membranes were exposed to phosphorimage plates which were scanned by a phosphorimage reader (Fuji BAS, Japan) with the integrated optical density (IOD) of bands measured using Imagemaster VDS software (Pharmacia Biotech, Castle Hill, Australia). To control for the amount of RNA loaded and to ensure changes in mRNA expression reflected specific regulation of the probed gene, the pro-collagen III, I and MMP-1 signal was normalised using the GapDH-IOD from the same sample. Representative autoradiograms of collagen I, III and MMP-1 probed RNA are shown in FIG. 6A together with the respective GapDH autoradiogram for each sample. FIG. 6B shows the graphical representation of the combined results of 4 replicates for each treatment which are represented as the fold change from the respective RNA expression in cells treated under basal conditions. Treating cells with 0.2 mg/ml BMF-1 induced collagen I and III mRNA expression by at least 2-fold compared to basal conditions. Cells treated with 2.0 mg/ml BMF-1 also showed increased collagen mRNA expression. The effects of BMF-1 is considered to be a direct effect on gene induction and does not just reflect an increase in cell number. In contrast, BMF-1 had a dose dependent inhibitory effect on the expression of MMP-1 mRNA ( FIGS. 6A and 6B ). As MMP-1 is an important enzyme in the degradation of the collagen molecule, this result implies that not only does BMF-1 stimulate collagen synthesis, it also inhibits its degradation. As collagen turnover is a dynamic process occurring in skin, the relative effect on synthesis and degradation is an important consideration. The ability of BMF-1 to both stimulate synthesis and inhibit degradation ensures treatment of skin by BMF-1 will ultimately result in an overall net increase in collagen deposition. This is confirmed by the results shown in FIGS. 2 and 5 where the amount of collagen measured was similar in cells ( FIG. 2 ) or skin ( FIG. 5 ) treated with low or high levels of BMF-1. Although the results shown in FIG. 6B indicate that higher doses of BMF-1 do not stimulate as much RNA synthesis as lower doses, the finding that BMF-1 also markedly inhibits the synthesis of the degradative enzyme MMP-1 in a dose dependant manner demonstrates the degradation of collagen by MMP-1 is reduced as the dose of BMF-1 is increased. Moreover, this would result in a similar net balance of collagen deposition by skin fibroblasts at each BMF-1 dose as shown in FIGS. 2 and 5 . Thus BMF-1 directly stimulates collagen synthesis by upregulating both collagen I and III gene expression and inhibits its degradation by down-regulating the expression of MMP-1. EXAMPLE 11 BMF-1 and BMF-2 Product Stimulate Collagen mRNA Synthesis by Human Skin Fibroblast Cells Human skin fibroblasts were seeded into T75 tissue culture bottles (Cellstar, Greiner GmbH, Frickenhausen) and grown until confluent before being starved overnight in complete growth medium containing 0.1% FBS (basal medium). Cells were then exposed to 0.1 mg/ml of BMF-1 or BMF-2 in basal medium for 48 hours. Cell pellets were harvested for total RNA extraction using a Quickprep RNA extraction kit according to the manufacturers instructions (Amersham Pharmacia Biotech, Piscataway N.J.). The RNA extracted from each bottle was used as a single replicate and gene expression analysed by standard Northern blot procedures. Assessment of collagen I and III expression was performed as described in Example 10. Representative autoradiograms of collagen I and III probed RNA are shown in FIG. 7A together with the respective GapDH autoradiogram for each sample. FIG. 7B shows the combined results of replicates for each treatment which are represented as the fold change from the respective RNA expression in cells treated under basal conditions. Treating cells with both BMF-1 and BMF-2 induced collagen I and III mRNA expression by up to 2-fold compared to basal conditions. Although there was a tendency for BMF-2 to have a greater effect on collagen expression ( FIG. 7A ), the overall results were comparable ( FIG. 7B ). As mentioned in Example 10 the stimulation of collagen RNA by BMF-1 and BMF-2 is considered to be the result of a direct effect on gene induction and not just reflect an increase in cell number. Thus BMF-1 and BMF-2 can directly stimulate collagen synthesis by upregulating both collagen I and III gene expression. EXAMPLE 12 Methodologies Used to Study the Effectiveness of Basic Milk Factors as a Therapeutic and Preventive Treatment for Skin Damage The invention may be used to treat skin damage caused by UV radiation as a result of sun exposure. The person skilled in the art will readily be able to investigate the claimed invention to treat skin damage caused by sun exposure. For example, hairless mice exposed daily to a measured Minimal Erythematous Dose (MED) of solar simulated UV irradiation have been widely used as an animal model of accelerated skin damage or photoageing (Maloney et al 1992). This suitable model would be used to induce skin damage followed with the application of formulated BMF-1 or BMF-2 (collectively referred to as “BMF”) either alone or in combination with supplementary active ingredients to the damaged skin. The ability of the treatment to repair or renew the skin to a more normal structural and functional state as well as prevent further deterioration of the skin would be determined. For example, to test the ability of the invention to repair photo-damaged skin, after a period of acclimatisation (approximately one week) Skh-1 hairless mice will be exposed to a Minimal Erythematous Dose (MED) to their whole body of mixed UVA and UVB radiation five times a week. This is the approximate minimum dose which causes the mouse skin to turn pink 24 hours after irradiation. After a period of continued irradiation up to and including 20 weeks, when signs of skin damage are generally detectable, irradiation will be discontinued and the mice will receive a daily topical application of formulated BMF product on the dorsum at a dose rate within the range of 0.001-200 mg/cm 2 . Preferably, at specified times after the commencement of treatment, animals will be euthanased by the administration of a lethal dose of sodium pentobarbitone. Various methods are known in the art for assessment and characterisation of the effectiveness of the repair of skin damage. For example, the skin is collected for analysis using histological, immunohistochemical and biochemical methods (including hydroxyproline, mRNA and metalloproteinase assays) to determine the ability of BMF containing formulations to repair the UV-damaged skin. On the basis of the results shown in Examples 2 to 11, the inventors expect that the invention used in this particular model would increase collagen synthesis and deposition and decrease matrix degradation by matrix-metalloproteinases resulting in improved dermal structure and function compared to the skin from matched control treated animals. The inventors also expect that the invention would enhance skin keratinocyte and fibroblast cell proliferation and viability. The inventors also expect that the invention would conceivably reduce wrinkling, skin sagging and other photoageing related changes that occur in the dermis of the skin. Moreover, the inventors expect the invention would improve epidermal structure and viability and thus restore the skin to a normal healthy and youthful appearance. Further, suitable methods are known in the art to investigate the ability of the invention to prevent skin damage. For example, mice would receive a daily topical application of formulated BMF product on the dorsum at a dose rate within the range 0.001-200 mg/cm 2 immediately after being exposed to UV-irradiation (MED). This treatment would be continued for up to 20 weeks and at various times animals would be anaesthetised and then euthanased. Various methods are known in the art for assessment and characterisation of the effectiveness of the prevention of skin damage. Preferably, the skin of BMF treated mice is compared to the skin of control treated mice using standard histological, immunohistochemical and biochemical analysis. On the basis of the results shown in examples 2 to 11, the inventors expect that the invention used in this particular model would reduce the signs of skin damage. EXAMPLE 13 Methodologies Used to Study the Effectiveness of Basic Milk Factors as a Cosmetic to Enhance the Appearance of Skin The invention may be used as a cosmetic to enhance the appearance and vitality of human skin. The person skilled in the art will readily be able to investigate the claimed invention to improve the cosmetic appearance of human skin. For example, a number of clinical indices can be used to determine the ability of topically applied cosmetics to enhance skin cosmesis. These include subjective measurements of skin wrinkling, skin appearance and vitality, skin dryness and scaliness, skin sensitivity, skin thickness and skin fragility. More objective measurements can also be taken such as measuring skin thickness by callipers or ultra-sound and measuring skin moisture kinetics by determining epidermal hydration using a corneometer and transepidermal water loss (TEWL, a measurement of transcutaneous water loss) using a tewameter. Similarly skin surface roughness can be measured by taking a natural negative impression of the skin surface using dental impression material and analysing the impressions with a profilometer. Also, the elastic properties of the skin can be assessed using an uniaxial extensometer. For example, to test the ability of the invention to produce desirable cosmetic effects on human skin, topical application of formulated basic milk factors to the skin, at any site requiring cosmetic improvement, would be performed at a dose rate within the range of 0.001-200 mg/cm 2 and at specified application frequencies ranging from daily to weekly to monthly. Preferably, before the commencement of treatment and at specified times after the commencement of treatment, various methods are known in the art for assessment and characterisation of the effectiveness of cosmetics to improve the appearance and vitality of human skin would be applied. For example, measurements of skin wrinkling, skin appearance and vitality, skin dryness and scaliness, skin sensitivity, skin thickness, skin fragility, skin water kinetics and skin elasticity would be used to determine the ability of basic milk factor containing formulations to improve skin cosmesis. On the basis of the results shown in examples 2 to 11, the inventors expect that the invention would improve the appearance and vitality of skin, thus restoring skin with an aged appearance to a more normal healthy and youthful appearance. EXAMPLE 14 Methodologies Used to Study the Effectiveness of Basic Milk Factors as a Treatment of Skin Damage Caused by Cutaneous Resurfacing The invention may be used as a treatment of skin damage caused by cutaneous resurfacing. The person skilled in the art will readily be able to investigate the claimed invention to improve the outcome of skin regeneration following cosmetic procedures using high-energy pulsed laser systems and electrosurgical coablation. For example, cutaneous resurfacing is the cosmetic procedure of choice for the correction of photodamaged skin, photo-induced rhytides, dyschromias, the amelioration of scars and for skin recontouring. Cutaneous resurfacing employs high-energy pulsed lasers of the carbon dioxide (CO 2 ), erbium:yttrium-aluminum-garnet (Er:YAG) or neodymium:yttrium-aluminum-garnet (Nd:YAG) variety or electrosurgical systems for coablation techniques. Despite their effectiveness and utility, cutaneous resurfacing techniques are also associated with some unwanted side effects that occur as a result of the repair processes stimulated by the procedures in damaged skin. For example, to test the ability of the invention to improve the outcome of human skin regeneration following cosmetic procedures using high-energy pulsed laser systems and electrosurgical coablation topical application of formulated basic milk factors to the skin, at the site of the procedure, would be performed at a dose rate within the range of 0.001-200 mg/cm 2 and at specified application frequencies ranging from daily to weekly. Preferably, before the commencement of treatment and at specified times after the commencement of treatment, various methods are known in the art for assessment and characterisation of the effectiveness of treatments to improve the appearance of resurfaced human skin would be applied. For example, measurements of skin wrinkling, skin appearance, skin thickness, skin fragility and skin elasticity would be used together with more specific determinations of erythema, edema, hyperpigmentation, delayed hypopigmentation and hypotrophic scar formation to determine the ability of BMF containing formulations to improve the rejuvenation of skin by cutaneous resurfacing procedures. On the basis of the results shown in examples 2 to 12, the inventors expect that the invention would improve the cosmetic outcome of skin resurfacing procedures, thus restoring skin more quickly to a more normal healthy and youthful appearance. It will be apparent to the persons skilled in the art that while the invention has been described in some detail for the purposes of clarity and understanding, various modifications and alterations to the embodiments and methods described herein may be made without departing from the scope of the inventive concept disclosed in this specification. References cited herein are listed on the following pages, and are incorporated herein by this reference. REFERENCES Bergfeld W F. Cosmetic use of alpha-hydroxy acids. Cleveland Clinic J. Med. 1997 64: 327-329. Clark R A F. 1995. Wound Repair: Overview and general considerations. The molecular and cellular biology of wound repair, 2 nd edition, R. A. F. Clarke, editor. Plenum Press, New York, pp 3. Gilchrest B A, A review of skin ageing and its medical therapy. Br. J. Dermatol. 1996 135: 867-875. Maloney S J, et al. The hairless mouse model of photoaging: Evaluation of the relationship between dermal elastin, collagen, skin thickness and wrinkles. 1992 Photochem. and Photobiol. 56(4):505-511. Mast B A. 1992. The Skin. In Wound Healing: Biochemical and clinical aspects. Cohen I K, Diegelmann R F, and Linblad W J, editors. Saunders W B, Philadelphia, 346-349. Oliver M H, Harrison N K, Bishop J E, Cole P J, Laurent G J. A rapid and convenient assay for counting cells cultured in microwell plates: application for assessment of growth factors. J. Cell. Sci. 1989 92: 513-518. Orentreich N, and Orentreich D. S. Dermabrasion. Clinics in plastic surgery. 2001 28: 215-230. Van Engeland M, Ramaekers F. C. S, Schutte B, and Reutelingsperger C. P. M. A novel assay to measure loss of plasma membrane asymmetry during apoptosis of adherent cells in culture. Cytometry 1996 24: 131-139.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention concerns a method for the mechanical production of pieces of the same length of fish conveyed transverse to their longitudinal axis as well as an apparatus for carrying out such a method, this apparatus comprising a trough conveyor which conveys the fish transverse to their longitudinal axis and at least one cutting means which overlaps at least the cross-sectional area of fish placed in the conveying troughs, the apparatus further comprising a displacing device for displacing fish tail first and an abutting device for limiting the displacement of the fish by catching the same by their tail roots. 2. Description of Prior Art Such fish pieces which are preferably produced from sardines, herrings, anchovies etc. are needed essentially as a filler for tins. They are offered to the consumer prepared in different ways. The tail pieces are usually preferred since especially in single reciprocal layers of such pieces a more profitable rate of feeding and a product which is more pleasing to the eye are achieved. Problems arise in trying to fulfil the quality demands in this respect as well as with regard to the weight tolerance, which problems are mainly due to the fact that the fish to be processed are of different lengths and maturity. The usual practice of putting a uniform number of pieces--for example four--into tins, requires a pre-sorting into several classes of small size and thickness tolerance due to differences in size and thickness. The device for cutting the pieces thus has to be adjustable to each necessary piece length. This is extremely difficult to achieve with the machines known so far so that these machines and the methods practised therewith are not satisfactory. A piece cutting device is known (e.g. U.S. Pat. No. 2,431,465) in which the fish are conveyed in the troughs of a trough conveyor transverse to their longitudinal axis. The upwardly extending walls of the troughs are provided with slots extending to under their bottom surface, at least one circular knife arranged above the trough conveyor entering into them. In order to sufficiently support the fish the slots lie at such a distance from each other that leftovers of the peripheries remain between the slots. Apart from the fact that only pieces of the same length--regarding the plane of decapitating--can be manufactured, the tail piece being the remnant, the shifting of the knife in order to achieve a different length for the pieces is very complicated and only possible in relatively rough gradation. There is further known (DE-PS No. 717 592) a device for the production of so-called "fork-size bites" whereby the fish not yet decapitated are inserted, after their tail fin has been removed, with their head facing the centre into a circular conveyor with partitions consisting of ridges running above a circular table. The circular table has openings. After being aligned with their snouts in the same position by means of a guide the fish fall through the openings into a set of pairs of disc knives which shear with each other and carry out the transverse severing. The disadvantages laid down in connection with the first-mentioned cutting device are also found here. However, a more delicate adjustment of the desired piece lengths is possible. Furthermore, a piece cutting or slicing device is known (DE-PS No. 26 44 024) in which the head end of the fish forms the remnant piece. The fish rumps lying in the receiving troughs are, for this purpose, pushed in the direction of their tail end under a measuring bar which forms an abutment supporting itself on the flank of the fish. Thus positioned, the fish rumps are led to a fixed circular knife which cuts off tail pieces of almost the same weight but differing lengths. Such fish pieces facilitate the compilation of a certain filler weight but make a reasonable positioning in the tins impossible. 3. Object of the Invention It is therefore an essential object of the present invention to show a way of manufacturing fish tail pieces of the same length which makes a continuous adjustment of the lengths of these pieces in a simple manner possible. SUMMARY OF THE INVENTION This object is solved according to the invention by a method in which the fish are conveyed transverse to their longitudinal axis and which comprises the steps of aligning the fish according to the position of their tail root, displacing the fish by a pulling engagement or gripping in the region of their tail fins, ending the displacement of the fish by interrupting the pulling engagement and separating the tail piece by means of a cut led transverse through the fish rump. The ending of the displacement of the fish resulting from the pulling engagement, i.e. its positioning for the separating cut which follows can occur by cutting off the tail fin or interrupting the pulling grip in the region of the tail fin according to whether the fish pieces are desired with or without their tail fins. Preferably a holding device for gripping the fish in the region of its tail is provided next to a tail side end of the conveying troughs in an apparatus as described in the introductory paragraph to carry out the method according to the invention, which holding device carries out an accompanying movement which is almost synchronous with the conveying speed of the trough conveyor and which diverges in respect of the conveying direction of the trough conveyor and is adjustable in connection with the position of its engagement resp. its release. The advantages achieved with the invention lie especially in that the length of the pieces can be adjusted precisely and easily in order to achieve an optimal degree of filling of the tins as well as an aesthetically pleasing filling. A functionally safe embodiment which is also simple to manufacture comprises a holding device including pincers which run in the plane of the bottom surfaces of the conveying troughs in a circular path and are adjustable with regard to their position of operation, i.e. their opening or closing places, which pincers are arranged in a partition which corresponds to the partition of the conveying troughs in the conveyor. In order to produce pieces of fish without tail fin the apparatus according to the invention can have a device for separating the tail fin, which device comprises a circular knife tangentially touching the circular path of the pincers. It is advantageous to provide the circular knife to be adjustable with regard to its angle to the conveying direction of the trough conveyor in order to be able to set, in a simple manner, the amount of displacement of the fish in the conveying troughs, i.e. the length of the fish pieces to be produced from the transverse cut which follows. In order to further reduce construction costs the pincers can each comprise a moveable leg which can be held pressed under the force of a spring against a circular disc which carries the pincers resp. their legs. For the sake of ensuring a safe grip the surface of the circular disc facing the legs of the pincers may comprise a well gripping and/or elastic covering, i.e. a top covering which guarantees a reliable conveying. BRIEF DESCRIPTION OF THE DRAWINGS Other and further objects of the present invention will be apparent from the following description and claims and are illustrated in the accompanying drawings which by way of illustration schematically show preferred embodiments of the present invention and the principles thereof and what now are considered to be the best modes contemplated for applying these principles. Other embodiments of the invention embodying the same or equivalent principles may be used and structural changes may be made as desired by those skilled in the art without departing from the present invention and the scope of the appended claims. The invention is described as follows with reference to the drawings: FIG. 1 shows an axonometrical view of an essential part of the device according to the invention, FIG. 2 shows a partial cross-section of the device of FIG. 1 in the moment when the tail fin of the fish is led into the holding apparatus, and FIG. 3 shows a top view of the device in working position shortly after the tail fin has been severed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A trough conveyor 1 running endlessly in a conveying direction indicated by the double line arrow in FIG. 1 is arranged in a not-shown machine frame, e.g. of a nobbing machine for small bulk fish, the conveyor having conveying troughs 2 arranged closely behind each other and transverse to the conveying direction. The troughs 2 are e.g. angular in cross-section, a wall 3 extending upward as well as a bottom surface 4 of the troughs 2 being provided with slots 5 and 6 at defined positions into which circular knives 7, 8 which form a decapitation knife and a slicer enter and are mounted to turn in bearings above the trough conveyor 1. A plate-like gripping device is mounted proximate to the front end 9 of the troughs and comprises a circular disc 11 upon which is mounted a circular array of spaced pincer members 12. The circular disc 11 is located in the plane of the bottom surface 4 of the troughs 2 and is mounted at its center upon an axle 20 (FIG. 2) for rotation about an axis substantially perpendicular to the conveying plane of the conveying troughs 2. The axle 20 is rotatable by conventional drive means (not shown) for rotation of the circular disc 11 in a clockwise direction, indicated by the arrow in FIG. 1, at a circumferential speed of rotation corresponding to the speed of progression of the conveying troughs 2, which move in a right-hand direction as viewed in FIG. 1. The top surface of disc 11 is covered with an elastomer or is otherwise made to grip easily in an appropriate manner. The pincer members 12 are mounted on the top surface of the circular disc 11 and each comprises a movable leg 13 mounted pivotably on a support bearing 14 and formed as an angle lever which extends radially of the disc 11. The pivotal axis of each leg 13 extends substantially parallel to the plane of disc 11 and perpendicularly to an imaginary circle shown in broken line in FIG. 3, which circle is concentric with the circumference of circular disc 11. A gripping shoe 15 is affixed to one end of each leg 13 and depends therefrom at an angle toward the top surface of circular disc 11 and thus faces the latter with its bottom gripping edge as shown in FIG. 2. Intermediate its ends, preferably above its pivotal mount as shown in FIGS. 1 and 2, each leg has an upstanding extension upon which is rotatably mounted a roller 16 which is positioned to engage and bear against an elongated arcuate cam 17, as shown in FIG. 3. The cam 17 is fixedly mounted above disc 11 and is sized and configured to extend substantially concentric with disc 11 over a sector of said disc at the area immediately upstream of the point at which the circumference of the disc 11 is closest to the front edge 9 of troughs 2, as shown in FIG. 1. The cam 17 ends approximately at this point of closest adjacency, as shown in FIG. 3. As shown in FIGS. 1 and 3, the pincer members 12 are spaced around the circular disc 11 at such distances that, as the disc 11 rotates in synchronization with the travel of trough conveyor 1, each successive pincer member, as it approaches the said point of closest adjacency, comes into registry with, and faces one of the troughs 2, so that it can grip the tail end of the fish projecting from said trough after the pincer member moves out of engagement with the cam 17, in a manner to be presently described. The end of each movable leg 13, opposite to the gripping shoe 15, is biased upwardly by a spring 18 bearing against the upper surface of the disc 11, so that when the support roller 16 is out of engagement with cam 17, the gripping shoe 15 is resiliently pressed against the top surface of circular disc 11 by means of spring 18. When the support roller 16 is in engagement with cam 17, however, the cam holds the leg 13 in the upwardly inclined position of FIG. 2, against the tension of spring 18, in which inclined position the gripping shoe 15 is elevated above the surface of the disc 11. A circular knife 19 is rotatably mounted on the machine frame substantially tangentially to the periphery of the circular disc 11 at a position downstream of the trailing end of cam 17, as shown in FIG. 3. The knife 19 is positioned to cut off the tail fins of the fish gripped by the pincers 12, and in this cutting operation touches the path of rotation of the circular disc 11 and performs a shearing action with the periphery of said circular disc. The cutting plane of the knife 19 is adjustable with respect to its position along the conveying direction of the trough conveyor 1. For this purpose, a bearing housing upstands from the axis 20, as shown in FIG. 3 and mounts the end of the drive rod carrying the circular knife 19. The knife 19 is therefore adjustably rotatable about the axis 20 so as to selectively move the knife 19 tangentially along the circumference of circular disc 11 toward or away from the point of closest adjacency between disc 11 and the troughs 2. The knife 19 may then be locked in adjusted position by means of a clamping device 21. The circular knife 19 is driven by suitable drive means (not shown), for example through the axis 20 by means of a suitable angular gear, in which case the axis 20 and its bearing housing would be made hollow. The walls 3 of the conveying troughs 2 are designed with edges sloping down towards the end 9 of the conveying trough 2 so that a stop rail 22 arranged fixed to the frame above this end leaves a wedge-shaped aperture with the bottom surface 4 of the conveying troughs 2 to let the tail fin of the fish pass. In order to span the space between the bottom surfaces 4 of the conveying troughs 2 and the circular disc 11 a support rail 23 which is adapted to the periphery of the circular disc 11 is installed. The mode of operation and function of the device shown as an embodiment of the invention are described with reference to the handling of a fish: A fish which is fed into the conveying troughs 2 and decapitated by decapitation knife 8 in a known manner after being aligned into the desired beheading position, is first displaced longitudinally in the tail direction as shown by the arrow in FIG. 1 in the respective conveying trough 2 by means of a not-shown brush or any other appropriate means. The tail end of the fish arrives under the stop rail 22, the tail fin passing through the aperture left between the stop rail 22 and the bottom surface 4 and coming to rest on the circular disc 11. The longitudinal displacement of the fish is ended when the tail root which is thicker than the tail fin abuts the stop rail 22. The pincer 12 opposite the preceding conveying trough 2 is open, with its gripping shoe elevated, until this moment due to the fact that its support roller 16 supports itself on the cam 17. While the trough conveyor 1 advances, and the circular disc 11 turns correspondingly the support roller 16 runs off from the cam 17 so that the gripping shoe 15 of the pincer 12 lowers and presses the tail fin lying beneath it against the circular disc 11 by the force of the spring 18 and therefore clamps it. The fish has in the meantime left the area of the stop rail 22 and is thus freed to be displaced longitudinally in the conveying trough 2 because the distance between the pincer 12 holding the fish and the end 9 of the conveying trough 2 is increasing. As shown in FIG. 3, as the circular disc 11 continues to turn in synchronization with the moving trough conveyor 1 the gripping pincer member 12 is moved away from the point of closest adjacency, and the distance between said pincer member and the adjacent trough 2 continuously increases. This results in the pincer member 12 effecting a pulling action upon the fish tail which it is gripping, thereby causing the fish to be drawn longitudinally forward in its trough toward the circular disc 11. This process continues until the circular knife 19 is reached which cuts off the tail fin with a cut running in the vicinity of the clamping position of the pincer 12, thereby freeing the fish from the gripping shoe 15 and ending the displacement of the fish in the conveying trough 2. The fish is led to the circular knife 8 of the slicer in the position thus achieved. The knife separates the fish at a position determined in this way. As can be seen, the position of the circular knife 19 is decisive for the lengths of the pieces attainable. The circular knife 19 is therefore arranged coaxially pivotally around the axis 20 of the circular disc 11 and designed lockable by means of the clamping device 21. The severed tail fin is released by returning the pincer 12 into the open position for receiving the tail fin of the next fish, and washed out of the clamping device e.g. by a jet of water. If pieces of fish with tail fin are desired, the cam 17 can be provided with an extension which reaches into the region of the circular knife 19 against the direction of rotation of the circular disc 11, and the circular knife 19 may be disposed of. The position in which the support rollers engage the cam 17 will then be designed adjustably in an appropriate manner so that the opening point of the pincer 12 can be adjusted.

1a

REFERENCE TO PRIOR APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/791,123, filed Feb. 22, 2001, which claims priority of U.S. provisional application Ser. Nos. 60/183,995, filed Feb. 22, 2000; 60/186,474, filed Mar. 2, 2000; and 60/245,034, filed Nov. 1, 2000. U.S. patent application Ser. No. 09/791,123 is also a continuation-in-part of U.S. patent application Ser. No. 09/371,460, filed Aug. 10, 1999, now U.S. Pat. No. 6,681,031, which claims priority to U.S. Provisional patent application Ser. No. 60/096,126, filed Aug. 10, 1998. The entire content of each application and patent is incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention related generally to motion tracking and, in particular, to a system operative to optically monitor and record full-body and partial-body movements. BACKGROUND OF THE INVENTION [0003] Numerous systems exist for measuring object surface or point locations by triangulation exist in the literature. The typical system projects a beam of collimated light onto an object and images that light through a sensor (typically a CCD) which is laterally displaced from the projector. The parallax displacement along the axis between the projector and the sensor can be used (along with the baseline between the sensor and projector) to compute range to the illuminated point. [0004] Typical examples of this type of system include those described in U.S. Pat. No. 5,198,877 (Schulz), U.S. Pat. No. Re. 35,816 (Schulz), U.S. Pat. No. 5,828,770 (Leis et al.), U.S. Pat. No. 5,622,170 (Shulz), Fuch et al., Yamashita et al., and Mesqui et al. U.S. Pat. No. 5,198,877 (Schulz) and U.S. Pat. No. Re. 35,816 (Schulz) presents an optical tracking device that samples the three-dimensional surface of an object by scanning a narrow beam of light over the surface of an object and imaging the illuminated points from multiple linear photo detector arrays. The three-dimensional location illuminated is determined by triangulation (i.e. from the parallax displacement along each detector array of the illuminated spot). The system described also uses fixed but widely separated light sources as a calibration source. These light sources are time multiplexed so as to distinguish them from each other at the detect array. This system uses a cylindrical lens system to project light spot images onto the linear photo detector array. [0005] U.S. Pat. No. 5,828,770 to Leis et al. presents a system for determining the spatial and angular orientation of an object in real-time based on activatable markers on the object imaged through two imaging sensors separated by a baseline. This system recognizes the light emitting markers based on geometrical knowledge from a marker-identification mode. Multiple markers are activated simultaneously and image together on the sensor focal planes. Mesqui, Kaeser, and Fischer (pp. 77-84) presents a system which is substantially the same as U.S. Pat. No. 5,828,770 except applied to mandible measurement and with some implementation details change. [0006] U.S. Pat. No. 5,622,170 to Schulz describes a means for determining the position of the endpoint of an invasive probe inserted into a three dimensional body by locating two light emitting targets located at known locations on a portion of the probe still visible outside of the body. The means for tracking the light emitting markers is through imaging on three linear CCD sensors. This system uses a cylindrical lens system to project light spot images onto the linear CCD array. [0007] Fuch, Duran, Johnson, and Kedem presents a system which scans laser light over a body and images the light spots through three cylindrical lenses and linear CCD cameras displaced in linear position and located out of plane from each other. Triangulation based on shift of the bright position along each CCD allows localization of the illuminated point on the body. Yamashita, Suzuki, Oshima, and Yamaguchi presents a system which is substantially the same as Fuch et al. except with respect to implementation details. Mesqui, Kaeser, and Fischer (pp. 52-57) is substantially the same as Fuchs et al. except that it uses only two linear CCD cameras instead of a photodiode array. [0008] West and Clarke describe how to improve simple light spot detection algorithms which threshold the digitized signal from the imaging sensor and determine the spot location by averaging or taking the center of area of the pixels over the threshold. This paper describes a more accurate method which is used in the invention describe following that correlates a model of the illumination (or light spot) with the image. The correlation approach, by fitting the model to the image data, can provide a more accurate estimate of spot location—typically 5 to 10 times better localization than would be possible through the simple thresholding approach. This method is important in three dimensional triangulation systems because small errors in spot location estimation on the imaging device translate into larger angular measurement errors and ultimately potentially very large errors in three-dimensional target location estimation. [0009] The target locating systems described are used to track specific body points for medical purposes or proved the means for capturing object surface points for the purpose of three-dimensional digitization of object geometry. In all of the systems above targets are either projected from scanned collimated light sources or are active light emitting markers affixed to the object that is tracked. Several of the methods utilize linear CCD sensors that capture light through cylindrical lens systems. Some of the systems utilize more than one active emitter, but these emitters are distinguished from each other through geometrical market identification (not time multiplexing). None of these systems describe a tag or marker controller that is synchronized with the imaging sensor systems. SUMMARY OF THE INVENTION [0010] Broadly, this invention resides in an optical system capable of tracking the motion of objects, including the human body or portions thereof. This system provides for near simultaneous measurement of a plurality of three-dimensional active markers preferably affixed to the object or person to be tracked. [0011] The system tracks active emitting markers through triangulation from data read via multiple linear CCDs through cylindrical lenses. The targets are identified with an improved method that resolves all need for geometrical identification. Each marker is lit in sequence so that it is in sync with a frame capture using the imaging system positioned and oriented so as to provide a basis for computing market three dimensional location. [0012] The system synchronizes the high-speed imaging of individual markers in the field via three synchronized linear CCD or photodiode arrays to localize position in three dimensions through triangulation techniques. In the preferred embodiment, the imaging system detects an infrared signal which is sent out by the tag controller as part of the tag/marker illumination sequence at the beginning of the first tag position capture time. The controller then traverses through the tags in time sync with each imaging system frame capture cycle. Thus, only one unique tag will be lit during each image capture of the cameras, thereby simplifying identification. Using linear CCD sensors, the frame time (i.e. point acquisition time) is very short, allowing very many markers to be sampled and located sequentially in real time. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 illustrates an infrared tracking system scenario according to the invention; [0014] FIG. 2 shows how the absolute 3D position of each IR LED (tag) is computed from the angle of arrival detected by the optical sensors using triangulation methods; [0015] FIG. 3 is a schematic diagram of an infrared tag controller according to the invention; [0016] FIG. 4 is a tracking system timing diagram assuming 30 LEDs are active and tracked; [0017] FIG. 5 is a schematic diagram of an optical sync detector according to the invention; [0018] FIG. 6 is a linear camera schematic; and [0019] FIG. 7 is a schematic diagram of a camera array controller constructed in accordance with this invention. DETAILED DESCRIPTION OF THE INVENTION [0020] This invention resides in a real time computer vision system capable of tracking the motion of objects, including the human body or portions thereof. The system is capable of tracking the gestures and behaviors through an unstructured and possibly cluttered environment, then outputs the position of the tracked features in each observed scene. [0021] To determine position in an immersive environment, a user is preferably outfitted with active infrared emitters which are tracked by custom linear cameras. A set of design specifications associated with an implemented system are shown in Table 1: TABLE 1 Design Specification of Existing Body Tracking System Field of View 45 × 45 degrees Range  7 meters Accuracy  2.5 mm @ 5 meters Numbers of sensors 1-255 30 Sensor scan rate  30 Hz Camera frame rate 900 Hz Latency 5 milliseconds maximum [0022] The implemented system is capable of determining the location of 30 points, 30 times a second with a resolution of 2.5 mm within 5 meters of the tracking system. The field of view, range and accuracy have been specified to provide a reasonably large working volume to accommodate a variety of applications. The number of sensors was selected to allow for placement of multiple sensors on desired tracking points to allow the same point to be located irrespective of orientation to reduce the adverse effects of line-of-sight occlusion. Virtual reality applications such as head tracking for head/helmet mounted display (HMD) generation dictate the high accuracy, sensor scan rate (same as display update rate), and low latency, all of which are desirable to help combat simulator sickness. [0023] The invention relies on an infrared-based, non-contact motion measurement system. Referring to FIG. 1 , small infrared (IR) light emitting diodes (LEDs) called tags ( 102 ) attached to the person or object are flashed in sequence using a controller 104 and tracked with a set of three linear optical sensors 106 . Optical filters shown in FIG. 6 are used to reduce background IR emissions and highlight the IR LEDs, thereby reducing the complexity of the image processing algorithms and improving system performance. The system works well in indoor conditions where diffuse incandescent or fluorescent light is present. The presence of direct incandescent light or sunlight can be tolerated somewhat. The absolute 3D position of each IR LED (tag) is computed from the angle of arrival detected by the optical sensors using triangulation methods shown in FIG. 2 . [0024] The IR LED tags are button-sized devices (preferably no greater than 0.25 inch diameter) that are attached to the objects/points to be tracked as applicable to the object/point (Velcro®, double sided surgical tape, etc.). The tags preferably use 890 nm low directivity LEDs. The relative intensity of the IR radiation is 80 percent at 90 degrees off axis, allowing the tag to be readily imaged when the camera is in the half-plane field of view. [0025] Each tag is preferably constructed by encapsulating the backside of the LED in plastic both for a smooth mounting surface as well as to provide strain relief for the electrical connections. The total tag package is small, and so light that it may be unobtrusively affixed to a persons face and be used to resolve facial features. [0026] The wires from the tags are then run to the tag controller 104 , which is a walkman sized, untethered, battery powered device that may be attached to a person's belt. The tag controller also has a RS-232 serial port for local (on the person) communication, and an Infrared Data Access (IrDA) compliant serial port for external communication and programming with a maximum baud rate of 115.2 kbps. [0027] The tag controller 104 turns the IR LED tags on and off in sequence with precise timing to allow the position sensor array to view only one tag per camera exposure. FIG. 3 is a block diagram of the IR LED tag controller 104 . The controller allows for the tag illumination sequence to be initiated based on an external electrical signal (which can be generated from the camera array controller). If so connected, the controller synchronizes the tag sequence which the sync signal. If not, the tag controller cycles the tags based on its internal crystal clock timing circuits. The controller provides an incrementing output to decode circuits that directly drive the tag LEDs. [0028] The default mode of the tag controller is to scan 30 tags at 30 Hz, but it can be programmed to scan fewer tags at higher rates or more tags at lower scan rates. Thirty LEDs are sequenced in 33.333 milliseconds. If fewer than 32 LEDs are programmed, the sequence complete more quickly. The capabilities of the tag controller could be expanded to include more sensors at lower scan rates provided that the aggregate frame rate of 900 Hz is not exceeded. A few alternate sensor scan rates are given in Table 2: TABLE 2 Sample Sensor Scan Rates Sensors Sensor Scan Rate Camera Frame Rate 30  30 Hz 900 Hz 20  45 Hz 900 Hz 15  60 Hz 900 Hz 10  90 Hz 900 Hz 2 450 Hz 900 Hz 1 900 Hz 900 Hz [0029] FIG. 4 shows the tracking system timing diagram assuming 30 LEDs are active and tracked. SYNC is the sync signal either generated electrically by the camera array controller or detected via the IR optical sync detector that is a part of the camera array controller. Note that first LED in the sequence is shorter in duration and brighter in intensity. In the preferred embodiment, this LED is also modulated with a 200 kHz signal which helps makes detection of the pulse easier against the constant background radiation presented to the optical sync detector photodiode by ambient lights (overhead fluorescent and incandescent lights). [0030] The optical sync detector shown in FIG. 5 detects the first (and all other LED) IR pulses using a photodiode 502 . Because the signal from the diode is very low level, it is amplified by a high gain front-end circuit 510 . Then the signal is filtered at 512 to remove all high frequency noise (frequencies greater than the 200 kHz modulation frequency). Then the signal is filtered by a narrow bandpass filter 514 set at 200 kHz. Because LED 0 is modulated at this frequency and all ambient light and light from other higher numbered LEDs are not, only when LED 0 is lit is there an output to the envelope detector 516 . This signal appears when LED 0 is lit, or when the tag sequence begins. The start signal is conditioned by an isolation amplified-Schmitt trigger pair 520 and present to the camera array controller ( FIG. 7 ) as a signal to initiate frame capture of target 0 . [0031] The position sensor consists of three near infrared linear CCD cameras mounted on a 1 meter bar that views each tag from three separate locations, as shown in FIGS. 1 and 2 . In the preferred embodiment, two cameras are oriented horizontally and one vertically to provide a complete basis vector for computing three-dimensional location of the tags. Each connects to the camera array controller through a serial digital interface. The camera system itself is controlled via a DSP that accepts commands from the array controller and send data back to the array controller via the serial digital interface. The DSP operates the linear CCD through a CCD controller circuit that handles all CCD timing and control and provides for digitizing the analog CCD circuit outputs for read into the DSP (through a FIFO buffer circuit). [0032] The current implementation uses a 2048 element linear CCD circuit. Analog outputs from the CCD bucket brigade are digitized to eight-bit accuracy. As shown in FIG. 6 , each tag image is presented to the CCD active area 606 through a high pass optical filter 606 (which moves a substantial portion of the visible band from the input light energy spectra) and a cylindrical lens 604 which elongates the tag spot image perpendicular to the CCD linear extent. Using cylindrical optics 604 and IR-pass filter 606 , the linear cameras measure the angular position of the tags in one dimension only. [0033] The DSP detects the bright area projected from a tag using a spot fitting algorithm so that the localization of spot position is not limited to the resolution set by the linear camera pixel density (2048 in this implementation). Rather, resolution along the CCD linear extent of nominally ten times better is achieved by the subpixel-processing algorithm. [0034] The CCD array 602 interfaces to a specialized linear CCD processor 610 . The processor 610 controls timing of the CCD readout, has variable gain amplifiers and an 8-bit A/D converter and can support pixel scan rates of up to 2.5 Megapixels/second. The image is processed in real time in the camera itself by digital signal processor (DSP, 620 ) to determine the angle of arrival. The horizontal (or vertical) resolution of the proposed system can be adjusted by varying the field of view and the number of pixels in the CCD, as set forth in Table 3: TABLE 3 Resolution Limits Assuming No Subpixel Resolution Enhancement Processing CCD Field of Pixels View Distance Resolution Distance Resolution Distance Resolution 2048 45 1 0.40 5 2.02 8 3.24 2048 90 1 0.98 5 4.88 8 7.81 2048 60 1 0.56 5 2.82 8 4.51 2048 30 1 0.26 5 1.31 8 2.09 1024 45 1 0.80 5 4.04 8 6.47 4096 45 1 0.20 5 1.01 8 1.62 [0035] The resolution in the depth dimension can be adjusted by varying the distance between the two horizontal resolution cameras. A 1-meter separation of two 2048 pixel linear CCD cameras with a field of view of 45 degrees, results in a resolution of 4.56 mm in the depth dimension. At this point, it is important to note that the aforementioned resolution numbers assume that the location of the IR tag can be resolved to one pixel. This is a worst case resolution number since image processing algorithms that can easily achieve sub-pixel location and image registration are readily available. [0036] The camera array controller depicted in FIG. 6 generates an electrical sync signal at the start of each target capture cycle that be directly connected to the tag controller. In this mode, the camera systems and tag controller are electrically synchronized and not subject to any ambient lighting noise or other effects. Alternatively, the camera array controller accepts a sync signal at the beginning of each tag controller tag illumination sequence derived from the detected output of LED 0 . In either case, the camera array controller signals the DSP to initial frame capture simultaneously on the three linear CCD imaging systems (through the CCD controller integrated circuits that provide control and timing of the CCD circuits). [0037] Each camera subsystem produces digital output that locates the bright spot (from one of the tags) along the CCD linear extent. This location is read by the DSP from each camera and then used to compute the tag three-dimensional location based on factory calibration parameters. (Each camera system is placed on a fixed calibration frame at the factory. LEDs located at known places on the frame are lit in sequence so that where they project onto the linear cameras is determined. From this data it is possible to compute the transform which converts locations along each camera linear extent to three-dimensional points in the system field of interest. [0038] Once the angles of arrival have been determined by the individual cameras, the three angles are transmitted to another DSP in the camera array. This DSP computes the three dimensional calibrated position of the infrared tag in real time using the relationships shown in FIG. 2 , and transmits the result in the form of an output position value in X, Y, and Z via a serial RS-232 interface. The output may be delivered to a workstation or PC which captures the motion tracking data set for display or use in computer animation or gesture control applications. In addition to position values, each output includes a tag detection confidence factor. This is necessary because tags can be blocked from view so that no valid X, Y, and Z value can be computed. The output and camera data input interfaces could be any other type of digital transmission interface including Firewire, USB, Ethernet, or other parallel or serial digital interfaces. [0039] The overall approach of this system is very cost effective due the reduced cost of the required hardware. This is accomplished in at least two ways: 1) by decoupling the horizontal dimension from the vertical using cylindrical optics, and 2) through the use parallel processing to speed up the image processing. Each camera needs only to compute the angle of arrival, which is based on the location of the brightest spot on the CCD. [0040] An advantage of the invention over systems that use one or more two-dimensional CCD cameras is that high speed linear cameras are not as costly, and produce smaller raw images (three images of 2048 pixels as compared to two or more images of 1024×1024 pixels), which can be processed with simpler algorithms faster. This, combined with processing of each 2048 pixel image separately is the key to minimizing the system's latency. [0041] The system also has the advantage that 3D tracking may be accomplished in a noisy environment without interfering with the user's experience. In Table 3, the accuracies quoted exceed the desired 1 centimeter resolution at 8 meters without the use of subpixel resolution algorithms. To meet the field of view specifications, it may be desirable to adjust the optical components of the linear cameras to widen the field of view, however, that would still provide a 1 centimeter resolution. [0042] This invention finds utility in a variety of more comprehensive systems, including human body tracking and gesture recognition. Although different apparatus may be used, the optical body tracker described herein may be interfaced to the gesture recognition system disclosed in U.S. Pat. No. 6,681,031, or to the systems described in U.S. provisional patent application Ser. Nos. 60/183,995; 60/186,474; or 60/245,034, all of which were incorporated herein by reference above. [0043] U.S. Pat. No. 6,681,031, for example, describes a system engineered to control a device such as a self-service machine, regardless of whether the gestures originated from a live or inanimate source. The system not only recognizes static symbols, but dynamic gestures as well, since motion gestures are typically able to convey more information. A gesture is defined as motions and kinematic poses generated by humans, animals, or machines. Specific body features are tracked, and static and motion gestures are interpreted. Motion gestures are defined as a family of parametrically delimited oscillatory motions, modeled as a linear-in-parameters dynamic system with added geometric constraints to allow for real-time recognition using a small amount of memory and processing time. [0044] A linear least squares method is preferably used to determine the parameters which represent each gesture. Feature position measure is used in conjunction with a bank of predictor bins seeded with the gesture parameters, and the system determines which bin best fits the observed motion. Recognizing static pose gestures is preferably performed by localizing the body/object from the rest of the image, describing that object, and identifying that description. Further details regarding this and the other systems incorporated herein by reference may be obtained directly from the respective applications. [0045] In addition to the applications already described, the technology disclosed herein may also be used to detect and localize bright flashes of IR illumination over a longer distance. This could be useful for detecting the launch of man-portable air defense systems (MANPADS) or rocket propelled grenades (RPG's). Detection of these devices is currently very difficult. However, the capability is necessary to protect both commercial and military assets (including aircraft). [0046] Firefly already localizes bright IR illumination and produces a 3D position for the light. The projectile tracking scenario extends these capabilities to work over a larger range. However the general calculations and tracking principles are the same. The system is therefore applicable to both tracking and detection. Another application area is tracking head motions in a virtual reality simulator. Such simulators are well known to those of skill in the art.

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RELATED APPLICATION This application is a Continuation-In-Part of Provisional application Ser. No. 60/003,948, filed Sep. 19, 1995. RELATED APPLICATION This application is a Continuation-In-Part of Provisional application Ser. No. 60/003,948, filed Sep. 19, 1995. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates generally to garden tools and more particularly to the hoe type garden tool having a unique heart shape and includes multiple edges and angles configured to perform various garden tasks and a handle with a disconnect head which is equipped with three different angles. 2. Discussion of the Prior Art It is common practice when weeding and/or cultivating to use a hoe, which is a long handled implement having a straight edge blade fastened perpendicular to the handle. This implement performs a chopping action upon the ground for the purpose of breaking, loosening, and digging out weeds. This chopping and digging process is activated by the operator with his extended arm and offers very poor leverage. The straight cutting edge of this implement is very inefficient for cutting into the ground and further makes hoeing a very exhaustive and back breaking task. Agricultural implements of various kinds are known for use in manual operations for working the soil, cutting weeds, and their roots beneath the surface of the ground, pulverizing the upper crust of the earth for planting of seeds, furrowing the pulverized crust for planting, and hoeing or covering the planted seeds or fertilizer. Furthermore, various kinds of agricultural implements have been used which accomplish a combination of these agricultural operations. However, a single implement which is simply constructed and economical for purchase by the average homeowner who desires to have his own garden spot which is useful for weeding, pulverizing the upper crust of the earth, furrowing and covering the furrows, is not known. Several prior art devices have attempted to provide the required operations, as, for example, the U.S. Pat. No. 2,011,062 to Masamitsu which discloses a gardening implement comprised of a substantially flat plate-like blade of a generally triangular outline. The blade is shaped such that the two edges are concaved and of like curvature and length whereas the other and longer edge is formed at a point centrally of its ends with a rounded outwardly projecting edge portion. U.S. Pat. No. 3,545,551 to Niemeyer discloses an interchangeable blade hoe kit which includes a handle with a hollow cylindrical terminal portion which is threaded internally so as to screw on to the extensions of the blades. A hole is drilled angularly through both the handle and the extensions where they screw together to provide registering apertures for the insertion of a bolt which is engaged by a nut. U.S. Pat. No. 4,730,679 to Tallerico et al discloses a garden tool handle and a connected head part. The head part includes multiple sides, each formed into a tool part for performing a specific garden task. U.S. Pat. No. 5,272,788 to Gilstrap discloses an interchangeable handle and utility tool head system where different tool heads are used with the handle. The different tool heads have similar shanks with a screw threaded end. The handle has a female coupling on one end to receive the screw threaded shank. A positive securing device prevents rotation of the tool head relative to the handle where a keyway and key system prevents the rotation. U.S. Pat. No. 5,161,278 to Tomm discloses a handle connector with an anti-loosening lock comprising a head member having an internally threaded handle receiving opening with a handle connected with the head member by a manually releasable connector assembly positioned between the head member and a first end of the handle. U.S. Pat. No. 4,730,679 to Tallerico et al discloses a handle and a connected head part. The head part includes multiple sides each formed into a tool part for performing a specific garden task. The shorter end edges of the head are formed into a pointed nose and a slotted hoe. One longer side edge of the head part includes formed projections which define slots with the opposite side edge of the head part having downturned arched projections formed there along which alternate with flat projections. The head part is bowed form side edge to side edge to facilitate use of the nose and hoe. SUMMARY OF THE INVENTION The invention is a wooden handled, heart shaped garden tool and includes multiple edges and angles configured to perform various garden tasks and a bolt attached thereon to mate with a handle equipped with three different mounting angles. The handle is made from a hard wood or plastic and comes in either 5 foot or 6 foot lengths. The long handles allow for the user to stand upright while working. Attached to the end of the handle, furthest from the user is a 6 inch long connector with three different angled connections or bosses. These bosses are threaded on the interior to accept a 1/2" threadrod. One boss comes straight from the end of the connector, the second boss is ninety degrees from the connector and handle, and the third boss is fifty four degrees from the connector and handle. A disconnect has also been designed for the center of the handle to allow it to be taken apart for ease of shipping or storing or to add a longer length handle section. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top, rear, perspective view, partially cutaway, showing the heart shaped blade at 90° to the handle. FIG. 2 is a top, front, perspective view, partially cutaway, showing the heart shaped blade at 90° to the handle. FIG. 3 is a top view of the heart shaped blade of the invention. FIG. 4 is a side view of the heart shaped blade of the invention. FIG. 5 is a side sectional view of the disconnect head of the invention with the handle cutaway. FIG. 6 is a sectional view of a handle coupling. FIG. 7 is a side view of the heart shaped blade mounted in the 54° boss of the disconnect head of the invention. FIG. 8 a side view of the heart shaped blade mounted in the 90° boss of the disconnect head of the invention. FIG. 9 is a side view of the heart shaped blade mounted in the end boss of the disconnect head of the invention. FIG. 10 is a side view of the invention in a vertical cutting position. FIG. 11 is a side view of the invention in a horizontal cutting position. FIG. 12 is a side view of the invention in a horizontal position being used as a weed puller. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, the reference numeral 10 refers generally to the heart shaped garden tool of this invention. Tool 10 includes an elongated handle 17 formed of wood or similar material. The heart shaped head 18 is preferably formed of durable, rigid, material such as metal or metal alloys, and may comprise three different blades (4", 6" and 7") made from 12 gauge steel. A 1/2" threadrod 16, which is 3" long may be welded to the center of each blade at a thirty six degree angle. A locking nut 15 is threaded on the threadrod 16 and when the threadrod 16 is threaded into one of the threaded connector holes 12, 13, or 14 located in connector 11, on handle 17, the threadrod 16 is locked in place with locking nut 15. The heart shaped head 18 may be made in different sizes to suit the use for which it is being applied. A small heart (4") may be used for removing individual weeds from flower beds and yards. A (6") heart is for use for normal sized yards and gardens and the (7") heart is for larger yards and gardens. All three blade sizes are equipped with a very sharp edge 21 that has been hand sharpened. The heart shape results from forming the head 18 with a pointed snout 19 at a first end and a "V" shape 20 at a second end opposite the snout 19. When each of the several sized heart shaped heads 18 are connected to the handle 17 and connector 11, several different tools are created with various uses for each tool. FIGS. 3 and 4 more clearly show the sharpened edges 21 and 21' on the top surface of heart shaped head 18. FIG. 5 is a sectional view of the connector 11 having a mounting hole 22 beginning at a first end and running to a point near a second end of the connector 11 where three bosses 12, 13, and 14 are formed. Connector 11 is fastened to handle 17 with a set screw 34 threaded in a hole 23 formed in connector 11. A first threaded connector hole 12 (boss) is formed in connector 11 at 90° to the center line of connector 11. A second threaded connector hole 13 (boss) is formed in connector 11 at the end of connector 11 parallel to the center line of connector 11. A third threaded connector hole 14 (boss) is formed in connector 11 at 54° to the center line of connector 11. The relationship of the heart shaped blade head 18 with threadrod 16 which is 36° to head 18, when attached to the different angles on the handle connector 11 are as follows. When head 18 is attached to the boss 13 coming directly from the end of the handle 17, (FIG. 9) the resulting tool edges, weeds, cuts, pulls weeds, digs holes, and removes ice from walks and drives. The pointed end of snout 19 goes through the soil easier than a round shape. The "V" shape 20 in the back of the blade 18 becomes a weed puller by locking the "V" shape 20 (FIG. 12) on weed 41 growing in soil 40 and pulling handle 17 in the direction shown by arrow 43 and thereby pulling weed 41 up and out as shown by the arrow 42. The blade 18 becomes a weed puller by locking the weed 41 needing to be pulled and either jerking the weed 41 out of the soil 40, or in the case of a tough weed 42, the weed 42 is locked in the "V" shape 20 and the handle is lifted upwardly using the snout 19 of the heart shaped blade 18 as a fulcrum and the weed 42 is lifted roots and all. To dig holes, the operator simply sinks the snout 19 into hole. When the handle is lowered to a normal position for the user, the blade 18 will have cut its way across the hole and will be loaded with soil and in a flat position ready to be lifted from the hole. To remove ice from sidewalks, the user would turn the blade 18 on its side to be in the cutting position. A few chops of the blade 18 and an opening will be made in the ice. The point 19 and the sharp edge 20, 21 are placed under the sheet of ice to loosen and remove the ice. To remove sod, the blade 18 is turned on its side in the cutting position and a cut is made in the sod. The blade 18 is then turned on its other side and a second cut, opposite the first, is made. Two more cuts are made in the sod to create a square. The handle 17 is held in an upright position and the snout 19 is inserted into one of the cuts. By bringing the handle down, the blade 18 changes pitch and cuts under the sod. The blade 18 is now flat and completely under the sod which can be lifted from the ground. Attaching blade 18 to the fifty four degree boss 14 results in an angle of ninety degrees to the handle 17. This creates a tool similar to the common garden hoe but with a point entering the ground 40. In this position, the tool 10 not only weeds and chops, but creates a planting furrow by pulling the point of the heart through the soil. When the blade 18 is turned over with the "V" notch 20 facing downward, and pulled down the newly planted furrow, the two half round shoulders of the heart on either side of the notch 20 cover the furrow over. When the heart shaped blade 18 is attached to the ninety degree boss 12, the point 19 of the heart is angled backward and becomes a very effective digging tool that takes full advantage of the sharp blade 18, angle of entry, and pulling power of the user. The tool 10 in this position, will be used in those areas that are heavily overgrown or that contain hard, compacted soil. FIG. 6 shows a coupling which may be used to extend the length of handle 17. Sleeves 35 and 35' are placed over the FIG. 6 shows a coupling which may be used to extend the length of handle 17. Sleeves 35 and 35' are placed over the handle 17 ends and held in place with set screws 34'. The coupling consists of a bolt 37 welded inside the sleeve 35' and a locking nut is screwed thereon. Nut 36 is welded inside sleeve 35. The two handle 17 parts are joined with bolt 37 and reverse flange nut 36, and locked in place. With two different length handles, three different connecting angles on the handle, and three different heart shaped blades, the invention offers the user a variety of tools to make many jobs in the yard and garden much easier. The heart shaped garden tool of the invention cuts, trims, edges, and weeds in minutes with no bending or stooping. The heart shaped blade 18 may be a 12 GA. steel blade which resharpens easily with an ordinary file. Filing the top surface edge of the blade 18 provides a sharp cutting surface with the bottom surface being flat and the top surface being shaped downwardly to form the sharp edge. As pressure is exerted on the top of blade 18, the sharp edge begins to penetrate the ground surface and the sharpened edge continues to be guided downwardly, and deeper into the surface to be cut. Several other attachments have been designed for the handle 17 and connector 11 including hoes, a rake, a cultivator, fork and others. It will be realized that various changes may be made to the specific embodiment shown and described without departing from the principles and spirit of the present invention.

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BACKGROUND OF THE INVENTION 1. Field of the Invention This patent application contains improvements by the same inventor on co-pending utility patent application Ser. No. 14/087,401 filed on Nov. 22, 2014. The present invention relates to the field of compounds which include but are not limited to tooth whitening compounds, dental bonding and filling compounds used to fill a tooth after a cavity has been drilled out of the tooth, and adhesives used to bond two objects together, and in particular to apparatus which dispenses tooth whitening compounds used to whiten teeth, apparatus used to dispense dental bonding compounds, and apparatus used to dispense adhesives 2. Description of the Prior Art One significant problem with prior art apparatus used to retain and dispense tooth whitening compounds is that they are reused over and over, resulting in the possible transmission of diseases from one dental patient to another. The following 26 patents and published patent applications are the closest prior art references which were uncovered in the search. A complete set of copies of these patents and patent applications are enclosed herewith for your review. 1. U.S. Pat. No. 5,611,687 issued to Eugene C. Wagner on Mar. 18, 1997 for “Oral Hygiene Delivery System” (hereafter the “Wagner Patent”); 2. U.S. Pat. No. 6,176,632 issued to Hidehei Kageyama et al. on Jan. 23, 2001 for “Liquid Container” (hereafter the “'632 Kageyama Patent”); 3. U.S. Pat. No. 6,227,739 issued to Hidehei Kageyama on May 8, 2001 for “Liquid Container” (hereafter the “'739 Kageyama Patent”); 4. United States Published Patent Application No. 2005/0063766 to Sou Y, Chen et al. on Mar. 24, 2005 for “Applicator Pen” (hereafter the “Chen Published Patent Application”); 5. U.S. Pat. No. 6,918,515 issued to Yoshio Noguchi on Jul. 19, 2005 for “Liquid Container” (hereafter the “Noguchi Patent”); 6. United States Published Patent Application No. 2006/0275225 to Michael Prencipe et al. on Dec. 7, 2006 for “Applicator and Method For Applying A Tooth Whitening Composition” (hereafter the “Prencipe Published Patent Application”); 7. U.S. Pat. No. 7,201,527 issued to Richard Christopher Thorpe et al. on Apr. 10, 2007 for “Twist Up Pen Type Dispenser With Brush Applicator” (hereafter the “Thorpe Patent”); 8. United States Published Patent Application No. 2007/0086830 to Hidehei Kageyama on Apr. 19, 2007 for “Liquid Container” (hereafter the “Kageyama Published Patent Application”); 9. United States Published Patent Application No. 2008/0274066 to Robert Eric Montgomery on Nov. 6, 2008 for “Compositions, Methods, Devices, And Kits for Maintaining or Enhancing Tooth Whitening” (hereafter the “Montgomery Published Patent Application”). 10. U.S. Pat. No. 7,794,166 issued to Jun Zhang on Sep. 14, 2010 for “Press-Type Cosmetic Container with Anti-Press Means” (hereafter the “Zhang Patent”); 11. United States Published Patent Application No. 2011/0129288 to Junya Uehara on Jun. 2, 2011 for “Liquid Applicator” (hereafter the “Uehara Published Patent Application”); 12. U.S. Pat. No. 7,980,778 issued to Tetsuaki Akaishi et al. on Jul. 19, 2011 for “Liquid Applicator” (hereafter the Akaishi Patent”); 13. U.S. Pat. No. 8,328,449 issued to James C. Wightman et al. on Dec. 11, 2012 for “Click Pen Applicator Device And Method of Using Same” (hereafter the “Wightman Patent”); 14. Japanese Patent No. JP096151123A issued to Shiraishi Katsuhiko et al. on Jun. 10, 1997 for “Tooth Coating Liquid” (hereafter the “Katsuhiko Japanese Patent”); 15. Japanese Patent No. JP2007130437A issued to Kageyama Shuhei on May 31, 2007 for “Liquid Container” (hereafter the “Shuhei Japanese Patent”). 16. U.S. Pat. No. 4,121,739 issued to William David Devaney et al. on Oct. 24, 1978 for “Dispenser With Unitary Plunger And Seal Construction” (hereafter the “Devaney Patent”); 17. U.S. Pat. No. 5,104,005 issued to Franz K. Schneider, Jr. et al. on Apr. 14, 1992 for “Dual Component Mechanically Operated Caulking Gun” (hereafter the “Schneider Patent”); 18. U.S. Pat. No. 5,310,091 issued to Walter B. Dunning et al. on May 10, 1994 for “Dual Product Dispenser” (hereafter the “Dunning Patent”); 19. U.S. Pat. No. 5,333,760 issued to Christen Simmen on Aug. 2, 1994 for “Dispensing And Mixing Apparatus” (hereafter the “Simmen Patent”); 20. U.S. Pat. No. 5,535,922 issued to Bernard J. Maziarz on Jul. 16, 1996 for “Caulking Gun Dispensing Module For Multi-Component Cartridge” (hereafter the “Maziarz Patent”); 21. U.S. Pat. No. 6,116,900 issued to Calvin D. Ostler on Sep. 12, 2000 for “Binary Energizer And Peroxide Delivery System For Dental Bleaching” (hereafter the “Ostler Patent”); 22. U.S. Pat. No. 6,283,660 issued to Patrick J. Furlong et al. on Sep. 4, 2001 for “Pen Dispensing And Cartridge System” (hereafter the “Furlong Patent”); 23. United States Published Patent Application No. 2009/0095777 to Frank Francavilla on Apr. 16, 2009 for “Dispensing Pen” (hereafter the “Francavilla Published Patent Application”); 24. U.S. Pat. No. 7,748,980 issued to Paul Mulhauser et al. on Jul. 6, 2010 for “Dispenser for Dental Compositions” (hereafter the “Mulhauser Patent”); 25. U.S. Pat. No. 7,882,983 issued to Dean K. Reidt et al. on Feb. 8, 2011 for “Capsule for Two-Component Materials” (hereafter the “Reidt Patent”); 26. U.S. Pat. No. 8,096,449 issued to Wilheilm A. Keller on Jan. 17, 2012 for “Dispensing Appliance for a Multiple Cartridge” (hereafter the “Keller Patent”). The Wagner Patent discloses: “A delivery system for a liquid oral hygiene preparation suitable for tooth whitening, tooth cleansing and the treatment of. The delivery system includes an elongate barrel shaped body. A supply of the hygiene preparation saturates a fibrous wadding carried in a hollow chamber of the body. At an end of the body, an applicator formed of felt or synthetic fibers is seated. The applicator includes a broad tip and a stem wick which is received in the wadding and draws the preparation to the tip by capillary action. The preparation is applied to tooth surfaces, oral lesions, and the like by pressing the tip against the surface to receive the preparation and, where appropriate, wiping the tip along the surface. In an alternate embodiment, ball applicator is provided and the hygienic preparation may be carried in the chamber without the wadding.” The '632 Kageyama discloses: “A liquid container such that the liquid received in it will not easily spring out from its tip even if it is wrongly operated, comprises a tank portion for receiving a liquid, a knock bar stretching axially movably within the tank portion which is designed to have on its axial tip portion a pump shelf portion whose diameter have been enlarged, an induction bar fixed into the tip of the knock bar, a brush provided on the tip side of the induction bar, and a spring for always energizing the above knock bar and induction bar rearward. On the internal periphery surface of the above tank portion, a plurality of ribs are formed which stretch axially and on top of which the above pump shelf portion can slide, the internal periphery surface ahead of the ribs is at the same level as and continuous with the top face of the ribs and designed as a diameter-reducing portion where the pump shelf portion can slide. The pump shelf portion slidably touches the ribs when it is not biased.” The '739 Kageyama patent is related to the previously discussed patent and discloses: “A liquid container includes a body having a tank portion housing liquid, and a liquid supply port at a front side thereof, a piston moving forward inside the tank portion, a piston rod being integrally connected to the piston and extending rearward, the piston rod having an external thread formed in a periphery thereof, an operation cylinder being attached to a rear part of the body in a relatively rotatable fashion, a piston rod guide being adapted to be rotated integrally with the operating cylinder, the piston rod guide having an internal thread hole which is engaged with the external thread of the piston rod, and a ratchet cylinder being fixed in the rear inside the body, the ratchet cylinder having a bore through which the piston rod is pierced in a relatively unrotatable fashion. The operation cylinder is formed with serrated gear teeth at a front end thereof, and the ratchet cylinder is formed with a ratchet gear tooth which is brought into engagement with the serrated gear teeth and adopted to be selectively protruded or retracted in an axial direction, at a rear end thereof.” The Chen Published Patent Application discloses: “FIG. 1 is a cross-sectional view of an applicator pen 100 according to a first embodiment. The applicator pen 100 is formed of a number of different sub-assemblies that are then combined in an engaging manner to form the applicator pen 100. More specifically, the applicator pen 100 includes a body 110 and an applicator assembly 200 that serves to restrict and disperse an applicator material 112 that is stored within the body 110. The applicator pen 100 also includes a drive mechanism 300 for advancing the applicator material 112 within the body 110 such that it is introduced into and dispersed through the applicator assembly 200 to the consumer. The drive mechanism 300 is coupled to a button assembly 400 that permits the consumer to simply advance the applicator material 112 an incremental amount within the body 110 upon manipulation of the button assembly 400, e.g., a press and release action of the button assembly 400. While the applicator material 112 can be any number of different types of materials, it will be appreciated that one exemplary use of the applicator 100 is as a cosmetic applicator and therefore, in this particular use, the applicator material 112 is in the form of a cosmetic product. For example, the applicator material 112 can in the form of conventional make-up, such as an eye shadow or liner, lipstick, other facial products, etc. The applicator material 112 is typically a viscous material, such as a liquid, gel or other material that has some flow properties.” The focus of this patent application is primarily a cosmetic applicator for eyeshadow, a liner, etc. and not for teeth whitening. The Noguchi Patent discloses: “In a liquid container, the dimension of inside diameter of a liquid supply portion is not subject to any restriction, and also a liquid leakage suppressing mechanism that is not subject to any restriction by the viscosity of stored liquid is provided. A liquid container includes a body having a tank for storing a liquid; a supply mechanism which is connected to the tip end portion of the body and has a brush for supplying the liquid; and a drive mechanism for pushing out the liquid L in the tank T to the supply mechanism. A valve which is normally closed and can be opened only when the drive mechanism is operated is provided between the tank and the supply mechanism.” The Prencipe Published Patent Application discloses: “The dispenser 10 is shown as a complete unit in FIGS. 1 and 2. The dispenser is comprised of three sections. These are an applicator section 12, a whitening product storage section 14 and a dispenser drive section 16. The applicator section is comprised of an overcap 18, an applicator surface 30, an applicator surface holder 32, an applicator mounting unit 36 and a delivery channel 34. The whitening product in product chamber 40 is delivered to the applicator surface through delivery channel 34. A tubular wall 20 forms the product chamber 40. Piston 42 forms the upper wall of product chamber 40. The dispenser drive section 16 is comprised of the mechanism to advance piston 42 downward in whitening product chamber 40. This dispenser drive section is shown in more detail in FIG. 5. Rotating unit 22 will rotate while tubular wall 20 of the whitening product chamber is stationary. FIG. 7 shows an applicator tip with a fibrillated surface The applicator tip is comprised of channel 60 having a cross-section 65 which receives the peroxide containing tooth whitening composition from storage chamber 40. Fibrillated surface 62 is the application surface to apply the composition to the teeth. The peroxide tooth whitening composition flows through opening 64 of the channel 60. Applicator surface holder 66 holds channel 60 and is in turn held in place by applicator mounting unit 68. FIG. 8 is an exploded view of the applicator tip of FIG. 7. Additionally shown in this view is a chamber 70 on the applicator surface holder channel 72 of the applicator mounting unit 68. Flange 74 holds the applicator surface holder 66 in applicator mounting unit 68.” The Dwyer Published Patent Application discloses: “A method for manufacturing a cosmetic product applicator assembly includes selecting a disposable handle having a desired design from a number of handles of various designs. Each of the handles includes an elongated, decorative housing with a first end having an opening, a hollow chamber extending from the opening into the housing, and a flattened portion for displaying a word, phrase, symbol or design. A cosmetic product applicator having a first terminal end from which the cosmetic product is dispensed and a second terminal end opposite the first terminal end is inserted into the handle. The hollow chamber is adapted to receive and engage the second terminal end of the applicator in a non-rotatable manner.” The Thorpe Patent discloses: “As shown in FIGS. 2 and 5, the twist up pen type dispenser with brush applicator 1 comprises a body 2, preferably substantially in the shape of a cylinder, having a top 3, a bottom 4, an outer surface 5 and an inner surface 6 which defines an annular space 7. As shown in FIGS. 4 and 5, material 8 may be within the annular space 7, which functions as a reservoir for the material 8 within the twist up pen type dispenser with brush applicator 1. The material 8 may be a dentifrice, such as tooth gel, tooth paste, mouthwash, mouth rinse, tooth whitener and combinations thereof, cosmetics, such as mascara and eyeliner, hair colorants such as darkeners, like darkeners for facial hair such as moustaches, dyes or similar materials, or skin treatment compositions, combinations thereof, and the like.” The Kageyama Published Patent Application discloses: “To provide a liquid container which includes a liquid supply member that is exchangeably mounted thereto and prevents liquids in liquid supply members from being mixed each other after exchanging the liquid supply members. The liquid container is provided which includes a container body with a tank section to hold a liquid, an applicator coupled to the front end of the container body, a piston which is advanced through the tank section, and a piston advancing mechanism which has a pushing member and causes the piston to be advanced through the tank section in response to the operation of the pushing member. The applicator is removably coupled to the container body, and the piston advancing mechanism causes the piston to be moved only forward.” The Montgomery Published Patent Application discloses: “The first and/or second tooth whitening compositions are preferably disposed in a delivery device 10 (e.g., FIGS. 2-4, 9, and 10), such as a dispensing tube, pencil, pen or liquid stick having an applicator 12, such as a felt tip 14 (FIG. 3), brush 16 (FIG. 4), roller ball, or non-woven pad. In one embodiment, the delivery device 10 includes more than one applicator 12 that may be removably engaged with the device 10. In an embodiment wherein the device 10 is a pen or a pencil, the applicator 12 may be retractable and/or housed in a cap 18. The tooth whitening compositions of the present invention may be housed directly within a reservoir 20 in the device 10 or may be supplied in a removable cartridge (not shown) within the reservoir 20 that may be replaced or refilled. The delivery device 10 may dispense the tooth whitening composition through a transfer channel 21 through capillary action, such as in a flow through pen, or through an actuator 22, such as mechanical piston with a click mechanism, twist button and ratchet mechanism, or pushbutton mechanism, or through a vacuum method of ejection, or through other such mechanical means for transferring the composition from the device to an oral cavity surface in need of treatment. The actuator 22 may be present on first end 24 of the device 10 and the applicator on a second end 26 of the device 10 or the actuator 22 may be present on a side wall 28 of the device. In one embodiment, the delivery device 10 includes a felt tip 14 or brush 16 applicator 12 wherein the inventive composition is dispensed to the applicator 12 through actuation of the actuator 22, such as by a clicking or twisting mechanism. Kotobuke Pencil, Japan, is one manufacturer of such types of delivery devices 10 (see, e.g., U.S. Pat. No. 6,176,632). The Zhang Patent discloses: “The present invention is related to a press-type cosmetic container with an anti-press means. That is, a cosmetic container adopts the way of pressing to output the material therein. More particularly, the press cover of the cosmetic container is stopped by a block to prevent discharging or leaking the material in the cosmetic container.” Claim 1 of the patent reads as follows: “A press-type cosmetic container with an anti-press means comprising: a tube member having a sleeve at the one end thereof, the outer edge of the sleeve being disposed a collar base; a rotating tube member being disposed a female ringing slot at the inner edge of the one end thereof, the rotating tube member being female-connected to the outer edge of the sleeve and the collar base of the tube member being slid on the female ringing slot so as to make the rotating tube member be turned around on the sleeve, wherein two axial extending ribs are disposed at the inner wall of the another end of the rotating tube member, a block is disposed between the two ribs, and a resisting member is disposed beside the two ribs; a press cover having two wedging member being extended outwardly and disposed on the two side edges thereof respectively, the one end of the press cover located at the wedging member being embedded at the inner edge of the free end of the rotating tube member, and the one wedging member being disposed beyond the two ribs; herein the block stops pressing the press cover in order to stop outputting material in the cosmetic container and then achieve the function of preventing improper pressing, and the rotating tube member is then turned around, the two wedging members are moved to locations beside the resisting member so as to output the material.” The Uehara Published Patent Application discloses: “The present invention is a liquid applicator which, in its assembled state an applying part, joint, and front barrel are fixed to a barrel body front end portion, the step of an indented/projected engaging portion on the inner peripheral side of the applying part rear end portion is abutted from behind against and engaged with the step of an indented/projected engaging portion on the outer peripheral side of the forward part of the joint. At the same time, an indented/projected engaging portion on the outer peripheral side of the applying part rear end portion is abutted against and engaged with an indented/projected engaging portion on the inner peripheral side of the front barrel's forward part, and an indented/projected engaging portion on the inner peripheral side of the front barrel rearward part is engaged with an indented/projected engaging portion on the outer peripheral side in the rearward part of joint, whereby applying part, joint and front barrel are formed so as to fix the applying part to barrel body by means of the joint and the front barrel.” The Akaishi Patent discloses: “A liquid applicator includes a liquid pressing mechanism 6 for pressurizing an application liquid 4 inside a main body 2 so as to supply the application liquid to an applying member 10 at the front end by the pressing of liquid pressing mechanism 6, wherein the applying member 10 is made of an elastic material, has a valve structure 8 which is formed with a communication path 24 for communication between the inside and outside of main body 2 and can close the communication path 24 by elasticity in the normal condition and open the communication path 24 by elastic deformation of the communication path when the application liquid is pressurized by liquid pressing mechanism 6, and, an ejection opening 24a of communication path 24 of valve structure 8 is arranged to front onto the applying portion 10a of the applying member 10.” The Wrightman Patent discloses: “A click pen applicator device that provides predetermined dosing of the formulation for precise application, and rapidly primes the formulation using the dosing click mechanism to prepare the applicator for use.” Claim 1 of the patent reads as follows: “A device for dispensing a formulation comprising: a centerband having a proximal end and a distal end and defining a storage section having the formulation disposed within; an applicator section situated at the distal end of the centerband; and a multistage actuator section situated at the proximal end of the centerband for rapid priming with a click dispensing mechanism with a piston seat having two sets of external threads on a shaft with an unthreaded length therebetween.” The Katsuhiko Japanese Patent discloses: “PROBLEM TO BE SOLVED: To obtain a coating liquid capable of coloring tooth or tooth crowns to white or any other color by using an acrylic resin prepared by neutralizing an acrylic ester-methacrylic eater-based copolymer with a specific compound. SOLUTION: This tooth coating liquid contusions ethanol and an acrylic resin prepared by neutralizing an acrylic ester-methacrylic ester-based copolymer with 2-amino-2-methyl-1,3-propanediol or 2-amino-2-methyl-1-propanol, and may also contain a color pigment or extender pigment, and furthermore, ceramic(s) and/or a vinyl acetate resin. It is preferable that this coating liquid comprises 10-94.8 wt. % or more of ethanol, 0.1-30 wt. % of a pigment, 0.1-20 wt. % of the above acrylic resin, and 5-30 wt. % of ceramic(s) and/or butyl acetate resin. The pigment is pref. titanium dioxide (optimally, 100 nm primary particle diameter on average).” The Shuhei Japanese Patent discloses: “PROBLEM TO BE SOLVED: To provide a liquid container which includes a liquid supply member that is exchangeably mounted thereto and prevents liquids in liquid supply members from being mixed each other before and after exchanging the liquid supply members. SOLUTION: The liquid container includes a container body 12 with a tank section T to hold a liquid, an applicator 20 coupled to the front end of the container body 12, a piston 22 which is advanced through the tank section T, and a piston pressing mechanism 23 which has a knocking member 32 and causes the piston 22 to be pressed through the tank section T in response to the operation of the knocking member 32. The applicator 20 is removably coupled to the container body 12, and the piston pressing mechanism 23 causes the piston 22 to be moved only forward.” The Devaney Patent discloses: “A dispenser for precisely metering viscous fluids from a cartridge. The dispenser includes a cartridge body and a plunger having a piston head at its extremity. The plunger is unitarily configured from a plastic material, including seal rings in the piston head. Each piston head including two such seal rings axially spaced from one another and configured to include sharp peripheral edges permitting resilient wedging contact within the bore of the cartridge.” The Schneider Patent discloses: “A dual component caulking gun which utilizes a gun body to which there is affixed a dual component cartridge assembly designed to carry dual component cartridges. A ball screw is journaled within the gun body for rotary motion but locked against axial motion and extends in a direction opposite the component cartridge assembly. A pair of ram rods are journaled through the gun body and terminate at the first end in ejector rams and at their opposite end in a transfer bar that is interconnected to the ball screw by means of a ball screw nut.” The Dunning Patent discloses “A dispenser for simultaneously dispensing and mixing a pair of fluid products such as chemically reactive resins, from a pair of axial adjacent front and rear chambers. A piston is mounted within each of the chambers and is moveable with respect to the hollow interior of the respective chamber for dispensing the fluid product therefrom. Telescopic movement of the rear chamber within the front chamber moves the pistons synchronously through the chambers to provide for controlled discharge of the products through a front discharge nozzle. A fixed hollow delivery tube extends through the interior of the front chamber and telescopically receives therein a post which is mounted on a rear wall of the rear chamber. The rear chamber has a relatively tight sliding fit within the front chamber so that a partial vacuum is formed within an annular space which forms between the two pistons as they move apart upon discharge of the two products to produce a “suck back” effect on product remaining in the discharge nozzle.” The Simmen Patent discloses: “A dispensing and mixing apparatus for simultaneously dispensing from a cartridge into a static mixing element components which harden when mixed. The components exit the cartridge into the mixing element without intermixing as the components leave the cartridge. The initial intermixing of the components takes place within the mixing element. The cartridge is reusable since the components do not become mixed and harden as they come out of the cartridge. The chambers in the cartridge are of semi-cylindrical configuration and have rounded corners. Ribs can be provided on the cartridge for stiffening the cartridge from deforming under extrusion.” The Maziarz Patent discloses: “The invention provides a dispensing module for dispensing multi-part adhesive from a multi-component cartridge utilizing a standard caulking gun. The dispensing module comprises a piston actuator and a module housing which when assembled with a standard multi-component cartridge and inserted into a standard caulking gun allows the components from the multi-component cartridge to be dispensed.” The Ostler Patent discloses: “A dental bleach storage, mixing and delivery device and related method are disclosed. The device includes a barrel with at least two chambers. The chambers store components that when mixed can form a dental bleach or whitener. A plunger is provided that can be reciprocated within the barrel to force such components from their chambers. A mixing tip is provided for the end of the barrel. The components may be forced through the mixing tip which thoroughly mixes them together. The resulting bleach or whitener is applied to a patient's teeth where oxygen ions released from the bleach or whitener and will whiten the patient's teeth.” The Furlong Patent is a pen dispensing cartridge system which issued in 2001 and is still in full force and effect. The patent discloses: “The present invention features a pen used, for example, to dispense nail polish for finger nail application. The design is for a unit of use, meaning that the preferred pen uses cartridges, i.e., units. In a preferred embodiment, each cartridge is filled with polish and has a brush head. After the cartridge is used, the user simply disposes of the old cartridge and replaces it with a new cartridge for the next application.” The Francavilla discloses: “The present invention is related to a dispensing device. The dispensing device includes a container; a dispensing opening located at one end of the container; a plunger located inside the container; a pushbutton associated with the plunger; and a drive mechanism configured to drive the plunger linearly inside the container from a first position towards the dispensing opening when the pushbutton is pressed and to hold the plunger at a second position, wherein the second position is closer to the dispensing opening than the first position.” The Reidt Patent discloses: “Capsule (10) for two or more components of a material which are to be mixed together, comprising a cartridge (11) comprising an outlet (12), a first component chamber (13) for containing a first component, and a second component chamber (14) for containing a second component, the two chambers (13, 14) opening into the outlet (12); and a piston (15) which at least with its front end sits in the cartridge (11), lies with its rear end outside the component chambers (13, 14) and, when it is pushed forwards, presses the two components out of their component chambers (13, 14).” The Mulhauser Patent discloses a dispenser for dental compositions. Claim 1 of this patent reads as follows: “An apparatus for dispensing dental compositions, the apparatus comprising: a) a body comprising a top shell portion, a bottom shell portion, and a chamber received therein; b) a replaceable cartridge having at least two lumens with at least two pistons, the cartridge operable to dispense a component of a dental compound contained within the lumens, and wherein the cartridge is further operable to be at least partially inserted into the chamber; c) an inner mechanical system disposed in the body, the inner mechanical system comprising a rack system, said rack system having at least two racks operable to be urged forward to engage a piston in each lumen of the cartridge; d) a button system in contact with the body, the button system operable to be depressed in a direction substantially forward and in line with the rack system by a user such that the button system engages the inner mechanical system when depressed, such that the rack is advanced a predetermined distance such that a metered amount of the components of the dental compound is dispensed from the at least two lumens; and e) wherein the inner mechanical system further comprises a plurality of teeth disposed on the rack system, and a drive spring and a pawl spring disposed on the body, the drive spring and the pawl spring being operable to interface with at least one of a plurality of teeth on the rack system and at least one surface of the button system such that depression of the button system by a user initiates drive spring to advance the rack system a predetermined distance proportional to the distance between a first selected tooth located on the rack and a second selected tooth located on the rack and initiates the pawl spring to disengage from a third selected tooth on the rack and engage a fourth selected tooth on the rack located at a distance substantially equal to the distance between the first tooth and the second tooth, and release of the button causes the drive spring to disengage from said first selected tooth and engage the second selected tooth on the rack.” The Keller Patent discloses a dispensing appliance for a multiple cartridge. The broadest claim is Claim 1 which reads as follows: “A dispensing appliance for a multiple cartridge or syringe, comprising: a housing configured to receive the multiple cartridge or syringe, and wherein the housing has a housing thread and a rotatable portion that has a complementary thread, wherein the housing thread and the rotatable portion cooperate in such a manner that by a mutual rotation of the housing thread and the rotatable portion, the rotatable portion is continuously displaceable relative to the housing in a dispensing direction, wherein the housing is configured to receive the multiple cartridge or syringe having at least two adjacent and parallel storage containers, wherein a thrust force of the rotatable portion is transmitted to a multiple ram with a single thrust plate, and wherein the multiple ram slides in the at least two adjacent and parallel storage containers of the multiple cartridge or syringe and the thrust plate is non-rotatably guided inside the housing.” There is a significant need for an improved apparatus to dispense compounds including but not limited to tooth whitening compounds where the tooth whitening compounds are dispensed from a new and unused retainers. There is also a significant need for an improved apparatus to dispense dental bonding compounds from new and unused retainers and adhesive compounds from new and unused retainers. SUMMARY OF THE INVENTION The present invention involves the field of numerous types of compounds which by way of example includes tooth whitening compounds and in particular, to specific apparatus which are used to retain tooth whitening compounds and then dispense them either into a dental tray where the tray is placed over the patient's teeth for a period of time or the tooth whitening compound is directly applied to the patient's teeth by the dentist or the dental assistant. More broadly described, the present invention includes compounds and applicators used to dispense the compounds including tooth whitening compounds, dental bonding and filling compounds, adhesives such as glue, finely ground powder, jells, creams, paints, cosmetics, lipstick, non-medicated cosmetics, medicated cosmetics, construction material compounds, and virtually any substance that has a sufficient viscosity to be pushed through a dispensing cartridge in a dispensing pen and either out of the cartridge, from the cartridge into an applicator, or from the cartridge into a mixing chamber and then out of the mixing chamber primarily into an applicator, which are hereafter jointly referred to in this patent application as “compounds”. The cartridges have either a single interior chamber or two interior chambers where the dual or two chambers are separated by a dividing wall. For a compound that does not require mixing, a single compound in a single interior chamber cartridge is used. Where two compounds are divided and only mixed immediately before use, the dual interior chamber cartridge is used. Although the summary discussed below relates to tooth whitening compounds in detail, it is understood that the present invention includes all products defined above as compounds and is not limited to tooth whitening compounds. The present invention involves a dispensing pen which removably retains a single use capsule containing tooth whitening compound and removably retains disposable tooth whitening applicators. One of the major problems with prior art tooth whitening applicators is that the applicator itself is reused over and over again through syringes which contain the tooth whitening compound and even though they are sterilized, run the risk of transmitting disease from one patient to another. Therefore, there is a significant need for an improved tooth whitening apparatus where the capsule containing the tooth whitening compound or compounds is disposable and replaceable with a new clean capsule with a fresh supply of tooth whitening compound or compounds and the applicator heads which are used to apply the compounds to teeth or to a dental tray are also disposable and replaced with new applicators so that the patient receives a completely new and sterile system for the purpose of applying tooth whitening compounds. The only portion of the apparatus which is reused is the retaining pen which is used to removably retain the tooth whitening compound and to removably retain the tooth whitening applicators. The variations of the embodiments of the present invention involve two variations on the interior of the single use capsule. The variations of the embodiments of the present invention also involve the location of the single use capsule. In one embodiment of the present invention, the interior chamber of the unidose single use cartridge or capsule contains tooth whitening compound in a sealed condition with a cap that has an openings which is sealed by a frangible opening which seals the capsule until it is ready for use and a screw on cap which contains at a remote end a piercing object to pierce the frangible seal so that the tooth whitening compound can be dispensed from the capsule. In one variation, the capsule or cartridge has a single interior chamber so that the tooth whitening compound does not require any mixing before the tooth whitening compound is dispensed from the capsule or cartridge (capsule and cartridges are used and referred to interchangeably). For this variation, the rear of the interior chamber of the capsule or cartridge contains a single plunger having a pair of spaced apart sidewalls forming a seal against the interior sidewall of the cartridge. The rear of the plunger also includes a single pocket which receives a pushing piston from the retaining pen, the pushing piston is moves in a forward direction within the pen by an improved ratchet mechanism of the present invention. The pushing piston engages and pushed the single pocket in the rear of the single plunger to push the compound out of the cartridge through an opening in a front nozzle of the capsule after a seal on the nozzle is opened. In one sub-variations of this embodiment, the cartridge is retained within an interior chamber of the pen with the nozzle extending through a front opening in the pen. In another sub-variation, the pen has a threaded exterior sidewall with male threads adjacent the front of the pen and the cartridge has mating interior female threads by which the cartridge is threaded onto the front of the pen and extends from the front of the pen and is exterior to the pen. The is still a similar sealing configuration on the rear of the cartridge which the single piston pushing against the single pocket in the sealing plunger which now extends out of the pen into the exterior cartridge. The same new and novel ratch mechanism pushes the piston in increments to push the plunger which pushes the whitening compound out of the opening in the nozzle. In an alternative embodiment of the present invention, the interior chamber of the unidose single use cartridge or capsule also contains tooth whitening compound in a sealed condition with a cap that has an openings which is sealed by a frangible opening which seals the capsule until it is ready for use and a screw on cap which contains at a remote end a piercing object to pierce the frangible seal so that the tooth whitening compound can be dispensed from the capsule. In the alternative variation, the capsule or cartridge has an interior longitudinal dividing wall with separate tooth whitening compounds in each chamber bounded by an interior surface of the cartridge and the dividing wall. The divided interior chamber retains two separate compounds which are separated from each other while in the cartridge by the a dividing wall. The interior rear of the cartridge has a different plunger having opposing interior faces to push a compound in a respective portion of the interior of the cartridge forward and out of the cartridge, and a pair of opposed angular sidewalls ending in rear wall sidewalls forming a seal against the interior sidewall of the cartridge. Each rear end of the plunger has a pocket to receive a respective pushing piston from a dual piston mechanism in the retaining pen. The interior chamber is divided into two equal chambers which contain different compounds which cannot come in contact with each other because the dividing wall extends for the entire diameter and length of the interior chamber of the cartridge. For dual compounds where less is need of one of the two compounds, the dividing wall is thicker on one side to reduce the volume of compound in the smaller chamber, the design of the plunger is modified to accommodate the revised sidewall. For the operating mechanism for the dual chamber cartridge, the mechanism includes a pair of pistons which are respectively used to engage a respective pocket of the two-pocket plunger used with the dual chamber cartridge and a ratchet mechanism to incrementally move each pushing piston in a forward direction within the pen by an improved ratchet mechanism of the present invention. The pushing pistons respectively engage and push a respective one of the two pockets in the rear of the dual plunger to push the compounds out of the cartridge through an opening in a front nozzle of the capsule after a seal on the nozzle is opened. After the compounds are pushed out of the cartridge, they are mixed in ax a mixing chamber before being dispensed. In one sub-variation of this embodiment, the cartridge is retained within an interior chamber of the pen with the nozzle extends through a front opening in the pen. In another sub-variation, the pen has a threaded exterior sidewall with male threads adjacent the front of the pen and the cartridge has mating interior female threads by which the cartridge is threaded onto the front of the pen and extends from the front of the pen and is exterior to the pen. The is still a similar sealing configuration on the rear of the cartridge which the dual pistons respectively pushing against a respective one of the two pockets in the sealing plunger which now extends out of the pen into the exterior cartridge. The same new and novel ratch mechanism pushes the pistons in increments to push the plunger which pushes the whitening compound out of the opening in the nozzle into the mixing chamber. The additional significant improvement is the new sand novel ratchet mechanism which mechanically pushes the single piston or dual pistons in increments to push a plunger in increments to dispense a desired amount of compound. After the compound, whether single or mixed dual is dispensed, it extends to an applicator. With respect to alternative embodiments of the applicators, one embodiment is a straight applicator which is generally frustum shaped having a narrow dispensing tip and a threaded end which is threaded onto either the threaded end of the mixing tip or a threaded end of the cartridge and through which the tooth whitening compound flows and can be placed either into a dental tray or onto a patient's teeth. In an alternative embodiment of the applicator, the applicator is horn-shaped or bent so that the tooth whitening can be directly applied to locations in the patient's mouth where teeth are near the back of the mouth, either upper or lower teeth and usually on the exterior but if necessary, also on the top or interior of the tooth. In an alternative embodiment of the applicator, the applicator has an opening with a brush so that the tooth whitening compound extends through the applicator opening and then the brush is used to apply the tooth whitening compound onto the patient's tooth. It is a primary object of the present invention to provide a reusable capsule and reusable applicator so that tooth whitening compounds which are contained in the capsule are used only once and the applicators used to apply the tooth whitening compound are also used only once and then discarded and replaced with a separate tooth whitening compound retaining capsule or cartridge and also replaced with separate applicator heads. It is a further object of the present invention to provide a single use cartridge or capsule which contains a single compound which does not need to be mixed with any other compound and can simply be dispensed once the sealed capsule or cartridge is opened to dispense the tooth whitening compound onto teeth or onto a dental tray where it can be used. It is a further object of the present invention to provide a single use capsule which has a dividing wall so that the capsule contains two separate compounds which are separated from each other and which may either have equal amounts of compounds on either side of the dividing wall or different amounts of compound where one compound is less than the other compound depending upon the formulation required for that tooth whitening application and then the compounds are mixed when they enter a chamber for mixing purposes. It is the primary object of the present invention to provide a non-reusable container and non-reusable applicator head so that a fresh container containing fresh tooth whitening compounds, fresh dental bonding and filling compounds and adhesive compounds and fresh new applicators are used every time a new compound is dispensed so that a compound is not reused from one patient to another or from one adhesive bonding application to another, thereby providing safety and health to subsequent patients and products. Further novel features and other objects of the present invention will become apparent from the following detailed description, discussion and the appended claims, taken in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS Referring particularly to the drawings for the purpose of illustration only and not limitation, there is illustrated: FIG. 1 is a cross-sectional view of the dispensing pen which retains a single use cartridge within the dispensing pen and further discloses the new and novel mechanical ratchet mechanism of the present invention; FIG. 2 is a top left perspective view of the dispensing pen with the dispensing pen illustrated in a transparent exterior to enable illustration of a portion of the opera+ting mechanism of the new and novel mechanical ratchet mechanism; FIG. 3 is a top left enlarged perspective view of a section of the dispensing pen with the enlarged section of the dispensing pen illustrated in a transparent exterior to enable illustration of an enlarged portion of the operating mechanism of the new and novel mechanical ratchet mechanism; FIG. 4 is a top right enlarged perspective view of a section of the dispensing pen with the enlarged section of the dispensing pen illustrated in a transparent exterior to enable illustration of an enlarged portion of the operating mechanism of the new and novel mechanical ratchet mechanism; FIG. 5 is a top right perspective view of the dispensing pen with the dispensing pen illustrated in a transparent exterior to tenable illustration of a portion of the opera+ting mechanism of the new and novel mechanical ratchet mechanism; FIG. 6 is a top perspective view of the unidose single use cartridge which contains a compound as defined above including compound selected from the group consisting of a tooth whitening compound, a dental bonding and filling compound, and an adhesive compound in a sealed condition with the cap threadedly retained onto the single use cartridge, and which cartridge is disposed of and replaced with a new single use cartridge for subsequent application of a compound; FIG. 7 is an exploded view showing the same capsule illustrated in FIG. 6 but with the sealing cap removed, the single use capsule or cartridge (the term capsule or cartridge are used interchangeably) having an exterior surface which is generally cylindrical in shape and a rear surface which is generally flat with an opening, a front surface which is generally frustum shaped extending from the body of the cylinder to a nozzle having a cylindrical surface extending from the frustum and extending to a dispensing nozzle tip having threads on the exterior surface and a frangible seal on the front end of the tip, also illustrating the threaded cap which is cylindrical and a front end with an interior chamber having a piercing tooth; FIG. 8 is a bottom perspective view of the unidose single use cartridge with an anti-rotation slit in the bottom of exterior surface of the exterior wall of the tooth whitening retaining cartridge, the slit does not extend so deep that it goes into the interior chamber of the cartridge, the purpose of the anti-rotation slit is to be inserted into a mating member in the dispensing pen to prevent the cartridge from rotating once it is placed into the pen. FIG. 9 is a side cross-sectional view of a first embodiment of the unidose single use cartridge illustrating a single interior chamber which retains one compound, and a rear plunger having an interior face to push the compound in the interior of the cartridge forward and out of the cartridge, and an angular sidewall ending in a rear wall forming a seal against the interior sidewall, the rear end of the plunger having a pocket to receive a single pushing piston; FIG. 10 is an exploded view illustrating the front of the multi-sectional shaft and a single piston and a dual piston; FIG. 11 is a top cutaway view of a second embodiment of the unidose single use cartridge having a divided interior chamber which retains two separate compounds which are separated from each other while in the cartridge by a dividing wall, and a rear plunger having opposing interior faces to push a compound in a respective portion of the interior of the cartridge forward and out of the cartridge, and a pair of opposed angular sidewalls ending in rear wall sidewalls forming a seal against the interior sidewall of the cartridge, each rear end of the plunger having a pocket to receive a respective pushing piston from the dispensing pen; FIG. 12 is an exploded view illustrating a top right perspective view of the unidose dispensing pen with a single piston affixed to the new and novel ratchet operating mechanism illustrated in FIG. 1 within the dispensing pen, and a single chamber cartridge before it is inserted into a chamber adjacent the front of and within the dispensing pen and also illustrating a cartridge anti-rotation member within the chamber; FIG. 13 is a top right side perspective view of the dispensing pen of the present invention as illustrated in FIG. 12 , with the cartridge within the dispensing pen having the new and novel ratchet mechanism of the present invention as illustrated in FIGS. 1-5 , with the single use cartridge retained within the interior chamber of the dispensing pen with the front portion of the top removed and the threaded nozzle protruding through the front opening of the dispensing pen; FIG. 14 is a longitudinal cross-sectional view of the mixing nozzle of the present invention used with a cartridge having a divided interior housing two separate compounds; FIG. 14A is perspective view of the entire mixing nozzle including the two halves as illustrated in FIG. 14 sonic welded together at their respective mating surfaces at a location illustrated along a seam line to form an entire mixing tip; FIG. 15 is a perspective view of a straight dispensing nozzle used with a single chamber cartridge or used with a mixing tip and a dual chamber cartridge; FIG. 16 is a cross-sectional view of the straight dispensing nozzle illustrated in FIG. 15 ; FIG. 17 is a perspective view of a bent horn tip dispensing nozzle used with a single chamber cartridge or used with a mixing tip dual chamber cartridge; FIG. 18 is a cross-sectional view of the bent horn tip dispensing nozzle used with a single chamber cartridge or use with a mixing top dual chamber cartridge; FIG. 19 is a cross-sectional view of an applicator brush; FIG. 20 is a cross-sectional view of the dispensing pen which retains the new and novel mechanical ratchet mechanism of the present invention, with a single use cartridge threaded onto the front of the cartridge, the single use cartridge being either a single chamber cartridge as previously described with a single pushing piston or a dual chamber cartridge with a dual piston as previously described, the applicators and mixing chamber, as required respectively threaded onto the threaded nozzle in the front of the cartridge; FIG. 21 is a side cross-sectional view of a first embodiment of the unidose single use cartridge illustrating a single interior chamber which retains one compound, and a rear plunger having an interior face to push the compound in the interior of the cartridge forward and out of the cartridge, and an angular sidewall ending in a rear wall forming a seal against the interior sidewall, the rear end of the plunger having a pocket to receive a single pushing piston, where the single chamber cartridge is retained on the front of the dispensing pen; FIG. 22 is a top cutaway view of a second embodiment of the unidose single use cartridge having a divided interior chamber which retains two separate compounds which are separated from each other while in the cartridge by a dividing wall, and a rear plunger having opposing interior faces to push a compound in a respective portion of the interior of the cartridge forward and out of the cartridge, and a pair of opposed angular sidewalls ending in rear wall sidewalls forming a seal against the interior sidewall of the cartridge, each rear end of the plunger having a pocket to receive a respective pushing piston from the dispensing pen; and FIG. 23 is a top view of the present invention dispensing pen in the closed position. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Although specific embodiments of the present invention will now be described with reference to the drawings, it should be understood that such embodiments are by way of example only and merely illustrative of but a small number of the many possible specific embodiments which can represent applications of the principles of the present invention. Various changes and modifications obvious to one skilled in the art to which the present invention pertains are deemed to be within the spirit, scope and contemplation of the present invention as further defined in the appended claims. The variations on the single use cartridges have been summarized in detail in the summary of the invention section. The cartridge variations are summarized as follows: (1) a single use cartridge having a single interior chamber housing a compound. This variations has two sub-variations: (a) the single use cartridge is within a chamber within the mechanical dispensing pen with a nozzle extending out of an opening in the dispensing pen; and (b) the single use cartridge is threaded onto threads adjacent the opening of the mechanical dispensing pen and is outside of the dispensing pen. In both sub-variations, the nozzle from the single use cartridge is threaded onto an applicator or brush. (2) A single use cartridge having a double interior chamber divided by a dividing wall so that a respective compound is in each separate chamber of the dual chamber single use cartridge. This variations also has the same two sub-variations: (a) the single use cartridge is within a chamber within the mechanical dispensing pen with a nozzle extending out of an opening in the mechanical dispensing pen; and (b) the single use cartridge is threaded onto threads adjacent the opening of the dispensing pen and is outside of the dispensing pen. In both sub-variations, the nozzle from the single use cartridge is threaded onto a mixing chamber where the two compounds are mixed after being dispensed from the single use cartridge, and the mixing chamber has a nozzle which is threaded onto an applicator or brush after the mixing process. These variations and sub-variations will be described after discussion of the new innovations in this invention. The variations are all utilized with the innovative new mechanical ratchet mechanism for advancing the piston within the dispensing pen to push against a pocket in a sealing plunger located adjacent the interior rear of the single use cartridge. For the variation where the single use cartridge has one chamber, the sealing pushing plunger has one pocket to receive one pushing piston. For the variation where the single use cartridge has a dual chamber, the sealing pushing plunger has two pockets to respectively receive a respective one of the dual pushing pistons to push a respective half of a the sealing plunger to dispense each respective compound. In either variation, the new and novel ratchet mechanism to push either a single or dual pushing piston is the same. The dispensing pen has two variations, one where there is an interior chamber to receive the single use cartridge within the dispensing pen. This variation will be described first. FIG. 1 is a cross-sectional view of the dispensing pen 1000 which retains a single use cartridge 10 A within the dispensing pen. A cross-sectional view of the new and novel ratchet mechanism 1100 is disclosed in the cross-sectional view of FIG. 1 . FIG. 2 is a top left perspective view of the dispensing pen with the dispensing pen illustrated in a transparent exterior to enable illustration of a portion of the operating mechanism of the present invention. FIG. 3 is a top left enlarged perspective view of a section of the dispensing pen with the enlarged section of the dispensing pen illustrated in a transparent exterior to enable illustration of an enlarged portion of the operating mechanism of the present invention. FIG. 4 is a top right enlarged perspective view of a section of the dispensing pen with the enlarged section of the dispensing pen illustrated in a transparent exterior to enable illustration of an enlarged portion of the operating mechanism of the present invention. FIG. 5 is a top right perspective view of the dispensing pen with the dispensing pen illustrated in a transparent exterior to enable illustration of a portion of the operating mechanism of the present invention. Referring to FIGS. 1 through 5 , the dispensing pen 1000 has a circumferential wall 1020 with an exterior surface 1022 and an interior surface 1030 (See FIG. 2 ). The dispensing pen 1000 has an open rear end 1060 covered by a sealing cap 1200 . The dispensing pen has a front end wall 1080 with a front end opening 1090 extending from the front end wall 1080 . The interior surface 1030 and sealing cap 1200 surrounds an interior chamber 1300 which retains the ratchet operating mechanism 1400 which is comprised of the following components. An operating pushbutton 1410 which has a rear end 1420 and an arcuate lower surface 1430 about which the operating pushbutton 1410 pivots. The circumferential wall 1020 of the dispensing pen 1000 has an opening 1024 through which the front end 1432 and top surface wall 1436 of the operating pushbutton 1410 extend. Referring to FIG. 5 , the lower arcuate surface 1430 of the operating pushbutton 1410 rests on a pushbutton connection base 1440 having a seat 1442 on which the lower arcuate surface 1430 pivots. The pushbutton connection base 1440 (See FIG. 2 ) has a first foot 1444 A (see FIG. 4 ) extending from a width-wise first front and underside member 1444 B, the first foot member 1444 A has a longitudinal body 1444 C terminating in a slanted front face 1444 D and a parallel oppositely disposed second foot 1446 A extending from a width-wise second front and underside member 1446 B, the second foot member 1446 A has a longitudinal body 1446 C terminating in a slanted front face 1446 D. The pushbutton connection base 1440 has a rear end 1448 (see FIG. 4 ) with a longitudinal pivot member 1448 A (see FIG. 2 ) extending away from the rear end and against an interior location 1030 A of interior wall 1030 which serves as a connection point for the pushbutton connection base 1440 . Beneath the pushbutton connection base 1440 is a longitudinal slide member 1550 having a longitudinal exterior surface 1552 with a first circumferential stop member or ring 1554 (see FIG. 2 ) encircling the longitudinal exterior surface 1552 at a spaced apart location from the front 1556 of the longitudinal slide member 1550 . A rear circumferential stop member or ring 1558 located at a rear end 1560 of the longitudinal slide member 1550 (see FIG. 4 ) and including an upper shaft holder 1562 (see FIG. 3 ) extending away from the rear end 1560 , the upper shaft holder having a downwardly extending clip 1562 A; a lower shaft holder 1564 extending away from the rear end 1560 and having an upwardly extending clip 1564 A The longitudinal exterior surface 1552 has a first or right flatted sidewall 1552 R with a first or right ramp 1552 RR extending from an interior surface section 1554 I of first circumferential stop ring 1554 to adjacent a bottom longitudinal portion 1554 RB of the right flattened sidewall 1552 R and a second or left flattened sidewall 1552 L with a second or left ramp 1552 LR extending from an interior surface section 1554 I of first circumferential stop ring 1554 to adjacent a bottom longitudinal portion 1552 LB of the left flattened sidewall 1552 L. The longitudinal slide member 1550 includes an interior longitudinal generally cylindrical opening 1550 -O extending for the entire length “L 1 ” of the longitudinal slide member 1550 and bounded by a longitudinal interior circumferential wall 1550 IW, and open at its front end 1550 -OF and open at its rear end 1550 -OR. A multi-section shaft 1570 has a smooth outer surface section 1772 which extend through the entire length of the interior longitudinal generally cylindrical opening 1550 -O and for a given distance beyond the open front end 1550 -OF adjacent a front interior wall 1070 has a cylindrical supporting arm 1070 A extending interiorly toward the longitudinal side member 1550 , and having a central opening 1070 -O which receives and supports a front end 1570 F of shaft 1570 . A first compression spring 1580 SP is supported by cylindrical supporting arm 1070 A at a front end and by a front section 1570 SF of the slide member 1570 , the slide member having a front cylindrical exterior separation wall which separates the rear of the first compression spring 1580 SF from the pushbutton 1410 when it is depressed. The second section 1574 of the multi-section shaft 1570 has a multiplicity of adjoining ratchet teeth 1600 extends from a given distance “L 2 ” behind the opening at the rear end 1570 -OR of slide member 1570 to adjacent a rear multi-section end 1570 -RE of the multi-section shaft 1570 . The rear end 1570 -RE ends in a solid plug member 1560 which in turn in received in and supported by sealing cap 1200 . Each individual ratchet tooth is in the shaped of an isosceles triangle beginning with a sloped side and extending at an upward slant to a rear end for a shot straight edge of the triangle, a second section 1574 serving as the long straight edge of the triangle. The triangles are formed as identical mirror images of each other at a same location of the second section 1574 and respectively above and below the second section 1574 . Each ratchet tooth above the second section 1574 is referred to as an upper ratchet tooth 1600 -U with an upper vertical wall 1600 -UV and an upper forwardly slanted surface 1600 -USL. Each ratchet tooth below the second section 1574 is referred to an a lower ratchet tooth 1600 -L with a lower vertical wall 1600 -LV and a lower forwardly slated surfaced 1600 -LSL. A second or rear compression spring 1580 SR extends around all of the multiplicity of ratchet teeth 1600 and is retained at a rear end on the solid plug member 1060 and retained on a front end is retained on upper shaft holder 1562 and on lower shaft holder 1564 . In operation, the novel and unique improved mechanical ratchet operating mechanism 1400 is operated as follows. The first compression spring 1580 SP and the second compression spring 1580 SR are in their uncompressed state. The operating pushbutton 1410 is elevated in the uncompressed state. The downwardly extending clip 1562 A rests on an uppermost portion of an upper forwardly slanted surface 1600 -USL adjacent a vertical wall 1600 -UV of an upper ratchet tooth 1600 -U and an upwardly extending clip 1564 A rests on a lowermost portion of a lower forwardly slanted surface 1600 -LSL adjacent a lower vertical wall 1600 -LV of a lower ratchet tooth 1600 -L To begin the process of moving the multi-section shaft 1570 incrementally forward by a ratchet step (as will be described the front end 1570 F is connected to a single or double piston which pushes a sealing plunger in a cartridge forward to push the compound or compounds within the cartridge forward and eventually out of the cartridge), the operating pushbutton 1410 is pressed downwardly by pushing top surface wall 1436 adjacent a front location 1432 of the top surface wall 1536 towards the slide member 1570 . In this process, the downwardly pressed pushbutton 1410 causes its arcuate lower surface 1436 to pivot causing pushbutton connection base 1440 to move in the same downward direction which in turn causes slanted front faces 1444 D and 1446 D of the respective first foot member 1444 A and second foot member 1446 A to respectively slide down right ramp 1552 RR and left ramp 1552 LR of slide member 1550 . When the operating pushbutton 1410 is fully pressed all the way down, the first and second foot 1444 A and 1446 A of the pushbutton connection base 1440 have respectively slid down ramps 1552 RR and 1552 LR which caused the slide member 1570 to move forwardly by the horizontal distance of the ramps ( 1552 RR-HD and 1552 LR-HD). This in turn compresses first compression spring 1580 SP and advances the multi-section shaft 1570 forward by the a horizontal distance of a tooth ( 1600 -U and 1600 -L) which in turn compresses second spring 1580 SR. When the operating pushbutton is released, the clips 1662 A and 1664 A have slid down a respective slanted surface 1600 -USL and 1600 -RSL and respectively stop at the next vertical wall 1600 RV and 1600 -LV of a ratchet and holds the multi-sectioned shaft 1570 from moving backward. The slide member 1570 moves backwards due to the uncompressed first compression spring 1580 SB by first and second foot 1444 A and 1446 A sliding back up respective ramps 1552 RR and 1552 LR which then allows clips 1562 A and 1564 A to jump to the next slanted surface 1600 -USL and 1600 -RSL of the next tooth 1600 -U and 1600 -L. This process continues as the operating pushbutton 1410 is pressed until the multi-section shaft 1570 is completely extended and the second compression spring 1580 SR is completely compressed. To retract the multi-section shaft back to its original or starting point, it is necessary to disengage the ratchet teeth 1600 -U and 1600 -L from the downwardly extending ratch tooth engagement clip 1562 A and upwardly extending ratchet tooth engagement clip 1564 A. Surrounding the exterior surface 1022 of the exterior wall 1020 of the dispensing pen 1000 at a location between the slide member 1570 and the upper shaft holder 1562 -U and lower shaft holder 1564 -L is a rotational switch 1700 . Referring to FIGS. 2 and 3 , the rotational switch 1700 is connected to a locking element 1710 attached to a cylindrical locking member 1720 physically attached to the multi-section shaft 1570 . When the rotational switch 1700 is rotated, the locking element 1710 and cylindrical locking member 1720 also rotate, thereby causing the multi-section shaft 1570 to rotate until clips 1562 A and 1564 A are disengaged from the ratchet teeth 1600 -U and 1600 -L. Upon such disengagement, second compression spring 1580 SR retracts the multi-section shaft 1070 back to its starting position. The rotational switch 1700 is rotated in the opposite direction back to its original position, the locking element 1710 and cylindrical locking member 1720 are also rotated back to their original position, thereby causing the multi-section shaft 1570 to rotate back its original position until clips 1562 A and 1564 A are re-engaged with the ratchet teeth 1600 -U and 1600 -L to begin the starting position. Referring to FIG. 6 , there is illustrated an exterior perspective view of a cartridge or capsule 10 A with a front cap 30 A attached, which is used when the cartridge is inserted into an interior chamber within the dispensing pen 1000 . The interior will vary as discussed above. For a single interior chamber cartridge, the letter “A” is used with a corresponding part. The letter “A” is not used when the interior of the cartridge 10 has a dual chamber. The exterior is the same for both. In FIGS. 6, 7 and 8 , the letter “A” is used since the cross-sectional view of FIG. 9 illustrates a cartridge 10 A with a single interior chamber. Further referring to FIG. 7 , there is illustrated an exploded exterior view of a single use capsule or cartridge 10 A (the term capsule or cartridge are used interchangeably) with the cap 30 unscrewed. The single interior use cartridge 10 A contains an exterior surface 12 A which is generally cylindrical in shape and a rear surface 14 A which is generally flat. The front surface 18 A is generally frustum shaped extending from the body of the cylinder 10 A to a nozzle 32 A having a cylindrical surface 20 A extending from the frustum 18 A and extending to a dispensing nozzle tip 22 A having threads 24 A on the exterior surface and a frangible seal 26 A on the front end of the tip 22 A. The threaded cap 30 A is cylindrical with a front end 38 A with an interior chamber 40 A having a piercing tooth 42 A within the interior 40 A which extends inwardly from the front end 38 A of the sealing cap 30 A. In use, after the cartridge 10 A is placed in the dispensing pen 1000 as will be discussed, the front or tip 22 A of the single use cartridge 10 A extends through an opening in the dispensing pen and the threaded cap 30 A which is previously unscrewed from the threads 24 A of the capsule 30 A before the capsule or cartridge 10 A is inserted into the dispensing pen 1000 , is then rotated 180 degrees so that the sharp tooth 42 A penetrates the frangible seal 26 A so that the tip 22 A is opened and a selected compound 100 A is dispensed from the interior 50 A of the cartridge or capsule 10 A. Referring to FIG. 8 , there is a illustrated bottom perspective view of the unidose single use cartridge 10 A. The difference between the top view and the bottom view is that bottom view shows an anti-rotation slit 44 A in the bottom of exterior surface 12 A. The slit 44 A does not extend so deep that it goes into the interior chamber as will be discussed. The purpose of the anti-rotation slit 44 A is to be inserted into a mating member in the pen to prevent the cartridge 10 A from rotating once it is placed into the interior chamber of the dispensing pen 1000 . Referring to FIG. 9 , there is illustrated a side cross-sectional view of a first embodiment of the unidose single use cartridge with sealing cap affixed, illustrating a single interior chamber which retains one compound, and a rear plunger having an interior face to push the compound in the interior of the cartridge forward and out of the cartridge, and an angular sidewall ending in a rear wall forming a seal against the interior sidewall, the rear end of the plunger having a pocket to receive a single pushing piston. The cartridge 10 A has a single interior chamber 50 A with a single compound 100 A retained in the interior chamber 50 A. A rear plunger 54 A having an interior face 56 A is used to push the compound 100 A in the interior chamber 50 A forward and out of the cartridge 10 A. The rear plunger 54 A has a pair of opposed rear angular sides 60 A and 62 A extending from opposite ends of the interior face 56 A and respectively ending in rear sidewalls 64 A and 66 A forming a seal against the interior sidewall 51 A of the cartridge 10 A, the interior of each rear sidewall 64 A and 66 A of the plunger 54 A forming the sidewalls of a pocket 72 A to receive the pushing piston from the retaining pen. Further referring to FIG. 9 , the single use capsule or cartridge (the term capsule or cartridge are used interchangeably) with the single interior chamber 51 A contains an exterior surface 12 A which is generally cylindrical in shape and a rear surface 14 A which is generally flat with an opening 16 A through which a pushing piston 210 S is inserted into pocket 72 A, a front surface 18 A which is generally frustum shaped extending from the body of the cylinder 10 A to a nozzle 32 A having a cylindrical surface 20 A extending from the frustum 18 A and extending to a dispensing nozzle tip 22 A having threads 24 A on the exterior surface and a frangible seal 26 A on the front end of the tip 22 A. A threaded cap 30 A is cylindrical with an interior surface 32 A with threads 34 A adjacent the rear 36 A of the sealing cap 30 A and a front end 38 A with an interior chamber 40 A having a piercing tooth 42 A within the interior 40 A which extends inwardly from the front end 38 A of the sealing cap 30 A. In use, after the cartridge 10 A is placed in the dispensing pen 1000 as will be discussed, the front or tip 22 A of the single use cartridge 10 A extends through an opening in the dispensing pen and the threaded cap 30 A which is previously unscrewed from the threads 24 A of the capsule 30 A before the capsule or cartridge 10 A is inserted into the dispensing pen 1000 , and is then rotated 180 degrees so that the sharp tooth 42 A penetrates the frangible seal 26 A so that the tip 22 A is opened and a selected compound 100 A is dispensed from the interior 50 A of the cartridge or capsule 10 A Referring to FIG. 10 , there is illustrated the two types of pushing pistons attached to the front of the multi-sectional shaft 1570 described in detailed when discussing FIGS. 1 through 5 . The front 1570 F of the multi-sectional shaft 1570 has a first mating member 1570 SM which in an illustrative embodiment has male threads. There is a single piston 210 S with a shaft second mating portion. 210 SMT. For the illustrative embodiment where the first mating member 1570 SM of the multi-sectional shaft 1570 has male threads, the shaft second mating portion 210 SMT has mating female threads within the single piston 210 S. In an embodiment, the single pushing piston 210 S has a cylindrical exterior with a rounded bullet shaped front 210 SE which is inserted into pocket 72 A in the interior of single chamber cartridge 10 A. The single pushing piston 210 S has a partially hollow interior which would have the female mating threads. For a cartridge 10 having a dual chamber, the pushing piston 210 has a mating section 210 MMT which branches into a first piston 210 and a spaced apart second piston 220 . For the illustrative embodiment where the first mating member 1570 SM of the multi-sectional shaft 1570 has male threads, the mating section 210 MMT shaft second mating portion 210 SMT has a partially hollow interior which would have mating female threads within its interior 210 MSI. In an embodiment, the mating section 210 MMT has a cylindrical exterior which branches into first piston 210 having a bullet shaped front 210 DFB and a second piston 220 with a bullet shaped front 220 DFB which are respectively inserted in pushing plunger pockets as will be described. FIG. 1 illustrates a cross-sectional view where a pushing piston is placed onto the front end 1570 F of the multi-sectioned shaft 1570 . As illustrated in FIG. 1 , in one variation, the single use cartridge is placed within an opening adjacent to front of the dispensing pen with the threaded nozzle extending through the opening in the front of the dispensing pen 1000 . For the single chamber cartridge 10 A illustrated in FIG. 7 , the single piston mating section 210 SMT is affixed to the front 1570 F of the multi-section shaft 1570 and the single pushing piston 210 S is guided into rear pocket 72 A. For the dual chamber cartridge 10 illustrated in FIG. 8 , the mating section 210 MMT is affixed to the front 1070 S of the multi-section shaft and a respective one of the dual pushing pistons 210 and 220 is guided into a respective pocket 68 and 70 . Referring to FIG. 11 , the alternative cartridge 10 with a dual chamber interior is illustrated in a top cutaway view of the second embodiment of the unidose single use cartridge 10 containing the divided interior chamber 50 which retains two separate compounds 100 and 110 which are separated from each other while in the cartridge by a dividing wall 52 , and a rear plunger 54 having opposing interior faces 56 and 58 to push a compound 100 or 110 in a respective portion of the interior 50 of the cartridge forward and out of the cartridge 10 , and a pair of opposed angular sidewalls 60 and 62 ending in rear wall sidewalls 64 and 66 forming a seal against the interior sidewall 51 of the cartridge, each rear end 68 and 70 of the plunger 54 having a pocket 72 and 74 to receive a respective pushing piston from the dispensing pen 1000 . Referring to FIG. 8 , it can be seen that the chamber 50 is divided into two equal chambers 53 and 55 which contain different compounds which cannot come in contact with each other because the dividing wall 52 extends for the entire diameter “D 1 ” and Length “L 1 ” of the interior chamber 50 of the cartridge 10 . For dual compounds where less is need of one of the two compounds, the dividing wall 52 is thicker on one side to reduce the volume of compound in the smaller chamber, the design of the plunger is modified to accommodate the revised sidewall 52 . Figure also shows the frustum shaped front and threaded nozzle and threaded cap with a piercing tip. This portion of the cartridge 10 having a frustum shaped front leading to a threaded nozzle 32 with threads 20 and a frangible seal 26 and threaded cap 30 with interior mating threads 34 , a piercing element 42 in an interior 40 of front 38 of cap 30 . Referring to FIG. 12 , there is illustrated a top right side view of the present invention unidose dispensing pen with the new and novel ratchet dispensing mechanism 1400 illustrated in FIGS. 1 through 5 retained within the dispensing pen 1000 including illustrating the operating pushbutton 1410 , the ratchet disengagement switch 1700 , the open chamber 301 A with an anti-rotation member 305 A and the opening 1090 . The cartridge 10 A with cap 30 A removed is inserted into chamber 301 A with anti-rotation member 305 A engaging anti-rotation slit 44 in the bottom surface of cartridge 10 A with threads 22 A protruding through opening 1090 . Single pushing piston 210 S is also illustrated. FIG. 13 is a top left side perspective view of the present invention unidose dispensing pen 1000 with the new and novel mechanical ratchet dispensing mechanism 1400 illustrated in FIGS. 1 to 5 retained within the dispensing pen 1000 including illustrating the operating pushbutton 1410 , the ratchet disengagement rotational switch 1700 , a visible portion of an exterior of a pushing piston 210 S and a single use cartridge 10 A within the dispensing pen 1000 . It will be appreciated that the dual chamber cartridge 10 is inserted the same way. As illustrated in FIG. 1 , in one variation, the single use cartridge 10 A is placed within an opening 301 A adjacent to front 1080 of the dispensing pen 1000 with the threaded nozzle 20 A extending through the opening 1090 in the front 1080 of the dispensing pen 1000 . For the single chamber cartridge 10 A illustrated in FIG. 9 , the single piston mating section 210 SMT is affixed to the front 1570 F of the multi-section shaft 1570 and the single pushing piston 210 S is guided into rear pocket 72 A. For the dual chamber cartridge 10 illustrated in FIG. 11 , the mating section 210 MMT is affixed to the front 1570 F of the multi-section shaft 1570 and a respective one of the dual pushing pistons 210 and 220 is guided into a respective pocket 68 and 70 . In operation, the multi-sectioned shaft 1570 in incrementally moved forward by the present invention operating ratchet mechanism illustrated in FIGS. 1 to 5 and discussed above. For the single chamber cartridge 10 A, pushing piston 210 A is used to engage a pocket 72 A of the single-pocket plunger 54 A used with a single chamber cartridge and the ratchet mechanism of the present invention moves the pushing piston 210 S in the forward direction to push the plunger 54 A forwardly to dispense a selected compound 100 out of the cartridge through nozzle 10 A For the dual chamber cartridge 10 , pushing pistons 210 and 220 are respectively used to engage a respective pocket 72 and 74 of the two-pocket plunger 54 used with the dual chamber cartridge and the ratchet mechanism of the present invention moves the two pushing pistons 210 and 220 in the forward direction to push the plunger 54 forwardly to dispense a selected compound 100 and 110 out of the cartridge through nozzle 10 . For the single chamber cartridge 10 A, the ratchet mechanism incrementally moves the move the pushing piston 210 S forwardly to move the plunger 54 A forwardly to push the compound 100 A out of the cartridge 10 S through nozzle 30 S. If the volume of he two compounds is different, the dividing wall 52 is thicker on one side to reduce the volume of compound in the smaller chamber, the design of the plunger is modified to accommodate the revised sidewall 52 . FIG. 17 are the same as in FIGS. 5, 6, 7 and 8 with an “S” at the end of each number. Except for combining two compounds in a mixing nozzle, the operation after the compound is pushed out of the cartridge is the same. Referring to FIG. 1 , there is illustrated a top perspective view of the unidose single use cartridge 10 which contains a compound as defined above including compound selected from the group consisting of a tooth whitening compound, a dental bonding and filling compound, and an adhesive compound in a sealed condition with the cap 30 threadedly retained onto the single use cartridge 10 , and which cartridge is disposed of and replaced with a new single use cartridge for subsequent application of a compound. Referring to FIG. 14 , there is illustrated a cross-sectional view of one half 400 H of the mixing nozzle 400 which is used with a dual chamber cartridge. The mixing nozzle 400 has internal threads 410 on its internal surface 420 adjacent its rear end 430 and on nuts external surface 418 external threads 440 adjacent its front end 450 and contains a multiplicity of semi-closed shelves 460 and also straight shelves 470 so that as the compounds 100 and 110 are driven through the mixing nozzle 400 , the angular shelves 460 and the straight shelves 470 cause the compounds 100 and 110 to mix together and go through a series of angular shelves 460 and straight shelves 470 to make sure that the compound is fully mixed when it gets to the opening 480 of the mixing chamber 400 . A rear opening 414 permits the compounds 100 and 110 to enter the mixing tip 400 after it is screwed onto the threads 24 of tip 26 of capsule 10 . FIG. 9 illustrates one half of the mixing nozzle. The opposite half is a mirror image of half 400 H. The two halves of sonic welded together along their longitudinal interior faces 412 to form a complete mixing nozzle 400 illustrated in FIG. 14A . Referring to FIG. 14 a , there an exterior view of the mixing nozzle with a seam line 408 illustrates the location of the sonic weld. A key innovation of the present invention mixing nozzle 400 is that it is comprised of internal built in shelves which thoroughly mix the compound portions as they are forced through the mixing nozzle. This is a major improvement over the prior art where an insert is placed into a chamber and compounds mixed through the insert which leads to less mixing and much more inefficiency in the mixing. Referring to FIGS. 15 and 16 , there is illustrated a straight applicator 500 which contains an exterior surface 510 and an interior chamber 528 which has a widened end 520 with interior threads 522 surrounding a rear opening 524 that either thread around the end of the mixing tip or thread around the threaded end of the compound capsule and a front opening 530 through which the compound is dispensed. The compound enters through rear opening 524 and exits through front opening 530 . In an alternative embodiment illustrated in FIGS. 17 and 18 , the applicator is a horn-shaped applicator 600 which has an exterior wall 610 and an interior chamber 620 which has a rear opening 624 and a rear interior wall 526 having threads 622 which can be threaded onto the end of the mixing tip or threaded onto the end of the tooth whitening compound cartridge and also has an opening 630 in front end 640 which is bent at an angle so that the tooth whitening compound can be applied to rear surface or to teeth near the back of the patient's mouth, the dental bonding compound can be applied to rear teeth fillings and the adhesive compound can be applied at a rear area of objects to be bonded together. The selected compounds enter from rear opening 624 and exits through front opening 640 . Referring to FIG. 12 (before the cartridge 10 or 10 A is inserted into the pen 1000 ) and FIG. 13 (after the cartridge 10 or 10 A is inserted into the pen 1000 ) there is illustrated an exploded view showing how the mixing pen operates. The cartridge 10 A containing the compound 100 is inserted into chamber 301 A near the front of the dispensing pen 1000 where the pocket 72 A of the plunger 54 A is retained against the single piston 210 S and the front tip 12 A of the cartridge 10 A extends out of the opening 1090 in the pen 1000 . The anti-rotation slit 44 on the cartridge is placed into the anti-rotation longitudinal stop shelf 305 A in chamber 301 A so the cartridge 10 A will not rotate once inside the dispensing pen 1000 . The sealing cap 30 A is shown removed from the cartridge 10 A. After the cartridge is inserted into the dispensing pen 1000 , the cap 30 A is used to penetrate the frangible seal 26 A of the tip 22 A of the cartridge 10 A which extends out of the opening 1090 in the dispensing pen 1000 and thereafter either the straight applicator 500 or the horn-shaped applicator 600 is threaded onto the threads 22 A of the cartridge 10 A so that as the ratchet mechanism causes the piston 210 S to move toward the front of the dispensing pen 1000 , the piston 210 S pushes on the back of the plunger 54 A causing the plunger 54 A to move the compound 100 out of the cartridge 10 A into an applicator. For the dual chamber interior cartridge 10 containing the compounds 100 and 110 is inserted into chamber 301 A near the front of the dispensing pen 1000 where the pockets 72 and 74 of the plunger 54 are retained against the dual pistons 210 and 220 and the front tip 12 of the cartridge 10 extends out of the opening 1090 in the pen 1000 . The anti-rotation slit 44 on the cartridge is placed into the anti-rotation longitudinal stop shelf 305 A in chamber 301 A so the cartridge 10 will not rotate once inside the dispensing pen 1000 . The sealing cap 30 is shown removed from the cartridge 10 . After the cartridge is inserted into the dispensing pen 1000 , the cap 30 is used to penetrate the frangible seal 26 of the tip 22 of the cartridge 10 which extends out of the opening 1090 in the dispensing pen 1000 and thereafter the mixing tip 400 is threaded onto the cartridge 10 e and either the straight applicator 500 or the horn-shaped applicator 600 is threaded onto the mixing tip 400 so that as the ratchet mechanism causes the pistons 210 and 220 to move toward the front of the dispensing pen 1000 , the pistons 210 and 220 push on the back of the plunger 54 causing the plunger 54 to move each compound 100 and 110 from each separate section of the cartridge 10 into the mixing tip 400 where the compounds 100 and 110 are mixed and then exit the mixing tip 400 into the applicator so that the mixed tooth whitening compound is either placed in a dental tray or placed on the patient's tooth. Referring to FIG. 19 there is illustrated an applicator brush 800 which has interior mating threads which are threaded onto the exterior threaded nozzle of the single use cartridge from which compound is dispensed onto the brush or onto the mixing tip nozzle for the dual chamber cartridge. In a variation of the cartridge location, referring to FIG. 20 , there is a perspective view of the dispensing pen 2000 which for the interior operating ratchet mechanism 1570 , functions the same as the previous dispensing pen 1000 . The difference is that instead of having the reusable cartridge 10 or 10 A within a chamber within the dispensing pen, the dispensing pen has a front section 2100 which has a threaded exterior surface 2150 having mating threads 2200 thereon. The multi sections movable shaft 1570 has its front end 1570 F pushed forwardly of the section 2100 through an opening 2300 through which the multi section shaft protrudes. The variation of the reusable cartridge is the same as shown in FIGS. 9 and 11 but instead has internal threads thereon. Referring to FIG. 21 , for the single use cartridge having a single chamber which will be described as 10 -SC, the single use cartridge having a single interior chamber has interior threads 80 AE which mate with the exterior threads 2200 at the front of the dispensing pen 2000 . As a result, instead of being within the chamber, the single use cartridge with internal threads 80 AE now is extending from the front of the cartridge. The operating mechanism is the same as before with the single piston 210 S affixed to the front 1570 F of multi-sectional shaft 1570 and moved forwardly in increments by the novel and unique operating ratchet mechanism of the present invention to move pocket 72 AE of pushing plunger 54 AE. The compound is moved through the exterior cartridge 10 A-SC through its exterior nozzle 20 AE which also has threads and then dispensed into any of the applicators or any identified in FIGS. 15 to 18 . The remaining components are numbered similar to the numbers in FIG. 9 but are numbered with AE. Alternatively, for a dual chamber cartridge, the mechanism described in FIG. 22 is applied to the front of the pen 2000 so that multi section movable shaft 1570 extends into a respective pocket of the dual chamber cartridge which since it is an exterior cartridge will be referred to as 10 -DC. This exterior cartridge also has internal threads 80 E which are threaded onto the mating threads 2100 of the second variation of the reusable pen so that the respective pistons 210 and 220 is moved into a respective pocket 72 E and 74 E of the exterior dual chamber reusable cartridge so that the dual compound is respectively pushed through the cartridge and out the exterior nozzle 20 E and then into the mixing chamber which is threaded onto the exterior surface of the cartridge with the same process as previously discussed. The remaining components are numbered similar to FIG. 11 with “E” after each number. The compound that is used with the present invention can be any multiplicity of compounds as previously discussed. The single use cartridge, whether it is retained within the dispensing pen or 10 -SC which is exterior to the dispensing pen, can be any compound. If, by way of example, the compound 100 is a tooth whitening compound, then after being dispensed from the single use cartridge, the tooth whitening compound is placed in the dental tray where the tray is placed over the patient's teeth for a period of time or the tooth whitening compound is directly applied to the patient's teeth through a brush 800 as illustrated in FIG. 19 . Alternatively, if it is a dual chamber single use cartridge 10 , then two compounds 100 and 110 go through the chamber as tooth whitening compounds and then are combined together when they exit the nozzle 20 E and go into the mixing chamber 400 where the two tooth whitening compounds are combined together in the mixing chamber 400 before they can be dispensed into a dental tray or other dental applicator. Similarly, the compounds can be any type of products such as a glue, an adhesive, a powder, a gel, a cream, paint, cosmetics, lipstick, non-medicated cosmetics, medicated cosmetics, construction material compounds and virtually any other compound. If the compound does not need to be mixed with another compound, then a single use cartridge is used. If the compound needs to be mixed with another compound, then the dual chamber cartridge is used where they are respectively pushed through the dual chamber cartridge and then through the front nozzle and into the mixing nozzle where the two compounds are mixed together before they then can be applied to any one of the applicators or brushes set forth in FIGS. 15 to 18 . Referring to FIG. 23 , there is a perspective view of the revised dental dispensing pen 2000 illustrating an exterior cartridge 10 -SC or 10 -DC threaded onto the front of the dispensing pen 2000 where the ratchet removable switch 1700 and the pushbutton 1410 are illustrated. The operation of the mechanism is the same as before and the new and novel operating ratchet mechanism incrementally pushes a single piston or a dual piston through a respective pocket or dual receiving pocket in the single use chamber to push the compound through the chamber where it can be either sent to a mixing chamber for mixing or directly applied through an applicator. If it is first sent to a mixing chamber, then it is mixed and then applied to the applicators. Of course the present invention is not intended to be restricted to any particular form or arrangement, or any specific embodiment, or any specific use, disclosed herein, since the same may be modified in various particulars or relations without departing from the spirit or scope of the claimed invention hereinabove shown and described of which the apparatus or method shown is intended only for illustration and disclosure of an operative embodiment and not to show all of the various forms or modifications in which this invention might be embodied or operated.

1a

BACKGROUND OF THE INVENTION The present invention relates in a general way to devices and installations for accommodating living animals, and is particularly concerned with an integrated assembly designed specifically to facilitate cohabitation with house pets, particularly cats and dogs, who normally live under conditions of semi-freedom in the lodgings of their master. In most countries, and particularly in industrial countries where life is for the most part urban, many people seek to alleviate their solitude or lack of natural environment by way of the company of a cat, a dog, or another familiar house pet. In France, for example, the total number of such house pets is in the millions. It is known that large numbers of cats and dogs are maintained for the sole pleasure of their masters while being condemned to lonely lives in apartments or homes which can only provide such animals with an environment very different from their natural habitat, since such environments are specifically adapted for human needs in unnatural surroundings. In practice, the only concessions made in connection with the presence of house pets who permanently reside with their masters consist in putting at the disposition of such house pets simple objects such as mats, cushions or baskets for sleeping, litter boxes, scratch boards, or doors provided with special openings for such animals, and various playthings such as balls or bones made of rubber or plastic, as well as special edible products including tins of cat or dog food, preparations simulating natural foods, the sales volume of which surpasses the sales volume of food for babies or the protein requirements of underdeveloped countries. In particular, there is at the present time no available equipment especially designed for use by such a house pet in the absence of his master or, on the contrary, for maintaining the private needs of such an animal in the presence of their master. As a result, such animals are compelled to conform to the life style of their master, which can be irregular and even incompatible with the requirements of the animals themselves. Abandoned to himself, such an animal risks a life of boredom and deterioration, or on the other hand disturbs the peacefulness of his master's lack of occupation. On the other hand, in the presence of unknown individuals and in the absence of any refuge, such animals are likely to get in the way and even to become aggressive. Finally, the artificial life style imposed on such animals, and in particular the isolation of such animals from companions and the absence of stimulation responding to the natural needs of such animals, such as their instincts for chase or play, are likely to diminish the physical and intellectual capabilities of such animals, as has been demonstrated by numerous experimental studies concerning the influence of the environment on animal behavior. In summary, the lack of equipment capable of satisfying the needs of house pets living in human habitations is likely to result in unstable animal behavior which deprives the master of the important pleasure resulting from the friendly presence of an animal, with the cohabitation with such an animal even becoming insupportable and as a result leading to improper treatment of the animal and even illegal and immoral abandoning of the animal. SUMMARY OF THE INVENTION It is accordingly a primary object of the present invention to provide a structure which will alleviate the above deficiencies. In particular, it is an object of the present invention to provide a relatively complex equipment, as opposed to a simple object, designed to place at the disposition of a house pet living freely but confined in an artificial environment a collection of material devices which respond to the essential needs of the animal with a view to preserving the tranquility of masters, present or absent, and as a result leading to mutual pleasant relationships between man and animal. There are three orders of essential needs for animals: In the first place, and most importantly, an animal requires a refuge which forms a mini-territory, in the ecological sense of the term, with the animal having the sole ownership of such a territory where the animal can, as a result, feel perfectly secure and sheltered from all exterior sources of disturbance while being surrounded by objects which provide familiar sensual impressions. Secondly, for the subsistance and comfort of the animal as well as for achieving freedom of action for his master, there should be placed at the permanent disposition of the animal, to be used according to his individual inclinatons, all of the means required to satisfy the natural animal needs of hygiene, nourishment, and exercise. Lastly, it is desirable to offer the animal the free use of articles of play or stimulation so as to enable the animal to make use of his natural instincts and, in the absence of the master, to benefit from the output of items which are a substitute for companionship. The satisfying of the above requirements enables the house pet to retain the spontaneity of his behavior, which in fact forms the basis of his attraction, and in addition supports the acquisition of mutual habits which form the basis of the friendship. As a result, it is possible for the owner of such an animal to enjoy without constraint the pleasure of the presence of the pet, without needing to fear any servitude to the animal, or any servitude in connection with maintaining the animal and in connection with the requirements which have involved up to the present time cohabitation with a house pet. It is furthermore an object of the invention to satisfy the above needs by way of a modular type of equipment which can easily be modified according to the particular animal and its environment, while at the same time the equipment of the invention is easily transportable so as to avoid subjecting the animal to any brutal deprival of territory, as occasioned, for example, during periods of vacation or change of domicile. According to the invention, an integrated assembly for facilitating cohabitation with house pets, particularly cats and dogs, who normally live under semi-free conditions in the lodgings of their master, includes a movable support means and a plurality of module means interchangeably carried by the movable support means for fulfilling a number of functions which include arrangement in available space, provision of bodily conveniences, stimulation of instincts and/or simulation of a presence, with the plurality of module means being selectively combinable for providing for a given house pet specific needs which include territorial refuge, vital comforts, physical and mental exercise, and/or friendship. BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way of example in the accompanying drawings which form part of this application and in which: FIG. 1 is a schematic elevation of one possible structure according to the invention, with FIG. 1 showing a cover situated above the structure to be covered thereby, with part of the cover being shown in section; FIG. 2 is a top plan view of the integrated assembly of modules of FIG. 1 as it appears when looking downwardly on the structure beneath the cover which is shown in FIG. 1; and FIGS. 3-6 are respectively sectional elevations taken along lines 3--3, 4--4, 5--5, and 6--6 of FIG. 2 in the directions of the arrows and showing schematically details of various different modules which form part of the modules shown in FIG. 2. DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings, the structure of the invention which is illustrated therein includes a support means which is easily movable and which includes a plate 10 made of any suitable rigid material such as a suitable plastic, this plate 10 being fixed with vertical partitions 12 and 14 which divide the upper surface of the plate 10 into a number of compartments as illustrated. Thus the partition 12 extends longitudinally along the center of the upper surface of the plate 10 while the partitions 14 extend perpendicularly from the central partition 12 to divide the space at the upper surface of the plate 10 into a number of compartments. The material utilized for the plate 10 and the partitions 12 and 14 may be, for example, a suitable synthetic resin which is inert with respect to natural secretions of the animal as well as with respect to products for disinfection and maintaining the animal. In the illustrated example the plate 10 is provided with feet 16 and wheels 18, the feet 16 being situated, for example, at the regions of the left corners of the plate 10 while the wheels 18 are situated at the regions of the right corners of the plate 10, as viewed in FIGS. 1 and 2. Thus, by reason of this feature it is easily possible to move the plate 10 and the structure carried thereby to the best possible location. Moreover, a cover 20 is provided as schematically shown in FIG. 1. This cover 20 may be made, for example, of a transparent plastic. It has a top wall provided with a handle 22. Moreover, at the region of its lower periphery the cover is formed with a series of openings 24 capable of receiving the spring-pressed pivoted catch elements 26 which are carried in a known way by the plate 10 at the periphery thereof. Thus, with an animal situated on the plate 10 it is possible to slip the cover 20 over the plate 10 so that the catches 26 will snap respectively into the openings 24, and in this way it is possible easily to carry about the entire structure with an animal situated therein. Of course the distance of the top wall of the cover 20 from the bottom edge thereof is adequate for the particular animal. In order to remove the cover 20 it is only necessary to depress a pair of the catches 26 such as those at the left in FIGS. 1 and 2, and in this way the left end of the cover 20 can be displaced above the thus-depressed catches 26, the cover having sufficient clearance with respect to the plate 10 for this purpose. Then one or more of the remaining catches 26 can be depressed to enable the entire cover to be removed after the animal with the structure of the invention has been transported to a desired location. The several modules of the invention, as described below, are of a size which enables them to be respectively situated in the compartments formed at the top of the plate 10 by way of the partitions 12 and 14. The plurality of module means of the invention can have widely varying configurations and purposes, and preferably can be designed to be utilized individually or in combination in a manner which will be apparent from the description which follows. Thus, for example, one of the module means of the invention can be a "refuge" type of model formed by an enclosure 28 which is closed except for an access opening 30 through which the animal can conveniently travel into and out of the enclosure 28. The size of the opening 30 is preferably made just large enough to permit entry and exit of the particular animal. This enclosure and its entrance and exit opening may be constructed in the manner of a niche or a cage for birds. In the interior of the enclosure there are provided suitable accessories for the comfort of the animal. Thus, for example, in the interior of the enclosure 28 there is a cushion 32 having in its interior an electric heating element 34 shown schematically in FIG. 2 connected into a suitable circuit having batteries 36 and a thermostat 38 as well as a switch 40 which responds to the presence of the animal on the cushion for closing the illustrated circuit and thus causing the cushion to be heated to the temperature set by the thermostat 38. In addition, the interior surface of the enclosure 28 is lined with a sound-deadening material 42 which provides for sound insulation which will minimize noise in the vicinity of the enclosure 28, the sound-deadening material 42 being particularly designed for preventing transmission of ultrasonic wave lengths to which the particular animal may be particularly sensitive. A further module means, which is not illustrated, may be similar to a nursery and provided with automatic feeding devices and other accessories of appropriate function as well as with means for protecting access to the module. An additional module means 44 is of the bodily convenience type, of benefit both to the animal and its master, and may include a receptacle 46 containing an absorbent material 48 and partly covered by a cover 50 having a central opening through which the animal has access to the material 48. This cover 50 has a suitable rough upper surface 52 which preferably forms a scratch surface. Thus this scratch surface forms a border surrounding the receptacle 46. In addition there may be provided an unillustrated distributor of a deodorant product for the receptacle 46. A further unillustrated module also designed for bodily convenience may include a reserve of food and/or beverage contained in a device designed to meter the supply of the food and/or beverage so as to permit access thereto according to a predetermined time program, thus facilitating an extended absence of the master without the risk of overfeeding on the part of the animal. As is shown in FIGS. 2 and 5, a further module means of the invention fulfills the function of friendship and may be utilized in the case of absence of the master. This module means 54 includes on a suitable supporting plate 56 a recording play-back device 58 in the form, for example, of a suitable tape recorder which plays back the sound which is stored on a tape. When the animal places itself on the plate 56 the animal will depress a plate 60 which will close a circuit 62 schematically shown in FIG. 2, so as to energize the recorder 58 which thus operates to provide for the animal the sound which is stored on the tape. This sound may be a program providing for the animal sounds and/or voices simulating a friendly presence. Also, it is possible to provide a module means 64 which, as shown in FIGS. 2 and 6, includes a container 66 having a perforated cover 68 and containing in its interior old linens 70 or other suitable material impregnated with the odor of an absent individual. The several module means of the invention also include an exercising module means 72 in the form of an endless band 74 guided by rollers 76 which are suitably braked with respect to the shafts 78 on which they turn, the endless band 74 being suitably inclined as illustrated, and if desired the inclination can be rendered adjustable in any suitable way. The surface of the endless band 74 is covered with felt, for example, offering a suitable surface to be engaged by the claws of the animal. A similar type of unillustrated module may include a ball or other solid decoy connected by a suitable flexible cord or the like to a spring mounted in a suitable socket. An animated type of module means of the invention may include the module means 80 shown in FIGS. 2 and 3. This module means is formed by a stretchable elastic sheet 82 covering a suitable enclosure 84 in which there are a plurality of mechanisms in the form of plugs or projections 86 which move upwardly to stretch the sheet 82 when certain other projections 86 are depressed by the animal. Thus a plurality of tiltable levers 88 may be supported on suitable pivots in the enclosure 84 and may carry at their ends the plugs 86 so that when one plug 86 is depressed the other will be raised to cause the sheet 82 to project upwardly in an uncontrollable and surprising manner. FIG. 3 schematically illustrates a paw 90 of the animal depressing a part of the sheet so as to depress one projection 86 shown at the left of FIG. 3 so as to cause the projection 86 at the right of FIG. 3 to rise as illustrated. A further module of this general type may include the module 92 illustrated in FIGS. 2 and 4. This module 92 includes a support plate 94 on which there is turnably supported by way of a suitable central pivot a circular plate 96 carrying a number of figurines 98 simulating different animals. Thus, when the house pet engages the plate 96 or one of the figurines 98, the several figurines will move past the house pet in a haphazard manner. In addition it is possible to provide any projections or the like which serve a similar function to the extent that the faculties of perception and intelluctual capacity of the animal permits. Finally, a module to be utilized all the time by the animal and which is ornamental with respect to the apartment or house may be formed by a house garden or the equivalent thereof planted together with a grassy type of covering. The several examples referred to above of course are not exhaustive but on the contrary serve only to show clearly the entire concept and combination forming the object of the present invention and serving for all adaptations and accommodations which can contribute toward pleasant cohabitation with a given animal of known or predictable habits in a particular living framework whose primarily artificial character is at least partly minimized by way of the present invention. In effect, the modular nature of the integrated assembly of the invention and the variety of the modules which can be utilized assure the precise adaptation of the assembly to the capacities and needs of a given animal. A further advantage of the structure of the invention, relating to its transportable character, is that it avoids any trauma with respect to separation of the animal from a given environment in the case of permanent or temporary removal from a given abode. Yet another advantage of the structure of the invention is that it may structurally evolve to the same extent as the growth of the animal. Finally, and above all, the structure of the invention has the advantage of providing a solution to the conflicts inherent in modern life as a result of the artificiality thereof, while fulfilling the desire to possess a house pet while providing for the house pet at least partially the impression of living in a natural environment. It is of course to be emphasized that this advantage is of benefit not only to the animal but also to the master.

1a

FIELD [0001] The subject matter herein generally relates to a drilling control system and a drilling control method. BACKGROUND [0002] Tissue penetration is one of the important surgical procedures, such as soft tissue biopsy, lumbar puncture, bone marrow biopsy, craniotomy or osteotomy. Osteotomy is frequently performed in orthopedic surgery and neurosurgery. Usually, a bone drilling machine is used by a surgeon to make a hole for screw insertion in orthopedic surgery, such as internal fixation, external fixation, artificial joint replacement, spinal fusion, and spinal fixation. Implantation of pedicle screws is extremely risky because of the small target and the extreme closeness of neural tissue all around the pedicle of the vertebra, such as cervical, thoracic and lumbar spines. For example, performed in the posterior lumbar interbody fusion (PLIF). [0003] Conventional surgery needs a complete pre-operative evaluation and planning to decide the drilling location and trajectory. However, with limited surgical incision, the surgeon may only recognize the drilling trajectory through surface anatomy and need to repeat fluoroscopic imaging to confirm the drilling trajectory. Not only has the problem of unnecessary doses of X-ray exposure to the surgeons and patients but also the inaccuracy of the procedure remained unsolved. Many image guided medical instruments assist surgeons by visualization of the location of the bone drilling machine. Though, the drilling process still greatly depends on the operator's experience to align the tool and the severe failure events are hardly detected by the surgeons before those events occur. The inaccuracy often leads irreversible damage to the patients in the certain critical surgical procedures. [0004] Therefore, it would be very advantageous to provide surgeons a system or a method for controlling the drilling process precisely. With the present disclosure, the failure events occurred during drilling process is greatly reduced. It will be appreciated that the drilling control system and method assist the surgeon in accurate controlling the spindle speed and distinguishing among different tissue types. BRIEF DESCRIPTION OF THE DRAWINGS [0005] Implementations of the present technology will now be described, by way of example only, with reference to the attached figures. [0006] FIG. 1A shows the system diagram of the drilling control system. [0007] FIG. 1B shows an example of the drilling control system coupled to a display module and a spatial sensor system when applied on spinal surgery. [0008] FIG. 2A shows an information flow diagram that the control unit may receive biomechanical information and drilling information and may generate a control output. [0009] FIG. 2B shows a diagram of calculation of the discrepancy according to the biomechanical and the drilling information. [0010] FIG. 2C shows a flow diagram of the drilling control method. [0011] FIG. 3A shows biomechanical information with the planned drilling trajectory visualized in three-dimensional model. [0012] FIG. 3B shows the planned spindle speed along the planned drilling trajectory. [0013] FIG. 3C shows biomechanical property along the drilling depth. [0014] FIG. 4A shows biomechanical information simulated according to the force along z-axis as a function of drilling depth. FIG. 4B shows biomechanical information simulated according to the torque along z-axis as a function of drilling depth. FIG. 4C shows biomechanical information simulated according to the force along y-axis as a function of drilling depth. FIG. 4D shows biomechanical information simulated according to the torque along y-axis as a function of drilling depth. FIG. 4E shows biomechanical information simulated according to the force along x-axis as a function of drilling depth. FIG. 4F shows biomechanical information simulated according to the torque along x-axis as a function of drilling depth. [0015] FIG. 5A shows one example of the drilling control system applied on spinal surgery. [0016] FIG. 5B shows a graph illustrating the drilling information and the biomechanical information along the drilling depth. [0017] FIG. 5C shows a graph illustrating the discrepancy index along the drilling depth. [0018] FIG. 6A shows an example of the force/torque sensor coupled to the drilling motor. [0019] FIG. 6B shows an example of the joint force sensor coupled to the kinetic pairs. [0020] FIG. 6C shows an example of the motor current sensor coupled to the driving motor. [0021] FIG. 6D shows an example of the robotic assembly comprising universal-prismatic-spherical joint pairs. [0022] FIG. 6E shows an example of the robotic assembly comprising universal-prismatic-universal joint pairs. [0023] FIG. 7A shows an example of the operation base, which is a fixation base. [0024] FIG. 7B shows an example of the operation base, which is a combination of a fixation base and a handheld handle. [0025] FIG. 7C shows an example of the operation base, which is a handheld handle. [0026] FIG. 8A shows an example of the drilling control system coupled to the spatial sensor system, which is an optical tracking system. [0027] FIG. 8B shows an example of the drilling control system coupled to the spatial sensor system, which comprises multiple inertial measurement units and a drilling trocar with a position sensor. [0028] FIG. 8C shows an example of the drilling control system coupled to the spatial sensor system, which comprises multiple inertial measurement units and a drilling trocar with a proximeter. [0029] FIG. 9 shows an example of the drilling control system coupled to a C-arm fluoroscopy. [0030] FIG. 10 shows an example of the drilling control system capable of adjust alignment by the control unit. DETAILED DESCRIPTION [0031] It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein can be practiced without these specific details. In other instances, methods, procedures and components have not been described in detail so as not to obscure the related relevant feature being described. The drawings are not necessarily to scale and the proportions of certain parts may be exaggerated to better illustrate details and features. The description is not to be considered as limiting the scope of the embodiments described herein. [0032] Several definitions that apply throughout this disclosure will now be presented. [0033] The term “coupled” is defined as connected, whether directly or indirectly through intervening components, and is not necessarily limited to physical connections. The connection can be such that the objects are permanently connected or releasably connected. The term “comprising” means “including, but not necessarily limited to”; it specifically indicates open-ended inclusion or membership in a so-described combination, group, series and the like. [0034] In one example as shown in FIG. 1A , a drilling control system may comprise a control unit 600 and a drilling device 200 . The drilling control system 100 may be coupled to a spatial sensor system 400 to receive spatial information. The spatial sensor system 400 is configured to detect the spatial information of the drilling device 200 and the fiducial marker on the patient and to deliver the spatial information to the control unit 600 . The control unit 600 is configured to receive and store control input, to calculate control output according to the control input and to deliver control output to the drilling device 200 . The control input may comprise spatial information, mechanical information, spindle information and biomechanical information. The control unit 600 may receive control input from outside of the control unit 600 , such as, the spatial sensor system 400 , the drilling device 200 , computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography or a C-arm fluoroscopy or may store the control input, such as biomechanical information pre-processed from medical images. The drilling device 200 is configured to deliver mechanical information and spindle information to the control unit 600 , to receive the control output from the control unit 600 and to perform drilling process according to the control output. The drilling device 200 may comprise a mechanical sensor 220 , a drilling motor 240 , a driving motor, a robotic assembly 230 , and a surgical tool 210 . The mechanical sensor 220 may detect the mechanical information and deliver the mechanical information as a part of the control input to the control unit 600 . The control output may be delivered to the drilling motor 240 for controlling the spindle speed of the surgical tool 210 or to the robotic assembly 230 for controlling the orientation or the position of the surgical tool 210 . [0035] The drilling device 200 may comprise a surgical tool 210 , a drilling motor 240 driving the surgical tool 210 , a mechanical sensor 220 detecting mechanical information, a robotic arm assembly and an operation base 300 coupled to the robotic arm assembly. The surgical tool 210 is configured to create a hole powered by the drilling motor 240 . The surgical tool 210 may be a drill bit. The drilling motor 240 provides rotational power to drive the surgical tool 210 and may be controlled by the control unit 600 . The drilling motor may deliver the spindle information to the control unit according to the electric current passing through the drilling motor or via a motor rotation speed detection integrated circuit. In addition, the drilling motor may comprise a rotary encoder, a synchro, a resolver, a rotary variable differential transducer (RVDT), or rotary potentiometer to obtain the spindle speed of the surgical tools driven by the drilling motor and deliver the spindle information to the control unit. Usually, the drilling motor 240 is an electric motor such as a stepper motor, a servo motor or an ultrasonic motor. The servo motor may be an alternative current (AC) servo motor, a direct current (DC) (such as brush or brushless) servo motor. The mechanical sensor 220 is configured to detect mechanical information. The mechanical information may be the force or the torque applied on the surgical tool 210 and he force or the torque may be measured along x-axis, y-axis or z-axis. The mechanical sensor 220 may be a force sensor to detect the axial force or the deviation force. The mechanical sensor 220 may be a torque sensor to detect the rotational torque. The mechanical sensor 220 may be a torque sensor to detect the rotational torque. The robotic assembly 230 is configured to adjust the position and/or the orientation of the surgical tool 210 . The robotic assembly 230 comprises at least a kinetic pair, such as a prismatic arm, a universal joint pair, a screw joint pair or a cylindrical joint pair. Also, the robotic assembly 230 may comprise multiple kinetic pairs, such as Stewart type robotic arm or delta robotic arm. Each kinetic arm may be powered by a driving motor controlled by the control unit 600 . The operation base 300 is configured to serve as a static mechanical support to the robotic assembly 230 and to position the drilling device 200 near the surgical area. The operation base 300 may be a handheld handle 320 , a fixation stand 310 or a combination of a handheld handle and a fixation stand. The handheld handle gripped by a surgeon provides mobility during drilling process. The fixation stand may be coupled to the operation table fixed on the ceiling or fixed on the floor so that a surgeon may save most effort for handling the drilling device 200 . [0036] The spatial sensor system 400 is configured to detect the spatial information of the drilling device 200 corresponding to the fiducial marker at a surgical area. The spatial sensor system 400 may be optical tracking system, magnetic tracking system, ultrasound tracking system, global positioning system (GPS), wireless positioning system, inertial measurement unit (IMU) device or visible light camera device for localization of the drilling device 200 . For example, the spatial sensor system 400 may be an optical tracking system comprising a tracking sensor 410 , a device marker 430 and a fiducial marker 420 . The spatial information comprises three-dimensional coordinates and may further be recorded along with time series. [0037] In one example as shown in FIG. 1B , the spatial sensor system 400 may be an optical tracking system comprising a tracking sensor 410 , a fiducial marker 420 and a device marker 430 . The fiducial marker 420 and the device marker 430 may comprise an array of tracking points arranged in a specific geometry, for example, triangular arrangement or quadrilateral arrangement, for precise recognition with the use of the tracking sensor 410 . The fiducial marker 420 may be placed on the subject's skin surface or on a certain anatomical site, such as spinous process. The device marker 430 may be placed on the drilling device 200 . For example, the spatial sensor system 400 may comprise two device markers, wherein the first device marker 431 is coupled to the base platform of the drilling device 200 and the second device marker 432 is coupled to the moving platform 232 of the drilling device 200 . The tracking sensor 410 is capable of sensing the spatial information according to the relative location of the fiducial marker 420 and the device markers 430 so that the displacement and/or the orientation of the drilling device 200 can be recorded. The spatial information may comprise position and/or orientation in the sensing area, wherein the position in the area are noted as x, y, z and the orientation along x-axis, y-axis, z-axis are noted as α, β, γ. The drilling control system may further comprise a user interface 700 coupled to the control unit 600 to visualize the biomechanical information and the drilling information. [0038] In one example as shown in FIG. 2A , the drilling control system is configured to generate control output 640 according to the received control input for controlling the drilling device 200 during the drilling process. The control input may comprise the biomechanical information 610 and the drilling information 620 . The control unit 600 may send the control output to control the drilling device 200 . For example, the control output may be a visual or audio alarm to alert the surgeon, may be a spindle speed control signal to the drilling motor 240 , or may be a motion control signal to the robotic assembly 230 . [0039] As shown in FIG. 2B , the control unit calculate discrepancy index 630 according to the biomechanical information 610 and the drilling information 620 . The biomechanical information may be generated by the control unit or other processing units according to the image information and the planning information. The biomechanical information 610 may be modeled from image information such as an X-ray image of the surgical area or from a series of computed chromatography (CT) images of the surgical area. For example, the image information may comprise three-dimensional voxels with CT numbers. The planning information may comprise the planned spindle speed at each voxel and may further comprise the planned feed rate. Therefore, the biomechanical properties of each voxel may be generated according to the planned information. The biomechanical information 610 may comprises one-dimensional coordinate with corresponding biomechanical properties, may comprise two-dimensional pixels with corresponding biomechanical properties or may comprise three-dimensional voxels with corresponding biomechanical properties. The biomechanical properties may represent stiffness, hardness, smoothness, drilling impedance or resistance. The drilling information 620 is generated by the control unit 600 according to the mechanical information 622 , the spatial information 624 and the spindle information 626 . The drilling information 620 may be generated from the mechanical information 622 as a function of the spatial information 624 . The mechanical information 622 is the force or torque in specific direction detected by the mechanical sensor 220 . The spatial information 624 comprises the location of the drilling device 200 corresponding to the anatomical site and may be used to calculate feed rate. The spindle information may comprise the spindle speed of the surgical tool or the drilling motor. The spindle information 626 may be delivered from the drilling motor to the control unit so that the control unit may confirm and adjust the spindle speed consistent with the planning information. [0040] As shown in FIG. 2C , the drilling control method may be performed at a drilling control system. The drilling control method comprises detecting 910 mechanical information; receiving and storing 920 biomechanical information, mechanical information spatial information and spindle information; generating 930 drilling information according to the mechanical information, the spatial information, and spindle information; calculating 940 a discrepancy index according to the biomechanical information and the drilling information; sending 950 a control input according to the discrepancy index. In one example, the detecting step 910 is performed at a mechanical sensor of a drilling device in the drilling control system. The receiving and storing step 920 is performed at a control unit of the drilling control system wherein the biomechanical information may be received from a medical imaging device (such as CT or X-ray) or a medical image processing server, the mechanical information is received from the mechanical sensor, the spatial information is received from a spatial sensor system and the spindle information is received from a drilling motor. The generation step 930 , the calculating step 940 , and the sending step 950 is performed at the control input. [0041] In one example as shown in FIG. 3A , an image information is reconstructed as a three-dimensional model from a series of CT images for spinal pedicle drilling process. In some examples, the biomechanical information may comprise of biomechanical properties along the planned drilling trajectory. Then the surgical tool 210 touches the entry point (denoted as a in FIG. 3A ) of a vertebra. When the surgical tool starts breaking through the cortical bone on the vertebra, the value of the biomechanical property increases at the beginning and then drops to lower value after the tool penetrates the boundary (denoted as b in FIG. 3A ) between the cortical bone and the cancellous bone. Afterwards, a different spindle speed, say a low spindle speed, is assigned to the drilling tool. The biomechanical property keeps low values until the tool touches another boundary (denoted as c in FIG. 3A ) between the cortical bone and the cancellous bone again. At the exit point (denoted as d in FIG. 3A ) of pedicle, the biomechanical property decease drastically. [0042] As shown in FIG. 3B , the planning information comprises the spindle speed varying along the drilling depth. Different spindle speeds of the surgical tool are assigned for different stages in drilling process. The spindle speed profile of the drilling tool can be determined from the simulation of the surgical planning software. Drilling the cortical bone at a high spindle speed can reduce the possibility of deviation from the planned trajectory at this critical stage of bone drilling procedure. For example, a high spindle speed is assigned when the surgical tool touches the entry point of the cortical bone to achieve a desired feed rate along the planned drilling trajectory. After breaking through into the cancellous bone, the spindle speed is decreased by the control unit to have better detection of the biomechanical property. Therefore, the discrepancy index is more sensitive if the drilling information does not match the biomechanical information. [0043] As shown in FIG. 3C , the biomechanical property along the drilling depth is distinguishable at a low spindle speed. The biomechanical properties for drilling cortical bone and cancellous bone at a low spindle speed can be more distinguishable than at a high spindle speed. During simulation, the control unit is also capable of generating the biomechanical information along other trajectories. At an optimized spindle speed, the surgical tool maintains good stability on the planned trajectory and the biomechanical properties of the planned trajectory and other fault trajectories are distinguishable to the control unit. [0044] The biomechanical information comprising a biomechanical property per voxel is generated from the image information. The planning information comprising a planned drilling trajectory and a planned spindle speed may be predetermined by a surgeon or may be determined by optimization algorithm. In the example, the planned drilling trajectory is starting from the pedicle of a lumbar vertebra to the vertebral body. For ease of description, the z-axis is defined along the planned drilling trajectory, y-axis is defined as perpendicular to the vertebral body, and x-axis is the cross product of y-axis and z-axis. Accordingly, biomechanical information comprising biomechanical properties per voxel along the planned drilling trajectory can be predicted. The image information may be reconstructed into biomechanical information comprising biomechanical properties (denoted as u) and tissue types (denoted as t) corresponding to spatial location with three reference axes (denoted as rx, ry, rz). For example, each voxel with certain biomechanical information may be described as V(rx, ry, rz, t, u). In biomechanical simulation, the simulated force or torque may be calculated according to the cutting speed, uncut thickness, rake angle, inclination angle and width of the cutting edge element in each voxel under the condition of the planned information. The biomechanical property may be stored as a vector in directional components. For example, a z-component of the biomechanical property may be calculated as the torque along the z-axis divided by the planned spindle speed. In addition, the biomechanical property may be the force divided by the planned feed rate, the force divided by the planned spindle speed, or the torque divided by the feed rate. Tissue type may be classified according to the CT number (or Hounsfield unit) and may be used to highlight the neural tissue so that the control drilling system is capable of avoiding damage to the neural tissue. The planned drilling trajectory is determined before the drilling process by a surgeon or computer-assisted program. [0045] The biomechanical information may be the biomechanical property as a function of drilling depth. One of the typical drilling impedance patterns, for example, may display the large value at the entry point, then drops to low values and last for a certain distance in the pedicle tunnel due to low resistance of the cancellous bone inside the pedicle. Afterwards the tool reaches the cortical bone at the exit of the pedicle, the drilling impedance again increases to high values at the contact of cortical bone and drops to low values after breaking through the cortical bone. However, if the tool deviates from the planned trajectory for some reasons, the increasing or dropping pattern of the drilling information will display earlier than expected location on the planned trajectory even though the image displays that tool is on the planned trajectory. The difference of drilling impedance pattern will be able to be used as a second opinion and gives a warning to the surgeon for safety check for the possibility of tool deviation. [0046] The biomechanical information may be simulated according to at least one force along an axis or one torque along an axis in varying drilling depth. As shown in FIG. 4A , the biomechanical property is simulated according to the force along z-axis. As shown in FIG. 4B , the biomechanical property is simulated according to the torque along the z-axis. As shown in FIG. 4C , the biomechanical property is simulated according to the force along y-axis. As shown in FIG. 4D , the biomechanical property is simulated according to the torque along y-axis. As shown in FIG. 4E , the biomechanical property is simulated according to the force along x-axis. As shown in FIG. 4F , the biomechanical property is simulated according to the torque along x-axis. [0047] In one example as shown in FIG. 5A , the drilling control system is applied on a spinal pedicle drilling process. The mechanical sensor 220 detects mechanical information and the spatial sensor system detects the spatial information. In one example, the spatial sensor system acquires the spatial information by the tracking sensor 410 detecting the fiducial marker 420 and the device marker 430 . The drilling information comprising the measured biomechanical property along the drilling trajectory will be compared with the biomechanical information comprising the biomechanical property along the planned trajectory. The differences of the drilling information and the biomechanical information are used for the judgment whether the surgical tool 210 is following the planned trajectory. [0048] As shown in FIG. 5B , the biomechanical information 610 is presented as the biomechanical property under the condition of the planning information and the drilling information 620 is the measured biomechanical property recorded as a function of the spatial information. The measured biomechanical property is derived from the mechanical information, the spatial information and the spindle information. For example, the measured biomechanical property may be defined as the ratio of the force/torque over the surgical tool's feed rate/spindle speed along the moving direction. The control unit 600 monitoring the deviation between the drilling information and the biomechanical information. [0049] In the example, the deviation may be determined by the discrepancy index. The discrepancy index is calculated according to the correlation between a first data window extracted from the biomechanical information 610 and a second data window extracted from the drilling information 620 . First of all, a window with width N is assigned (as shown in FIG. 5B ). The biomechanical information 610 is represented as the biomechanical property, I p , as a function of the drilling depth z. The discrete calculation of the cross correlation between the biomechanical information and the drilling information in the window with width Nis presented as: [0000] r pm  ( z k ) = ∑ n = k - N + 1 k   I p  ( z n )  I m  ( z n ) , [0000] where z k is the kth sample of the drilling depth, n is the nth sample of the drilling depth, r pm (z k ) is the cross correlation of Ip and Im at drilling depth z k , (z n ) is the biomechanical property at the nth sample of the drilling depth along the planned trajectory, and I m (z n ) is the measured biomechanical property at the nth sample of the drilling depth during the drilling process. Furthermore, the normalized cross correlation is calculated as: [0000] ρ pm  ( z k ) = r pm  ( z k ) r pp  ( z k )  r mm  ( z k ) ,  where r pp  ( z k ) = ∑ n = k - N + 1 k   I p  ( z n )  I p  ( z n ) ,  r mm  ( z k ) = ∑ n = k - N + 1 k   I m  ( z n )  I m  ( z n ) . [0000] ρ pm (z k ) is defined as the cross correlation normalized by the square root of the product of the autocorrelation. Then the discrepancy index is defined as: Ψ(z k )=1−ρ pm (z k ). The discrepancy index is zero when these two curves are completely matched and increases from zero when one of the two curves is away from the other. [0050] As shown in FIG. 5C , the discrepancy index along drilling depth is represented corresponding to the biomechanical information 610 and the drilling information 620 in FIG. 5B . During the depth from z a to z k , the discrepancy index is around zero. At the depth z b , the drilling information 620 shows increasingly deviated from the biomechanical information 610 . Therefore, the increase of the discrepancy index is noted. The control unit detects the discrepancy index and then send a control signal to slow or even stop the drilling motor if the discrepancy index is greater than the predetermined threshold. [0051] In another example, the discrepancy index is calculated according to the slope of the biomechanical information and the slope of the drilling information. The control output is determined by the discrepancy index compared to a defined threshold. For example, the control output may be an alarm signal triggered or a spindle speed control signal to decrease the spindle speed when the discrepancy index is greater than the defined threshold; the control output may be a spindle speed control to keep the spindle rate when the discrepancy index is smaller than the defined threshold. [0052] In one example as shown in FIG. 6A , the mechanical sensor is a force/torque sensor 221 capable of sensing the force in x-axis, y-axis, z-axis and the torque in x-axis, y-axis, z-axis. The mechanical sensor may be a six-axis force/torque sensor 221 coupled to the moving platform 232 of the robotic assembly 230 and the surgical tool 210 , wherein the force/torque sensor 221 detects mechanical information including the force and the torque along x-axis, y-axis and z-axis and delivers the mechanical information to the control unit. [0053] In one example as shown in FIG. 6B , the mechanical sensor may be a joint force sensor 225 capable of sensing the strain or the force along the kinetic pair. The joint force sensor 225 may be a strain gauge coupled to the kinetic pairs 235 of the robotic assembly, wherein the joint force sensor 225 detects mechanical information and delivers the mechanical information to the control unit. The joint force sensors 223 is capable of sensing the force and the torque along x-axis, y-axis and z-axis. [0054] In one example as shown in FIG. 6C , the mechanical sensor is a motor current sensor coupled to the driving motors of the robotic assembly, wherein the mechanical sensor 220 detects mechanical information and delivers the mechanical information to the control unit. The drilling device may comprise multiple driving motors for the kinetic pairs and each of the motor current sensors is coupled to one driving motor of the robotic assembly. The mechanical sensor 220 is capable of sensing the electric current of the driving motors and then calculating the force and the torque along x-axis, y-axis and z-axis. [0055] In one example as shown in FIG. 6D , the robotic assembly may be a Stewart type platform comprising six universal-prismatic-spherical (UPS) kinetic pairs. The UPS pair comprises a universal joint pair 236 coupled to the base platform 231 , a prismatic joint pair 237 coupled to the universal joint pair 236 and a spherical joint pair 238 coupled to the moving platform 232 and the spherical joint pair 238 . [0056] In one example as shown in FIG. 6E , the robotic assembly may be a Stewart type platform comprising six universal-prismatic-spherical (UPS) kinetic pairs. The UPS pair comprises a universal joint pair 236 coupled to the base platform 231 , a prismatic joint pair 237 coupled to the universal joint pair 236 and a universal joint pair 236 coupled to the moving platform 232 . In one example as shown in FIG. 7A , the drilling control system comprises an optical tracking system, a drilling device 200 and a control unit 600 , wherein the operation base 300 of the drilling device 200 is a fixation base 310 . The fixation base provides 310 mechanical stability so that the robotic assembly is steadily controlled with minimal unexpected movement. The fixation base 310 may be standing on the floor, hung on the ceiling or clamped to an operation table. The fixation base 310 may further comprise multiple mechanical joints 330 to stabilize the motion of the drilling device 200 . [0057] In one example as shown in FIG. 7B , the operation base 300 comprising the fixation base 310 may further comprise a handheld handle 320 and mechanical joints 330 so that the surgeon may have a degree of motion control of the drilling device 200 . [0058] In one example as shown in FIG. 7C , the fixation base 300 is a handheld handle 320 so that the surgeon may have most motion control of the drilling device 200 and compatible with the surgeon's user experience. [0059] In one example as shown in FIG. 8A , the spatial sensor system 400 is a drilling trocar 460 comprising a position sensor 450 , wherein the position sensor 450 detects the spatial information of the drilling device 200 and delivers the spatial information to the control unit 600 . The position sensor 450 may be configured on the tunnel of the trocar so that the spatial information comprising at least one degree of freedom as drilling depth is detected. Furthermore, the spatial sensor system 400 may be a combination of the drilling trocar and the optical tracking system capable of detecting spatial information comprising six degree of freedom. [0060] In one example as shown in FIG. 8B , the spatial sensor system 400 is a drilling trocar 460 comprising a position sensor 450 , wherein the position sensor 450 detects the spatial information of the drilling device 200 and delivers the spatial information to the control unit 600 . The position sensor 450 may be configured on the tunnel of the drilling trocar 460 so that the spatial information comprising at least one degree of freedom as drilling depth is detected. The position sensor 450 may be a linear variable displacement transducer (LVDT) or a displacement sensor. Furthermore, the spatial sensor system 400 may be a combination of the drilling trocar and the inertial measurement units (IMU) 440 capable of detecting spatial information comprising six degree of freedom. In one example, the IMUs 440 may be configured on the base platform, moving platform 232 and an anatomical site. [0061] In one example as shown in FIG. 8C , the spatial sensor system 400 is a drilling trocar 460 comprising a position sensor 450 , wherein the position sensor 450 detects the spatial information of the drilling device 200 and delivers the spatial information to the control unit 600 . The position sensor 450 may be configured on the outer part of the trocar so that the spatial information comprising at least one degree of freedom as drilling depth is detected. In the example, the position sensor may be a telemeter or a proximeter 455 to detect the distance between the outer part of the drilling trocar 460 and the moving platform 232 . Furthermore, the spatial sensor system 400 may be a combination of the drilling trocar and the optical tracking system capable of detecting spatial information comprising six degree of freedom. [0062] In one example as shown in FIG. 9 , the drilling control system may receive the image information from a C-arm fluoroscopy to update the biomechanical information. Furthermore, the image information from the C-arm fluoroscopy may be used to confirm the spatial information. The drilling control system comprises a drilling device 200 and a control unit 600 and the control unit 600 is coupled to a C-arm fluoroscopy 850 . In addition, the C-arm fluoroscopy may provide a part of spatial information for confirming the position and the orientation of the surgical tool. The drilling control system may further comprise a user interface 700 coupled to the control unit 600 to visualize the biomechanical information and the drilling information. [0063] In one example as shown in FIG. 10 , the robotic assembly may be a parallel manipulator configured to position the moving platform 232 with multi-degree-of-freedom. The control unit may generate control output according to the drilling information to compensate mis-alignment of the surgical tools during drilling process. Therefore the handheld robot-assisted surgical system can reduce the errors from surgeon's manual mis-alignment. When surgeon holds the handheld robot to the nearby of the target position/orientation on the vertebras, the handheld robot will automatically adjust the surgical tool 210 to the desired position/orientation and keep the desired position/orientation no matter any motion caused by surgeon's hand or anatomy. In one example as shown in FIG. 10 , the control unit 600 may generate a control output according to the drilling information. The control output may be a motion control signal to control the robotic assembly or a spindle speed control signal to control the spindle rate of the drilling motor 240 . The mechanical sensor 220 measures the forces and/or torques applied on the surgical tool 210 in the directions, for example, along x-axis, y-axis and z-axis. The robotic assembly adjusts the position/orientation of the surgical tool 210 according to the measured deviation forces/torques so that the deviation of the tool from the planned drilling trajectory can be reduced. Moreover, the force and/or torque along the planned trajectory together with the spatial information from marker and/or marker, is used to calculate the drilling impedance. Therefore, the robotic assembly can control the surgical tool 210 attached to the moving platform 232 to align with the desired position/orientation. [0064] Furthermore, the control unit may send a motion control signal to the drilling device according to the planning information. For example, the planning information is the feed rate of drilling process. The drilling device may adjust the force apply on the z-axis by slightly protracting or retracting the robotic assembly. In addition, the drilling device may also be adjusted according to the force or the torque in x-axis and y-axis to reduce deviation from the planned drilling trajectory. [0065] It is contemplated that the control unit may be a solitary work station coupled to the drilling device or may be a system in package embedded in the drilling device. [0066] The examples shown and described above are only examples. Therefore, many such details are neither shown nor described. Even though numerous characteristics and advantages of the present technology have been set forth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in the detail, including in matters of shape, size and arrangement of the parts within the principles of the present disclosure up to, and including the full extent established by the broad general meaning of the terms used in the claims. It will therefore be appreciated that the examples described above may be modified within the scope of the claims.

1a

This is a divisional of application Ser. No. 07/797,523, filed on Nov. 25, 1991, now U.S. Pat. No. 5,268,352, which is a continuation of application Ser. No. 07/440,179, filed on Nov. 22, 1989, abandoned. BACKGROUND OF THE INVENTION This invention relates to novel and useful agricultural formulations of herbicidal agents which exhibit poor solubility characteristics in both aqueous and organic media. Emulsifiable suspension concentrate compositions (or oil flowable dispersions) are compositions which consist essentially of an active agent in a solid state suspended in a non-aqueous liquid containing a surfactant or a mixture of surfactants and said compositions having the property of forming an emulsion when diluted with water. Emulsifiable suspension concentrate compositions containing pesticides such as herbicides and fungicides as the active agent and paraffinic oils as the non-aqueous liquid are described in European Patent Applications EP-A1-243872 and EP-A2-142670. However, said patent applications do not describe the use of aromatic solvents as the non-aqueous liquid. Herbicidal agents, such as N-phosphonomethylglycine (glyphosate) and 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)nicotinic acid (imazapyr), are especially useful for controlling undesirable plant species when applied postemergence. In addition to being highly effective herbicides, said compounds are zwitterionic in nature and generally relatively insoluble in both aqueous and non-aqueous media. Therefore, these types of herbicidal agents are routinely formulated as the corresponding salts as described in European Patent Application EP-A2-220902 and U.S. Pat. No. 4,816,060. It is an object of this invention to provide an emulsifiable suspension concentrate composition of the free acids of a herbicidal agent, such as N-phosphonomethylglycine and 2-(imidazolin-2-yl)pyridine carboxylic acids, without the pre-formulation of the corresponding herbicidal salts. It is an object of this invention to produce herbicidal compositions which are physically stable and readily dilutable in hard or soft water to give a sprayable herbicidal emulsion. SUMMARY OF THE INVENTION The present invention relates to a novel emulsifiable suspension concentrate composition of a herbicidal agent characterized by a relative degree of insolubility in both aqueous and non-aqueous media. The emulsifiable suspension concentrate composition of the invention is comprised of an active herbicidal agent, or combination of agents, in a solid state suspended in a water immiscible solvent containing an anionic surfactant and a nonionic surfactant and optionally containing an antifoam agent and a suspending or thickening agent. The water immiscible solvent is a non-paraffinic heavy aromatic solvent consisting of a mixture of aromatic hydrocarbons, such as naphthalenes and alkylnapthalenes, having a distillation range of about 118° to 305° C. The above-described compositions allow the formulation of active herbicidal agents such as amino acids and imidazolinylnicotinic acids without further chemical modifications, such as salt or ester formation. The above compositions provide a stable, concentrated, readily dilutable form of a herbicide suitable for spray application. The compositions also exhibit surprising herbicidal efficacy comparable to the efficacy of the corresponding salts. DETAILED DESCRIPTION OF THE INVENTION The present invention also relates to an emulsifiable suspension concentrate composition of a herbicidal agent comprising an amino acid or imidazolinylpyridine carboxylic acid (alone or in combination) in a solid state suspended in a water immiscible liquid containing an anionic surfactant and an ethoxylated fatty acid surfactant and optionally containing an antifoam agent and a thickening or suspending agent. The herbicidal agent is usually sold in a concentrated form either as a solid or a liquid and, just prior to application, the concentrate is diluted with water, or water containing adjuvants, and sprayed on fields of soil and/or actively growing plants. Solid concentrate formulations, such as granulars, wettable powders and dusts, may also be used. Since not all solid concentrate formulations of the free acid form of herbicidal agents, such as N-phosphonomethylglycine, exhibit the same high magnitude of efficacy and further since certain highly effective herbicidal compounds, such as N-phosphonomethylglycine and imidazolinylnicotinic acids, are relatively insoluble in water and conventional organic solvents, they are not readily amenable to commercial formulation. Chemical modification of said compounds to give the corresponding salts is required to improve their solubility characteristics. Surprisingly, it has been found that compounds, such as amino acids and imidazolinylnicotinic acids, may be formulated as liquid concentrates without further chemical modifications of said compounds and with a high degree of retention of efficacy. The emulsifiable suspension concentrate compositions of the present invention are comprised of about 10% to 50% of a herbicidal agent, such as N-phosphonomethylglycine or an imidazolinylnicotinic acid, alone or in combination, suspended in about 29% to 84% of a non-paraffinic aromatic solvent mixture having a distillation range of 118° to 305° C. containing about 3% to 10% of an anionic surfactant, about 3% to 10% of an ethoxylated fatty acid surfactant, 0 to about 0.10% of an antifoam agent and 0 to about 2.0% of a suspending or thickening agent. One preferred composition comprises about 30% to 50% of an active herbicidal agent or combination of agents, about 40% to 57% of a non-paraffinic aromatic solvent mixture having a distillation range of 118° to 305° C., about 5.0% to 7.0% of an anionic surfacant, about 5.0% to 7.0% of an ethoxylated fatty acid surfactant, about 0.02% to 0.15% of an antifoam agent and 0.5 to 2% of a suspending agent. Among the herbicidal agents suitable for use in the compositions of the invention are amino acids such as glyphosate and imidazolinylpyridine carboxylic acids such as imazapyr and combinations thereof. A preferred herbicidal agent is glyphosate, alone or in combination with an imidazolinylnicotinic acid. Solvents suitable for use in the compositions of the invention include heavy aromatic solvent mixtures having a distillation range of 118° to 305° C. Preferred solvents include those mixtures of aromatics having a distillation range of about 183° to 285° C., and the most preferred aromatic solvent mixtures is that which distills in a range of about 225° to 280° C. Anionic surfactants suitable for use in the present invention include alkylarylsulfonic acids such as C 8 -C 18 alkylbenzenesulfonic acid, with dodecylbenzenesulfonic acid being the preferred anionic surfactant. Among the ethoxylated fatty acid surfactants which may be employed are ethoxylated castor oils with about 15-60 ethylene oxide units per molecule. Preferred ethoxylated castor oils are those which have about 36-40 ethylene oxide units per molecule. Suitable antifoam agents include silicone polymers containing silica such as dimethylsilicone polymer plus silica, and suitable suspending or thickening agents include hydrated fumed silica or attapulgite clays or amine treated attapulgite clays. The herbicidal emulsifiable suspension concentrate compositions may be prepared by dissolving an anionic surfactant in an aromatic solvent and adding a solid herbicidal agent or combination of agents, with vigorous agitation to form a suspension. This suspension is milled to the required particle size distribution. A median particle diameter of 1-2 microns provides suitable physical properties. The milled suspension is treated with an ethoxylated fatty acid surfactant and, optionally, an antifoam agent and a suspending or thickening agent and mixed thoroughly. Alternatively, the herbicidal agent is milled as a dry powder and is added to a solution of the anionic surfactant in the aromatic solvent with vigorous agitation to ensure complete dispersion and the remaining components are added with stirring. The above-prepared emulsifiable suspension concentrate compositions are physically stable and demonstrate excellent dilution properties in hard and soft waters to produce a sprayable herbicidal emulsion. In practice, it is generally preferable to dilute the compositions of the invention in water containing about 0.25% of an adjuvant such as a polyoxyethylene sorbitan laurate surfactant to obtain an especially high degree of herbicidal activity. In order to facilitate a further understanding of the invention, the following examples are presented primarily for the purpose of illustrating certain more specific details thereof. The invention is not to be deemed limited thereby except as defined in the claims. Unless otherwise noted, all parts are by weight. EXAMPLE 1 ______________________________________Component %______________________________________N-phosphonomethylglycine 41.90Dodecylbenzenesulfonic acid 6.00Ethoxylated castor oil, 36 C..sup.1 6.00Dimethylsilicone polymer with silica.sup.2 0.10Mixture of aromatic hydrocarbons with 46.00a distillation range of 226°-279° C..sup.3 100.00______________________________________ .sup.1 36 units of ethylene oxide per molecule Flomo ® 36 C., manufactured by DeSoto .sup.2 TH 100IND ® antifoam, manufactured by ThompsonHayward .sup.3 Aromatic 200°, manufactured by EXXON Method 1 An anionic surfactant, dodecylbenzenesulfonic acid, is dissolved in a water immiscible solvent, Aromatic 200®, with stirring. This solution is treated with the herbicidal agent, N-phosphonomethylglycine, in a crystalline or powder state with vigorous stirring to give a dispersion. The resultant dispersion is milled until a median particle size of 1-2 microns is obtained. The milled dispersion is treated with an ethoxylated fatty acid surfactant, castor oil, 36C 1 , and an antifoam agent, dimethylsilicone polymer with silica 2 and mixed thoroughly. Method 2 The herbicidal agent, N-phosphonomethylglycine, is milled to give a median particle size of 1-2 microns and then added to a solution of an anionic surfactant, dodecylbenzenesulfonic acid in a water immiscible solvent, Aromatic 200®, with vigorous agitation. The resultant dispersion is treated with an ethoxylated fatty acid surfactant, castor oil, 36C 1 , and an antifoam agent, dimethylsilicone polymer plus silica 2 , and mixed thoroughly. Physical Properties The physical characteristics of the above-described N-phosphonomethylglycine emulsifiable concentrate composition are shown below. ______________________________________Viscosity (Brookfield LVT at 22° C. 500-600 cPspindle #2, speed 30 rpm)Density at 20° C. 1.41 g/mLParticle size (Horiba CAPA 700) 1.21 microns (median)pH, 2% diluted in deionized water 2.0-2.4Dispersibility in water (in both Good emulsifica-standard hard and soft waters), tion, no oil sep-2.5 g in 100 ml total volume. aration after 24 hours.______________________________________ EXAMPLE 2 ______________________________________Components A B______________________________________Imazethapyr -- 33.3Imazapyr 33.33 --Dodecylbenzenesulfonic acid 5.00 5.00Ethoxylated castor oil, 36 C..sup.1 5.00 5.00Dimethylsilicone polymer with 0.03 0.03silica.sup.2Mixture of aromatic hydrocarbons 56.64 56.64with a distillation range of226°-279° C. 100.00 100.00______________________________________ .sup.1 36 units of ethylene oxide per molecule Flomo ® 36 C., manufactured by DeSoto .sup.2 TH IND30 ® antifoam, manufactured by ThompsonHayward .sup.3 Aromatic 200 ®, manufactured by EXXON Method The herbicidal agent, as a finely divided powder, is added to a rapidly stirred solution of the anionic surfactant, dodecylbenzenesulfonic acid, in the aromatic solvent, Aromatic 200®. The resultant dispersion is treated with the remaining components and placed on a high shear mixer for 3 minutes. Optionally the solid herbicidal agent is milled to a median particle size of 1-2 microns prior to use in the above-described preparation. ______________________________________Physical Properties A B______________________________________Dispersibility in water, Good emulsi- Good emulsi-4.0 g in 100 ml total fication, fication,volume. slight settl- slight settl- ing after 24 ing after 24 hours, easily hours, easily resuspended resuspended______________________________________ EXAMPLE 3 ______________________________________Preparation of combination emulsifiable suspension con-centrate compositionsComponents C D______________________________________Glyphosate 37.69 32.89Imazapyr 4.20 9.00Dodecylbenezenesulfonic acid 6.00 6.00Flomo ® 36 C..sup.1 6.00 6.00TH 100IND ® antifoam.sup.1 0.10 0.10Aromatic 200 ®.sup.1 46.01 46.01 100.00 100.00______________________________________ .sup.1 As described in Example 1. Method A solution of dodecylbenzene in Aromatic 200® is treated with glyphosate with rapid stirring. The resultant dispersion is treated with the remaining components and placed on a high shear mixer for 3 minutes. Optionally, a dispersion of glyphosate and the imidazolinylnicotinic acid solid in a solution of dodecylbenzenesulfonic acid in Aromatic 200® is milled to give a median particle size of 1-2 microns prior to the addition of the remaining components. ______________________________________Physical Properties C D______________________________________Dispersibility in water, Good emulsi- Good emulsi-4.0 g in 100 ml total fication, fication,volume. slight oil slight oil separation separation after 24 after 24 hours, easily hours, easily resuspended resuspended______________________________________ EXAMPLE 4 Greenhouse Postemergent Herbicidal Evaluation This is an evaluation of the postemergent herbicidal activity of the emulsifiable suspension concentrate composition of N-phosphonomethylglycine as compared to a commercial aqueous solution composition of the isopropylammonium salt of N-phosphonomethylglycine. The test compositions used for this evaluation are the emulsifiable suspension concentrate composition of N-phosphonomethylglycine which is described in Example 1 and referred to herein as Glyphosate 40 ESC and an aqueous soluble composition of the isopropylammonium salt of N-phosphonomethylglycine which is commercially sold by Monsanto under the trademark ROUNDUP® and referred to herein as Glyphosate Salt. Seedling plants are grown in jiffy flats for about 2 weeks. The glyphosate 40 ESC composition is dispersed in water containing 0.25% TWEEN-20®, a polyoxyethylene sorbitan monolaurate surfactant manufactured by Atlas Chemical Industries in sufficient quantity to provide the equivalent of about 0.063 kg to 0.500 kg per hectare of N-phosphonomethylglycine to the plants when applied through a spray nozzle operating at 40 psi for a predetermined time. The Glysphosate Salt is dispersed in water according to the label directions and applied to the plants as described above. After spraying, the plants are placed on greenhouse benches and cared for in the usual manner commensurate with conventional greenhouse practices. The plants are evaluated at 7 and 14 days after treatment and rated according to the rating system shown below. ______________________________________Rating System % Control______________________________________No effect 0Possible effect 1-10Slight effect 11-25Moderate effect 26-40Definite injury 41-60Herbicidal effect 61-75Good Herbicidal effect 76-90Approaching complete kill 91-99Complete kill 100______________________________________ ______________________________________Plant Species UsedCommon Name Scientific Name______________________________________Mustard Wild Brassica kaberCotton Gossypium hirsustumCorn Zea maysMorningglory Ipomoea purpureaSoybean Glycine maxBarnyard Grass Echinochloa crus-galliLambsquaters Chenopidium albumRagweed Ambrosia artemisifoliaGreen Foxtail Setaria veridis______________________________________ The data obtained at 14 days after treatment are reported in Table I below. TABLE I__________________________________________________________________________Postemergence Herbicidal Evaluation Grn Rate Must Cot Field Morn Soy Barn Lambs Rag FoxComposition (ka/ha) ard ton Corn glry bean yardg quart weed tail__________________________________________________________________________Glyphosate Salt 0.500 80.0 80.0 90.0 66.7 78.3 98.7 99.3 38.3 100.0Glyphosate ESC 0.500 60.0 50.0 95.0 71.7 80.0 94.3 96.3 40.0 91.7Glyphosate Salt 0.250 38.3 35.0 58.3 63.3 63.3 71.0 83.3 33.3 85.0Glyphosate ESC 0.250 33.3 40.0 85.3 75.3 71.7 78.3 100.0 53.3 93.3Glyphosate Salt 0.125 13.3 20.0 18.3 30.0 20.0 23.3 61.7 6.7 46.7Glyphosate ESC 0.125 26.7 3.3 71.7 30.0 50.0 48.3 83.3 23.3 81.7Glyphosate Salt 0.063 0.0 3.3 3.3 15.0 6.7 16.7 36.7 0.0 20.0Glyphosate ESC 0.063 6.7 0.0 61.7 10.0 20.0 35.0 70.0 13.3 40.0__________________________________________________________________________ EXAMPLE 5 Field Postemergent Herbicidal Evaluation The test compositions used are Glyphosate 40 ESC and Glyphosate Salt, and are as described in Example 4. A field containing established, actively growing plants is divided into plots of 10 meters×30 meters and is sprayed with a tractor mounted compressed air sprayer with a delivery of 200 liters per hectare. The Glyphosate 40 ESC composition is dispersed in water containing 0.25% TWEEN-20® in sufficient quantity to provide the equivalent of 2.0 kg to 0.5 kg per hectare to the plants. Glyphosate Salt is dispersed in water according to the label directions and applied to the plants as described hereinabove. The plots are evaluated at 7 and 14 days after treatment. Each treatment is replicated once. The data obtained for 14 days after treatment is reported in Table II. ______________________________________Plant SpeciesCommon Name Scientific Name______________________________________Redroot pigweed Amoranthus retroflexusCommon lambsquarters Chenopodium albumCommon purslore Portulara oleraceaCommon ragweed Ambrosia artemisiifolaLarge crabgrass Digitaria sanguiralisFall panicum Panicum diclotomiflorumBarnyard grass Echirochloa curs-galliFoxtail millet Setaria italica______________________________________ TABLE II__________________________________________________________________________Postemergence Field Evaluation Red Root Fox Rate Pig Lambs Rag Crab Fall Bard tailComposition kg/ha weed quart weed gras pani yardq millet__________________________________________________________________________Glyphosate Salt 0.5 100 80 98 100 95 100 100Glyphosate ESC 0.5 100 100 85 100 98 100 100Glyphosate Salt 1.0 100 100 100 100 100 100 100Glyphosate ESC 1.0 100 100 100 100 100 100 100Glyphosate Salt 2.0 100 100 100 100 100 100 100Glyphosate ESC 2.0 100 100 100 100 100 100 100__________________________________________________________________________

1a

This application is a division of application Ser. No. 10/741,646, filed Dec. 19, 2003, now abandoned which is a continuation-in-part of application Ser. No. 10/453,002, filed Jun. 3, 2003 now abandoned claiming the benefit of the filing date of provisional application Ser. No. 60/385,082, filed Jun. 3, 2002 entitled SILICA-CALCIUM PHOSPHATE COMPOSITE FOR IMPROVED SYNTHETIC GRAFTED RESORBABILITY AND TISSUE REGENERATION, which are incorporated by reference herein. FIELD OF THE INVENTION This invention relates to bone tissue generation and more particularly to a method for bone tissue generation employing a method for the generation of bone tissue by the preparation and the application to bone defect sites of a resorbable silica-calcium phosphate bioactive composite (SCPC) that finds utility as a bone tissue engineering scaffold. BACKGROUND OF THE INVENTION Silica-based bioactive glasses and calcium phosphate ceramics have long been known to serve as synthetic materials useful in the promotion of bone formation in repairing bone fractures and the like. These materials are considered bioactive because they bond to bone and enhance bone tissue formation with a variable degree of success. An estimated 11 million people in the United States have at least one medical device implant. Two types of implants, fixation devices (usually fracture fixation) and artificial joints are used in orthopedic treatments and oral and maxillofacial procedures. Approximately 80% of the fracture fixation requires adjuvant grafting. Among the joint replacement procedures an increasing number are revision surgeries with their adjuvant need for bone grafting. Current approaches to difficult bone repair problems include utilization of autografts, allografts and synthetic grafts. Although at present auto graft material is preferentially used, there is limitation in its use, including donor site morbidity, limited donor bone supply, anatomical and structural problems and elevated levels of resorption during healing. The use of allografts has a disadvantage of eliciting an immunalogical response due to genetic differences and the risk of reducing transmissible diseases. Considerable attention has been directed to the use of synthetic materials for bone graft, most notably hydroxyapatite, tricalcium phosphate and bioactive glass. The synthetic graft material is also used to form coatings on implants, such as pins and the like, to promote attachment of new bone growth to the implement. In addition, these materials are also used as fillers in biopoloymer composites and drug delivery vehicles. SUMMARY OF THE INVENTION In accordance with the present invention, there is provided a method for the generation of bone tissue by the preparation and the application to bone defect sites of a resorbable silica-calcium phosphate bioactive composite (SCPC) that finds utility as a bone tissue engineering scaffold. The resorbable silica-calcium phosphate bioactive composite can be applied directly to bone defect or can be employed as a bioactive coating on implants to facilitate bone growth around the implant. The improved SCPC defines a surface that can contain four different phases; 1) silica modified with calcium and/or phosphorous, 2) unmodified silica/silanol groups required to nucleate calcium phosphate precipitation, 3) calcium phosphate modified with silica and 4) unmodified calcium phosphate. These four different phases ensure the availability of a surface with superior bioactivity as compared to calcium phosphate ceramic or bioactive glass conventionally used as a scaffold to promote bone tissue growth. In addition the presence of sodium in the form of β-NaCaPO 4 has a synergistic effect on the absorbability of protein that contributes to improved bioactivity. While the resorption and bioactivity of bioactive glass is limited by the diffusion of Ca and P ions from the glass bulk to the surface, the resorption and bioactivity of the SCPC does not depend on the bulk composition. In addition to providing an immediate bioactive surface layer that enhances protein adsorption and cell function, the silicon released from the surface may have a stimulatory effect on bone cell function. The bioactivity and the resorbability of the SCPC is affected and controlled by its chemical composition, which prior to thermal treatment, comprises a mixture of an organic or inorganic silica salt and a calcium phosphate. In addition, its crystalline structure, the degree of the alkaline environment presented by the SCPC composition, its porosity and its thermal treatment temperature combine to provide the improved bioactivity as compared to conventionally used compositions such as bioglass. For example disruption of the crystalline structure of the bioactive phases caused by the exchange of silica in the calcium phosphate phase and the exchange of phosphate into the silica phase improves the bioactivity of the SCPC. Moreover, the corrosion rate and resorbability are enhanced by this ion exchange in the bioactive phases. Similarly the porosity of the SCPC, which may range between about 10 vol % to about 80 vol %, controlled during its formation by particle size of the ingredients, the presence of a fugitive agent or a foaming agent, and/or the pressure applied when forming green shapes prior to sintering, improves bioactivity with increasing porosity. It is preferred that the size of the pores be less than 800 μm and it has been found that good results are achieved when pore size ranges from about 0.1 μm to 500 μm The presence of an alkaline environment, such as provided by the presence of sodium ions, has been found to increase the bioactivity of the SCPC. Likewise the sintering temperature effects a change in the bioactivity and resorbability of the SCPC. In the present invention after thermal treatment the silica is present both in amorphous form and in crystalline form. The crystal form can comprise L-quartz and/or α-cristobalite (tetragonal crystal structure). The silica may be present in amounts ranging from 0.3094 moles to 0.9283 moles. The calcium phosphate portion of the SCPC can be present in many forms such as for example, hydroxyapatite, tricalcium phosphate, dibasic calcium phosphate, calcium pyrophosphate (β-Ca 2 P 2 O 7 (H)) and/or β-NaCaPO 4 (rhenanite). The precise structure of the SCPC will depend on the initial chemical concentration of each component and on the thermal treatment protocol. DESCRIPTION OF THE FIGURES FIGS. 1 , 2 and 3 show the results of histological evaluations of critical size bone defects, created in the cortical bone of the femora of New Zealand rabbits. DESCRIPTION OF THE INVENTION The SCPC is prepared by forming an aqueous or non-aqueous paste of a sufficient amount of an organic or inorganic silica salt such as sodium silicate to provide between about 0.31 mole and about 0.93 mole of silica in the thermally treated composite and calcium phosphate such as bicalcium phosphate. In the alternative, an alkali metal oxide such as sodium oxide may be included in a mixture comprising silica in place of the sodium silicate. The paste may be pressed into pellets for more convenient handling. It will be understood that the silicate salt and calcium phosphate may be mixed as a dry powder with good results. The mixture, be it in the form of pellets or other formed shape or as a dried powder, is sintered at temperatures ranging from about 130° C. to about 1200° C. The composition of the samples after thermal treatment, shown in Table 1 below, was determined by X-ray diffraction analysis and scanning electron microscopy. The relatively high molar concentration of silica that derived from a silica salt causes a shift in the 20 in the position of the characteristic signals of the silica and calcium phosphate phases and is indicative of the silicate-phosphate ion substitution. The ion substitution exchange resulted in significant decrease in the crystallization temperature in both the silica and calcium phosphate phases. For example as shown in the table, cristobalite, which normally is formed when low quartz is heated to around 720° C., was formed in the phase composition of the composite at the lower temperature of 690° C. The formation of these crystalline phases at lower temperature increased the bioactivity of the SCPC. TABLE 1 Sample SiO 2 Temp Id. No. (Mole) (° C.) Phase Composition C3S1 0.3094 355 L-quartz (L) + β-Ca 2 P 2 O 7 (H) + β-Ca 3 (PO 4 ) 2 (I) + β-NaCaPO 4 (L) C1S1 0.6193 355 L-quartz (L) + γ-Ca 2 P 2 O 7 (H) + β-Ca 3 (PO 4 ) 2 (I) + β-NaCaPO 4 (L) C1S3 0.9283 355 L-Quartz(L) + β-NaCaPO 4 (L) C3S1 0.3094 690 a-cristobalite(I) ++ β-Ca 2 P 2 O 7 (H) + β-NaCaPO 4 (L) C1S1 0.6193 690 a-cristobalite (H) + β-NaCaPO 4 (H) + L-Quartz C1S3 0.9283 690 a-cristobalite (H) + β-NaCaPO 4 (H) + Na 2 Si 3 O 5 C3S1 0.3094 800 a-cristobalite (H) ++ β-Ca 2 P 2 O 7 (H) + β-NaCaPO 4 (H) C1S1 0.6193 800 a-cristobalite (H) + β-NaCaPO 4 (H) + L-quartz(L) C1S3 0.9283 800 a-cristobalite (H) + β-NaCaPO 4 (H) + L-quartz(L) Following thermal treatment, the SCPC material is ready for use such as by forming granules into a desired shape, such as a block, sphere or sheet or application of a layer of the composite over at least a portion of a suitable prosthesis for implant. For example, the composite can be deposited as a layer on a device such as a pin for insertion in the bone being repaired. In addition the composite may be applied directly to bone being repaired. As mentioned above, it is highly preferred that the bioactive composite be porous. Good results can be achieved when porosity ranges from 10 vol % to about 80 vol %. For the higher porosities it is preferred to include a suitable pore former such as a fugitive material that is consumed during the thermal treatment process. Likewise, pore formation can be initiated in the raw composite mix by including a foaming agent or a fugitive solvent. Pore forming and fugitive agents for use in ceramic composites are well known and are commercially available and the selection of a suitable agent is clearly understood. In many cases the solvent of the composite paste will itself form pores in sufficient number and size as it leaves the paste during thermal treatment. It is preferred that the pores be less than 800 μm to aid in maintaining the structural integrity of the finished composite. The bioactive composite may have a pore size of between about 0.1 μm to about 500 μm and good results are achieved with pore sizes ranging from about 10 μm to about 300 μm The composites of Table 1 were tested for adsorption of serum protein, a necessary first step to the production of new bone growth around the SCPC, and it was found that protein adsorption varied with the sintering temperature which the material was pretreated at during processing. It was found that protein adsorption dropped as the sintering temperature was increased to about 690° C. and thereafter sharply increased between 690° C. and 800° C. Although it is not fully understood, this may be attributed to the transformation of silica from amorphous phase to a crystalline phase which may inhibit protein adsorption onto the surface of the SCPC thermally treated at the lower temperature below 690° C. However, the silica is transformed from L-quartz into α-cristobalite (after thermal treatment above 690° C.) which is associated with a significant increase in serum protein adsorption. In addition, the formation of β-NaCaPO 4 which also begins forming at about 690° C. and increases as the treatment temperature increases above about 690° C. is also associated with a significant increase in serum protein adsorption. Regardless of the thermal treatment, however, the SCPC of the present invention absorbs more protein than the standard bioactive glass alone. Also, the disruption of the structure of the SCPC caused by the exchange of silica in the calcium phosphate phase and the exchange of phosphate into the silica phase improves protein adsorption. SCPCs, identified in Table 1 as C3S1, C1S1 and C1S3 were sintered at temperatures ranging between 355° C. and 800° C. The phase compositions at several sintering temperatures have been determined and are set out in Table 1. The compositions were tested for protein absorption as reported by Ahmed, El-Ghannam and Fouda, biomaterials Forum, 27 th Annual Meeting Transactions, 23, May-Jun. 2001 in the following manner. Particles (90-250 μm) from each of the samples were separately immersed in a simulated body fluid comprising fetal bovine serum for 3 hours at 37° C. After immersion the protein was extracted using 1% SDS. Protein concentration was determined using a gold staining dot block technique. For a comparison, a control experiment using bioactive glass particles of the same particle size range was run in parallel. After the samples were cooled down to room temperature they were immersed in protein solution. The adsorbed protein was determined as described above. Samples containing α-cristobalite and β-NaCaPO 4 adsorbed statistically significant higher amounts of serum protein than samples containing L-quartz and pyrophosphate. As the amount of the cristobalite increased the adsorption of protein increased. EXAMPLE 1 The following example illustrates the effect on bone tissue regeneration by the resorbable bioactive SCPC of the present invention. Samples prepared as described above and identified in Table 1 above as C1S1 and C1S3 and thermally treated at 690° C. were analyzed along with a control consisting of a commercially available bioglass were evaluated for bone tissue response in the following manner. A rabbit femur model was used to evaluate bone tissue response to the new material. Nine (9) rabbits 3-4 months weighing about 3 kg were used. A critical size bone defect (7 mm in diameter) was created in the cortical bone of each femur. Granules of C1S3 and C1S1 as well as the control bioglass were used separately in sufficient amount to fill the defects. The animals were sacrificed after 3 weeks. Bone segments containing the defects were fixed, dehydrated, decalcified, sliced into thin sections (5-7 micron) and stained with H & E. Scanning electron microscopic analysis of the C1S3 particles showed a pore size ranging from 10-300 μm. Measurements of porosity using mercury intrusion method showed that the particles acquired 54% porosity. The pore size is large enough to allow for bone cell colonization and vascularization of the newly formed bone. The high porosity percent provides high surface area for bone cell attachment and stimulation of bone bioactivity reactions that results in bone formation. Moreover, the porosity regulates graft material resorption during new bone tissue formation. FIGS. 1 , 2 and 3 show the histological evaluations of critical size bone defects, created in the cortical bone of the femora of New Zealand rabbits that were grafted with particles (150-600 μm) of C1S3 ( FIG. 1 ), C1S1 ( FIG. 2 ), both sintered at 690° C., and bioactive glass ( FIG. 3 ), the compositions of which are shown in Table 1 above. After 3 weeks, defects grafted with C1S3 were almost completely filled with new bone ( FIG. 1 ). Bone formed in the internal side of the defect has been completely remodeled and few vascular cavities remained. The bone defect treated with composition C1S1 ( FIG. 2 ) also showed substantial development of new bone tissue. The defect treated with bioactive glass (BG) alone ( FIG. 3 ) exhibited less new bone tissue and a considerable amount of BG is observed filling the marrow cavity and the defect itself. These results indicate that SCPCs containing a high silica concentration not only have strong stimulatory effects on bone cell function but also resorb in harmony with the new bone tissue formation. New bone is also present within the marrow cavity that was initially filled with graft material. The architecture of the remodeled cortical bone and marrow resembles that of normal healthy bone. This indicates that the composition of the present invention, particularly the C1S3 material, has a strong stimulatory effect on stem cell differentiation into osteoblasts and can be used as a delivery system for mesnechymal stem cells. EDX analysis of the new bone that formed inside the defect indicates that it is mineralized bone with a Ca/P ratio of 1.65. On the other hand, defects grafted with BG were filled with a substantial quantity of graft materials in addition to bone. It is interesting to note that new bone tissue formed not only on the outer surfaces of C1S1 particles but also inside the pores of the particulates. These results clearly demonstrate that the porous SCPC of the present invention is highly bioactive in that it has a strong stimulatory effect on bone cell attachment, proliferation, differentiation and bone tissue regeneration. The foregoing example is by way illustration only and should not be taken as limiting the invention. Although preferred embodiments have been described herein in detail, it is understood by those skilled in the art that variations may be made thereto without departing from the spirit and scope of the invention as defined by the claims appended hereto.

1a

FIELD OF THE INVENTION The invention relates to lottery ticket game structures and in particular to lottery games where a game is printed on a set of instant tickets having play indicia indicating whether or not the ticket is a prize winner printed on the tickets underneath a scratch-off coating or where an image of an instant lottery ticket is displayed on a computer terminal or video lottery terminal having play indicia indicating whether or not the ticket is a prize winner. BACKGROUND OF THE INVENTION In most instant lottery ticket games a set of tickets is printed or in electronic games the tickets displayed on a computer or video lottery terminal screen with play or prize value indicia under a scratch-off coating according to a predetermined prize structure. For electronic tickets, termed “eTickets” the data is transferred from a central system or a site controller to the video lottery terminal. Typically, the prize structure consists of one or more large value prizes, a number of lesser value prizes and a large number of tickets that are not prizewinners. The prize values in a game are distributed randomly on the tickets so that in theory each player has an equal chance to win one of the prizes. In certain circumstances, however, problems have arisen with this type of game structure. There are, for instance, certain lottery administrations in the United States that post on their web sites the remaining prizes within a game. As a result, a lottery administration might post, for example, that there are two $100,000 prizes in a particular game. As the game is sold, the tickets having the various prizes are cashed. In some cases, the game will still have a significant number of tickets to be sold after the top prizes are cashed. This can lead to complaints from customers that it is no longer possible to win one of the top prizes as advertised by the lottery administration in its general promotional literature. Moreover, state-run lotteries can include in their contract with the game vendor the restriction that players must have the opportunity to play for the top prize throughout the life of the game. In many instant lottery systems, especially those in the United States that are administered by state governments, winning tickets are presented by players to lottery agents for redemption. In many cases, in particular where the ticket has a high value, the lottery agent will enter ticket identification or validation data from the ticket into an agent terminal using a bar code reader or manually inputting this data. This information is then transmitted to a host computer at the state lottery administration where this information is used to access a validation file. Typically, there is one record in the validation file for each such winning ticket that contains the redemption value of the ticket. This redemption value is transmitted to the lottery terminal and if the transmitted redemption value matches the printed winning value on the lottery ticket, the agent will pay this amount to the player. Similarly, in electronic lottery systems, winning eTicket vouchers are presented by players to lottery agents or lottery validation systems for redemption. In many cases, in particular where the eTicket has a high value, the lottery agent or system will transfer eTicket identification or validation data from the eTicket into an agent terminal via a bar code or manually inputting this data. This information is then transmitted to a host computer at the state lottery administration where this information is used to access a validation file. As with the instant ticket systems, there typically is one record in the validation file for each such winning eTicket that contains the redemption value of the ticket. This redemption value is transmitted to the agent terminal and if the transmitted redemption value matches the printed winning value on the voucher, the agent will pay this amount to the player. Usually the validation file contains a fixed or static prize value for all tickets that contain a winning prize value. However, while maintaining a static prize value for each ticket in the validation file has been considered desirable from a security standpoint, maintaining the static value reduces the flexibility of lottery administrations to create new types of games and to compensate for various problems such as the problem described above. SUMMARY OF THE INVENTION It is therefore an object of the invention to provide an instant or an electronic lottery game structure and supporting validation system that will encourage player interest throughout the duration of the game. It is another object of the invention to provide an instant or an electronic lottery game structure and supporting validation system that will provide for an electronic mechanism to hold an End of Game Draw. It is a further object of the invention to provide an instant or an electronic lottery game structure, both for traditional instant lottery tickets and electronic instant lottery tickets, having a dynamic prize structure option. This structure can include the player vehicle (the printed instant or the eTicket), file structures for implementing the game structure, an electronic draw mechanism, and processes and procedures that allow a lottery administration to account for the variable prizes from the beginning of the game until the game is closed. Another object of the invention is to allow for the secure modification of information, such as the prize values for certain tickets, in the validation file. Still another object of the invention is to provide the computer software and computer file structures that allow for the secure modification of information, such as the prize values for certain tickets, in the validation file. It is still another object of the invention to provide an instant or an electronic lottery game structure where the winners of certain of the prize values for particular tickets are not determined until a predetermined time has elapsed or an event has occurred such as the end of the game. The prize values for these tickets can be, for example, determined at the end of the game by an electronic drawing. Yet another object of the invention is to provide an instant or an electronic lottery game structure where at least certain of the tickets are specified as having dynamic or variable prize values that are changed periodically during the game. A ticket having one of these variable prize values can then be redeemed by a player for the specified prize value at a particular time during the game or the player can opt to wait until the game is over where a drawing determines the value of the ticket. A further object of the invention is to provide a validation file where the prize value of at least a portion of the instant or the electronic lottery tickets can be changed by the lottery administration. For example, the validation file can include a sub file containing records for each of the tickets having a variable prize value. The sub file can be used to change the prize values at periodic intervals during the game for all of the tickets in the sub file and can be used to implement an electronic drawing for certain prize values at the end of the game. As an alternative to the sub file, the traditional validation file can include validation identifiers, such as a set of unique prize codes, that allow the traditional validation file to identify those prizes that are designated as having variable value or those prizes that are eligible for the electronic End of Game Draw. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front plan view of an instant or an electronic lottery ticket having a fixed prize value; FIG. 2 is a front plan view of an instant or an electronic lottery ticket having a variable prize value according to the invention; FIG. 3 is a block diagram of a lottery system according to the invention; and FIG. 4 is a block diagram of a validation file for use with the system of FIG. 3 . DETAILED DESCRIPTION OF THE INVENTION A first embodiment of the invention will be described in terms of a printed instant ticket with a scratch-off material covering play indicia. FIG. 1 is a simplified representation of a conventional instant lottery ticket 10 that includes a printed identification 12 of the ticket 10 , a printed instruction 14 on how to play the ticket and a scratch-off material 16 covering a set of play indicia 18 . Also, printed on the lottery ticket 10 is a set of validation data 20 that can be in alphanumeric or bar code form or both. The validation data 20 can be printed on the back of the lottery ticket 10 as well. In the representation of FIG. 1 , the lottery ticket 10 is shown with most of the scratch-off material 16 removed which, in this case, reveals the play indicia 18 that indicates to the player that the prize value of the lottery ticket 10 is $100,000.00. In conventional instant lottery games, the tickets 10 are all printed with play indicia 18 that indicate the prize value of the lottery ticket 10 . FIG. 2 is a simplified representation of an instant lottery ticket 22 according to one aspect of the invention. The principal difference between the lottery ticket 22 and the conventional lottery ticket 10 is that a set of play indicia 24 printed beneath the scratch-off material 16 on the lottery ticket 22 represents a variable prize value as indicated on the lottery ticket 22 by a coined term such as “MYSTERY PRIZE” as shown in FIG. 2 or “BONUS PRIZE”. Here, the play indicia 24 also includes a message to the effect that the player should read instructions (not shown) on the back of the lottery ticket 22 that will provide guidance on how to redeem a prize for the lottery ticket 22 . In the preferred embodiment of the invention, most of the lottery tickets in the game will be printed with play indicia representing the actual value of prize as shown at 18 on the ticket 10 in FIG. 1 . Additionally, and evenly dispersed throughout the game, will be a set of the lottery tickets 22 having the printed play indicia 24 indicating a variable prize value. These tickets 22 will be dispersed evenly throughout the game and, preferably, in such volume to greatly increase the likelihood that at least one of the “Mystery” prize winning tickets 22 remains in the game at all times. In this embodiment of the invention, it is desirable that the odds are extremely high that at least one of the “Mystery” prize ticket 22 remain in the game after the last static top prize is sold. If the last static top prize as shown at 18 on the ticket 10 is redeemed for cashing before all tickets in the game have been redeemed, at least one of the remaining ‘MYSTERY’ prize tickets 22 would be eligible to be ‘promoted’ to the top prize. This “Mystery” top prize would be distributed during the End of Game Draw procedure. In this manner, it would always be possible to win one of the top prizes as advertised by the lottery administration in its general promotional literature, and thus render moot any complaint that the top prize no longer remains in the game. It is common practice that drawings of this type are conducted by a manual process whereby players mail in to the lottery a stub or some portion of the ticket. In the preferred embodiment, this manual system is replaced by an electronic system reducing the workload on the lottery and reducing the chance for fraud or error. With reference to FIG. 3 , operation of the preferred embodiment of the instant lottery game will be described. To illustrate a representative environment for the invention, FIG. 3 provides a block diagram of the basic hardware structure of a typical state administered lottery system 26 for selling and redeeming instant lottery tickets such as lottery tickets 10 and 22 . Included in the system 10 is a lottery ticket redemption mechanism which in this embodiment can include a number of validation or agent terminals 28 A–C that are connected, as represented by a set of lines 30 A–C, to a lottery host computer 32 . The agent terminals 28 A–C usually include bar code readers, keyboards, displays and printers that a lottery agent can use for selling, validating and redeeming instant lottery tickets. The connections 30 A–C to the host computer 32 can be dedicated or dial-up telephone lines or other methods of communication such as satellite communications systems. Included in the host computer 32 is a validation file 34 that contains validation information for lottery tickets usually stored in the form of records each having a ticket identification and a prize code as represented generally at 35 as shown in FIG. 4 . The prize code can be a code or the actual prize or redemption value of the lottery ticket 10 or 22 . Usually there is one record 35 for winning lottery tickets that requires validation through the host computer 32 . However in some cases, the validation file 34 contains records 35 for only the winning lottery tickets in a game or contains records 35 for all of the tickets in the game. Connected to the host computer 32 is a lottery administration terminal 36 that usually contains or is connected to a data input device 38 such as a compact disk (CD) reader along with a printer 40 for printing out reports to the lottery administration. Also in some state lotteries, the lottery administration provides information to the public via an access system regarding the status of a game by, for example, a toll free telephone number as represented by a block 42 and, or in some cases, by Internet access represented by a block 44 It is typical practice in the United States lottery industry for a ticket vendor to provide a state lottery administration with one or more sets of tickets where each set is defined as a game. Each game will normally have a prize structure with a predetermined number of winning tickets and a predetermined number of losing tickets. Very often the winning tickets are divided between high tier winners, which have a high winning prize value and low tier winners that have relatively low winning values. It is also industry practice for the vendor to supply the validation file 34 for each game, which is generally structured to contain one record 35 having the prize code for each winning ticket in the game. In conventional game structures, the prize value represented by the prize code in each record 35 provided by the vendor is fixed or static. For some games, the validation file 34 will contain a record 35 for each winning ticket or in some cases, the validation file 34 will contain a record 35 for each lottery ticket in the game. This vendor supplied validation file is then loaded into the host computer validation file 18 using the data input device 38 . In many state lotteries the practice is to require that high tier lottery tickets that are presented by a player to a lottery agent for redemption be validated by having the lottery agent transmit ticket identification information or the validation data 20 from the agent terminal 28 A to the host computer 32 . This information is then used to access the record 35 in the validation file 34 that contains the prize code or redemption value for the lottery ticket 10 and this value is then transmitted back to the agent terminal 28 A. The usual practice is to have the lottery agent compare this value from the host computer 32 with the winning value 18 printed on the lottery ticket 10 and if they are the same, the agent will pay the player this amount or provide the player with a form that he can use to redeem the ticket from the lottery administration. Referring to FIG. 4 , in one embodiment of the invention, an instant lottery game structure is provided where a subset of the lottery tickets, such as the lottery ticket 22 , is printed with the play indicia 24 which indicates to a player that the prize can have a variable value. The rest of the lottery tickets in the game, such as lottery ticket 10 , are printed with play indicia 18 that have a static prize value and for a large number of the lottery tickets 10 the play indica 18 will indicate that the lottery ticket 22 has no redemption value. In the validation file 34 , the first set of records 35 corresponds to the lottery tickets 10 that have static prize values and a second set or a sub file of records 45 corresponds to the lottery tickets 22 that have variable prize values. Other methods that identify the variable prizes within the ticket population in a game can be used as well, such as a special prize code unique to variable prize tickets. In the preferred embodiment, the initial prize values represented by the prize codes in each of the records 45 in the sub file will have the same relatively low value, for example $50.00, at the beginning of the game. For other embodiments, each initial prize code can have a different value or even a null value. Here, the $50.00 value represents the prize value that the lottery tickets 22 in the sub file 45 can be redeemed for, at least at one point, during the time period that the game is being marketed to the public. In addition, the host computer 32 can automatically at periodic intervals change the prize values in the records 45 in the validation sub file. These changes can be random within a certain predetermined range or alternatively, the changes in the prize values can be made by the host computer 32 in response to inputs from the lottery administration via the terminal 36 . For example, the lottery administration can, by using this system, alter the redemption value of the variable tickets 22 to increase ticket sales or as a part of its marketing plan as it relates to a specific dynamic prize structure for the game. The host computer 32 will mark as paid the records 45 in the sub file that represent lottery tickets 22 that are redeemed during the game period. Then, preferably at a publicly announced date after the termination of the game period, the host computer 32 would perform an electronic draw based on all or a subset of the records 45 in the sub file to determine the winner of the final top prize in the game. Alternatively, the system could be used to distribute all remaining, unredeemed prizes in the game among those players who hold a ‘mystery’ prize winning ticket 22 . If, for example, there were one thousand records 45 in the mystery prize sub file and the lottery administration wished to distribute one hundred high tier prizes that remained in the game, the electronic draw program in the host computer 32 would randomly distribute those remaining prizes into the one thousand records 45 in the sub file. Normally, the lottery administration would establish the total prize payout before the beginning of a game. One of the primary advantages of the system described above is that, the lottery administration will know what the total payout for a game is while at the same time because a portion of the prizes are dynamic, it will have the ability to control the amount and timing of certain of the redemption values for the lottery tickets 22 . Because security is an important factor in lotteries, it is desirable that the systems such as 26 shown in FIG. 3 , and the file structures such as the validation files 36 and the sub file 45 shown in FIG. 4 along with administrative procedures utilize the latest security technology. Preferably, only authorized lottery administrative personnel should be able to dynamically modify the value of the lottery tickets 22 . One approach is to use the audit techniques described in U.S. patent application Ser. No. 10/317,577, assigned to the assignee of this application and which is hereby incorporated by reference. For example, the approach described in this patent application of using a read only memory to check the total prize value of a game can be used to test the integrity of the records 45 in the sub file. The following is an example of how the game structure described above might operate. After purchasing the lottery ticket 22 , the player scratches off the scratch-off material 16 . If the play indicia 24 indicates that the lottery ticket 22 has a variable redemption value, e.g., the “Mystery Prize”, the player, depending on the rules of the particular game, will have the option to: (1) redeem the lottery ticket 22 for its current value and/or (2) be included in the end of the game prize drawing. In one embodiment of the invention, these two options are mutually exclusive; in another embodiment, the Mystery prize winner is automatically entered in the End of Game draw, regardless of whether he has redeemed his ticket. The redemption value of the prize during the game period can be, for example, $50 during week 1 of the game, $100 during week 2 , back to $50 during week 3 etc. . . . as described above. In this example, the players can learn the redemption value of the lottery tickets 22 during the game by utilizing the Internet 44 or the 1–800 number 42 . The players who opt to remain in the final draw held at the end of the game can likewise learn the value of their lottery tickets 22 via the public access system such as the Internet 44 or the 1-800 number 42 . At any time until the game is closed, a player can redeem his Mystery ticket for the current posted value. In one embodiment, if he chooses to remain ‘in the draw’, his Mystery Prize ticket 22 is guaranteed to be of some minimal value. If he opts for the draw, he might win the top prize or some other high-valued prizes such as a car or a trip. Alternatively, the player might win some sort of relatively low value promotional item such as a t-shirt promoting the lottery. In another embodiment, the player can both redeem his Mystery Prize for its current value AND expect to be included in the End of Game draw. Yet another embodiment of the invention will be described in terms of an electronic ticket with a simulated scratch-off material covering play indicia. In particular, a set of dashed lines 46 in FIGS. 1 and 2 represent a display of a video lottery terminal or a personal computer that can be connected to the host computer 32 to play an electronic version of an instant lottery game. Here, the lottery tickets 10 and 22 are electronic visual simulations of instant lottery tickets where the scratch-off coatings 16 can be removed by the player by operation of a mouse or some other control device connected to the terminal. Again, FIG. 3 depicts in block diagram form the basic hardware structure of the typical state administered lottery system 26 that can be used for selling and redeeming electronic lottery tickets such as lottery tickets 10 and 22 . Included in the system 10 are a number of video lottery terminals 48 A–C that can be for example video terminals in a gaming establishment or player owned personal computers. The video lottery terminals 48 A–C can be connected, as represented by a set of lines 50 A–C, to the lottery host compute 32 by a variety of mechanisms such as the internet or a lottery site controller 52 which in turn is connected to the host computer 32 . The video lottery terminals 48 A–C, as represented by the terminal 45 A in FIG. 3 , can include the graphical capabilities such as the display 46 for a lottery player to the play the electronic tickets 10 and 22 and a reader 52 for receiving credit cards or coupons to permit the player to play the game. Also, a printer 54 can be included or connected to the terminals 48 A–C for printing out a payment voucher such as an eTicket 56 having for example a bar code 58 that can be used by a player to redeem a winning ticket at one of the agent terminals 28 A–C. It should be noted that a variety of redemption mechanisms can be used including various internet secure payment systems. To enable a player to remove the simulated scratch-off coating 16 , a control device 59 such as a keyboard or a mouse can be used with the video lottery terminals 48 A–C. This system permits a player to pay for and play electronic tickets as well as ‘cash out’ when finished. The connections 50 A–C to the host computer 32 can be dedicated lines, dial-up telephone lines or other methods of communication such as satellite or internet-based communications systems such as shown at 44 . As with the printed instant lottery games discussed above, it is typical practice in the United States lottery industry for a ticket vendor to provide a state lottery administration with one or more sets of “electronic” tickets such as lottery tickets 10 and 22 where each set is defined as a game. Each game will normally have a structure with a predetermined number of winning tickets and a predetermined number of losing tickets. Very often the winning tickets are divided between high tier winners which have a high winning prize value and low tier winners which have relatively low winning values. It is also industry practice for the vendor to supply the validation file 34 for each game, which is generally structured to contain one record having the redemption or prize value for each high tier winning ticket. In conventional game structures, the prize value in each record provided by the vendor is fixed or static. For some games, the validation file 34 will contain a record for each winning ticket or in some cases; the validation file 34 will contain a record for each lottery ticket in the game. This vendor supplied validation file is then loaded into the host computer validation file 18 using the data input device 38 . In many state lotteries the practice is to require that the high tier lottery electronic ticket vouchers that are presented by a player to a lottery agent or a lottery validation system for redemption be validated by having the lottery agent or system transmit ticket identification information or the validation data 20 from the agent terminal 28 A to the host computer 32 . This information is then used to access a record in the validation file 34 which contains the redemption value for the lottery ticket 10 and this value is then transmitted back to the agent or validation terminal 28 A. Referring again to FIG. 4 , in one embodiment of the invention, an instant lottery game structure is provided where an electronic lottery tickets, such as the lottery ticket 22 , is displayed on the display 46 with the play indicia 24 which indicates to a player that the prize can have a variable value. The system 26 then functions essentially the same way the printed instant lottery system functions as described above. The following is an example of how the electronic instant lottery game structure described above might operate in one embodiment of the invention. After selecting and purchasing the electronic lottery ticket 22 at the video lottery terminal 48 A, the player receives a graphical representation of his selected ‘pull’ or ticket 10 or 22 . If the play indicia 24 indicates that the lottery ticket 22 has a variable redemption value, e.g., the “Mystery Prize”, the player will have the option to: (1) redeem the lottery ticket 22 for its current value or (2) opt to be included in the end of the game prize drawing. The redemption value of the prize during the game period can be, for example, $50 during week 1 of the game, $100 during week 2 , back to $50 during week 3 , etc. . . . as described above. In this example, the players can learn the redemption value or any other value or non-value of the lottery administration's choosing of the lottery tickets 22 during the game by utilizing an information access system such as the Internet 44 , the 1-800 number 42 or, in this case, the video lottery terminals 48 A–C. The players who opt to remain in the final draw held at the end of the game can also learn the value of their lottery tickets 22 via the Internet 44 , the 1-800 number 42 or the video lottery terminals 48 A–C. At any time until the game is closed, a player can redeem his Mystery ticket for the current posted value. If he chooses to remain ‘in the draw’, his Mystery Prize ticket 22 is guaranteed to be of some minimal value. If he opts for the draw, he might win the top prize or some other high-valued prizes such as a car or a trip. Alternatively, the player might win some sort of relatively low value promotional item such as a t-shirt promoting the lottery or nothing. In another embodiment of the invention, the player can both redeem his electronic Mystery Prize for its current value AND expect to be included in the End of Game draw. The existence of Mystery Prizes tickets 22 within an instant (or an electronic game) and the Mystery Prize Validation sub file 45 delivered to the Lottery administration can form the basis for the electronic End of Game (or End of Sales) draw. The validation numbers 20 of the Mystery Prize winning tickets 22 are separately stored in the validation sub file 45 (or in another embodiment, a special prize code identifies the Mystery Prize winners in the traditional validation file 34 .) In either case, the electronic draw is based on these validation numbers 20 which uniquely identify the population of all Mystery Prize winning tickets within the game. Valid or redeemed Mystery Prize winners within a game can be further identified by a voucher that is produced at the agent terminal 28 A upon redemption of the Mystery Prize winning ticket 22 . At this point, player information can be recorded in a database. Alternatively, the Internet 44 or a 1-800 number 42 can be used to identify validated Mystery Prize winners. There can be other methods of identifying those lottery players who have indeed won a Mystery Prize. The result of the identification is to populate or mark the validation sub file 45 with valid Mystery Prize winners who are eligible for the electronic drawing. By the methods described above, once the lottery has satisfactorily populated the validation sub file 45 with valid Mystery Prize winners, the Lottery can choose one of the records 45 from this file. Typically, this would occur at some predetermined point in the lifecycle of the game, for example the end of retail sales for the game. The selection of this single record 45 can be accomplished using several common methods, but the most common is the use a specialized random number generator by the host computer 32 . This random number generator would identify ONE of the Mystery Prize winners as the Grand Prize Winner—and thus distribute the remaining Top Prize in the Game to this individual Mystery Prize winner. Since Mystery Prize tickets 22 are available throughout the sales of the game, all lottery players will have the opportunity to play for the top prize until the game sales have been halted by the Lottery Administration. It will be understood that the dynamic game structure concepts described above can also be applied to non-gambling games. As an example, this type of structure can be used with supermarket type sweepstakes where sweepstake coupons are not sold.

1a

BACKGROUND [0001] The present invention relates generally to grafting for cartilage repair, and in one particular aspect to novel shaped osteochondral plug grafts and their use in articular cartilage resurfacing procedures. [0002] As further background, lesions in articular cartilage, such as that which occurs in the knee joint, generally do not heal well due to the lack of nerves, blood vessels and a lymphatic system. Hyaline cartilage in particular has a limited capacity for repair, and lesions in this material without intervention typically form repair tissue lacking the biomechanical properties of normal cartilage. [0003] A number of techniques are used to treat patients having damaged articular cartilage. Currently, the most widely used techniques involve non-grafting repairs or treatments such as lavage, arthroscopic debridement, and repair stimulation. Such repair stimulation is conducted by drilling, abrasion arthroplasty or microfracture. The goal is to penetrate into subchondral bone to induce bleeding and fibrin clot formation. This promotes initial repair. However, the resulting formed tissue is often fibrous in nature and lacks the durability of normal cartilage. [0004] In a small number of procedures conducted today, cells grown in culture are transplanted into an articulating cartilage lesion. One such process involves the culture of a patient's own cells, and the reimplantation of those cells in defective cartilage. After implantation of the cells, an autologous periosteal flap with a cambium layer is used to seal the transplanted cells into place and act as mechanical barrier. [0005] In another mode of treatment, osteochondral transplantation, also known as “mosaicplasty”, is used to repair articular cartilage. This procedures involves removing injured tissue from the articular defect and drilling cylindrical holes in the base of the defect and underlying bone. Cylindrical plugs of healthy cartilage and bone are obtained from another area of the patient, typically a lower-bearing region of the joint under repair, and are implanted into the drilled holes. In addition to the placement of autologous plugs of cartilage and underlying bone (osteochondral plugs), allograft osteochondral plugs have been suggested for use in repairing articular cartilage defects. Such allograft osteochondral plugs have been used clinically to some extent, in either fresh or frozen forms. [0006] Despite work thus far in the area, needs remain for improved and/or alternative grafts and grafting techniques that are useful in the repair of articular cartilage. The present invention is addressed to these needs. SUMMARY [0007] In one aspect, the present invention features the provision of plug implants having unique geometric and functional characteristics and their use in articular cartilage repair. Aspects of the present invention relate to osteochondral plug grafts including at least one bone portion exhibiting a cross-sectional profile other than that of a circle and configured for stable, durable and interlocking receipt within a corresponding surgically created opening in subchondral bone. Such osteochondral grafts or corresponding synthetic grafts or implants can be used in repair procedures in which the graft or other implant cooperates with the opening so as to provide a mechanical stop to resist rotation of the graft within the hole. Additionally or alternatively, such grafts/implants can cooperate with bone surfaces of adjacent implanted osteochondral plugs to provide such a mechanical stop to resist rotation. In this fashion, effective and stable graft materials and techniques are provided for the repair of patient articular cartilage. [0008] One embodiment of the invention provides a method for repairing articular cartilage in a patient that includes implanting at least one osteochondral plug graft at an articular cartilage site in the patient, the plug graft including a cartilage layer attached to an underlying body of bone. As implanted, the body of bone includes a bone sidewall positioned adjacent a separate bone surface. The bone sidewall and adjacent bone surface together are configured to provide a mechanical interlock that resists rotation of the implanted osteochondral plug graft. The osteochondral plug graft can advantageously be an allograft osteochondral plug graft for implantation in a human. The mechanical stop can be provided by at least one region in which rotation of the plug graft would cause a wall or wall portion of the plug to impinge upon a wall of patient bone or a wall of an adjacent implanted plug and stop rotation of the plug. Thus, mechanical interlocks, apart from simple interference fits which involve only friction, are provided in accordance with this aspect of the invention. In other inventive aspects, synthetic plug grafts with corresponding features can be used in similar methods. [0009] In another aspect, the present invention provides an osteochondral graft configured for stable implantation within a prepared surgical opening in subchondral bone of a patient at an articular cartilage site, the surgical opening having a three-dimensional contour other than a circular cylinder. The inventive osteochondral graft includes an osteochondral plug graft having a cartilage cap and a body of bone attached to the cartilage cap. The body of bone includes a stabilizing portion for receipt within the surgical opening, wherein the stabilizing portion of the bone body presents an external three-dimensional contour other than a circular cylinder. The stabilizing portion is further configured for mated receipt within the surgical opening to provide a mechanical interlock against rotation. In certain embodiments, osteochondral graft plugs include a body of bone having a cross-sectional profile that is non-circular but includes at least a portion defining an arc of a circle. Illustratively, such osteochondral graft plugs can take the form of multi-lobed grafts, wherein each lobe has a cross-sectional profile forming an arc of a circle. Such grafts may have two, three, four, or more such lobes. In further embodiments, osteochondral graft plugs of the invention can have bone bodies with polygonal cross-sectional profiles such as triangular, rectangular (including square), heptagonal, hexagonal, etc. cross-sectional profiles. Such grafts, or synthetic grafts having similar features, can for example be implanted into surgically prepared openings of similar shape to provide implanted grafts locked against rotation. As well, embodiments of the invention provide grafts including a bone body having an ovate cross-sectional profile, which can be implanted in openings of similar shape. [0010] In a further aspect, the present invention provides a grafting system for treating an articular cartilage site comprising a first plug graft and a second plug graft. The first and second plug grafts are configured to cooperate with one another to nest, to mechanically lock at least one of the grafts against rotation, and/or to mechanically lock the grafts against lateral separation, when implanted at an articular cartilage site in a patient. The plug grafts can be osteochondral plug grafts, or synthetic plug grafts. [0011] In another aspect, the present invention provides a graft for receipt within an opening in subchondral bone at an articular cartilage site of a patient, wherein the graft includes an osteochondral graft including a bone plug having an upper surface, sidewalls depending from the upper surface, and a lower surface, and a layer of cartilage attached to the upper surface of the bone plug. The bone plug further includes at least a portion wherein the bone plug sidewalls present a cross sectional profile selected from a non-circular profile that includes at least one circular arc, a polygonal profile, an ovate profile, and a multi-lobed profile having two to four lobes. Corresponding synthetic plug grafts also provide another feature of the invention. [0012] In another embodiment the present invention provides a method for repairing an articular cartilage site in a patient that includes providing a prepared surgical opening in subchondral bone of a patient at an articular cartilage site and inserting a plurality of graft plugs into said surgical opening, wherein the plurality of plugs together provides a plug assembly substantially filling the opening. In some embodiments mated plug assemblies can be used to provide close packing of plug grafts with minimal gaps therebetween, and enhanced resurfacing effects at the site being treated. The graft plugs are desirably osteochondral plug grafts but in certain embodiments can also be synthetic plugs. [0013] Another embodiment of the invention provides a graft system configured for stable implantation within a prepared surgical opening in subchondral bone of a patient at an articular cartilage site, wherein the system includes a plurality of graft plugs together providing a plug assembly configured to substantially fill the surgical opening. [0014] Additional aspects as well as features and advantages of the invention will be apparent from the descriptions herein. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIGS. 1 and 2 provide top and prospective views of a bilobal osteochondral graft of the invention respectively. [0016] FIG. 3 shows a drill pattern for a hole for receiving a bilobal graft such as that depicted in FIGS. 1 and 2 . [0017] FIGS. 4 and 5 show top and prospective views of a trilobal osteochondral graft in accordance with the invention, respectively. [0018] FIG. 6 shows a drill pattern for creating a hole for receiving a trilobal osteochondral graft such as that depicted in FIGS. 4 and 5 . [0019] FIGS. 7 and 8 provide top and prospective views of an osteochondral graft of the invention have four lobes, respectively. [0020] FIG. 9 shows a drill pattern for creating a void for receiving an osteochondral graft such as that depicted in FIGS. 7 and 8 . [0021] FIGS. 10 and 11 depict perspective and top views of an oval-shaped osteochondral graft in accordance with the present invention. [0022] FIGS. 12 and 13 provide top and perspective views of a generally square-shaped osteochondral graft in accordance with the invention. [0023] FIGS. 13A and 13B provide top views of mating osteochondral graft assemblies of the invention. [0024] FIGS. 14 and 15 depict osteochondral plug grafts of the invention which can be used in a nested arrangement. [0025] FIG. 16 provides a top view of a nested arrangement of osteochondral grafts depicted in FIGS. 14 and 15 . [0026] FIGS. 17 through 19 depict top views of bilobal osteochondral grafts of the invention that can be used in a nested arrangement. [0027] FIG. 20 provides a top view of an osteochondral graft of the invention having first and second lobes and a central region connecting the lobes. [0028] FIG. 21 provides a top view of the graft of FIG. 20 in a nested arrangement with another similar graft. [0029] FIGS. 22 and 23 provide top views of osteochondral plug grafts of the invention that can be used in a mated graft assembly. [0030] FIG. 24 provides a top view of a mated graft assembly including the grafts depicted in FIGS. 22 and 23 . [0031] FIGS. 24 and 25 provide top and perspective views, respectively, of an osteochondral plug graft of the invention having a cruciform cross-sectional profile. DETAILED DESCRIPTION [0032] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to certain embodiments thereof and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the described embodiments, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. [0033] As disclosed above, the present invention provides plug grafts such as osteochondral grafts having unique geometrical and functional characteristics as well as their use in novel grafting procedures. In particular aspects, plug grafts of the invention are arranged to provide and are used in a fashion wherein mechanical interlocking features resist rotation of the grafts when implanted, and/or wherein mechanical interlocking features resist lateral separation of adjacent implanted grafts, and/or wherein nested arrangements with adjacent plug grafts are achieved. [0034] Osteochondral plug grafts of and for use in the invention can be harvested from the recipient or from a suitable human or other animal donor, from any appropriate structure including hyaline cartilage and underlying subchondral bone. Suitable harvest locations in large part occur in weight bearing joints of mammals, including humans. These harvest locations include, for example, articular cartilage and rib cartilage. A wide variety of articular cartilages may be used including for example those taken from articulating surfaces of the knee, hip, or shoulder joints. As specific examples, osteochondral plugs may be taken from the femoral condyle, the articulating surfaces of the knee, or the articulating surfaces of the shoulder. [0035] Osteochondral grafts of the invention can be harvested at their final shape for implant or can be manipulated after harvest to provide the desired shape. In this regard, an osteochondral plug graft of the invention can have a cross sectional profile that is substantially constant or that varies along its length. For example, in certain embodiments, the cartilage layer or cap can have a cross sectional profile that is the same as the profile of the underlying bone plug, while in others the cartilage cap can have a cross sectional profile that differs from that of the bone plug. The latter may occur, for instance, in grafts having a cartilage cap that extends beyond the periphery of the bone plug, or terminates short of the periphery of the bone plug. As well, the bone plug itself may have a cross sectional profile that is constant along its length, or that varies along its length. Illustrative of the latter point, a cross sectional profile providing a unique, non-circular geometry as discuss herein may occur along only a portion of the bone plug, and yet provide stabilization features as described herein. These and other potential variations will be apparent to the skilled artisan from the descriptions herein. [0036] In certain aspects of the present invention, an osteochondral plug graft for treating an articular cartilage defect includes a bone body with sidewalls having a cross-sectional profile other than a circular cylinder. In some inventive embodiments, such cross sectional profile will be that of a polygon, including equilateral and non-equilateral polygons, and regular and non-regular polygons. The polygon will typically having from three to about ten sides, including e.g. triangles, rectangles, pentagons, hexagons, cruciforms, etc. In other embodiments, such cross sectional profile will be non-circular, but will include at least one arc of a circle (sometimes herein referred to as a “circular arc”). These cross sections include desirable embodiments wherein the cross sectional profile of the bone body is defined by multiple, intersecting circular arcs, e.g. two, three, four or more intersecting circular arcs. In additional embodiments, the cross sectional profile presented by sidewalls of the bone body will be ovate, or will be multi-lobed, in some embodiments having from two to four lobes. Osteochondral plug grafts of the invention having such shapes can be configured for receipt within surgically prepared openings in a human or other mammalian knee, hip or shoulder joint to provide a mechanically interlocked arrangement as described herein, and to be capable of withstanding the biomechanical loads typically experienced at such joints without significant occurrence of fracture of the bone body of the osteochondral plug. Especially in embodiments in which protruding segments are provided to participate in mechanical locking (e.g. in multi-lobed devices), the cross-sectional profile and other physical attributes of the graft can be controlled to resist substantial fracture or break-off of the protruding segments under the ordinary loading conditions of a knee, hip, shoulder or other articular joint of a human or other mammalian patient in which the graft is to be implanted. [0037] In the case of allograft osteochondral plugs, these can be either fresh (containing live cells) or processed and frozen or otherwise preserved to remove cells and other potentially antigenic substances while leaving behind a scaffold for patient tissue ingrowth. A variety of such processing techniques are known and can be used in accordance with the invention. For example, harvested osteochondral plugs can be soaked in an agent that facilitates removal of cell and proteoglycan components. One such solution that is known includes an aqueous preparation of hyaluronidase (type IV-s, 3 mg/ml), and trypsin (0.25% in monodibasic buffer 3 ml). The harvested osteochondral plugs can be soaked in this solution for several hours, for example 10 to 24 hours, desirably at an elevated temperature such as 37° C. Optionally, a mixing method such as sonication can be used during the soak. Additional processing steps can include decalcification, washing with water, and immersion in organic solvent solutions such as chloroform/methanol to remove cellular debris and sterilize. After such immersion the grafts can be rinsed thoroughly with water and then frozen and optionally lyophilized. These and other conventional tissue preservation techniques can be applied to the osteochondral grafts in accordance with the present invention. [0038] Osteochondral grafts of the invention can be used in the repair of articular cartilage in patients, including for example that occurring in weight bearing joints such as those noted above and especially in the knee. The articular cartilage in need of repair can, for example, present a full thickness defect, including damage to both the cartilage and the underlying subchondral bone. Such defects can occur due to trauma or due to advanced stages of diseases, including arthritic diseases. [0039] The articular cartilage site to be treated will typically be surgically prepared for receipt of the osteochondral graft. This preparation can include excision of patient cartilage and/or subchondral bone tissue at the site to create a hole or void in which the graft will be received. Tissue removal can be conducted in any suitable manner including for instance drilling and/or punching, typically in a direction substantially perpendicular to the articular cartilage layer at the site, to create a void having a depth approximating that of the graft to be implanted. In certain embodiments of the invention as discussed below, the opening for receiving the graft will be created using a drill or punch having a circular cross-section. Multiple, overlapping passes with the drill or punch are made, in order to create an opening having a cross-section defined by multiple, intersecting circular arcs. In this way, a multi-lobed surgical void can be created for receiving a correspondingly shaped osteochondral graft of the present invention in a mechanically locked condition. In other embodiments, a drill or punch that provides an opening with a non-circular cross-section with a single pass is used. [0040] Turning now to a discussion of the Figures, shown in FIGS. 1 and 2 are top and perspective views, respectively, of a bilobal osteochondral graft product of the present invention. Graft 30 has an osteochondral structure including an underlying bone body 34 to which is attached a cartilage layer 32 , desirably an articular (hyaline) cartilage layer. Bilobal graft 30 includes a first lobe 36 and a second lobe 38 . Lobes 36 and 38 in the illustrated embodiment are provided as portions of right circular cylinders. Thus each lobe 36 , 38 provides a cross-sectional profile that includes an arc of a circle. With reference now also to FIG. 3 , which shows a drill pattern, the osteochondral graft 30 can thus be friction or interference fitted within an opening 40 in the patient tissue created by using a circular punch or drill to create holes 42 and 44 which overlap to an extent as shown at 46 . In this manner, the osteochondral graft 30 may not only be frictionally fit into the opening 40 , but this fit will also be of a nature that provides a mechanical interlock or stop against rotation of the graft 30 within the opening 40 . [0041] With reference now to FIGS. 4 and 5 , shown are top and perspective views, respectively, of another multi-lobed osteochondral graft of the present invention. Graft 50 also includes a cartilage layer 52 attached to an underlying bone body 54 . Graft 50 is provided having three lobes 56 , 58 , and 60 . As in graft 30 discussed above, the lobes 56 , 58 , and 60 are provided as longitudinal portions of right circular cylinders and thus present external surfaces and a cross-section defined by multiple, intersecting circular arcs. With reference to FIG. 6 , shown is a drill or punch pattern to create an opening 62 having a three-dimensional profile generally corresponding to that of the external surfaces of graft 50 . In particular, a circular punch or drill can be used to create three overlapping cylindrical bores 64 , 66 , and 68 , to define opening 62 presenting walls of a shape corresponding to the shape of graft 50 . Again, in this manner, graft 50 can be fit within opening 62 , optionally including a friction or interference fit, and will in cooperation with opening 62 provide a mechanical interlock to resist rotation of the graft 50 within the opening 62 . [0042] Shown in FIGS. 7 and 8 are top and perspective views of an osteochondral graft 70 of the present invention including four lobes. Graft 70 includes an overlying layer of cartilage 72 attached to an underlying bone body 74 . Graft 70 includes four lobes 76 , 78 , 80 , and 82 . These lobes are provided as longitudinal sections or portions of right circular cylinders, and thus provide a cross-sectional profile defined by multiple interconnected circular arcs. In this manner, and with reference to FIG. 9 , graft 70 can be implanted within an opening 84 of corresponding shape created with four overlapping passes of an instrument that forms right cylindrical bores 86 , 88 , 90 , and 92 such as a circular punch, drill or other suitable mechanism. The graft 70 so implanted in opening 84 will be mechanically interlocked against rotation. [0043] With reference now to FIGS. 10 and 11 , shown are top and perspective views of one illustrative ovate osteochondral graft 100 of the present invention. Graft 100 thus includes a layer of cartilage 102 attached to an underlying body of bone 104 . Graft 100 can be implanted into a correspondingly-dimensioned ovate opening created in the patient tissue at the implant site, and will thereby be mechanically locked against rotation within the implant site. Receipt of the graft 100 within the corresponding opening can also include an interference fit if desired. It will be understood that other symmetrical or unsymmetrical ovate shapes can also be used to provide similar functions. [0044] FIGS. 12 and 13 show a top and perspective view of a rectangular parallelepiped-shaped osteochondral graft of the present invention. Graft 110 includes a generally rectangular parallelepiped-shaped body of bone 114 attached to a generally rectangular parallelepiped-shaped layer of cartilage 112 . Graft 110 can be implanted into a corresponding bore created at the implant site having a rectangular cross-section to achieve a non-rotating mechanical interlock fit within the opening. It will be understood that graft 110 depicts one possible parallelepiped-shape, in that other similar graft having differing rectangular cross-sectional shapes also form a part of present invention, including among others generally cube-shaped osteochondral grafts as well as those which are more or less elongate than that depicted for graft 110 . In one illustrative example, a square or otherwise rectangular punch can be used to create a corresponding opening in the patient tissue for receiving graft 110 in a mated fit providing the non-rotatable arrangement. [0045] A plurality of grafts 110 can be used to provide an advantageous graft assembly of the invention, configured for receipt within a single surgically prepared opening so as to mate with one another along one wall and substantially fill the opening. In this fashion, a close-fit between adjacent plugs can be achieved, providing better filling of the articular defect under treatment. Specifically with reference to FIG. 13A , shown are two graft plugs 110 a and 110 b mated together along one wall and received within the same, rectangular-shaped surgical opening. In certain embodiments, such graft assemblies include more than two graft plugs, for example from two to six plugs. In this regard, depicted in FIG. 13B is a graft assembly including four rectangular (square) graft plugs 110 a, 110 b, 110 c and 110 d mated together and closely packed within a single surgical opening in patient subchondral bone. It will be understood that graft plugs having cross sectional profiles other than rectangles can also be used in mated fashion in a surgical opening, wherein walls of the plugs are configured to conform to one another along an extended length when the plugs are received together within the opening. Such mating or conforming walls can have generally straight or curved profiles or combinations thereof, or any other suitable mating shape. [0046] FIGS. 14 and 15 provide top views of osteochondral graft 120 and 122 of the invention which are configured to nest with one another as implanted. Specifically, shown in FIG. 16 is a nested assembly 124 including graft 120 and graft 122 , wherein at least one arcuate convexity or protrusion of one of the grafts (e.g. graft 122 ) is matingly received within a generally corresponding arcuate concavity or cut-out region of the adjacent graft (graft 120 ). Such nested arrangements can be used to provide advantageous close packing of multiple implanted osteochondral grafts to facilitate an effective fill of a larger damaged tissue region, and/or can participate in preventing rotation of one or more of the implanted, nested grafts. [0047] FIGS. 17 and 18 illustrate another set of osteochondral grafts which are nestable with one another. In particular, graft 130 presents two lobes 132 and 134 and a concave cut-out 136 presenting a generally concave surface 138 . Osteochondral graft 140 is similar to that depicted in FIGS. 1 and 2 and thus presents a first lobe 142 and a second lobe 144 . In the illustrated grafts 130 and 140 , each graft presents external surfaces that correspond to longitudinal sections of right circular cylinders, as does their nested overall profile. In this regard, referring to FIG. 19 , graft 140 is shown partially nested within graft 130 , with a portion of lobe 142 of graft 140 received within concavity 136 and abutted against concave surface 138 . The nested configuration shown in FIG. 19 can be inserted into a corresponding unitary opening created in the patient tissue using a series of right cylindrical bores made in an overlapping pattern. The assembled graft shown in FIG. 19 both nests and provides a mechanical interlock against rotation when implanted. [0048] With reference to FIG. 20 , shown is another osteochondral graft 150 in accordance with the present invention. Graft 150 includes a first lobe 152 and a second lobe 154 presenting exterior surfaces 156 and 158 consistent with those of circular cylinders. Lobes 152 and 154 are interconnected by a central portion 160 which presents a generally concave surface on each side. In this manner, as depicted in FIG. 21 , a number of grafts 150 can be nested together as implanted to provide a nested assembly 160 . An opening of corresponding shape can be created in the patient tissue to receive the nested assembly 160 using a punch having a shape corresponding to the exterior shape of graft 150 , or using a drill or other device manipulable to create an opening of the appropriate size and shape. [0049] FIGS. 22-24 illustrate additional osteochondral grafts and assemblies of the invention, which are configured to mechanically interlock with one another to resist lateral separation, e.g. by providing a interleaved joint (e.g. as provided in a dovetail or other similar undercut arrangement) between portions of the grafts. Specifically as shown, osteochondral graft 170 is provided generally as right circular cylinder having a dovetail cut-out 172 extending longitudinally therein. Dovetail cut-out 172 presents a series of inner walls 174 for receiving and mechanically restraining a corresponding dovetail protrusion. Graft 170 presents an arcuate outer wall 176 consistent with that of a circular cylinder, for receipt within a corresponding cylinder bore at the implant site. Osteochondral graft 178 ( FIG. 23 ) includes a generally circular cylindrical portion 182 and a dovetail-shaped protrusion 180 extending along its length. In this manner, as shown in FIG. 24 , grafts 170 and 178 can be implanted together in an interleaved fashion forming a dovetail joint between the two, whereby they are mechanically together against lateral separation. As well, the interleaved assembly 184 can be implanted within an opening in the patient tissue of a corresponding shape, which in turn can be created as overlapping circular bores using conventional drills, punches or other equipment for creating the same. It will be understood that the assembly 184 depicts one illustrative embodiment of interleaved, mechanically locked grafts, and that many other arrangements which provide for interleaving portions of adjacent grafts so as to provide locking or resistance to lateral separation and/or rotation can be used within the spirit and scope of the present invention. [0050] FIGS. 25 and 26 provide top and perspective views, respectively, of a cruciform osteochondral plug graft 190 of the present invention. Graft 190 includes a cartilage layer 192 attached to an underlying bone body 194 , and have a cross sectional profile defined by four generally rectangular projecting segments 196 , 198 , 200 and 202 , forming an overall cruciform or cross-shaped profile. Graft 190 can be implanted into a corresponding bore created at the implant site having a cruciform cross-section to achieve a non-rotating mechanical interlock fit within the opening. Such an opening can be surgically prepared for example using a correspondingly-shaped punch, or using multiple overlapping passes of an appropriately rectangular punch. [0051] While certain discussions above have focused upon the use of harvested osteochondral plug grafts, in other aspects of the invention, plug grafts of and for use in the invention can be manufactured from other materials or components. Illustratively, plug grafts adapted for receipt in surgical openings in subchondral bone at articular sites, and desirably for integration with the subchondral bone, can be synthesized from natural or synthetic materials. For example, plug bodies can be synthesized from biopolymers or from synthetic polymers (bioabsorbable and non-bioabsorbable synthetic polymers), ceramics, or combinations thereof. Illustrative synthetic bioabsorbable, biocompatible polymers, which may act as suitable matrices for plug bodies can include poly-alpha-hydroxy acids (e.g. polylactides, polycaprolactones, polyglycolides and their copolymers, such as lactic acid/glycolic acid copolymers and lactic acid/caprolactone copolymers), polyanhydrides, polyorthoesters, polydioxanone, segmented block copolymers of polyethylene glycol and polybutylene terephtalate (Polyactivea3, poly (trimethylenecarbonate) copolymers, tyrosine derivative polymers, such as tyrosine-derived polycarbonates, or poly (ester-amides). Suitable ceramic materials include, for example, calcium phosphate ceramics such as tricalcium phosphate, hydroxyapatite, and biphasic calcium phosphate. These or other suitable materials can be used to form plug grafts useful in articular cartilage resurfacing procedures. In this regard, such grafts may have a uniform composition throughout, or may vary, for instance having a plug body formed of a first, relatively strong and loadbearing material (e.g. a ceramic, polymer or composite), and a cap formed of another material to provide the articulating surface formed by another material, for example a relatively smooth polymer layer. These and other variants will be apparent to the skilled artisan from the descriptions herein. [0052] Plug grafts of the invention can be used in conjunction with other materials helpful to the treatment. For example, the grafts can be used in combination with a growth factor, and especially a growth factor that is effective in inducing formation of bone and/or cartilage tissue. Desirably, the growth factor will be from a class of proteins known generally as bone morphogenic proteins (BMPs), and can in certain embodiments be recombinant human (rh) BMPs. These BMP proteins, which are known to have osteogenic, chondrogenic and other growth and differentiation activities, include rhBMP-2, rhBMP-3, rhBMP4 (also referred to as rhBMP-2B), rhBMP-5, rhBMP-6, rhBMP-7 (rhOP-1), rhBMP-8, rhBMP-9, rhBMP-12, rhBMP-13, rhBMP-15, rhBMP-16, rhBMP-17, rhBMP-18, rhGDF-1, rhGDF-3, rhGDF-5, rhGDF-6, rhGDF-7, rhGDF-8, rhGDF-9, rhGDF-10, rhGDF-11, rhGDF-12, rhGDF-14. For example, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7, disclosed in U.S. Pat. Nos. 5,108,922; 5,013,649; 5,116,738; 5,106,748; 5,187,076; and 5,141,905; BMP-8, disclosed in PCT publication WO91/18098; and BMP-9, disclosed in PCT publication WO93/00432, BMP-10, disclosed in U.S. Pat. No. 5,637,480; BMP-11, disclosed in U.S. Pat. No. 5,639,638, or BMP-12 or BMP-13, disclosed in U.S. Pat. No. 5,658,882, BMP-15, disclosed U.S. Pat. No. 5,635,372 and BMP-16, disclosed in U.S. Pat. Nos. 5,965,403 and 6,331,612. Other compositions which may also be useful include Vgr-2, and any of the growth and differentiation factors [GDFs], including those described in PCT applications WO94/15965; WO94/15949; WO95/01801; WO95/01802; WO94/21681; WO94/15966; WO95/10539; WO96/01845; WO96/02559 and others. Also useful in the present invention may be BIP, disclosed in WO94/01557; HP00269, disclosed in JP Publication number: 7-250688; and MP52, disclosed in PCT application WO93/16099. The disclosures of all of these patents and applications are hereby incorporated herein by reference. Also useful in the present invention are heterodimers of the above and modified proteins or partial deletion products thereof. These proteins can be used individually or in mixtures of two or more. rhBMP-2 is preferred. [0053] The BMP may be recombinantly produced, or purified from a protein composition. The BMP may be homodimeric, or may be heterodimeric with other BMPs (e.g., a heterodimer composed of one monomer each of BMP-2 and BMP-6) or with other members of the TGF-beta superfamily, such as activins, inhibins and TGF-beta 1 (e.g., a heterodimer composed of one monomer each of a BMP and a related member of the TGF-beta superfamily). Examples of such heterodimeric proteins are described for example in Published PCT Patent Application WO 93/09229, the specification of which is hereby incorporated herein by reference. The amount of osteogenic protein useful herein is that amount effective to stimulate increased osteogenic activity of infiltrating progenitor cells, and will depend upon several factors including the size and nature of the defect being treated, and the carrier and particular protein being employed. In certain embodiments, the amount of osteogenic protein to be delivered will be in a range of from about 0.05 to about 1.5 mg. [0054] An osteogenic protein used to form bone can also be administered together with an effective amount of a protein which is able to induce the formation of tendon- or ligament-like tissue in the implant environment. Such proteins include BMP-12, BMP-13, and other members of the BMP-12 subfamily, as well as MP52. These proteins and their use for regeneration of tendon and ligament-like tissue are disclosed for example in U.S. Pat. Nos. 5,658,882, 6,187,742, 6,284,872 and 6,719,968 the disclosures of which are hereby incorporated herein by reference. [0055] Growth factor may be applied to the tissue source in the form of a buffered aqueous solution. Other materials which may be suitable for use in application of the growth factors in the methods and products of the present invention include carrier materials such as collagen, milled cartilage, hyaluronic acid, polyglyconate, degradable synthetic polymers, demineralized bone, minerals and ceramics, such as calcium phosphates, hydroxyapatite, etc., as well as combinations of these and potentially other materials. [0056] Other biologically active materials may also be used in conjunction with osteochondral grafts of the present invention. These include for example cells such as human allogenic or autologous chondrocytes, human allogenic cells, human allogenic or autologous bone marrow cells, human allogenic or autologous stem cells, demineralized bone matrix, insulin, insulin-like growth factor-1, interleukin-1 receptor antagonist, hepatocyte growth factor, platelet-derived growth factor, and Indian hedgehog and parathyroid hormone-related peptide, to name a few. [0057] In certain modes of practice, suitable organic glue material can be used to help secure the graft in place in the implant area. Suitable organic glue material can be obtained commercially, such as for example; TISSEEL® or TISSUCOL® (fibrin based adhesive; Immuno AG, Austria), Adhesive Protein (Sigma Chemical, USA), Dow Corning Medical Adhesive B (Dow Corning, USA), fibrinogen thrombin, elastin, collagen, casein, albumin, keratin and the like. [0058] When used, the growth factor and/or other material(s) can be applied directly to the plug graft and/or to the site in need of repair. For example, the growth factor and/or other material may be physically applied to the graft (e.g. the bone and/or cartilage tissue of an osteochondral graft) through spraying or dipping, or using a brush or other suitable applicator, such as a syringe. Alternatively, or in addition, amounts of the growth factor or other material(s) can be directly applied to the site in need of tissue repair, for example by filling or coating the surgically-prepared opening with one or more of these substances. [0059] Instability of grafted plugs within prepared defect sites can contribute to delayed or failed incorporation of the grafted material with the patient tissue. Osteochondral plug grafts and grafting methods of the present invention can be used in certain aspects of the invention to provide improved implant stabilization, more rapid or complete incorporation of the graft into patient tissue, and/or an enhanced ability to restore articular cartilage defects. In addition, the use of circular cross section graft plugs in adjacent, separate surgical openings leaves gaps between grafts, which can present a relatively non-uniform articulating surface and can also provide pathways for the migration of synovial fluids into the subchondral bone, which may impair graft integration or otherwise deleteriously affect patient outcome. In certain aspects of the invention, grafts having non-circular cross section can be used adjacent to one another, including in the same surgical opening, in a fashion that leaves fewer or smaller gaps in the resurfaced area and enhances the grafting procedure. In these regards, it will be understood that while these particular enhanced features can be provided in certain inventive aspects, they are not required in all embodiments or broader features of the present invention. It should also be understood that while the use of the word preferable, preferably or preferred in the description above indicates that the feature so described may be more desirable, it nonetheless may not be necessary and embodiments lacking the same may be contemplated as within the scope of the invention, that scope being defined by the claims that follow. In reading the claims it is intended that when words such as “a,” “an,” “at least one,” “at least a portion” are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. Further, when the language “at least a portion” and/or “a portion” is used the item may include a portion and/or the entire item unless specifically stated to the contrary. [0060] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. All publications, patents and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference as set forth in its entirety herein.

1a

Priority of U.S. Provisional Application Ser. No. 60/478,198 filed Jun. 13, 2003 is hereby claimed. BACKGROUND OF THE INVENTION Background of the Invention The provisional continuation application described here pertains to “A Non-invasive, Miniature, Breath Monitoring Apparatus”, application Ser. No. 09/891,106, Filed on Jun. 25, 2001, incorporated herein by reference. Said application describes a spectroscopic gas analyzer for rapid, non-invasive, multicomponent analysis of breath and subsequent determination of cardiac output, or other useful physiological measurements. While the device is appropriate for clinical or out-patient (i.e., point-of-care) use in its current configuration, a number of specialized applications require an even smaller system. These include, but are not limited to: “Mobile” human testing; device is carried by the human subject/patient (e.g., in backpack) during the test. This configuration allows freedom of motion, such as running, cycling, or other, Highly portable; for measurements in remote, inaccessible applications such as high altitude research, airplane or spacecraft missions (e.g., sustained micro-gravity research), military field clinics, screening of underserved civilian communities, especially in remote locations, home use, Integrated sensor suite; device is embedded with other sensors to form part of a package such as stress test equipment, ambulance diagnostics, Animal testing; device is strapped to animal subject for unimpeded diagnostic measurement. This is important as the animal cannot always be tested in the laboratory under controlled conditions. Examples of relevant applications include: cardiac output determination in race horses or dogs running on a track, or dolphins under water. The continuation disclosed herein teaches a novel means of miniaturizing the technology from our application Ser. No. 09/891,106. BRIEF DESCRIPTION OF THE INVENTION The principal purpose of the disclosed invention consists of the quantitative analysis of gas-phase components of breath and the subsequent determination of cardiac output ({dot over (Q)}). This measurement is made non-invasively by using novel embodiments of spectroscopic gas sensing technology there-by facilitating further miniaturization than in the original disclosure. The present invention is unique in its optical design allowing multiple species to be monitored simultaneously to determine an accurate measure of {dot over (Q)}. The use of such an approach has not been reported previously to make {dot over (Q)} measurements on subjects at rest or during exercise, nor any other form of breath analysis. By making minor adjustments, the instrument is capable of measuring alternative analytes that may be of interest for {dot over (Q)} monitoring (e.g., methane and Freon 22). The integration of an O 2 measurement channel allows the metabolic measurements to be carried out in conjunction with {dot over (Q)} monitoring. Similarly, the instrument has the capability of measuring numerous other gases, such as NH 3 , CO, N 2 O, ethanol, acetone, aldehydes, etc. for other biomedical applications, as described in our original application. Substitution of the standard four measurement channels (i.e., CO 2 , H 2 O, C 2 H 2 , and SF 6 ) with any of the above does not necessitate any software modifications and only requires minor hardware modifications (i.e., substitution of the optical filters). The above and other objects, advantages, and novel features of the invention will be more fully understood from the following detailed description and the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS The accompanying figures illustrate complete preferred embodiments of the present invention and the best modes presently devised for the practical application of the principles thereof, in which: FIG. 1 . Schematic representation of the disclosed invention. FIG. 2 . Drawing of lead-salt detector array. FIG. 3 . Optical layout of the disclosed invention interfaced with 4-element detector array. FIG. 4 . Three-dimensional representation of light pipe-gas cell-detector array assembly. FIG. 5 . Optomechanical layout of the disclosed invention, using a four-detector mid-IR array in conjunction with one far-IR detector. FIG. 6 . Prism-based beam combiner. DESCRIPTION OF THE PREFERRED EMBODIMENTS A typical embodiment of the invention disclosed in application Ser. No. 09/891,106, filed on Jun. 25, 2001 is shown schematically in FIG. 1 . In summary, radiation from emitter ( 1 ) is collected by miniature sample cell ( 2 ) (the emitter is said to be “butt-coupled” to the sample cell), where sample cell ( 2 ) consists of a low volume light pipe. The breath sample to be analyzed is continuously aspired through sample cell ( 2 ). The radiation exiting the sample cell is modulated by optomechanical chopper ( 3 ) and collected by optic ( 4 ), which can consist of an off-axis parabolic reflector, collimated by optic ( 4 ) and projected into optical chamber ( 6 ). The modular design of optical chamber ( 6 ) made up one of the novel features of application Ser. No. 09/891,106 incorporated by reference and is discussed in detail therein. In summary, collimated beam ( 5 ) is partitioned to a plurality of detectors ( 7 ) and ( 11 ) by means of suitable beamsplitters, mirrors, and lenses. Each detector is equipped with a narrow bandpass optical filter (NBOF)—not shown—which isolates the appropriate spectral window to make the measurement of the corresponding analyte (see application Ser. No. 09/891,106 for a detailed explanation). The signals from the detectors are amplified and conditioned by pre-amplifier boards ( 8 ) and ( 12 ), and analog signal ( 9 ) is relayed to computer and electronics stack ( 10 ), where the signals are conditioned further and digitized. The invention disclosed herein concerns miniaturization of optical chamber ( 6 ). One embodiment of the disclosed invention is motivated by the recent availability (e.g., SensArray Corporation, Burlington, Mass.) of small lead-salt (e.g., lead sulfide, PbS, and lead selenide, PbSe) arrays that do not require cryogenic cooling to respond sensitively to infrared (IR) radiation appropriate for measuring the compounds of interest for breath analysis (see application Ser. No. 09/891,106); i.e., in the 1.0–6.0 μm wavelength range. These arrays only include a small number of elements, say 2–16, and can be custom-engineered with the appropriate mask for a wide range of pixel sizes and geometries. FIG. 2A illustrates a four-element array (front view), where each detector ( 13 ) is symmetrically distributed in a standard electronics package ( 14 ). A 3-D representation is given in FIG. 2B . FIG. 3 schematically illustrates a preferred embodiment of the invention where the light pipe ( 2 ) bolts directly to gas filter correlation cell ( 21 ), which, in turn, bolts directly to detector heat sink ( 19 ). Cell ( 21 ) is isolated from ( 2 ) and ( 19 ) via a pair of optical windows ( 20 ). Another window—not shown—at the other end of light pipe ( 2 ) seals low volume conduit ( 18 ) from the sample stream aspired continuously from the human/animal subject being tested. Gas cell ( 21 ) consists of four independent chambers ( 17 ) that can be filled with a suitable gas filter correlation (GFC) gas via ports ( 16 ). Gases of interest to breath analysis commonly measured by GFC spectroscopy include C 2 H 2 , CH 4 , CO, N 2 O, etc. (see application Ser. No. 09/891,106 for further details). When GFC is not employed, chambers ( 17 ) can be filled with room air, N.sub.2, argon, or can be sealed under vacuum. Each detector element ( 13 ) of the array can be apertured by a different gas cell and NBOF using this simple approach. A 3-D representation of the assembly shown in FIG. 3 is shown in FIGS. 4A and 4B and further teaches how such a novel optical chamber can be configured. FIGS. 4A and 4B also show optical block ( 22 ), which houses IR source ( 1 ). Note that a gap may be required for the blade of optomechanical chopper ( 3 ); in many cases a chopper is not required as the array can be integrated/gated electronically. FIGS. 4A and 4B also illustrate the modular nature of the design. Optomechanical blocks ( 2 ), ( 19 ), ( 21 ), and ( 22 ) can conveniently and economically be machined out of aluminum. This novel miniature assembly also has the advantage of being very economically attractive, as many optical elements used in the original design (see application Ser. No. 09/891,106) can be omitted. The inherent simplicity of the design also makes it very robust. The approach used in FIGS. 3 and 4A and 4 B can be employed to monitor a wide range of breath gases, including, but not limited to, the following combinations: Four mid-IR detector system for {dot over (Q)} monitoring; C 2 H 2 reference (GFC compartment filled with C 2 H 2 ), C 2 H 2 sample (GFC compartment filled with N 2 ), CO 2 reference (GFC compartment filled with N 2 ), CO 2 sample (GFC compartment filled with N 2 ). This approach also requires far-IR detector ( 11 ) for SF 6 monitoring (see application Ser. No. 09/891,106), as illustrated schematically in FIG. 5 , where beamsplitter ( 23 ) reflects the long wavelength IR radiation through optical block ( 25 ), Six mid-IR detector system for {dot over (Q)} monitoring; C 2 H 2 reference (GFC compartment filled with C 2 H 2 ), C 2 H 2 sample (GFC compartment filled with N 2 ), CO 2 reference (GFC compartment filled with N 2 ), CO 2 sample (GFC compartment filled with N 2 ), CH 4 reference (GFC compartment filled with CH 4 ), CH 4 sample (GFC compartment filled with N 2 ). This configuration does not require a far-IR detector, as CH 4 is used in lieu of SF 6 as the blood-insoluble gas, Four mid-IR detector system for CO pulmonary diffusive capacity monitoring; CO reference (GFC compartment filled with CO), CO sample (GFC compartment filled with N 2 ), CH 4 reference (GFC compartment filled with CH 4 ), CH 4 sample (GFC compartment filled with N 2 ). This configuration does not require a far-IR detector, as CH 4 is used in lieu of SF 6 as the blood-insoluble gas, Six mid-IR detector system for {dot over (Q)} and CO pulmonary diffusive capacity monitoring; C 2 H 2 reference (GFC compartment filled with C 2 H 2 ), C 2 H 2 sample (GFC compartment filled with N 2 ), CO 2 reference (GFC compartment filled with N 2 ), CO 2 sample (GFC compartment filled with N 2 ), CO reference (GFC compartment filled with CO), CO sample (GFC compartment filled with N 2 ). This approach also requires far-IR detector ( 11 ) for SF 6 monitoring (see application Ser. No. 09/891,106), as illustrated schematically in FIG. 5 , where beamsplitter ( 23 ) reflects the long wavelength IR radiation through optical block ( 25 ). Note that N 2 O can be substituted directly for C 2 H 2 , where desired, as the blood-soluble gas. Many other permutations are possible due to the modular nature of the design. In another preferred embodiment of the disclosed invention, GFC cell assembly ( 21 ) and detector array assembly ( 22 ) are replaced entirely by a dispersive mid-IR spectrometer including a linear array, consisting of a plurality, typically 128 or more, of detectors. Examples of suitable array detectors for IR measurements include: pyroelectric and thermopile array systems, as supplied by Ion Optics, Inc. (Waltham, Mass.), multiplexed lead sulfide and lead selenide arrays Textron Systems (Petaluma, Calif.) and/or Litton Electro-Optical Systems (Tempe, Ariz.) and/or SensArray Corporation (Burlington, Mass.) would be suitable. Other detector arrays, such as mercury cadmium telluride, supplied by Cincinnati Electronics Corp. (Mason, Ohio), and indium antimonide, supplied by Litton Electro-Optical Systems (Tempe, Ariz.), could also be used for IR measurements The array, which needs to have a response time below 30 ms, is optically interfaced with a grating, such as a holographic grating, which disperses the broadband radiation into its component wavelengths without the need for moving mechanical parts using a standard spectrometer design (e.g., Czerny-Turner). This allows spectra to be processed to extract analyte concentrations using standard methods (see Baum, M. M.; Lord, H. C. Spectroscopic Remote Sensing Exhaust Emission Monitoring System. U.S. Pat. No. 6,455,851, Sep. 24, 2002). In one preferred embodiment of the disclosed invention, a mid-IR spectrometer (e.g., using a PbSe array) is used in conjunction with a far-IR SF 6 detector in an analogous fashion to the configuration shown in FIG. 5 . When an array is used with sensitivity in the far-IR, (e.g., mercury cadmium telluride), all analytes of interest may be monitored in the dispersive spectrometer. Alternatively, CH 4 can be used in lieu of SF 6 as the blood-insoluble gas and all analytes of interest can be monitored in the mid-IR spectrometer. Finally, FIG. 6 shows a preferred embodiment of the disclosed invention for combining the emission from a plurality of IR sources ( 26 ) including, but not limited to: Pulsable broadband emitter (e.g., SVF360-8M, CalSensors, NL8LNC, Ion Optics, Waltham, Mass.), IR light emitting diode (LED) (suppliers include: Institute of Semiconductor Physics, Nauky, Ukraine, Telcom Devices Corporation, Camarillo, Calif., Physico-Technical Institute, St. Petersburg, Russia, Laser Monitoring Systems Ltd., Devon, England), Superluminescent diode (Sarnoff Corporation, Princeton, N.J.), Narrow-band semiconductor incandescent source (Ion Optics), Tunable diode laser, a tunable quantum cascade laser, a pulsed miniature CO 2 laser, such as LASY-1 manufactured by Access Laser Co. (Marysville, Wash.), Any other emitter of radiation that can be electronically pulsed. The output from the IR emitted is collimated using suitable optics ( 27 ) and the resulting beams ( 29 ) are combined using (optically coated) prism ( 28 ). The combined beam traverses light pipe ( 2 ) and can be analyzed with the optical chamber(s) disclosed in the original application, or with any of the embodiments discussed above. This embodiment does not require chopper ( 3 ) as all beams are already electronically modulated/pulsed. This invention is not to be limited by the embodiment shown in the drawings and described in the description which is given by way of example and not of limitation, but only in accordance with the scope of the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation-in-part application to commonly owned application ser. No. 60/422,559 filed Oct. 30, 2002 and titled “Proposition Wager for Blackjack”. FIELD OF THE INVENTION The present invention relates to Blackjack-style games and more particularly to methods for playing live and electronic machines for Blackjack-style games where there is a bonus feature. BACKGROUND There is known in the prior art casino card games where one or more players assemble hands of cards and compete against a hand representing a dealer's hand. One of the most common and popular such games is the game of Blackjack, sometimes referred to as “21.” In a live Blackjack card game, each player makes a wager and the dealer deals two cards to each player to define an initial holding and two cards to himself defining a dealer's initial holding. The cards may be dealt from a single, standard deck of fifty-two playing cards, or from a “shoe” containing multiple decks of cards. The cards to the player(s) may be dealt face up or face down. For the dealer, in the traditional game, one of the dealer's cards in his initial holding is turned face up, which is often referred to as the “up” card, and the other card is dealt face down, which is often referred to as the “hole” card (in some European casinos the dealer will not-deal himself a hole card until all players have completed their hands). Each player, in turn, has the opportunity to complete their hand in a manner well known in the art. The object of the game is for the player to assemble a final hand which (1) has a higher count value than the dealer's final hand without the value exceeding a predetermined target value which, in traditional Blackjack, is 21. In this regard each player may exercise the following options: 1. To stand on the value of the initial holding making the initial holding the player's final holding; 2. Being dealt additional cards (taking “hits”) to try to achieve or come close to the target value; 3. To “double down” (double their initial wager), which may be made, according to the casino's rules, sometimes only available when the count of the initial player hand is 10 or 11; 4. To split card pairs of the initial holding into two hands and play each hand separately; 5. To “surrender” their hand by giving up half their wager (this may not be permitted by some casino rules or only permitted when the dealer has a certain value of the exposed card); and/or. 6. Take insurance by wagering an amount equal to their game wager and if the dealer has a “Blackjack” or “natural” (initial holding composed of an Ace and a ten-value card), the player wins 2:1 and therefore, basically, does not win or lose. As stated above the rules of traditional Blackjack regarding the player's actions are well known in the art. Once the players have completed their hands, the dealer does as well by taking hits or standing according to the house rules. A variation included in those rules is that the dealer may be required to stand on a “soft 17”(i.e., a hand count of 17 including an Ace which counts as a 1 or an 11). Other rules require the dealer to hit a soft 17. If the player exceeds the target value of “21” they, lose their wager regardless of whether the dealer also exceeds the target value. This is because the players complete their hands first. If the player's hand does not exceed the target value and (1) his hand has a value exceeding the dealer or (2) the dealer exceeds the target value, the player wins and is paid 1:1 on their game wager. If 1.5 the dealer does not exceed the target value and his hand has a greater value than the player's final hand, the player loses their wager. If the player's and the dealer's final hand values are the same, it is a tie (or “push”) and the player neither wins nor loses. In traditional Blackjack the hand values are based upon a card valuing schedule as follows: Card Value Ace 1 or 11 K, Q, J, 10 10 2-9 card value It has also been known to program a computer for a player to play the game against the computer. Hand held, electronic, Blackjack game devices have also been known. In what many consider to be a drawback with traditional Blackjack, the most the player can win is a 3:2 award based on their game wager which occurs when the player has a natural and the dealer does not have a natural. Recently some casinos have reduced the award to 6:5. Thus there is no offering for the player to win a greater amount. Another Blackjack-style game is known as “Spanish 21” where all the “10s” are removed from the deck. The game plays like blackjack although the odds are slightly worse for the player due to the removal of the 10s. Yet another Blackjack-style game is known as “No Bust 21” or “21 st Century Blackjack” where no hands can “bust.” If the player hand goes over 21, instead of losing their wager immediately as in traditional Blackjack, the player's is wager stays until the dealer plays out his hand. Unless the dealer hand also goes over 21 and is closer to 21 than is the player hand, the player won't lose the wager. Some Blackjack-style games have been adopted and played which provide for a side (“bonus”) wager that (1) the dealer will have a Blackjack, (2) the dealer's hand will have a certain combination of cards such as suited Queens, or (3) the dealer will take a certain number of hits, or (4) the dealer will bust. In Griffiths, U.S. Pat. No. 5,174,579, there is disclosed a Blackjack side wager “21 or over”. The player making this side wager is betting that the dealer will either bust or achieve exactly a hand count of 21 with 3 or more cards. When the dealer has either busted or achieved an exact hand count of 21, the player is paid according to predetermined odds of 1:1, 3:2 or 2:1. One drawback to this wager is the low payoff odds which limit the attractiveness of the game. There are many Blackjack side wagers that pay much higher odds such as a game known as Lucky Ladies where the top payoff odds are 1000:1 if the player has a hand of Queens of the same suit. Thus “21 or over” won't be enticing, exciting enough for the players. The reason “21 or over” cannot pay odds more than 2:1 is that its hit frequency (probability of the occurrence during play) of 36% is too high. In a “Blackjack game dealt from 6 decks with the “dealer hits a soft 17” rule, a dealer will bust 28.58% of his hands and achieve a count of 21 7.49% of the time. Since the odds are only 1.78:1 against winning a bet with a hit frequency of 36%, there is no way the casino can pay odds higher than 1.78:1, and even with a dealer hand count of 21 being a push, 2.24:1 would be the highest odds the casino can pay without incurring a loss. In Keller, U.S. Pat. No. 5,816,575, there are disclosed a number of side wagers, one of which allows the player to bet that the dealer will go bust. When the dealer busts, the player is paid at 5:2 (i.e., 2.5:1) odds. Again, like 21 or over”, the payoff odds for the side wager are unattractive. Furthermore, since the odds against the dealer going bust are only 2.499:1, the casino won't have an advantage if the side wager is paid 2.5:1. Thus the casino would not have a profit motive for hosting a game with such a side wager. In Forte, U.S. Pat. No. 5,934,998, there is disclosed a side wager that rewards the player if the number of consecutive dealer bust hands has exceeded a predetermined dealer bust event threshold of 5. The drawback to such a wager is that it not only requires additional equipment such as electronic displays and counters to tally the dealer bust event for every player, but once the dealer starts to bust, the player has to stay and continue to play until the dealer either stops busting or reaches the predetermined threshold. Hence side wagers that cannot be resolved in one single hand or round of play require more supervision and cause inconveniences for the players. Further, because new players may enter the game during the dealer busting sequence, maintaining the tally for each player is difficult and likely to lead to disputes. In Vancura, U.S. Pat. No. 5,673,917, there is disclosed a side wager for the player to make in addition to their base game wager in Blackjack. According to this patent, in one embodiment, the player may make a side wager based upon the number of “hits” the player will take in completing their hand. They are paid for their side wager according to one of several suggested pay tables. One drawback to this game embodiment is that the side wager is either fixed, a percentage of the base wager, or confined within strict limits to counteract the effect of an advantage obtained by professional card counters. When the outcome of a side wager depends on the base wager or is confined within limits determined by the possible effects of card counting (optimal advantage play by a card counter to beat the game) in a game where skill can impact the frequency and amount won such as Blackjack, most players will, in regard to the side wager, lose more than they should. The strategy for this side wager will presumably comprise a set of 2- to N-card strategies, where N equals the maximum winning number of successful hits minus 1 and each multi-card strategy is a matrix composed of “hit or stand” rules based on the player's current hand total of 12 through 20 versus the ten dealer up cards for a total of 90 rules times (N×2)! Furthermore, since the base wager and the side wager are paid at different odds, the optimal strategy will vary with the ratio of the base wager to to the side wager, thereby necessitating memorizing many more strategy deviations if the player wants to vary their wager size, which they often do. Thus the size of the side wager had better be a fixed amount or fraction of the base wager as stated in his claims 20 to 23 . Another embodiment described in Vancura is that the player may make one or more side wagers where he/she is attempting to predict the exact number of hits the dealer or player will take. If the player incorrectly predicts the exact number, e.g., the player wagers on two hits and the dealer only takes no hits, one hit or three or more hits, the player loses their side wager. There are several drawbacks to this side wager. First, the player must accurately and precisely predict the number of the dealer hits. If he does not so predict, the player loses their side wager. Second, the outcome of the side wager is also dependent upon the player hand. For the side wager where the player is predicting the number of dealer hits, exact prediction is required for the player to win their side wager. For the side wager on the number of player hits there is disclosed an “over” wager, i.e. three or more hits. Second, the outcome of the side wager is also dependent upon the player hand. Also, according to certain disclosed embodiments, if the player receives a natural (Blackjack), the side wager is a push. This means the player won't have a chance to win the bet an additional 4.7% of the time (the statistical frequency of player Blackjack(s)). Also, the side wager either pushes or loses if the player exercises one of such options as surrender, double down and splitting. This further deprives the player of their chances to win the side wager an additional 12% of the time. The requirement to precisely predict the dealer's hits and the dependency of the outcome of the side wager on the player hand reduce the frequency that the player will win their side wager. If players do win or see other side wagers won relatively frequently, they may abandon the game or at least the side wager. Further, since precise prediction is required for side wagers based on the dealer's hand, players may become frustrated by infrequent wins of the side wager. As for wagers on the player's hand, often the player will be put into a situation where they must choose between winning their base wager and trying to win their side wager. This creates a stressful situation which may cause casual players to shun the side wager altogether. It is further noted that limiting the side the side wager to ⅕ of the base game wager not only reduces both the excitement and betting action for the player and the revenue for the casino, but it also creates difficulties in calculating the exact bet amount for the player and in calculating and making the payment for the dealer as well when the bet amount is not a multiple of 5. Imagine a player making a base wager of $17. Hence there is a need for a game which: 1. does not require an accurate, precise, prediction of the number of hits taken by the dealer to complete their hand; 2. does not restrict the size of the side wager; 3. does not depend upon the play of the player hand for adjudicating the side wager; 4. is not tied to the base wager; 5. pays handsome awards when the player wins; 6. can provide a trigger event which increases the players side wager award; and 7. is configured to provide an acceptable advantage for the casino. SUMMARY OF THE INVENTION There is, therefore, set forth according to the present invention a method of play of a Blackjack-style game which provides for a side wager and which overcomes the drawbacks noted above. The improved method for playing a Blackjack-style card game includes using representations of a deck of cards (playing cards or, for an electronic device, generated representations), where the rules of the game have a predetermined target value which, if exceeded by the dealer's hand value can be declared a dealer hand bust. For traditional Blackjack or Spanish 21, this target value is 21. For “No Bust 21,” this target value is also 21, despite that a dealer hand that goes over 21 is not said to “bust.” The improved game includes the dealers hand receiving, according to the rules of the game, an initial set of cards S. For most, if not all Blackjack-style games, this set S is one or two cards, depending on whether the house rules require the dealer not to take a “hole” card before all players have completed their hands. However, whether the dealer takes a hole card before the players complete their hands does not change the probability of the dealer going over the predetermined target value. The method includes the player making a game wager according to the rules thereof and a side wager. Cards are distributed, e.g., dealt or displayed to the player and to the dealer, according to the rules of the game. For an improved, Blackjack-style game, initially each player is dealt a hand of two cards and the dealer is dealt one or two cards according to the house rules. The dealer and player complete their hands according to the rules of the game including the dealer's hand receiving a set of cards C in addition to said initial set S. The method includes resolving the game wager according to the rules of the game, e.g., according to the rules of Blackjack. The improvement further includes resolving the side wager according to the rules of, (1) if the dealers hand does not exceed a predetermined target value, the player losing their side wager; (2) if the dealer's hand exceeds a predetermined target value and the sum of cards in C+S exceeds a predetermined number of cards, issuing a bonus award to the player, otherwise the player losing their side wager, (3) if the dealer's hand exceeds a predetermined target value, issuing a bonus award to the player according to the point total of the card(s) in S and a predetermined multiplier in C+S, or (4) if the dealer's hand exceeds a predetermined target-value, issuing a bonus award to the player according to the point total of the card(s) in S and the sum of cards in C+S. Thus, for example, if the value sum of cards in the dealer's hand that goes over the predetermined target value (e.g. “21” for a Blackjack game) is 4, the player may win a first award. If the number is 5, the player may win a different, greater award and so forth. The award may also be based upon sum groups as well. For example, if the sum of cards is 3 to 5, the player may win a first award and if the sum is 6 to 7 the player may win a different award. In a further embodiment, in determining the sum and bonus award, certain preselected cards may be subtracted from the sum. For example, if one of a 10, Jack, Queen or King is in the dealer's hand, that card is not considered in determining said sum for the purpose of determining the award. Alternatively, such preselected cards are only subtracted (not counted) if they appear as the dealer's up card in set S, or in set C, or in either of sets S and C. In still a further embodiment, one or more cards may be designated as trigger cards used as an odds multiplier. Should a trigger appear in the dealer's hand, any bonus award to the player(s) is increased. For example, if a 2 is in the dealer's hand and the dealers hand goes over the predetermined target value and if the sum of cards meets the criteria for issuing an award, the award may be increased such as by being doubled. In still a further embodiment, the point or value total of each initial two-card holding in set S determines the payoff odds when the dealer hand goes over the predetermined target value and the sum of cards in C+S shall determine whether the payoff odds should increase. There are fifteen (2 through 16) point totals possible in set S. In case the dealer does not take a hole card until all players complete their hands, the first card the dealer draws is considered to be in S. The features of not requiring the player to precisely predict the number of hits taken by the dealer, provides a greater frequency that the players are issued a bonus award. The feature of scaling up the payoff odds based on the frequency of occurrence of the various dealer hands going over the predetermined target value (i.e., the sum of cards and the fifteen initial dealer two-card totals) enables the game to reward the players both proportionally and handsomely. The variant feature of discounting certain cards from the sum of the dealer's hand that goes over the predetermined target value, can act to, if desired, configure the award frequency and pays to make the game acceptable to the players and the casino. It also helps eliminate its vulnerability to card counting if those cards which are found to be in favor of the card counter when a surplus of such cards exists in the remaining portion of the deck to be dealt are discounted. The feature of the multiplier for increasing the amount of the bonus awards to the player(s) also increases the suspense and excitement attendant to the bonus feature. Furthermore, since the bonus award is based upon the dealer's hand, all player(s) are wagering on the same event and therefore win together. This promotes a comradery among the players. Last but not least, no matter how they choose to play their hand against the dealer, the players play of their hand will not affect the outcome of the player's side wager. DESCRIPTION The method of the present invention hereinafter set forth provides for a side, or bonus wager, for a Blackjack-style game. By Blackjack-style game what is meant is a game where there is a target value set for the valuation of the hands, players receive hands of cards as does a dealer, and winning and losing of the Blackjack-style game is based upon comparison of the dealer's and player's hands inter se as well as in relation to the target value. In connection with Blackjack-style games, the method of play of tradition Blackjack is well known but will briefly be described to aid in the understanding of the present invention. Other such Blackjack-style games include games such as “Spanish 21” as described in Lofink et al, U.S. Pat. No. 5,615,888 and “No Bust 21” as described in Mostashari, U.S. Pat. No. 6,170,828, the disclosure of which is hereby incorporated by reference as well as Blackjack games which offer various side wagers. TRADITIONAL BLACKJACK GAME METHOD The game, as is well known, is played by the player making a game wager to participate in the game. Once the players have made their wagers, the dealer deals to each participating player an initial hand of two-cards and deals himself an up card and a hole card to define an initial dealer's set S of cards. Each player, in turn, Is provided with several options to complete their hands. The basic object of the players' actions is to complete their hands to have a card sum value equaling or getting close to the game's predetermined target value, which for traditional Blackjack, is “21.” If the player's hand exceeds the target value, they automatically “bust” and lose their game wager. In summing the cards, the following values are assigned to the cards: Card Value Ace 1 or 11 K, Q, J, 10 10 2-9 card value As is well known in the game of traditional Blackjack, the following options may be exercised by each player: 1. The player may stand on the sum value of the initial two cards. For example, if the player has a Queen and an 8, their card sum value is 18 and the player would stand. If the player has a 4 and a 6, their initial holding (set S) has a value sum of 10 and the player would take at least one or more additional card(s), or “hit(s).” 2. The player may take one or more hits. For example, if the player's initial hand is a 4 and a 6, the player would take an additional card. If the first hit card is, for example, a 2 for a hand sum value of 12, the player may take another hit. If the second hit card is a Queen, the sum value would be 22 and the player would bust and immediately lose the game wager and be out of the hand of play. If the second hit card is a 9, the player would stand on a hand sum value of 21. 3. The player may, according to some rules, surrender their hand and one-half of their wager. 4. The player may “split” if their first two cards are a pair, e.g., a pair of 8s. The player matches their initial wager and splits each of the 8s into separate hands and hits or stands according to the above. 5. The player may double down on their first two cards. For example, if the player has a 4 and a 6 the player may double their game wager and receive one additional card to complete their hand. 6. If the dealer's up card is an Ace, the player may take insurance by matching their game wager. If the dealer has a ten-value hole card for a natural, the player loses their game wager but is paid 2:1 on their insurance wager thus resulting in no loss to the player. It should be noted that where the dealer's up card is an Ace and the dealer has a natural, the player automatically loses their wager and, except for insurance, can exercise no other option. Certain rules may be adopted such as, if the dealer's up card is an Ace and the player has a natural, the player may elect to receive a 1:1 payment on their game wager before the dealer checks the hold hole card for a natural. After all players have exercised their options in regards to their hand the dealer completes his hand. The dealer's actions are generally according to the following rules. If the dealer's hand sum value is less than 17, the dealer would take additional cards defining a set C of additional cards until his hand sum value is equal to or exceeds 17. Some rules require the dealer to stand on a soft 17 and some rules require the dealer to hit a soft 17. If the dealer's hand sum value exceeds the target value of 21, the dealer busts and he loses and all players who have not previously busted themselves, win their game wagers and are paid 1:1. If the dealer does not bust, the game wagers are resolved by comparing the dealer's hand sum value to that of each player in succession. If the player's value exceeds the dealer's, the player wins and is paid 1:1 based on their game wager. If the dealer's value is greater than the player's, the player loses their game wager. If the hand values tie, it is a push and the player neither wins nor loses. If the player has a natural (a Blackjack of an Ace and a 10-value card in set S), and the dealer does not, the player is awarded a pay greater than 1:1 such as 3:2 or 6:5. After resolution of the hands, the players make new wagers and a new hand is played. A drawback of the traditional, base game, of Blackjack is that the highest award (except for the insurance wager) to the player is for a natural which is paid 3:2 or 6:5. All other wagers are paid at even money (1:1). The Side Wager According to the present invention, the players are permitted to make an optional side wager. The side wager, according to one embodiment, is won or lost based upon the following criteria: 1. If the dealer hand does not exceed a predetermined target value (e.g. 21), the player loses their side wager. 2. If the dealer hand exceeds a predetermined target value, the player wins an amount according to a pay table which relates the number of cards in the dealer's hand (sets S and C) to a bonus award. An example of such a table based on a predetermined target value of 21 is shown in Table 1. TABLE 1 Number of Cards Award (times side wager) 3 1 4 2 5 8 6 20 7 50 8 500 9 5000 Other pay tables may be adopted as well. Thus, if the player made the side wager of $5 and the dealer's hand is 3, 2 (set S) and 7, 2, Ace and King (set C), there are six cards in the dealer's hand (S +C) and according to the example pay table above, the player would be paid $5×20=$100 on their side wager. Thus the player does not have to accurately predict the number of “hits” the dealer will take to win. Thus the frequency at which the players will win their side wagers will increase. Further, since all players who have made the side wager will be paid if the award criteria are met, the comradery between the players increases. In a further embodiment, certain cards may be designated to be subtracted from (not counted) the dealer's hand sum in determining whether the award criteria have been met as well as the award. For example, all ten-value cards may be designated as being subtracted from the sum. As but an example and using the pay table below, the following may occur: 1. The dealer hand is composed of 2, 4, King and 8 for a total value of 24, thus exceeding the predetermined target value of 21. 2. The dealers card sum would be 4−1 (the ten-value card of the King is subtracted) for a total of 3. The player would be paid the odds for cards on their side wager. An example of such a table based on a predetermined target value of 21 is given in Table 2. TABLE 2 Number of Cards Award (times side wager) 1 or 2 1 3 2 4 3 5 5 6 10 7 25 8 100 9 or more 1000 This variant of the game of the present invention may also be varied to only subtract those predetermined cards only when they appear in the initial set S of dealer's cards or just in the dealer's up card in set S. Still another variant is to subtract the predetermined card when it appears in the additional card set C of the dealer's hand. As an additional feature to the game, certain cards may be designated as triggers to enhance the award of the side wager to the player. As but an example, if the dealer hand that exceeds the predetermined target value meets the criteria for an award to the players and contains one or more predetermined trigger cards or card combinations, the award may be increased as by multiplying the award. For example, “7s” may be designated as such triggers and be a multiplier of 2. As long as there is a 7 in a dealer hand that goes over 21, the 2. An example of a pay table based on a predetermined target value of 21 is shown in Table 3. TABLE 3 Number of Cards Award (times side wager) 3 1 4 2 5 5 6 10 7 25 8 100 9 1000 The following would be an example of the application of the triggers using Table 3; The dealer hand is composed of 7, 7, Ace, Ace and 10, for a total of 0.5 cards. Since it pays 5 to 1 for 5 cards and there is a 7 in the dealer's hand, the player's award would be 5×2=10 times the wager. Further, all multipliers in the dealer's hand can be added up to become a larger multiplier. For example, three 7s in the dealer's hand will increase the multiplier to 2+2+2=6. Still further, all multipliers in the dealer's hand can be multiplied to become a larger multiplier. For example, three 7s in the dealer's hand will increase the multiplier to 2×2×2=8. Still further, each additional 7 in the dealer's hand may represent a different multiplier. Thus, the following would be examples of the application of the triggers: (1) The dealer hand is composed of 4, 5, 6 and 7 and the player's award would be two times the base bonus award because there is one 7. (2) The dealer hand is composed of 7, 7, 2 and 10 and the player's award would be triple the base bonus award because there are two 7s. (3) The dealer hand is composed of 7, 7, A, A and 7 and the player's award would be five times the base bonus award because there are three 7s. Other cards or card combinations in the dealer's hand may be used as triggers. As above, the triggers may be constrained to appear in the dealer's initial hand set of cards S or in the additional card set C. However, it is preferred that the triggers may be in any component C, S or C+S to trigger the enhanced award. As still a further embodiment, if the dealers hand exceeds a predetermined target value of 21, a bonus award will be issued to the player according to the value sum of the card(s) in S and the sum of cards in C+S. Aces count as 1 only for the purpose of determining the appropriate payoff odds for the side wager. An example of a pay table for multipliers for this embodiment is given in Table 4. TABLE 4 Sum of cards in the dealer's hand Initial Dealer 2-card that exceeds 21 Total 5 or less 6 or more 2 (A & A) 30 60  3 15 30  4 8 12 5 to 9 3 10 10 3 50 11 3 50 12 1 100 13 1 1000 14 or more 1 impossible For example, if the dealer's hand is composed of 4, 8 (set S) and A, A, 2 and 9 (set C), in that order, for a final total of 25, the player will be paid 100 to 1 because the initial dealer two-card total is 12 and there are six cards in the dealer's hand. As still a further embodiment, a predetermined card is used as a multiplier to increase the payoffs if at least one such card exists in the dealer's hand. For example, if the dealer's hand exceeds a predetermined target value of 21, a bonus award will be issued to the player according to the point total of the card(s) in S. Furthermore, if the dealer's hand contains the multiplier card, then the payoff is increased. Aces count as 1 only for the purpose of determining the appropriate payoff odds for the side wager. An example of a pay table for this embodiment wherein the multiplier is a 6 is given in Table 5. TABLE 5 Does the multiplier exist in the dealer's Initial Dealer 2-card hand that exceeds 21? Total No Yes 2 (A & A) 20 500 3 10 50 4 6 30 5 3 20  6 to 11 3 5 12 to 13 1 3 14 or more 1 1 For example, if the dealer's hand is composed of A, A (set S), 4, 6 and 10 (set C) in that order, for a final total of 22, the player will be paid 500 tol because the initial dealer two-card total is 2 and there is a 6 in the dealer's hand. Further, as described earlier, certain cards can be discounted from the set of S, C or S+C and/or certain cards can be designated as triggers. Further, certain 2-card totals can be discounted from the set of S to enhance the payoff odds at the low end of the pay table. An example of the 2-card total of 13 being excluded is given in Table 5.1: TABLE 5.1 Does the multiplier exist in the dealer's Initial Dealer 2-card hand that exceeds 21? Total No Yes 2 (A & A) 20 500 3 10 50 4 6 30 5 3 20  6 to 11 3 5 12  2 4 14 or more 1 1 As still a further embodiment, the side wager bonus award may be enhanced by the character of a player's initial holding that needs no draw. For example, a natural or a two-card “pat” hand of hard 17 to 20 needs no further action by the player. Thus, it can be awarded according to the following criteria: 1. The dealer's hand exceeds a predetermined target value and the player is entitled to an award based upon the applicable dealer hand card sum; 2. The player's hand has at least one predetermined holding such as, if the player has a natural, the pay table award would be multiplied by 2× or 3×. The examples given below assume that a player natural acts as a multiplier of 2×. An example of this application is given in Table 6. TABLE 6 Award When Player Number of Cards Award Has a Natural 3 1 2 4 2 4 5 8 16 6 20 40 7 50 100 8 500 1000 9 5000 10000 Another example is given in Table 7. TABLE 7 Initial Dealer 2-card Total No Player Natural Player Natural  2 40 80  3 20 40  4 8 16 5 to 9 3 6 10 3 6 11 3 6 12 1 2 13 1 2 14 or more 1 2 Another example is given in Table 8. TABLE 8 Sum of cards in the dealer's hand that exceeds the target value of 21 5 or less 6 or more Initial Dealer 2-card No Player Player No Player Player Total Natural Natural Natural Natural  2 30 60 80 160  3 15 30 40 80  4 8 16 10 20  5 to 9 3 6 10 20 10 3 6 30 60 11 3 6 30 60 12 1 2 100 200 13 1 2 1000 2000 14 or more 1 2 impossible impossible As stated above the enhancement of the award may be triggered by at least one predetermined card or card combination occurring in the dealer's hand or in the player's hand. Any of the foregoing methods can be incorporated into electronic Blackjack-style games. For example, for video Blackjack, the device may be configured to permit the player to lodge their side wager and play the base game as well as the bonus award game of the present invention. While I have described certain embodiments of the present invention, it should be understood that it is subject to modifications and changes which do not depart from the spirit and scope of the invention.

1a

RELATED CASE This application is a continuation-in-part of my copending U.S. Pat. application Ser. No. 13,244, filed Feb. 21, 1979, issuing as U.S. Pat. Ser. No. 4,250,893 on Feb. 17, 1981. BACKGROUND AND SUMMARY Copending U.S. Pat. application Ser. No. 13,244 discloses a sample collection device for drawing samples of blood and other fluids for clinical testing purposes. The device includes a deformable vial, a non-vented cap removably secured to the open end of the vial, and a closure member for initially sealing the collection tube and, following the collection of a sample, for closing the vial itself. The cap includes an integral collection tube extending therefrom, the tube terminating in a tip which, instead of being blunt with an end face extending at right angles to the axis of the tube, is beveled to define an oval end face sloping at an angle of approximately 45° with respect to that axis. For further details, reference may be had to such application and patent issuing therefrom, the disclosure of which is incorporated by reference herein. A main aspect of this invention lies in the discovery that beveling the face of a tube for collecting samples of blood and other biological fluids has the important effect of reducing resistance that might exist to the entry of such fluids into the bore of the tube. The beneficial effects are particularly noticeable with fine-bore collection tubes formed of polypropylene, polyethylene, polystyrene, and other polymeric materials commonly regarded as being hydrophobic in nature. Blood and other biological fluids that would strongly resist entering the bore of such a tube if the end face were disposed at right angles, and such end face were then brought into contact with a supported drop of such a fluid, are found to enter the bore quite readily if the end face is disposed at an angle of approximately 35° to 60° measured from a plane normal to the axis of the tube. The preferred range is 40° to 55°, with the optimum being approximately 49° to 52°. Beveling the tip as so described also yields important advantages even when the tube is formed of a material generally regarded as being hydrophilic, such as glass or cellulose acetate propionate. The ease with which biological fluids may be drawn into the bore of such a tube is noticably enhanced when the tip is beveled rather than blunt, and when the oval surface of the tip is brought into contact with a body of such fluid. Furthermore, when the tube is dimensioned to be filled by capillary action, the difference in tip construction is found to yield a decrease in the fill time for such a tube. Capillary tubes for use in collecting samples of blood and other biological fluids without the need for producing a partial vacuum or suction effect at the opposite ends of such tubes, are commonly formed of hydrophilic materials, partly because the use of other materials would make it difficult or impossible to cause liquid to enter the tubes by capillary action, and partly because such other materials exhibit insufficient attraction to such liquids to overcome the internal forces of the liquids. An important aspect of this invention lies in the discovery that if the tip of a small bore capillary tube is beveled as described, resistance to entry of biological fluids into the bore of such a tube is sufficiently diminished that such tube may be used as a standard capillary tube, being filled by capillary or gravity action, notwithstanding the fact that such tube is formed of a hydrophobic polymeric material. Other features, objects, and advantages of the invention will become apparent from the specification and drawings. DRAWINGS FIG. 1 is a side elevational view of a capillary tube having a tip construction embodying the present invention. FIG. 2 is an enlarged sectional view of the tip of the tube, such tip being shown in relation to a drop of blood resting upon a support surface. FIG. 3 is an end view taken along line 3--3 of FIG. 2. DETAILED DESCRIPTION Referring to the drawings, the numeral 10 designates a blood collecting pipette in the form of a straight cylindrical tube having a tip or collecting end portion 11 and an opposite end portion 12. The bore or lumen 13 of the open-ended tube has a uniform diameter which, in the case of a capillary tube, would not exceed about 2 millimeters. The length of the tube might vary considerably in accordance with desired volumetric capacity and intended use. A characteristic feature of collection tube 10 lies in the bevel of tip 11. End face 14, instead of extending along a plane normal to the longitudinal axis 15 of the tube, lies along a plane disposed at an oblique angle with respect to that axis. Specifically, end face 14 is oval in configuration with the long axis 16 of the oval (FIG. 3) intersecting a plane normal to the longitudinal axis 15 at an acute angle α within the range of about 35° to 60° and, preferably, 40° to 55°. The optimum range for most applications is believed to be approximately 49° to 52°, with angles in the upper part of such range believed to be more effective with tube materials of greater hydrophobicity. The material from which collection tube 10 is formed should be rigid, transparent, and inert with respect to biological fluids. Cellulose acetate propionate has been found particularly effective, although other polymeric materials such as polystyrene, polyethylene, polypropylene, trimethyl pentene, polyethylene terephthalate, and acrylics may be used. As indicated, the tube may also be formed of glass; however, in such a case some of the benefits of the invention will not be fully realized since one of the more important advantages of this invention lies in rendering polymeric materials operative for a use for which they have not previously been regarded as well suited, largely because of the resistance to the entry of blood and other biological fluids into the bores of blunt-ended plastic tubes. Most advantageously, therefore, tube 10 is formed of a plastic material which, although relatively rigid, should not be as brittle or frangible as glass. Referring to FIG. 3, it will be observed that the inner edge 14a of the annular end face 14 is of oval configuration, a necessary result from the facts that bore 13 is cylindrical and that planar face 14 extends at an angle within the range of 35° to 60° with respect to a plane normal to the axis of that bore. Outer edge 14b is also oval in configuration, although that is believed to be of lesser importance than the oval configuration of inner edge 14a. Outer edge 14b should be non-circular and, if oval, its long and transverse axes should ideally be superimposed or congruent with those of the oval defined by edge 14a. The precise reasons why angling or beveling the end face of a blood collection tube markedly increases the performance of that tube may not be fully known, but it is believed that the oval configuration of end face 14, and particularly inner edge 14a, presents to the liquid droplet surface, which tries under the action of intermolecular forces to maintain a configuration of minimum area, a gradual transition from the droplet configuration to the configuration defined by the bore. This droplet surface can assume highly complex configurations as the liquid tries to satisfy the minimum area condition subject to the constraints imposed by the surrounding solid surfaces. FIG. 2 somewhat schematically illustrates a drop of blood 17 on a support surface 18. Internal molecular forces of attraction or cohesion cause that drop to minimize its surface area; if the drop were free falling rather than supported, it would tend to assume a spherical configuration. Even when supported as shown, such a drop tends to define a circular area of contact with surface 18 and to provide an exposed surface 17a of uniform convexity about a central axis perpendicular to the support surface. Consequently, when tip 11 is urged into contact with drop 17, the oval end surface 14 and its concentric edges, particularly inner edge 14a, cause a reformation of the contour of surface 17a. If the end surface 14 were at right angles to the bore of the tube instead of being beveled as shown, then contact between that face and the surface of the drop would tend to be compatible with the surface tensioning forces acting to minimize the surface of the drop; in such a case, the line of contact between the drop and the inner edge of the bore would normally be circular, as presented by phanton line 19 in FIG. 3, and such a circular line of contact would result in minimal deformation of the fluid surface within the circular opening of such a tube. In such a case, urging the blunt tip of the tube more deeply into the drop would increase hydrostatic pressure but would not appreciably alter the line of contact; hence, if a blunt-tipped collection tube were formed of a plastic material generally regarded as being hydrophobic, contact between the tip and the drop would not sufficiently disrupt the surface tensioning forces to cause the liquid to enter the bore by capillary action unless, of course, a substantial pressure head were developed. Since a drop of blood, commonly produced by pricking a finger or heel with a lancet, is of only limited volume and depth, it is difficult if not impossible to create a sufficient pressure head to overcome the surface tension and cause the fluid to enter the mouth of a blunt-tipped tube of hydrophobic material. In contrast to the action of a blunt-ended tube, contact between the end face 14 of tube 10 and drop 17 tends to minimize the surface deformations required to transform the liquid surface from the droplet configuration to the configuration defined by the inside of the tube. If, for example, tube 10 were lowered into contact with drop 17 in the direction indicated by arrow 20, then it is believed apparent that the end face 14 would first contact the drop at two diametrically opposing points lying along the minor axis of the oval at inner edge 14a. The point contact then expands into line contact, but the line is an oval one defined by edge 14a rather than a circular one as previously described with regard to line 19. An oval line of contact along 14a, and an oval area of contact between surface 14 and liquid surface 17a, compel changes in the liquid surface that directly oppose those forces tending to minimize the surface area of the droplet. As the droplet reforms in an effort to restore itself to a condition of minimized surface area, it adopts a configuration that causes it to creep beyond edge 14a and enter the bore of the tube. Finally, once the liquid surface has entered the bore, continued flow proceeds, impelled by gravity draw and/or capillary forces. The explanation given above for the effectiveness of the tube is theoretical and it is possible that other factors may contribute to the physical operation of the present invention, but such effectiveness of operation is readily demonstrated. Microcapillary tubes of polypropylene, polyethylene, polystyrene, polyethylene terephthalate, and other plastics generally regarded as hydrophobic have been found to operate effectively as spontaneously-filling capillary blood tubes only if their tips are beveled as described. Blood from the exposed surface of a drop readily enters the tip of such a tube and, if the tube is disposed horizontally or sloped downwardly from its tip, will quickly fill such tube even though the material from which the tube is formed is generally classified as being hydrophobic. If such a tube is formed of a material considered to be only mildly hydrophobic or hydrophilic, then filling will occur against gravity with the tube sloping upwardly from its beveled tip end. The collection tube has been described as being formed of transparent material. The term "transparent" is used herein to mean a material having sufficient clarity to permit observation of the contents of the bore of such a tube and, therefore, such term is to be regarded as applying to materials which permit such observation even though they might be considered translucent rather than optically clear. Tube 10 has been shown in the drawings as having a uniform outside diameter; however, it is to be understood that such tube or its tip may be tapered, as disclosed in the aforementioned copending application, and such tube may have means at its opposite end for connection to a suitable collection vessel. The structure and advantages of the invention are also illustrated by the following example. EXAMPLE Acrylic capillary tubes of approximately 50 microliters capacity were compared with micropipettes formed of soda-lime glass of 50 microliters capacity, marketed by American Dade Division of American Hospital Supply Corporation, Miami, Florida under the designation ACCUPETTE. Several of the acrylic tubes and, initially, all of the glass tubes, had their end surfaces at right angles to the straight uniform bores of such tubes. Other acrylic tubes were identical to the first group of acrylic tubes except that their end faces were beveled at angles within the range of 45° to 55° as described above. The testing fluid was anticoagulated blood containing one milligram per milliliter of disodium EDTA. Each glass tube filled readily from a drop of blood carried by a support surface, using standard capillary pipetting technique. Using the same procedure with acrylic tubing having right angle tip surfaces, it was found to be extremely difficult to initiate entry of blood into the tips of the tubes, even when such tips were swirled or moved about in the blood droplets. Once entry was initiated, it was found that such acrylic tubes would fill; however, spontaneous entry of blood into the tips of such tubes, upon contact between the blunt ends thereof and the blood droplets, was not found to occur. Spontaneous entry of blood from droplets contacted by the beveled end faces of the acrylic tubes occurred, and such tubes filled quickly and smoothly. Entry and filling were found to occur most readily with a tip angle of approximately 51°. Certain of the glass tubes had their tips reformed to provide beveled surfaces within the range of 45° to 55° and were tested following the same procedure. Spontaneous entry occurred as before; however, a noticable reduction in fill time, as compared to glass tubes having blunt end faces, was observed. While in the foregoing I have disclosed an embodiment of the invention in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.

1a

This application is a national stage of International Application PCT/EP2010/061757, filed Aug. 12, 2010, and claims benefit of and priority to German Patent Application No. 20 2009 005 177.3, filed Aug. 25, 2009, the content of which Applications are incorporated by reference herein. BACKGROUND AND SUMMARY The present disclosure relates to a guide rail that can be mounted on bars of a grid-like side part of a baking oven, a dishwasher, or similar items of furniture. The bars run horizontally and are bent at an angle in bent end regions. The guide rail includes a quick fastening device that includes two mounting elements attached in the end regions of the guide rail and that can be detachably fixed on the bars of the grid-like side part. A first mounting section partially encloses the bar in a longitudinally extending region and a second mounting section partially encloses the bar at the bent end regions. The mounting section of the rear mounting element that is assigned to the rear, bent end region is open in the direction towards the back side of the guide rail. That is so that the guide rail, with the quick fastening device, can be slid onto and attached to one of the bars starting from the front side of the side grid. The front mounting element comprises a leg located below the bar in a section of the mounting element. The mounting section partially encloses the bar in its longitudinally extending region. A flexible catch lug extends upward from the leg, and the lug engages behind the bar enclosed by the mounting element in the assembled position of the guide rail. A guide rail having a quick fastening device of a generic type is known from DE 20 2006 002 251 U1. With the construction described therein, the upper, free end of the flexible catch lug extends to approximately a horizontal center plane, or slightly above, of the bar that is gripped by the mounting element. In order to release the guide rail, if necessary, from its designated mounting position on the bar, it is possible to pivot the catch lug in a manual operation downward to a level beneath the bar, thus enabling the mounting element to be removed sideways from the bar without hindrance. Under extremely unfavorable external circumstances and with the expenditure of large forces, as well as considering the possibility of deformation, it is at least conceivable, with the state-of-the-art technology, that the guide rail could be unintentionally released from the bar in question. The embodiments of the present disclosure, improve on and provide for a guide rail so as to guarantee, under all circumstances, a secure fixing to a bar, and in particular, in the front, end region of the bar. According to an embodiment of the present disclosure, this is achieved, for example, in that the upper, free end of a catch lug protrudes into an aperture of the leg of the mounting element overlapping the upper side of the bar. Through this structurally simple and inexpensive measure, a separation of the mounting element and, therefore, of the guide rail from the bar is only then possible when, by a manual operation, the catch lug is deliberately pulled so far downwards as to enable the mounting element to be pulled sideways over and away from the bar. An accidental release is completely excluded because the upper, free end of the catch lug is fixed in its detent position within the aperture of the upper leg of the mounting element. This, therefore, guarantees a perfect safeguard against inadvertent releasing. It is advantageous when the side edge of the catch lug facing the bar and tilted in the direction of the bar extends upwards. This ensures that, in the case of interaction of lateral forces acting on the mounting element in the release direction, the catch lug is pivoted upwards and is therefore even more securely fixed in the aperture of the upper leg. Thus, even under extremely high stresses and strains, or when slight deformations of the whole system occur over the course of time, an unintended release of the guide rail cannot occur. Other features of the embodiments of the present disclosure are discussed herein. Other aspects of the present disclosure will become apparent from the following descriptions when considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a perspective view of a grid-like side part, or side grid, with a guide rail fixed thereto, according to the present disclosure. FIG. 2 shows a perspective view, according to FIG. 1 , wherein the guide rail is removed from the side grid. FIG. 3 shows a perspective partial view of a rear, end region of the guide rail attached to the side grid, according to the present disclosure. FIG. 4 shows a perspective view of a rear, mounting element of the guide rail, according to the present disclosure. FIG. 5 shows a perspective partial view of the guide rail attached in its front, end region to a side grid, according to the present disclosure. FIG. 6 shows a perspective bottom view of a front mounting element of a guide rail, according to the present disclosure. FIG. 7 shows a perspective top view of the front mounting element of FIG. 6 . FIG. 8 shows a perspective view of FIG. 5 , wherein the guide rail is not finally attached. FIG. 9 shows a view through a fastening area of the front, end region of the guide rail, according to the present disclosure. FIG. 10 shows a view, corresponding to the type of view in FIG. 9 according to a another embodiment of a guide rail, and according to the present disclosure. DETAILED DESCRIPTION In the drawings, the reference sign 1 refers to a guide rail and the reference sign 2 refers a grid side part, or grid-like side part. The side part 2 includes several horizontally extending bars 3 that are each provided with bent end regions 3 a and 3 b . The bent end regions 3 a are, for example, at each front end, and the end regions 3 b are, for example, at each rear end of the bars 3 . The underside of the guide rail 1 is provided with a quick fastening device. The quick fastening device includes two mounting elements 4 and 5 that are fixed in the bent end regions 3 a , 3 b of the guide rail 1 . The mounting element 4 is located at the front end of the guide rail 1 and the mounting element 5 is located at the rear end. The front mounting element 4 , as shown in FIGS. 6 and 7 , is provided with two bracket-like mounting sections 4 a and 4 b . These mounting sections 4 a and 4 b are at an angle to each other, which corresponds to the number of degrees of the angle of the front, end region 3 a relative to horizontal bar 3 . To this extent, the bracket-like mounting sections 4 a and 4 b can, for example, be perpendicular to each other. However, it is within the scope of the present disclosure for the mounting sections 4 a and 4 b to be arranged at an angle of more than 90° to each other. In the assembled state, the mounting section 4 a grips bar 3 in its longitudinally extending region and the mounting section 4 b grips the bent, front end 3 a of a bar 3 , so that the mounting element 4 can, for example, be fastened in a tilt-proof manner relative to only one bar 3 . The fixing of the guide rail 1 in the pull-out direction takes place at a front vertical bar 6 of the grid-like side part 2 by a stop 400 that engages behind the vertical bar 6 . The stop 400 is arranged adjacent to the mounting section 4 b at an upper leg 41 . Due to the adjacent arrangement of the stop 400 and the mounting section 4 b , the fixing of the guide rail 1 takes place in the pull-out direction and also in a direction contrary to the pull-out direction without having to take into account, in this regard, the spacing tolerances to a rear vertical bar 7 . The mounting section 4 a is limited on its underside by a lower leg 40 and an upper leg 41 . A distance between these two legs 40 and 41 relative to each other corresponds, for example, to a diameter of bar 3 . At the lower leg 40 , which engages bar 3 from below in an assembled state, there is a resilient catch lug 42 that extends in an upward direction towards the upper leg 41 and protrudes with its upper, free end 43 into an aperture 44 of the upper leg 41 , as shown in FIGS. 7 and 9 . FIG. 9 represents a situation when the guide rail 1 is mounted to the bar 3 , for example, mounting element 4 is slid onto the bar 3 until it reaches its intended position of use. FIG. 9 illustrates how the resilient catch lug 42 engages behind the bar 3 , so that it is only then possible to release the mounting element 4 from the bar 3 when, to begin with, the catch lug 42 is pressed down manually in the direction of the arrow A, as shown in FIG. 9 , which is possible without further ado by pressing an operating section 45 . If the force that is directed downwards and onto the operation section 45 is removed again, the resilient catch lug 42 moves back into its position in accordance with that shown in FIGS. 6 , 7 and 9 . When the mounting element 4 is slid onto bar 3 , the catch lug 42 , via a lead-in chamfer 46 , is automatically pushed under and across the bar 3 until the catch lug 42 can again move freely upwards due to the resilient restoring forces. In the assembled state as shown in FIG. 9 , it is shown that the side edge 47 of the catch lug 42 facing the bar 3 extends upwards and is inclined towards the bar 3 . It has already been mentioned that the free end 43 of the catch lug 42 protrudes into an aperture 44 of the upper leg 41 . FIG. 9 shows again that the upper, front side free end 43 of the catch lug 42 is formed in a rounded fashion and with this rounded portion it lies against the underside of the guide rail 1 when corresponding high restoring forces are provided. The catch lug 42 is then pushed up if the mounting element 4 is inadvertently moved in a horizontal direction away from the bar 3 , because then the upwardly extending and inclined towards the bar 3 side edge 47 of the catch lug 42 lies against the bar 3 and the corresponding horizontal forces effect a raising of the catch lug 42 . A deflection of the catch lug 42 in a horizontal direction is additionally prevented by the safeguard of the end 43 form-fitting in the aperture 44 . In addition, in order to assist the form-fitting safeguard, the side of the end 43 facing away from the bar 3 can, for example, be steeper or even vertical (see, for example, FIG. 9 ). An inadvertent release is, according to the present disclosure, therefore, safely prevented also when high forces are applied. As shown in FIGS. 6 and 7 , the upper leg 41 has a bead 48 embossed downwards towards the bar 3 . The embossing of this bead 48 and its position are thus selected so that sliding the mounting element 4 onto the bar 3 requires a certain amount of force in order to slide the bead 48 over and away from the bar 3 during a simultaneous slight lowering of the upper leg 41 until the bead 48 engages in a position behind the bar 3 . This bead 48 indicates to the user during a potential assembly, that the mounting element 4 has assumed its designated position. That is because the user is sensitive to the different exertion forces involved. In addition, and aided by the springing back of the lower leg 40 into a relaxed position, the “jumping over” of the bead 48 over the bar 3 emits a sound that the user hears and can consider it to be a further indication of proper assembly. In order to facilitate the placement of the mounting element 4 , for the purpose of sliding it sideways onto a bar 3 , the upper leg 41 is provided with a bulge 49 extending in the direction of the bar 3 . The bulge 49 gives the user an easy orientation for the correct placement of the mounting element 4 in respect to the bar 3 to be engaged. The orientation guidance for the location and for mounting position of mounting element 4 relative to bar 3 , as described above in association with the bead 48 , for placing the mounting element 4 onto a bar 3 , can within the scope of the present disclosure, be implemented by a mounting element 4 ′, according to an embodiment of the present disclosure, as depicted in FIG. 10 . The bead 48 is replaced by an open embossed feature 48 a directed downwards and into whose opening area the upper, front end 43 of the catch lug 42 can, for example, engage and whose outer margin area, like the bead 48 , must be pushed over and away from bar 4 in order to be able to bring the mounting element 4 ′ into its designated mounting position. Also, a movement over the embossed feature 48 a results in the user receiving the previously noted orientation guidance for the proper location and/or mounting position of the mounting element 4 relative to the bar 3 . Furthermore, with a low material thickness of the leg 41 , the form-fitted safeguard of the end 43 in the embossed feature 48 a is improved. The rear mounting element 5 , as can be seen in FIGS. 3 and 4 , is provided with a bracket-like mounting section 5 a that, in the assembled state, engages around bar 3 in its longitudinally extending area. This bracket-like mounting section 5 a is limited by a lower leg 50 and an upper leg 51 , wherein the distance of these two legs 50 and 51 between each other corresponds, in turn, to the thickness of the bar 3 . In addition, at the rear end region of the guide rail 1 , the mounting element 5 is equipped with a support lug 52 that, in the assembled state as depicted in FIG. 3 , engages beneath the rear, bent end region 3 b of bar 3 . This support lug 52 is bent or angled downwards from the area of the upper leg 51 of the mounting element 5 and is located on the same plane as the lower leg 50 of the bracket-like mounting section 5 a . As the support lug 52 only engages beneath the end region 3 b , the distance tolerances between the vertical bars 6 and 7 are balanced out. In angled areas of the upper leg 51 , an adjoining downwardly directed web 53 , and the support lug 52 adjoined thereto, beads 54 are embossed that lead to a stiffening of the mounting element 5 in those angled areas. The installation of guide rail 1 , with the mounting elements 4 and 5 comprising the quick fastening device, to bar 3 of side grid 2 and starting from a position according to FIG. 2 , is carried out as follows. To start with, the rear mounting element 5 is set sideways at bar 3 and then, for the moment, is pushed so far to the rear until the web 53 of the rear mounting element 5 strikes the rear, bent end 3 b of bar 3 . After that, the guide rail 1 with the front mounting element 4 is pivoted in a horizontal movement onto bar 3 from a starting position, as follows from FIG. 8 . In the course of this pivoting, the front mounting element 4 , in a manner as specified above, is likewise pushed onto the longitudinally extending region of the bar 3 in the same way as onto the front, bent end 3 a of the same bar 3 . Self-locking then takes place, as was described above. In the case of a required disassembly, the catch lug 42 is, to start with, pivoted away and downwards from the plane of the bar 3 . Then, first, the guide rail 1 is pulled off the bar 3 in a horizontal pivoting movement, resulting in a position according to FIG. 8 . The, second, the guide rail 1 can be removed completely from the bar 3 by pulling in the pull-out direction, and then taken away, for example, for cleaning purposes. The mounting elements 4 and 5 , may, according to the present disclosure, be formed in one piece and may, according the present disclosure, be made either of metal or of plastic material. Although the present disclosure has been described and illustrated in detail, it is to be clearly understood that this is done by way of illustration and example only and is not to be taken by way of limitation. The scope of the present disclosure is to be limited only by the terms of the appended claims.

1a

RELATED APPLICATIONS [0001] This is a continuation-in-part of application Ser. No. 10/000,742, filed on Nov. 10, 2001. BACKGROUND [0002] Interleukin-12 (IL-12) is a heterodimeric cytokine (p70) composed of two subunits (p35 and p40), and plays key roles in immune responses by bridging innate resistance and antigen-specific adaptive immunity. Trinchieri (1993) Immunol Today 14: 335. For example, it promotes type 1 T helper cell (Th1) responses and, hence, cell-mediated immunity. Chan et al. (1991) J Exp Med 173: 869; Seder et al. (1993) Proc Natl Acad Sci USA 90: 10188; Manetti et al. (1993) J Exp Med 177: 1199; and Hsieh et al. (1993) Science 260: 547. Overproduction of IL-12 causes excessive Th1 responses, and may result in inflammatory disorders, such as insulin-dependent diabetes mellitus, multiple sclerosis, rheumatoid arthritis, psoriasis, Crohn's disease, or sepsis. See, for example, Gately et al. (1998) Annu Rev Immunol. 16: 495; and Abbas et al. (1996) Nature 383: 787. Thus, inhibiting EL-12 overproduction is an approach to treat the just-mentioned diseases. Trembleau et al. (1995) Immmunol. Today 16: 383; and Adorini et al. (1997) Chem. Immunol. 68: 175. For example, overproduction of IL-12 and the resultant excessive Th1 type responses can be suppressed by modulating IL-12 production. A compound that down-regulates IL-12 production can be used for treating inflammatory diseases. Ma et al. (1998) Eur Cytokine Netw 9: 54. SUMMARY [0003] In one aspect, this invention features pyrimidine compounds of formula (I): [0004] R 1 is [referred to hereinafter as NC(R a R b )]; each of R 2 and R 4 is H; R 3 is H, alkyl, aryl, heteroaryl, cyclyl, heterocyclyl, or alkylcarbonyl; R 5 is H or alkyl; n is 0, 1, 2, 3, 4, 5, or 6; X is NR c ; Y is covalent bond, CH 2 , C(O), C═N—R c , C═N—OR c , C═N—SR c , O, S, S(O), S(O 2 ), or NR c ; Z is N or CH; one of U and V is N, and the other is CR c ; and W is O, S, S(O), S(O 2 ), NR c , or NC(O)R c ; in which each of R a and R b , independently, is H, alkyl, aryl, heteroaryl; and R c is H, alkyl, aryl, heteroaryl, cyclyl, heterocyclyl, or alkylcarbonyl. Note that the left atom shown in any substituted group described above is closest to the pyrimidine ring. Also note that when there are more than one R c -containing substituted groups in a pyrimidine compound, the R c moieties can be the same or different. [0005] In some embodiments, one of R a and R b is H or alkyl; and the other is in which R d is H, alkyl, or alkoxyl; R e is halogen, CN, hydroxyl, alkyl, aryl, heteroaryl, alkoxyl, aryloxyl, or heteroaryloxyl; and m is 0, 1, 2, 3, or 4. [0006] In other embodiments, X is NH; Y is O; or n is 2. [0007] In still other embodiments, U is N; V is CH; and R 3 is heteroaryl (e.g., 1-oxy-pyridin-2-yl). Preferably, X is NH; Y is O; n is 2; and one of R a and R b is H; and the other is 3-methylphenyl. [0008] Alkyl, alkenyl, alkynyl, aryl, heteroaryl (e.g., 1-oxy-pyridinyl), cyclyl, heterocyclyl mentioned above include both substituted and unsubstituted moieties. The term “substituted” refers to one or more substituents (which may be the same or different), each replacing a hydrogen atom. Examples of substituents include, but are not limited to, halogen, hydroxyl, amino, alkylamino, arylamino, dialkylamino, diarylamino, cyano, nitro, mercapto, carbonyl, carbamido, carbamyl, carboxyl, thioureido, thiocyanato, sulfoamido, C 1 ˜C 6 alkyl, C 1 ˜C 6 . alkenyl, C 1 ˜C 6 alkoxy, aryl, heteroaryl, cyclyl, heterocyclyl, wherein alkyl, alkenyl, alkoxy, aryl, heteroaryl cyclyl, and heterocyclyl are optionally substituted with C 1 ˜C 6 alkyl, aryl, heteroaryl, halogen, hydroxyl, amino, mercapto, cyano, or nitro. The term “aryl” refers to a hydrocarbon ring system having at least one aromatic ring. Examples of aryl moieties include, but are not limited to, phenyl, naphthyl, and pyrenyl. The term “heteroaryl” refers to a hydrocarbon ring system having at least one aromatic ring which contains at least one heteroatom such as O, N, or S. Examples of heteroaryl moieties include, but are not limited to, furyl, pyrrolyl, thienyl, oxazolyl, imidazolyl, thiazolyl, pyridinyl, pyrimidinyl, quinazolinyl, and indolyl. The terms “cyclyl” and “heterocyclyl” refer to partially and fully saturated mono- or bi-cyclic rings having from 4 to 14 ring atoms. A heterocyclyl ring contains one or more heteroatoms (e.g., O, N, or S). Exemplary cyclyl and heterocyclyl rings are cycylohexane, piperidine, piperazine, morpholine, thiomorpholine, and 1,4-oxazepane. [0009] Below is an exemplary compound of this invention: [0010] In another aspect, this invention features a pharmaceutical composition that contains a pharmaceutically acceptable carrier and an effective amount of at least one of the pyrimidine compounds of this invention. [0011] In further another aspect, the present invention features a method for treating an IL-12 overproduction-related disorder (e.g., rheumatoid arthritis, sepsis, Crohn's disease, multiple sclerosis, psoriasis, or insulin-dependent diabetes mellitus). The method includes administering to a subject in need thereof an effective amount of one or more pyrimidine compounds of this invention. [0012] The pyrimidine compounds of this invention include the compounds themselves, as well as their salts and their prodrugs, if applicable. Such salts, for example, can be formed between a positively charged substituent (e.g., amino) on a compound and an anion. Suitable anions include, but are not limited to, chloride, bromide, iodide, sulfate, nitrate, phosphate, citrate, methanesulfonate, trifluoroacetate, and acetate. Likewise, a negatively charged substituent (e.g., carboxylate) on a compound can form a salt with a cation. Suitable cations include, but are not limited to, sodium ion, potassium ion, magnesium ion, calcium ion, and an ammonium cation such as teteramethylammonium ion. Examples of prodrugs include esters and other pharmaceutically acceptable derivatives, which, upon administration to a subject, are capable of providing the pyrimidine compounds described above. [0013] In addition, some of the pyrimidine compounds of this invention have one or more double bonds, or one or more asymmetric centers. Such compounds can occur as racemates, racemic mixtures, single enantiomers, individual diastereomers, diastereomeric mixtures, and cis- or trans- or E- or Z-double isomeric forms. [0014] Also within the scope of this invention are a composition containing one or more of the compounds described above for use in treating an IL-12 overproduction-related disorder, and the use of such a composition for the manufacture of a medicament for the just-described use. [0015] Other features, objects, and advantages of the invention will be apparent from the description and from the claims. DETAILED DESCRIPTION [0016] The compounds described above can be prepared by methods well known in the art, as well as by the synthetic routes disclosed herein. For example, a pyrimidine compound can be prepared by using 2,4,6-trichloro-pyrimidine as a starting material. The three chloro groups can be displaced by various substitutes. More specifically, first chloro group (e.g., at position 6) can react with, e.g., morpholine, to form a morpholinyl pyrimidine. 2-Aryl and 2-alkylpyrimidinde dichloro compounds can also be prepared by reacting an amidine with a malonic ester followed by treatment with phosphorous oxychloride. Second chloro group can be replaced by reacting with a nucleophile, such as an alcohol in the presence of base, e.g., sodium hydride. Isomeric forms may be produced. The desired isomeric product can be separated from others by, e.g., high performance liquid chromatography. Third chloro group undergoes a displacement reaction with, e.g., hydrazine, and the primary amine of the coupled hydrazine moiety further reacts with an aldehyde. Thus, a pyrimidine compound of this invention is obtained. [0017] The chemicals used in the above-described synthetic routes may include, for example, solvents, reagents, catalysts, and protecting group and deprotecting group reagents. The methods described above may also additionally include steps, either before or after the steps described specifically herein, to add or remove suitable protecting groups in order to ultimately allow synthesis of the pyrimidine compounds. In addition, various synthetic steps may be performed in an alternate sequence or order to give the desired compounds. Synthetic chemistry transformations and protecting group methodologies (protection and deprotection) useful in synthesizing applicable pyrimidine compounds are known in the art and include, for example, those described in R. Larock, Comprehensive Organic Transformations , VCH Publishers (1989); T. W. Greene and P. G. M. Wuts, Protective Groups in Organic Synthesis, 2 nd Ed., John Wiley and Sons (1991); L. Fieser and M. Fieser, Fieser and Fieser's Reagents for Organic Synthesis , John Wiley and Sons (1994); and L. Paquette, ed., Encyclopedia of Reagents for Organic Synthesis , John Wiley and Sons (1995) and subsequent editions thereof. [0018] A pyrimidine compound thus obtained can be further purified by flash column chromatography, high performance liquid chromatography, or crystallization. [0019] Also within the scope of this invention is a pharmaceutical composition that contains an effective amount of one or more of the pyrimidine compounds of this invention and a pharmaceutically acceptable carrier. Further, the present invention covers a method of administering an effective amount of such a compound to a subject in need of treatment of IL-12 overproduction related diseases (e.g., rheumatoid arthritis, sepsis, Crohn's disease, multiple sclerosis, psoriasis, or insulin-dependent diabetes mellitus). “An effective amount” refers to the amount of the compound which is required to confer a therapeutic effect on the treated subject. The interrelationship of dosages for animals and humans (based on milligrams per meter squared of body surface) is described in Freireich et al., (1966) Cancer Chemother Rep 50: 219. Body surface area may be approximately determined from height and weight of the patient. See, e.g., Scientific Tables, Geigy Pharmaceuticals, Ardley, N.Y., 1970, 537. An effective amount of the pyrimidine compound of this invention can range from about 0.001 mg/Kg to about 1000 mg/Kg. Effective doses will also vary, as recognized by those skilled in the art, depending on the diseases treated, route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments such as use of other agents. [0020] To practice the method of the present invention, a pyrimidine compound, as a component of a pharmaceutical composition, can be administered orally, parenterally, by inhalation spray, topically, rectally, nasally, buccally, vaginally or via an implanted reservoir. The term “parenteral” as used herein includes subcutaneous, intracutaneous, intravenous, intramuscular, intraarticular, intraarterial, intrasynovial, intrastemal, intrathecal, intralesional and intracranial injection or infusion techniques. [0021] A sterile injectable composition, for example, a sterile injectable aqueous or oleaginous suspension, can be formulated according to techniques known in the art using suitable dispersing or wetting agents (such as, for example, Tween 80) and suspending agents. The sterile injectable preparation can also be a sterile injectable solution or suspension in a non-toxic parenterally acceptable diluent or solvent, for example, as a solution in 1,3-butanediol. Among the acceptable vehicles and solvents that can be employed are mannitol, water, Ringer's solution and isotonic sodium chloride solution. In addition, sterile, fixed oils are conventionally employed as a solvent or suspending medium (e.g., synthetic mono- or diglycerides). Fatty acids, such as oleic acid and its glyceride derivatives are useful in the preparation of injectables, as are natural pharmaceutically-acceptable oils, such as olive oil or castor oil, especially in their polyoxyethylated versions. These oil solutions or suspensions can also contain a long-chain alcohol diluent or dispersant, or carboxymethyl cellulose or similar dispersing agents. Other commonly used surfactants such as Tweens or Spans or other similar emulsifying agents or bioavailability enhancers which are commonly used in the manufacture of pharmaceutically acceptable solid, liquid, or other dosage forms can also be used for the purposes of formulation. [0022] A composition for oral administration can be any orally acceptable dosage form including, but not limited to, capsules, tablets, emulsions and aqueous suspensions, dispersions and solutions. In the case of tablets for oral use, carriers which are commonly used include lactose and corn starch. Lubricating agents, such as magnesium stearate, are also typically added. For oral administration in a capsule form, useful diluents include lactose and dried corn starch. When aqueous suspensions or emulsions are administered orally, the active ingredient can be suspended or dissolved in an oily phase combined with emulsifying or suspending agents. If desired, certain sweetening, flavoring, or coloring agents can be added. A nasal aerosol or inhalation composition can be prepared according to techniques well-known in the art of pharmaceutical formulation and can be prepared as solutions in saline, employing benzyl alcohol or other suitable preservatives, absorption promoters to enhance bioavailability, fluorocarbons, and/or other solubilizing or dispersing agents known in the art. A pyrimidine compound of this invention can also be administered in the form of suppositories for rectal administration. [0023] The carrier in the pharmaceutical composition must be “acceptable” in the sense of being compatible with the active ingredient of the formulation (and preferably, capable of stabilizing it) and not deleterious to the subject to be treated. For example, solubilizing agents such as cyclodextrins, which form specific, more soluble complexes with the compounds of this invention, or one or more solubilizing agents, can be utilized as pharmaceutical excipients for delivery of the pyrimidine compounds. Examples of other carriers include colloidal silicon dioxide, magnesium stearate, cellulose, sodium lauryl sulfate, and D&C Yellow # 10. [0024] The biological activities of a pyrimidine compound can be evaluated by a number of cell-based assays. One of such assays can be conducted using cells from human peripheral blood mononuclear cells (PBMC) or human monocytic cell line (THP-1). The cells are stimulated with a combination of human interferon-γ (IFNγ) and lipopolysaccharide or a combination of IFNγ and Staphylococcus aureus Cowan I in the presence of a test compound. The level of inhibition of IL-12 production can be measured by determining the amount of p70by using a sandwich ELISA assay with anti-human IL-12 antibodies. IC 50 of the test compound can then be determined. Specifically, PBMC or THP-1 cells are incubated with the test compound. Cell viability was assessed using the bioreduction of MTS [3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium] (Promega, Madison, Wis.). [0025] A pyrimidine compound can also be evaluated by animal studies. For example, one of such studies involves the ability of a test compound to treat adjuvant arthritis (i.e., a IL-12 overproduction related disorder) in rats. [0026] Without further elaboration, it is believed that the above description has adequately enabled the present invention. The following specific embodiments are, therefore, to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever. All of the publications cited herein are hereby incorporated by reference in their entirety. EXAMPLE 1 Preparation of Compound 1: N-(3-Methyl-benzylidene)-N′-{6-morpholin-4-yl-2-[2-(1-oxy-pyridin-2-yl)-ethoxy]-pyrimidin-4-yl}-hydrazine [0027] To a solution of 4-[6-chloro-2-(2-pyridin-2-yl-ethoxy)-pyrimidin-4-yl]-morpholine (1.61 g, 5.0 mmol) in CH 2 Cl 2 (40 ml) was added methanol (10 ml) followed by the addition of MCPBA (70%, 1.43 g, 5.8 mmol) in one portion. The reaction mixture was stirred overnight at room temperature, affording a clear solution. The solution was cast into saturated aqueous NaHCO 3 (35 ml) then the organic phase was separated, washed with 10% aqueous Na 2 S 2 O 3 (40 ml) and brine (40 ml), and dried (Na 2 SO 4 ), filtered and evaporated in vacuo to give a pure product, 4-{6-chloro-2-[2-(1-oxy-pyridin-2-yl)-ethoxy]-pyrimidin-4-yl}-morpholine as a white solid, (1.46 g, 86.7%). [0028] 1 H-NMR (CDCl 3 ) (ppm), J(Hz): 8.25-8.23(m, 1H), 7.41-7.7.38(m, 1H), 7.20-7.16(m, 2H), 6.14(s, 1H), 4.71(t, J=6.0, 2H), 3.77-3.73(m, 4H), 3.63-3.55(m, 4H), 3.40(t, J=6.0, 2H), [0029] Anhydrous hydrazine (0.640 ml, 20 mmol) was added to a solution of 4-{6-chloro-2-[2-(1-oxy-pyridin-2-yl)-ethoxy]-pyrimidin-4-yl})-morpholine (1.35 g, 4.0 mmol) in dioxane (15 ml) under the nitrogen protection. The obtained mixture was heated at 95-100° C. for 2 h. [0030] After it was cooled down, the solvent was evaporated in vacuo until the white solid began to precipitate (to a half the original volume), and then H 2 O (15 ml) was added. The resulting precipitate was collected by filtration and washed with water (until the pH was neutral). {6-Morpholin-4-yl-2-[2-(1-oxy-pyridin-2-yl)-ethoxy]-pyrimidin-4-yl}-hydrazine (1.02 g) has been obtained in 76.7% yield. [0031] 1 H-NMR (DMSO-d 6 ) (ppm), J(Hz): 8.25(bs, 1H), 7.66(s, 1H), 7.44-7.41(m, 1H), 7.33-7.25(m, 2H), 5.59(s, 1H), 4.46(t, J=6.0, 2H),3.64-3.61(m, 4H), 3.41-3.38(m, 4), 3.17(t, J=6., 2H), [0032] To a solution {6-morpholin-4-yl-2-[2-(1-oxy-pyridin-2-yl)-ethoxy]-pyrimidin-4-yl}-hydrazine (820 mg, 2.46 mmol) and m-tolualdehyde (97%, 320 mg, 2.58 mmol) in methanol (7 ml) acetic acid (2 drops) was added. The reaction mixture was heated under reflux for 15 min. Upon cooling to room temperature, a precipitating has been formed, and the solid was collected by filtration, washed with little amount of methanol and Et 2 O, and dried to afford 950 mg (89%) of N-(3-Methyl-benzylidene)-N′-{6-morpholin-4-yl-2-[2-(1-oxy-pyridin-2yl)-ethoxy]-pyrimidin-4-yl}-hydrazine as a white solid (m.p. 187-188° C.). 1 H NMR (300 MHz, CDCl 3 ), δ (ppm): 10.86 (s, 1H), 8.28-8.26 (m, 1H), 7.98 (s, 1H), 7.50-7.43 (m, 3H), 7.33-7.26 (m, 3H), 7.17 (d, J=7.8 Hz, 1H), 6.05 (s, 1H), 4.53 (t, J=6.3 Hz, 2H), 3.68-3.64 (m, 4H), 3.54-3.50 (m, 4H), 3.21 (t, J=6.3, 2H), 2.33 (s, 3H); [0033] ESMS calcd for C 23 H 26 N 6 O 3 : 434.21; Found: 457.2 (M+Na) + . EXAMPLE 2 In Vitro Assays [0034] Reagents. Staphylococcus aureus Cowan I (SAC) was obtained from Calbiochem (La Jolla, Calif.), and lipopolysaccharide (LPS, Serratia marscencens ) was obtained from Sigma (St. Louis, Mo.). Human and mouse recombinant IFN-γ were purchased from Boehringer Mannheim (Mannheim, Germany) and Pharmingen (San Diego, Calif.), respectively. [0035] Human In Vitro Assay. Human PBMC were isolated by centrifugation using Ficoll-Paque (Pharmacia Biotech, Uppsala, Sweden) and prepared in RPMI medium supplemented with 10% fetal calf serum (FCS), 100 U/mL penicillin, and 100 μg/mL streptomycin. PBMC were plated in wells of a 96-well plate at a concentration of 5×10 5 cells/well, and primed by adding IFNγ (30 U/mL) for 22 h and stimulated by adding LPS (1 μg/mL), or by adding IFNγ (100 U/mL) and then stimulated by adding SAC (0.01%). A test pyrimidine compound was dissolved in DMSO, and added to wells of the 96-well plate. The final DMSO concentration was adjusted to 0.25% in all cultures, including the compound-free control. Human THP-1 cells were plated in wells, primed by adding IFNγ (100 U/mL) for 22 h and stimulated by adding SAC (0.025%) in the presence of different concentrations of the pyrimidine compound. Cell-free supernatants were taken 18 h later for measurement of cytokines. Cell viability was assessed using the bioreduction of MTS. Cell survival was estimated by determining the ratio of the absorbance in compound-treated groups versus compound-free control. [0036] The supematant was assayed for the amount of IL-12p40, IL-12p70, or IL-10 by using a sandwich ELISA with anti-human antibodies, i.e., a Human IL-12 p40 ELISA kit from R&D Systems (Berkeley, Calif.), and a Human IL-12 p70 or IL-10 ELISA kit from Endogen (Cambridge, Mass.). Assays were based on the manufacturer's instructions. [0037] Murine In Vitro Assay. Balb/c mice (Taconic, Germantown, N.Y.) were immunized with Mycobacterium tuberculosis H37Ra (Difco, Detroit, Mich.). The splenocytes were harvested 5 days and prepared in RPMI medium supplemented with 10% FCS and antibiotics in a flat bottom 96-well plate with 1×10 6 cells/well. The splenocytes were then stimulated with a combination of IFNγ (60 ng/mL) and SAC (0.025%) [or LPS (20 μg/mL)] in the presence of a test compound. Cell-free supernatants were taken 24 h later for the measurement of cytokines. The preparation of compound and the assessment of cell viability were carried out as described above. Mouse IL-12 p70, IL-10, IL-1β, and TNFα were measured using ELISA kits from Endogen, according to the manufacturer's instructions. [0038] The biological activities of pyrimidine compounds were tested on human PBMC or THP-1 cells. Unexpectedly, Compound 1 had an IC 50 value as low as 1.4 nM when tested on human PBMC cells. EXAMPLE 3 In Vivo Assays [0039] Treatment of adjuvant arthritis in rats: Adjuvant arthritis (AA) was induced in female Lewis rats by the intracutaneous injection (base of the tail) of 0.1 mL of a 10 mg/mL bacterial suspension made from ground, beat-killed Mycobacterium tuberculosis H37Ra suspended in incomplete Freund's adjuvant. Rats were given a test compound orally once a day for 12 days, starting the day following the induction. The development of polyarthritis was monitored daily by macroscopic inspection and assignment of an arthritis index to each animal, during the critical period (days 10 to 25 post-immunization). [0040] The intensity of polyarthritis was scored according to the following scheme: (a) Grade each paw from 0 to 3 based on erythema, swelling, and deformity of the joints: 0 for no erythema or swelling; 0.5 if swelling is detectable in at least one joint; 1 for mild swelling and erythema; 2 for swelling and erythema of both tarsus and carpus; and 3 for ankylosis and bony deformity. Maximum score for all 4 paws was thus 12. (b) Grade for other parts of the body: for each ear, 0.5 for redness and another 0.5 if knots are present; 1 for connective tissue swelling (saddle nose); and 1 for the presence of knots or kinks in the tail. The highest possible arthritic index was 16. [0041] Experiments with the AA model were repeated four times. Oral administration of pyrimidine compounds of this invention reproducibly reduced the arthritic score and delayed the development of polyarthritis in a dose-dependent manner. The arthritis score used in this model was a reflection of the inflammatory state of the structures monitored and the results therefore show the ability of the test compound to provide relief for this aspect of the pathology. [0042] Treatment of Crohn's disease in dinitrobenzene sulfonic acid-induced inflammatory bowel syndrome model rats: Wistar derived male or female rats weighing 200±20 g and fasted for 24 hours were used. Distal colitis was induced by intra-colonic instillation of 2,4-dinitrobenzene sulfonic acid (DNBS, 25 mg in 0.5 mL ethanol 30%) after which air (2 mL) was gently injected through the cannula to ensure that the solution remained in the colon. A test compound and/or vehicle was administered orally 24 and 2 hours before DNBS instillation and then daily for 5 days. One control group was similarly treated with vehicle alone while the other is treated with vehicle plus DNBS. The animals were sacrificed 24 hours after the final dose of test compound administration and each colon was removed and weighed. Colon-to-body weight ratio was then calculated for each animal according to the formula: Colon (g)/BW×100. The “Net” increase in ratio of Vehicle-control+DNBS group relative to Vehicle-control group was used as a base for comparison with test substance treated groups and expressed as “% Deduction.” A 30% or more reduction in colon-to-body weight ratio, relative to the vehicle treated control group, was considered significant. Unexpectedly, Compound 1 had about 63% reduction. [0043] Rats treated with test substance orally showed a marked reduction in the inflammatory response. These experiments were repeated three times and the effects were reproducible. [0044] Treatment of Crohn's disease in CD4 + CD45Rb high T cell-reconstituted SCID colitis model mice: Spleen cells were prepared from normal female BALB/c mice. For cell purification, the following anti-mouse antibodies were used to label non-CD4 + T cells: B220 (RA3-6B2), CD11b (M1/70), and CD8α (53-6.72). All antibodies were obtained from BioSource (Camarnllo, Calif.). M450 anti-rat IgG-coated magnetic beads (Dynal, Oslo, Norway) were used to bind the antibodies and negative selection was accomplished using an MPC-1 magnetic concentrator. The enriched CD4 + cells were then labeled for cell sorting with FITC-conjugated CD45RB (16A, Pharmingen, San Diego, Calif.) and PE-conjugated CD4 (CT-CD4, Caltag, Burlingame, Calif.). CD4 + CD 45 high cells were operationally defined as the upper 40% of CD45Rb-staining CD4 + cells and sorted under sterile conditions by flow cytometry. Harvested cells were resuspended at 4×10 6 /mL in PBS and injected 100 μL intraperitoneally into female C.B-17 SCID mice. Pyrimidine compounds of this invention and/or vehicle was orally administered once a day, 5 days per week, starting the day following the transfer. The transplanted SCID mice were weighed weekly and their clinical condition was monitored. [0045] Colon tissue samples were fixed in 10% buffered formalin and embedded in paraffin. Sections (4 μm) collected from ascending, transverse, and descending colon were cut and stained with hematoxylin and eosin. The severity of colitis was determined based on histological examination of the distal colon sections, whereby the extent of colonic inflammation was graded on a scale of 0-3 in each of four criteria: crypt elongation, cell infiltration, depletion of goblet cells, and the number of crypt abscesses. [0046] LP lymphocytes were isolated from freshly obtained colonic specimens. After removal of payer's patches, the colon was washed in Ca/Mg-free HBSS, cut into 0.5 cm pieces and incubated twice in HBSS containing EDTA (0.75 mM), DTT (1 mM), and antibiotics (amphotericin 2.5 μg/mL, gentamicin 50 μg/mL from Sigma) at 37° C. for 15 min. Next, the tissue was digested further in RPMI containing 0.5 mg/mL collagenase D, 0.01 mg/mL DNase I (Boehringer Manheim), and antibiotics at 37° C. LP cells were then layered on a 40-100% Percoll gradient (Pharmacia, Uppsala, Sweden), and lymphocyte-enriched populations were isolated from the cells at the 40-100% interface. [0047] To measure cytokine production, 48-well plates were coated with 10 μg/mL murine anti-CD3ε antibody (145-2C11) in carbonate buffer (PH 9.6) overnight at 4° C. 5×10 5 LP cells were then cultured in 0.5 ml of complete medium in precoated wells in the presence of 1 μg/mL soluble anti-CD28 antibody (37.51). Purified antibodies were obtained from Pharmingen. Culture supernatants were removed after 48 h and assayed for cytokine production. Murine IFNγ was measured using an ELISA kit from Endogen (Cambridge, Mass.), according to the manufacturer's instructions. [0048] Histological analysis showed that oral administration of pyrimidine compounds of this invention reduced colonic inflammation as compared to vehicle control. The suppressive effect was dose-dependent with a substantial reduction at a dose of 10 mg/kg. The calculated colon-to-body weight ratio was consistent with the histological score, showing attenuation by treatment with the test compound. Furthermore, analysis of cytokines from LP cells in response to anti-CD3 antibody and anti-CD28 antibody demonstrated that LP cells from vehicle control produced an augmented level of IFNγ and treatment with test substance greatly diminished the production. These results clearly demonstrated the potential of the test substance in treatment of inflammatory bowel disease represented by Crohn's disease. Other Embodiments [0049] All of the features disclosed in this specification may be combined in any combination. Each feature disclosed in this specification may be replaced by an alternative feature serving the same, equivalent, or similar purpose. Thus, unless expressly stated otherwise, each feature disclosed is only an example of a generic series of equivalent or similar features. [0050] From the above description, one skilled in the art can easily ascertain the essential characteristics of the present invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. For example, compounds structurally analogous a pyrimidine compound described in the specification also can be made, screened for their inhibiting IL-12 activities, and used to practice this invention. Thus, other embodiments are also within the claims.

1a

This application claims benefit of Provisional Ser. No. 60/205,656, filed May 18, 2000. The present invention is an embodiment of the designed phase-change canister material delivery system as applied to a fire extinguishing method and system in which the delivery capsule is formed by confining a fire extinguishing agent within a designed phase change container comprising the shell of a fire extinguishing agent in solid form. The container is delivered and allows delivery, in close proximity to burning substances such that release of the agent from the ruptured container and the container itself extinguishes or suppresses the fire. BACKGROUND OF THE INVENTION The present invention provides a fire extinguishing and fire retardant delivery method and system to suppress and extinguish fires, in particular, wildfires. Wildfires, which include forest and range fires, are fully self-sustaining and are either of such a size or in such a location, which make them unmanageable by conventional means. Current technologies for wildfire suppression are fuel starvation and/or removal and aerial delivery of suppression agents, such as water and retardant slurries. The self-sustaining nature of wildfires means that they generate very large incoming airflows, vertical updrafts and turbulence, which provide fuel/air sourcing and mixing. These airflow patterns generated by these fires make it difficult to deliver slurry retardant and/or water to the core of the fire. Delivery of such materials to the core of the fire can cool, block infrared transmission, and deprive the fire of fuel. The system of the present invention provides a method and means for delivering to a fire target, a retardant or extinguishing material in a thermal and/or pressure-sensitive container. Another direct application of the type of container embodied in this patent is the use as a non-lethal weapon. The rupture of the canister can have a stun effect coupled with the disbursement of material into a crowd. SUMMARY OF THE INVENTION A fire suppression or extinguishing method is provided comprising the step of confining a fire extinguishing or suppressing agent in slurry, liquid or gaseous form within a phase-change canister which comprises a shell of such an agent in solid form. The optimum system uses an agent in solid form which sublimates at atmospheric pressure at temperatures above about −150° C. The container is designed and delivered in close proximity to burning substances such that the container ruptures releasing the agent onto the burning substance. The container is formed such that the shell comprises an agent in solid form and the inner core is filled with an agent in slurry, liquid or gaseous form. The container may be made on an apparatus comprising a shaped molding cavity for receiving the liquid agent to form a shell; a feature for cooling the surface to solidify the liquid to form the shell, a feature for filling the shell with the liquid agent and sealing the shell to form the container, and a feature for releasing the container from the molding surface. Another apparatus for forming the container comprises a shaped molding cavity for receiving the liquid agent to form a shell; a feature to solidify the liquid to form the shell by a pressure-controlled phase change and a feature for releasing the container from the molding surface BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partial cut-away view of a container according to the invention for delivery to a fire. FIG. 2 is a cross-section of an apparatus for preparing the container shown in FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENTS The fire extinguishing or fire retardant agents typically used in the present invention are materials which can be totally absorbed and/or dispersed into the target environment, yet which are benign relative to the target environment. The preferred materials for the solid shell of the container are solid carbon dioxide, ice or other solid fire retardant or extinguishing agents. Carbon dioxide and ice are the preferred materials for use as the shell as a non-lethal weapon. As explained in more detail below, the container may be sealed under pressure or it may be unpressurized. The shell material is selected so that the shell material itself also serves as a fire extinguishing or retarding agent, thereby enhancing the effects of the material dispersed from the container. The shell composition and thickness are designed so that it will weaken or fail, releasing the enclosed material, either by the phase change of the shell material, i.e. melting or sublimation, and/or by bursting of the shell upon impact. The shell thickness of the container may be readily determined by those of ordinary skill in the art based on the type of material to be dispersed, the desired radius of dispersement, the time-delay, if any, between the placement of the container and the moment of dispersement, and the target environment conditions for dispersement of the encased material. A property of the container wall is that in the target environment it will undergo a change in phase consistent with that which would readily disperse or be absorbed by the target environment. Typically, the shell will change its physical state in accordance with the system state variables at the target or environment. That is, the shell material will melt and/or sublime at the temperature or other environmental conditions at the target site. The materials may be distributed at the target site by bursting of the container. For example, a shell of solid carbon dioxide may contain a core of a liquid dioxide, water, or other extinguishing agent or fire retarding agent. The shell may also, for example, be made of ice and contain a core of liquid carbon dioxide, water or other extinguishing agent or retarding agent. Furthermore, the shell may be made of a solid retardant and/or extinguishing agent and the core may contain liquid carbon dioxide, water, or other extinguishing agent and/or retarding agent. The contents may be pressurized or not, depending on the timing of the burst, desired radius of dissipation or desired dispersion method. Typically, the core material will be sublimable at a temperature above about −150° C. up to about 100° C. The bursting of the container due to changes in environmental conditions or impact at the target site is much more desirable than the use of explosives. Explosive bursting charges are environmentally unacceptable, can add undesirable debris to the environment and generate incendiary materials as a result of the explosion process. Another method of release of the materials is by diffuision mixing. The material within the container, i.e. bacterial agents or chemical agents may be diffuision driven for dispersion and thus may require a release mechanism involving the erosion of the container wall. Finally, release may be triggered by an environmental effect, such as thermal or pressure activation such that the thermodynamic and mechanical properties of the shell and the contents serve as rupture triggers within the container. The containers may be delivered from aircraft or thrown or shot into the target area using catapults, air pressure guns and the like. Referring to FIG. 1, there is shown a partial cutaway of one embodiment of a container according to the present invention. The container comprises a shell ( 10 ) and a hollow interior containing a slurry, liquid or gas of a fire extinguishing or fire retarding material ( 11 ). The shell ( 10 ) is also made of a fire extinguishing or retarding material. Indentations ( 10 a ) serve to facilitate release of the container from the mold from which it is made. Preferably, the container is of a relatively large size, having an interior volume determined by the fire suppression application. It can carry charges of sufficient amounts of material such as carbon dioxide, which will at room temperature be converted into a large volume of gaseous carbon dioxide and some liquid carbon dioxide. The vapor pressure of liquid carbon dioxide rises with temperature, and can reach approximately 1,000 atmospheres at temperatures of about 160° C. Thus, the containers in the practice of the invention when using carbon dioxide as an interior component should be constructed to resist rupture when introduced into a fire until the maximum internal stress in the shell wall is exceeded by either or both the internal pressure built up or external forces. In practice, the charged container is introduced into the fire by being dropped, thrown or shot into the blaze. The heat of the fire primarily reduces the shell thickness, and thus its overall strength to a point where the internal pressures cause shell rupture and disburse the contained material. This is assuming that the shell was not designed to rupture on impact. The heat of the fire raises the temperature slightly within this container design. The container explodes spreading the contents into the surrounding area. The liquid and gaseous contents expand rapidly with the liquid material phase changing to gaseous, thus chilling the surrounding area as well as displacing hot gases and replacing them with CO 2 . The contents of the container, as well as the shattered container particles are rapidly vaporized to provide a blanket in the target area which serves to smother and extinguish the blaze. The process of the invention may be employed with containers of varying size, from those which are very small, which may be manually thrown or dropped into the fire to those which must be either mechanically catapulted to the fire or dropped from an aircraft or balloon suspended above the fire. Referring to FIG. 2, there is shown an apparatus for forming a container according to FIG. 1 by controlled temperature time phase transition. For convenience, only half of the apparatus is shown with the mirror image of the other half (not shown) required to make a complete container. There is a piston ( 12 ) having a surface ( 13 ) in the shape of desired shape of the container with ridges (not shown) that form indentations such as ( 10 a ) in the exterior surface of the shell which serve to promote release of the shell from the mold. This piston can be cooled with a cooling agent such as liquid nitrogen, which is introduced through conduit ( 14 ). The piston ( 12 ) is compressed to form the shell from fluid (liquid, slurry or gaseous) initially introduced through line 15 . The shell is then filled through conduit ( 15 ) with the liquid, slurry or gas materials intended to comprise the core. The sealing piston ( 16 ) is utilized to seal the contents within the shell. The forming and sealing pistons ( 12 ) and ( 16 ) are then withdrawn, respectively, from each half of the formed container and the container is released from the surface ( 13 ). Alternatively, a solid shell can be formed using a similar apparatus having walls sufficient to withstand the necessary pressure for a controlled pressure-time phase transition. As shown, the liquid nitrogen coolant is supplied from pressurized tank 17 where it is collected in depressurized traps 18 . Excess nitrogen gas is vented through vent 19 . Carbon dioxide is supplied from tank 20 from which it is filtered through filter 21 and depressurized in traps 22 . The carbon dioxide which will be frozen to form the shell of the canister is introduced via conduit 23 to surface 13 . The carbon dioxide which will form the liquid/gas/solid contents of the container is introduced via line to conduit 15 . The hydraulic system for manipulating pistons 12 and 16 is provided by hydraulic fluid storage tank 24 and pump 25 . The flow of hydraulic fluid is controlled by valve controllers 26 to compress pistons 16 or 12 , respectively, by pressuring compartments 26 or 27 . The pistons 16 or 12 are withdrawn, respectively, by pressuring compartments 29 or 28 . Materials other than carbon dioxide may be utilized in tank 20 , such as water or aqueous slurries or solutions of fire retardant agents. It is understood that certain changes and modifications may be made to the above containers and apparatus without departing from the scope of the invention and it is intended that all matter contained in the above description shall be interpreted as illustrative and not limiting the invention in any way.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is related to and claims priority of (a) copending U.S. provisional patent application Ser. No. 60/328,454, filed on Oct. 10, 2001; and (b) copending U.S. patent application, entitled “Biodegradable Absorbents and Methods of Preparation,” Ser. No. 10/267,823, filed on Oct. 19, 2002. The disclosures of these copending applications are hereby incorporated by reference herein. BACKGROUND OF THE INVENTION [0002] The present invention relates to the field of biodegradable hydrophilic nonwoven absorbents and more particularly to microfiber biodegradable absorbents prepared by the electrohydrodynamic method from blends of synthetic biodegradable polyesters and poly(N-vinyl)lactams which can be used for a variety of applications including wounds and burns dressings, drug carriers and for cosmetic applications. [0003] It has been known to use poly(N-vinyl)pyrrolidone (PVP) complexes with polyurethanes to yield hydrophilic materials, which can be used as wound dressings or in cosmetic preparations. For example, U.S. Pat. No. 5,156,601 discloses a dressing, which includes a tacky gel of polyurethane and a poly(N-vinyl)lactam such as PVP. U.S. Pat. No. 5,420,197 describes hydrophilic gels formed by poly(N-vinyl)lactams, such as PVP, and chitosan. U.S. Pat. No. 6,121,375 disclose hydrophilic gel-like materials of PVP and polyaldehyde. Other references of general background interest include U.S. Pat. No. 5,206,322. All these materials are gel-like and non-biodegradable. [0004] Although some of these hydrophilic materials can be used for wound dressings and other surgical and cosmetic applications, many hydrophilic materials known in the arts are hydrophilic gels that are non-biodegradable, and most of them are reversible. [0005] It has also been known to make nonwoven fibrous-porous material on the base of a blend of poly(N-vinyl)pyrrolidone (PVP) and cellulose diacetate in component weight ratio of 1:(4-10) with high porosity and high moisture absorption prepared “in electrostatic field by continuous supply of an electrically charged polymeric solution through a nozzle” (Pat. RU No. 2111300). But this material is nonbiodegradable. [0006] There is also known, Pat. RU No. 2031661, a microfibrous wound-healing remedy used for first and outdoors aid, prepared by the electrohydrodynamic method. The remedy comprises a composition of poly-d.l-lactide, poly(N-vinyl)pyrrolidone and a powdered sorptive material like polysaccharides networks, polyacrylates, cellulose esters or polyvinyl alcohol derivatives. The material could absorb 5-8 g/g water or blood; exhibited haemostatic abilities within 40 seconds and moderate wound healing effects. But introduction of nondegradable or slow degradable components such as polyvinyl alcohol derivatives into this material significantly decreased its biodegradation ability and limited its use for external application. [0007] There is also known, Pat. RU No. 2120306, a totally biodegradable two layer dressing for wounds and burns consisting of a baking thin film layer (25-30 mkm) prepared from copoly(lactide-caprolactone) or copoly(lactide-glycolide) with a lactide/caprolactone or lactide/glycolide ratio of at most 50% w and a wound facing microfiber absorbent layer comprising a polylactide and poly(N-vinyl)pyrrolidone blend with a ratio of polylactide/poly(N-vinyl)pyrrolidone from 90/10 to 70/30 w/w. The microfiber absorbent layer is deposited on the film by the electrohydrodynamic method. The facing microfiber layer may also contain antiseptic, analgesic drugs and proteolysis ferments. The dressings described can absorb water and any biological liquids, including blood, at most 12 g/g and biodegrade within 12-36 days. However the vapor penetration of such dressings is at most 3.1 mg/cm 2 hour which precludes their use as dressings for wounds and burns that exhibit intensive “breathing”, for example, large external fresh burns, bleeding wounds or different kinds of external injuries. Furthermore these dressings have poorly controllable time of degradation, which limits their application in the treatment of wounds and/or burns, and especially in the treatment of internal wounds. Better control over the degradation time is desirable. [0008] There is also known a microfiber biodegradable polylactide web prepared by the electrospinning method from a polymer solution. The polymer concentration is 4-6% w. The voltage is 33-60 kV; the average fiber diameter is about 1 μm (See the article in Proceeding of the ACS, PMSE, p. 115, Mar. 26-30, 2000). But there is no evidence of any hydrophilic or bioactive properties of such a web. According to the article a solution of polylactide in dichloromethane was placed in a syringe. The syringe was positioned with its needle pointing down, The piston of the syringe was moved down with a controlled velocity by a motor. The negative pole was set at the metal capillary of the syringe and the positive pole on the substrate bearing. Paper was used as a substrate. SUMMARY OF THE INVENTION [0009] Some embodiments of the invention provide dressings, implants, dermatological compatible compositions and drug carrier compositions which include totally biodegradable non-gel materials having water, blood and other biological liquids absorption ability and possessing biological active properties like haemostatic and wound healing acceleration abilities, which are irreversible, retain their contour and shape when wet, and do not exhibit any swelling. [0010] Some embodiments provide totally biodegradable microfiber absorbents on the base of blends of synthetic biodegradable polyesters and poly(N-vinyl)lactams. These materials can be used in a variety of products such as cavity dressings, drug delivery patches, face masks, implants, drug carriers, wound and burn dressings with predictable biodegradation times and controlled absorption of biological liquids including blood, and with variable vapor penetration and controlled drug release for wounds and burns. [0011] Some embodiments provide a method of the totally biodegradable microfiber absorbent preparation. [0012] Some embodiments of the invention provide totally biodegradable microfiber absorbents which can be used for or incorporated into dressing compositions, dermatologicaly compatible compositions, wound packing, wound dressings, burn dressings, living cells like keratinocytes and/or fibroblasts transplants, drug delivery dressings, cosmetic masks, cosmetic wrap dressings, drug carrier compositions. The absorbents may incorporate (e.g. be soaked in) protein containing drug (e.g. insulin) and other drugs. The absorbents of the invention include a blend of synthetic biodegradable polyester and a polymer selected from a group of poly(N-vinyl)-lactams, preferably poly(N-vinyl)-pyrrolidone. [0013] The synthetic biodegradable polyesters useful in preparing the absorbents of the invention include, but are not limited to, homopolymers of L(−), D(+), d,l-lactide, glycolide, caprolactone, p-dioxanon and/or mixtures thereof, copolymers of L(−), D(+), d,l-lactide and glycolide, or caprolactone, or p-dioxanon, or polyoxyethylene glycols, and/or mixtures thereof, or copolymers of glycolide and caprolactone, or p-dioxanon, and/or mixture thereof. [0014] The poly(N-vinyl)lactams useful in preparing the absorbents of the invention include, but are not limited to, homopolymers, copolymers of N-vinyl lactams such as N-vinylpyrolidone, N-vinylbutyrolactam, N-vinylcaprolactam, and the like, as well as the foregoing prepared with minor amounts, for example, up to about 20 weight percent, of one or more of other vinyl monomers that are capable to copolymerize with the N-vinyl lactams like acrylic monomers or others. Of the poly(N-vinyl)lactam homopolymers, the poly(N-vinyl)pyrrolidone (PVP) homopolymers are preferred. A variety of poly(N-vinyl)pyrrolidones are commercially available. [0015] The absorbent is prepared by the electrohydrodynamic processing of a blend (a melt or a solution) of poly(N-vinyl)lactam and biodegradable polyester. In one embodiment, the blend is a solution at a polyester/poly(N-vinyl)lactam ratio from about 99/1 to about 1/99 w/w, preferably from about 98/2 to about 50/50 w/w. [0016] The present invention provides totally biodegradable absorbents which are capable of absorbing at least 20 w/w in water or blood without swelling, are irreversible and mechanically strong, have predictable biodegradation times, are capable of controlled medication delivery to the body, have a variable water vapor penetration. The materials of the present invention have the unexpected properties such as proper haemostatic properties, enhancing the healing of wounds, especially chronic wounds (e.g., diabetic wounds), ulcers, and proper antiseptics abilities. The dressing compositions of the present invention have the advantage of self-adhesion to the wet skin with easy peelability. [0017] Totally biodegradable absorbents may include at least one additional ingredient, which may be releasable from the absorbent. Preferably, the releasable ingredients are bioeffecting or body-treating substances including various low molecular weight or polymeric drugs for internal or external delivery to the body exactly where desired. Such absorbents may also be used as a transplantable solid support or scaffold for living cells, such as keratinocytes or fibroblasts, growing and applied as a living cell transplant for burns and wounds. [0018] The totally biodegradable hydrophilic nonwoven microfiber absorbents can be prepared by the electrohydrodynamic spinning from a polymer blend solution using 20-120 kV at a gap distance 15-40 cm, preferably 20-40 kV. The initial solution contains a blend of a biodegradable polymer and a poly(N-vinyl)lactam and may also contain different medications for immobilization of the material. It was unexpectedly discovered that by this method the material of the invention could be prepared. [0019] Other benefits will be identified in the following description. The description is not in any way intended to limit the scope of the present invention, but rather only to provide a working example of the preferred embodiments. The scope of the present invention will be pointed out in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 is a schematic representation of a basic part of an electrohydrodynamic spinning apparatus, which was used to prepare a biodegradable absorbent in one embodiment. The device contains housing 1 , container 2 for a polymer blend solution, power source 3 having one pole connected to a metal capillary electrode 10 . The other pole is grounded. Compressor 4 provides compressed air into container 2 . The compressed air forces the solution out of container 2 and into connecting tube 11 , which conducts the solution into capillary electrode 10 . The solution emerges from the electrode 10 as a jet flying towards the rotating drum 5 . The electrostatic field generated by source 3 in the area between electrode 10 and drum 5 pulls out the solution stream into a thin thread. The solvent evaporates, and the thread becomes a solid fiber. These fibers are deposited on the surface of drum 5 . Drum 5 can be replace with a stationary (non-moving) substrate. [0021] FIG. 2 is a schematic representation of a basic part of modified electrohydrodynamic spinning apparatus, which was used to immobilization for “dry” fine powder drugs including insoluble drugs into a biodegradable absorbent. The device as shown in FIG. 1 is modified by addition of a container 12 for a dry drug powder and of a microcompressor 13 . Compressor 13 provides compressed air into container 12 . The compressed air forces the powder out of container 12 and into connecting tube 14 , which conducts the powder into a ring channel 15 surrounding a capillary electrode 10 . The powder is sprayed towards the grounded surface of the rotating drum 5 and deposited simultaneously with the polymer microfibers or on the surface of a previously prepared microfiber mat. DETAILED DESCRIPTION [0022] Some embodiments of the invention provide a totally biodegradable hydrophilic nonwoven microfiber absorbents, impermeable to microbes, with variable degradation times and controlled vapor penetration for use in dressing, dressing compositions, drug carrier compositions, wound packing, wound dressings, burn dressings, including first aid dressings, drug delivery dressings, cosmetic mask dressings, cosmetic wrap dressings, cavity dressings for both internal and external applications. Cosmetic applications include skin rejuvenation and wrinkle removal. The absorbent of the invention includes a two-component blend. One component is a synthetic biodegradable polyester with different times of biodegradation selected from a group including, but not limited to, homopolymers or copolymers of L(−), D(+), d,l-lactide with glycolide, or caprolactone, or p-dioxanon, and/or mixtures thereof, or homopolymers or copolymers of caprolactone with L(−), or D(+), or d,l-lactide, or glycolide, or p-dioxanon and/or mixtures thereof, and copolymers of L(−), or D(+), or d,l-lactide, or caprolactone, or p-dioxanon with polyoxyethylene glycols (PEG) and/or mixtures thereof, or homopolymers or copolymers of p-dioxanon. The other component is a poly(N-vinyl)lactam selected from a group including, but not limited to, homopolymers, copolymers of N-vinyl lactams such as N-vinylpyrrolidone, N-vinylbutyrolactam, N-vinylcaprolactam, and the like, as well as the foregoing prepared with minor amounts, for example, up to about 15-20 weight percent, of one or more of other vinyl monomers copolymerizable with the N-vinyl lactams such as acrylic acid, acryl amides or hydroxyalkylacrylates. Of the poly(N-vinyl)lactam homopolymers, the poly(N-vinyl)pyrrolidone (PVP) homopolymers are preferred. A variety of poly(N-vinyl)pyrrolidones are commercially available. [0023] To prepare a material with controlled biodegradation times, the ratio of polyester/poly(N-vinyl)lactam is used in the range from about 99/1 to about 1/99, preferably from about 98/2 to about 50/50 w/w for polylactide, or co(poly-lactide-glycolide) with a lactide/glycolide ratio from about 99/1 to about 50/50. Preferably, the poly(N-vinyl)pyrrolidone is used. Preferably, the molecular weights of the two components are in the range from 3×10 4 to 50×10 4 Dalton for polyester and from 0.5×10 4 to 4×10 4 Dalton for poly(N-vinyl)pyrrolidone. The biodegradable polyester component may contain caprolactone homopolymers and/or caprolactone copolymers with lactide (or glycolide) with a caprolactone/lactide (or glycolide) ratio from about 1/90 to about 99/1 w/w and with the molecular weights at least 15×10 4 Dalton for the polyester component and the polyester/poly(N-vinyl)pyrrolidone ratio from about 90/10 to about 50/50 w/w. The biodegradable polyester component may contain copolymers of glycolide (or lactide) and p-dioxanon with a glycolide (or lactide)/p-dioxanon ratio from about 50/50 to about 1/99 w/w. [0024] For biodegradation time control, a low molecular weight polylactide or its copolymers with glycolide may be included into the blend in the amount of at least 5-10% w. The lactide/glycolide ratio is preferably 50/50 w/w. The molecular weights of these compounds are at least from 2×10 3 to 10×10 3 Dalton. Various low molecular weight or polymeric linear or branched alcohols such as mannitol, sorbitol, etc. or polyoxyethylene glycols (PEG) of different molecular weights, respectively, may be included into the blend in the amount of at least 5-10% w. [0025] The totally biodegradable, hydrophilic unwoven absorbent consists of microfibers at most 0.1-5 μm is irreversible with non-leachable poly(N-vinyl)lactam. The material is capable of unswelling absorption at least 20 w/w in water or blood and/or other biological liquids with high absorption rates without changing the contour or shape of the device. The material is capable of delivering medicaments externally or internally to the body exactly where desired. The material of the present invention has by itself unexpected properties such as a haemostatic property and antiseptics property. The material enhances the healing of wounds, especially chronic wounds (e.g., diabetic wounds) and ulcers and may be applied without any additional medications. The material and its degradation products are biocompatible and don't induce any tissues immune response. The products based on the materials of the present invention have a good mechanical strength and preserve their shape under wet conditions. They can be sterilized by X-ray radiation. Other advantages obtained in some embodiments include softness and compliance with skin surfaces, and self-adhesion to the wet skin but with easy peelability and a variable “breathability”. [0026] To obtain a totally biodegradable, hydrophilic unwoven absorbent, the electrohydrodynamic method for solution spinning can be applied. The method involves spraying the solution of a polymer blend through a capillary nozzle onto a substrate. More particularly, the method consists in providing a stream of compressed air or some other gas through a capillary nozzle, and continuously introducing into the air stream a solution of a blend of a biodegradable polyester and poly(N-vinyl)pyrrolidone or other poly(N-vinyl)lactams in a solvent (e.g dichloromethane or mixture of ethyl acetate and a lower alcohol. An exemplary concentration of the polymer in the solution is 1-40% w. The voltage between the nozzle and the substrate can be 20-120 kV, preferably 20-40 kV. The negative pole is set at the metal capillary of the nozzle. The substrate is grounded. The gap between the nozzle and the substrate is 15-40 cm. Depending on the voltage, gap value and polymer in the solution concentration, materials of a controlled density and microfiber diameters from 0.1-5 .mu.m can be prepared. After the completion of the process the microfiber unwoven material is removed from the substrate, cut into pieces (for example, squares) and vacuum dried. A finished product is packed and sterilized by .gamma.-radiation by conventional techniques. [0027] The substrate can be either a static surface or a rotating drum as described in Russian patent RU 2121036 (20 Oct. 1998). [0028] FIG. 1 shows a schematic representation of a basic part of an apparatus of electrohydrodynamic spinning which was used for biodegradable absorbent of the invention preparation. The device contains housing 1 , container 2 for polymer blend solution used for spinning, power source 3 connected to metal capillary electrode by one pole with the second pole setting grounded, compressor 4 connected with the container 2 . The solution of a blend of a biodegradable polymer and poly(N-vinyl)lactam in a solvent is providing by a stream of compressed air from compressor 4 through a capillary nozzle with high voltage imposed from the source 3 . A polymer solution jet flowing out of the capillary nozzle in the stream of compressed air under the action of electrostatic field forces is drawing off into at least one ultra thin fiber that is deposited on a grounded substrate surface that can be a rotating drum 5 or non-moving substrate. For apparatus productivity increase the device can be supplied with an additional compressed air source 13 comprising a ring channel 15 surrounding a capillary electrode 10 ( FIG. 2 ). [0029] Materials with a different degree of “breathability” can be obtained through: 1) selection of the microfiber thickness and packing density; 2) electrohydrodynamic microfiber deposition on at least 5-10 .mu.m thick polymeric films of the appropriate breathability. These films can be prepared from biodegradable polymers and copolymers like polylactide, or poly(lactide-co-glycolide) with a lactide/glycolide ratio from about 1/99 to about 99/1, or poly(lactide-co-caprolactone) with a lactide/caprolactone ratio from about 1/99 to about 99/1, polycaprolactone, poly-p-dioxanon or its copolymers with glycolide or lactide with a p-dioxanon/lactide or glycolide ratio from about 1/99 to about 99/1. These biodegradable films, which serve as backing films in such dressings, may be prepared by any conventional methods of polymer processing from either a polymer melt or a polymer solution. A backing film with variable vapor permeability (i.e. breathability) can also be prepared from a mixture of biodegradable polyesters listed above and other biocompatible polymers of various molecular weights like polyoxyethylene glycols in the amount of at least 15% w. The backing film may also improve the mechanical properties of the dressings. [0030] The “breathability” can also be increased by increasing the gap between the nozzle and the substrate if the electrohydrodynamic method is used. The “breathability” is believed to decrease if a higher voltage is used between the nozzle and the substrate. These techniques (gap size and voltage) can be used with or without the backing film. More particularly, in some embodiments, no backing film is present. The absorbent material is formed by the electrohydrodynamic method on a substrate as described above. The substrate can be a rotating drum. After this electrohydrodynamic deposition, the absorbent article is removed from the substrate. The article can be used without any backing film. Non-drum substrates including non-moving substrates, can be used. [0031] The absorbent of the invention may also include at least one additional ingredient, which may be releasable from the absorbent. Preferably, the releasable ingredients are bioeffecting or body-treating substances including different low molecular weight or polymeric drugs for internal or external delivery to the body exactly where desired. Particularly preferred as biologically-active additives are also antimicrobials such as tetracycline, neomycin, oxytetracycline, triclosan, sodium cefazolin, silver sulfadiazine, and also salicylates such as methylsalicylate and salicylic acid, nicotinates such as methyl nicotinate; capsaicin, benzocaine, alpha-hydroxy acids, vitamins and biostats and others, or antioncology active drugs like doxorubicin, and others or insulin, or interferon, or others. [0032] When the material is used for wound and burn healing acceleration, it may contain living human cells like keratinocytes or fibroblasts previously grown on the material as on the solid porous scaffold. [0033] To provide a prolonged and controlled drug release to the surface of internal and/or external wounds or burns, the material may contain two or more microfiber layers. Different layers may have different compositions. Each layer includes the biodegradable polymer with or without poly(N-vinyl)lactam. Different layers may also have different ratios of biodegradable polymer/poly(N-vinyl)lactam or different biodegradable polymers. Different types of polymers and/or copolymers may be used that may have different molecular weights, contain different biocompatible functional groups such as hydroxyl, carboxyl and/or amino groups or contain different additives such as low or high molecular weight alcohols like sorbitol, mannitol, starch, polyoxyethylene glycols, etc. Each layer may include at least one additional bioactive ingredient which may be releasable from the absorbent and which may be immobilized into polymeric matrix as by the electrohydrodynamic method as by conventional methods such as wetting of the material by drug solution. When the electrohydrodynamic method is used for drug immobilization into an absorbent, the drug can be dissolved in a polymeric blend solution and immobilized using the device shown in FIG. 1 or can be immobilized as dry fine particles by compressed air steam using the modified device shown in FIG. 2 . [0034] For drug delivery systems, the material of the present invention may contain drugs immobilized by the electrohydrodynamics or other methods and then ground into fine particles of a size less than 10 .mu.m. These particles can be used for parenteral drug administration as a suspension in water, or for oral delivery after tableting the particles prepared by conventional compression methods. Tablets for oral drug delivery may also be prepared by conventional methods of tablet compression of the non-ground material with immobilized drugs. For drug carrier usage, the material may be prepared for example from the blend of polylactide and poly(N-vinyl)pyrrolidone, and polylactide molecular weights are at least 5×10 4 Dalton. [0035] The following examples are intended to illustrate but not limit the invention. The claim will serve to define the invention. [0036] In the following examples the preparation of biodegradable absorbents is described, which absorbents can be used as wound and burn dressings, drug carriers and for cosmetic applications. These examples should not be viewed as limiting the scope of the invention. The claims will serve to define the invention. EXAMPLE 1 [0037] A biodegradable absorbent utilizing microfibres containing poly(lactide-co-glycolide and/or poly-(N-vinyl)pyrrolidone with variable “breathing” capabilities. [0038] Materials: [0039] Poly(d.l-lactide-co-glycolide) with a lactide/glycolide ratio 70/30 w/w and with an average molecular weight of 150000 Dal and Poly-d.l-lactide with an average molecular weight of 230000 Dal was synthesized by conventional ring-opening polymerization from d.l-lactide and glycolide that were purchased from Russian National Institute of Monomers (Tula, Russia). Poly-(N-vinyl)pyrrolidone with an average molecular weight of 30000 Dal was purchased from a Russian enterprise. [0040] Methods. [0041] 1 Solution Preparation. [0042] Poly(d.l-lactide-co-glycolide) (PLGA) was dissolved in ethyl acetate to make a 20% (w/w) solution with solution viscosity 1-2 poise (Solution A) or a 10% (w/w) solution with solution viscosity 0.5 poise (Solution B). Poly-(N-vinyl)pyrrolidone (PVP) was dissolved in ethanol making a 20% (w/w) solution and mixed with the PLGA solution in ethyl acetate at PVP/PLGA ratio of 20/80 (w/w) that was used for the electrohydrodynamic spinning. [0043] 2. Microfiber Material Preparation. [0044] The PLGA/PVP solution was filtered to remove mechanical and gel-like impurities and was placed into a container 2 ( FIG. 1 ) and spun into wound dressing materials in the form of microfiber mats, which were collected on the surface of a rotating drum 5 or on a film positioned on the surface of a rotating drum 5 that is used as a substrate. After the completion of the process, the microfiber unwoven material was cut into squares and vacuum dried to remove the solvent residue. The finished product was packed into a polyethylene laminated aluminum foil and sterilized by 2.5 Mrad .gamma.-radiation using a conventional procedure. [0045] 3. Measurements of Microfiber Material Properties. [0046] To measure the degree of absorbency, 2 cm 2 strips (0.5×4 cm) of the microfiber mat were cut and weighed (dry weight or DW), The end of the narrow side (0.5 cm side) of the strip was immersed in water or blood and soaked for 10-15 min. The liquid was drained and the strip was weighed (wet weight or WW). The content of water or blood absorbed by the material calculated using the equation: [0000] Water/blood absorbed content=(WW−DW)/DW, g/g [0047] Data on biodegradation times and haemostatic abilities of the material were obtained from in vivo experiments. [0048] Sample 1. [0049] Solution A: (PVP/PLGA in ethyl acetate, 20% PLGA) was spun by the electrohydrodynamic method with 30 kV at 25 cm gap distance L ( FIG. 1 ) for 1 hour. The microfiber thickness was around 1.5-2 μm with a surface density (a coating level) ˜5 mg/cm 2 . [0050] Sample 2. [0051] Solution B: (PVP/PLGA in ethyl acetate, 10% PLGA) was spun by the electrohydrodynamic method with 30 kV at 25 cm gap distance L ( FIG. 1 ) for 1 hour. The microfiber thickness was around 0.5-1 μm with a surface density (a coating level) ˜2.5 mg/cm 2 . [0052] Sample 3. [0053] Solution A: (PVP/PLGA in ethyl acetate, 20% PLGA) was spun by the electrohydrodynamic method with 40 kV at 25 cm gap distance L ( FIG. 1 ) for 1 hour. The microfiber thickness was around 1-1.5 μm with a surface density (a coating level) ˜5 mg/cm 2 . [0054] Sample 4. [0055] Solution A: (PVP/PLGA in ethyl acetate, 20% PLGA) was spun the electrohydrodynamic method with 30 kV at 40 cm gap distance L ( FIG. 1 ) for 1 hour. The microfiber thickness was around 1.5-2 μm with a microfiber surface density (a coating level) ˜3 mg/cm 2 . [0056] Sample 5. [0057] Solution A: (PVP/PLGA in ethyl acetate, 20% PLGA) was spun by the electrohydrodynamic method with 30 kV at 25 cm gap distance L ( FIG. 1 ). Drum 5 was covered by a poly(d.l-lactide) film (backing film) having a thickness of 8-10 μm. The film was formed from 10% w solution of Poly-d.l-lactide in methylene chloride. The microfibers were deposited on the film. The fiber size was around 1.5-2 μm with a microfiber surface density (a coating level) ˜5 mg/cm 2 . [0058] Test results for the materials in Samples 1-5 are summarized in Table 1. [0000] Moisture vapor penetration, Times of Sample Mg/cm 2 Water/Blood biodegradation Microbial # hour absorbance, g/g in vivo, days penetration 1 5-7 15-20/19-20 3-5 Non-penetrable 2 2-3.5 10-15/14-18 3-5 Non-penetrable 3 5-7 12-15/16-18 3-5 Non-penetrable 4 7-8 12-15/16-18 3-5 Non-penetrable 5 2-2.7 15-20/18-20 78 Non-penetrable EXAMPLE 2 [0059] Preparation of Fiber and/or Biodegradable Absorbent with Additional Therapeutic Performance [0060] Sample 1. [0061] Silver sulfadiazine was dissolved under slight heating in ethanol to form a 5% solution and then added to the PLGA/PVP solution described above to yield a 1% silver sulfadiazine concentration in the final material. The solution was spun by the electrohydrodynamic method with 30 kV at 25 cm gap distance L ( FIG. 1 ) for 1 hour. The microfiber thickness was around 1.5-2 μm with a surface density (a coating level) ˜5 mg/cm 2 . [0062] Sample 2. [0063] Silver sulfadiazine in the form of fine particles was placed into container 12 ( FIG. 2 ) and immobilized using a compressed air stream (˜0.5 atm) onto the surface of a just prepared absorbent deposited on a surface of a rotating drum using 30 kV at a gap distance 25 cm. [0064] The invention is not limited by the embodiments described above, For example, in the eletrohydrodynamic method, an altering electric field can be used. Also, solutions can be replaced by melts. Other embodiments are within the scope of the invention as defined by the appended claims.

1a

[0001] This application is a divisional of co-pending U.S. patent application Ser. No. 09/925,000 filed on Aug. 8, 2001, the entire contents of which are hereby incorporated by reference. This application also claims priority to Italian Patent Application PD2001 A 000031 filed in Italy on Feb. 9, 2001 under 35. U.S.C. §119. SUBJECT OF THE INVENTION [0002] The present invention concerns a process for the preparation of pure phosphatides starting from mixtures of natural phosphatides, or their single components, such as soybean or egg lecithin or animal phospholipids, or from synthetic phosphatides by reacting them with phospholipase D, with transphosphatidylation activity, in aqueous medium alone in the presence of defined substrates containing a primary or a secondary alcoholic group. [0003] The invention also refers to the preparation, purification and characterisation of the phospholipase D used in the process. BACKGROUND OF THE INVENTION [0004] The synthesis of pure phospholipids, particularly on an industrial scale, is a particularly widespread problem. Indeed, there have been numerous scientific publications and patents, including some very recent ones that describe various methodologies. Generally, said methods exploit the transphosphatidylation properties of phospholipase D to obtain optically active phosphatides. One of the main problems is the fact that each of these methods is suited to the preparation of one specific phosphatide alone and cannot be adapted for the synthesis of the whole class of compounds. Generally, the most widely studied phospholipid is phosphatidylserine (PS), as it is widely used in the preparation of pharmaceutical compositions, in the preparation of liposome formulations and food supplements. Relatively little or nothing is reported concerning the synthesis of sphingophospholipids. [0005] One limitation of all the methods reported in both the scientific and patent literature consists in the fact that the reaction of transphosphatidylation occurs in diphasic water/organic solvent systems. This presents a series of technical problems linked with the use of large quantities of solvent, especially when the industrial process is of a chemical nature, aimed at obtaining a quality product. In patent application No. DE 19917249 A1, a method is described that actually employs the aqueous phase alone, but neither the yield nor degree of purity of the PS obtained, nor the type of the utilised enzyme is reported. Moreover, there is no mention of whether it is possible to obtain other phospholipids besides PS by using the same technique and starting from the substrates used, or whether in the conditions described other phospholipids can act as reaction substrate. Japanese Patent Publication No. 5/42917 (JP 2130088) also discloses a method employing a medium comprised of water alone or a mixture of water and an organic solvent. However, this patent states that the water content is favored to be 10% by weight or less to prevent a side reaction. This reference, therefore, appears to suggest that using an aqueous environment alone is not favorable. In fact, the examples therein disclose only processes employing a biphasic mixture of water and ethyl ether. [0006] The generic nature of the information given or absence of teaching in the aforesaid prior art concerning the applicability of the transphosphatidylation reaction of phospholipase D in aqueous phase alone could in no way have led an expert in the field to think that this was the solution to the problem. Moreover, the importance of removing impurities deriving from the use of organic solvents in processes for the manufacture of products for use in the alimentary and pharmaceutical fields has only become known in recent years, following the limitations dictated by the United States Pharmacopoeia (USP) and the European guidelines (CPMP/CH/283/95). [0007] Another critical point that has not been investigated in-depth, either in the scientific literature or in patents, concerns the peroxidation of products caused by the use of heterogeneous phases of water/solvent in emulsion during the transphosphatidylation reaction, the reaction conditions used and the consequent need to perform numerous steps of the process (re-precipitation, washings and possibly also chromatography) to obtain products with a high degree of purity. Many of the solvents used for these reactions in the heterogeneous phase do not guarantee the absence of radicalic precursors typical of the initiation of the peroxidation reaction. Moreover, the shaking/stirring required to achieve a reaction in the heterogeneous phase increases the likelihood of there being contact with oxygen in the atmosphere and consequent triggering of oxidative phenomena. This peroxidation acts like a chain reaction, when even negligible initial primer steps can give devastating results over time, even though the triggering conditions have been eliminated or minimised. The peroxidation of a “fatty” substance such as triglycerides (oils or fats) and phospholipids too, causes the fatty acids to become “rancid”, with the consequent formation of an unpleasant smell and taste. It is particularly important that the products should have a high degree of palatability (smell and taste) when they, particularly PS, are used to prepare food supplements (nutraceuticals) with particular formulations such as granules or the so-called “functional foods”, to which the product is added to enrich their content. Consequently, it is important that the products obtained, particularly PS, should be clearly characterised in chemical terms, both with regard to the chemical composition of the fatty acids, and for the extent of their peroxidation and consequent palatability. [0008] Lastly, it should be pointed out that the phospholipase D enzymes available on the market mainly have transphosphatidylation activity on the phosphatidylcholine fraction of the phospholipid mixture. Therefore, the other components such as phosphatidylethanolamine (PE) undergo hydrolysis to phosphatidic acid, thus reducing both the yield and the degree of purity of the finished product. DETAILED DESCRIPTION OF THE INVENTION [0009] Surprisingly, the Applicant has discovered that by using a purified fraction of phospholipase D from Streptoverticillium hachijoense, which is now properly referred to as Streptomyces hachijoense, it is possible to obtain a transphosphatidylation reaction with various alcoholic from a mixture of natural phosphatides or their purified fractions in a 100% aqueous environment with high yields of product, a high degree of purity and a peroxide index (degree of peroxidation) of less than 5, established according to the European Pharmacopoeia—Suppl 2000, page 41 (method A), by one single reaction step and one single precipitation. [0010] The transphosphatidylation reaction can be conducted in various conditions of temperature and substrate concentration, adjusting the former between 20 and 60° C., preferably 45° C., and the latter between 10 and 500 mg/ml, preferably 150 mg/ml, according to the dispersibility of the substrates. [0011] A second aspect of the present invention consists in the fact that this particular enzymatic preparation has a transphosphatidylation activity with high yields even on substrates other than phosphatidylcholine (lecithin), thus enabling the process to be used with low-cost, unpurified raw materials too. [0012] The importance of the strain used for the preparation of the Phospholipase D and its fractionation can be deduced from the following table, where a comparison with different commercial enzymatic preparations is reported for the purified enzymatic fraction prepared according to Example 1. Preparation of phosphaditylserine Strain Company Product PS PA PC Streptomyces sp. Sigma P4912 50% 45% 5% type VI Streptomyces sp. Asahi Chemical PL-DP 50% 45% 5% Industry Co., Ltd Streptomyces Sigma P8023 40% 40% 20% chromofuscus type VI Actinomadura sp. Meito Sangyo No code 45% 40% 15% Co., Ltd Streptoverticillium Fidia FRS 95% 5% — hachijoense [0013] Another advantage of the actual enzyme preparation and of the reaction conditions described in the instant invention is the practically complete conversion of the substrate to PS as compared to the conversion rate of not more than 70% achieved in JP 213008's diphasic water/organic solvent system. [0014] A third aspect of the present invention concerns the preparation of pharmaceutical and cosmetic compositions and food and dietary supplements based on phospholipids, obtained according to the process described above, having a degree of peroxidation of less than 5 and a high degree of palatability, such as to make them preferable to other, similar products on the market that do not however have the above said characteristics. [0015] The pharmaceutical compositions and the food and dietary supplements are particularly indicated in the treatment of conditions of psycho-physical stress with attention, concentration and memory deficits, often associated with advancing age, and they can be prepared, for example, in the form of capsules, tablets and granules. [0016] The cosmetic compositions can chiefly be applied in the treatment of skin with impaired physiological functions and as aids in the therapy of dermatitis of an eczematous and/or inflammatory type, and they can be prepared, for example, in the form of creams or gels. For purely illustrative purposes, we report hereafter some preparation examples of Phospholipase D and phospholipids derived from it according to the present invention. EXAMPLE 1 Preparation of Phospholipase D [0017] The Streptoverticillium hachijoense ATCC 19769 strain is used. [0018] Preparation of the inoculation to be used in the fermentation test begins with a colony on solid medium in a Petri dish. The composition of the solid medium is as follows: 21.0 g/litre Y.M., 2% agar. The bacteria taken from the Petri dishes are used to start a “scale-up” system in Ehrlenmeyer flasks as follows: [0019] the bacteria are taken from the solid medium with a sterile platinum loop and inoculated in a 100-ml flask containing 20 ml of medium with the following composition: 21.0 g/lt of Y.M. broth; [0020] the flask is placed in a shaker incubator set at 30° C., 150 rpm for 48 hours; [0021] 20 ml of culture is transferred to a 5.0-lt flask containing 2.5 lt of medium with the composition described above; [0022] the flask is placed in a shaker incubator set at 30° C., 150 rpm for 72 hours. [0023] At this point the culture is ready to be inoculated in the fermenter. This operation is made possible by the fact that the culture is in a flask fitted with a silicone tube and needle system. The fermenter used has a capacity of 50 lt (Braun Biostat U). The composition of the medium is as follows: Y.M. broth 21.0 gr/lt, pH 6.5 (the medium is sterilised directly in the fermenter by the addition of an antifoaming agent); the parameters of fermentation are: shaking at 200 rpm, temperature 30° C., air flow 0.5 vvm. [0024] After 72 hours fermentation is interrupted. The maximum amount of enzyme reached is 5,000 U/lt and enzymatic activity is determined by the modified method of Kato et al. described in the literature (K. Shimbo et al., Agric. Biol. Chem. 54(5), 1189-93, 1990). [0025] The culture broth is filtered to eliminate the biomass, the supernatant is concentrated using a spiral cartridge in cellulose acetate with a molecular cut-off of 10,000 D, and dialised against 50 mM Tris-HCl buffer, pH 8.0. The sample thus obtained is loaded on a chromatographic column (i.d.=10 cm, h=50 cm) packed with 500 gr of Whatman DE-52 anion-exchange resin pre-balanced with the same buffer as was used for dialysis. The enzyme is not adsorbed and elutes from the column, it is dialised against 20 mM Na-phosphate buffer, pH 5.4 and is then loaded on a chromatographic column (i.d.=10 cm, h=50 cm) packed with 50 gr of cationic exchange resin CM-Sephadex Pharmacia C-50 pre-balanced with the same buffer as the enzyme. The enzyme is eluted with a pH gradient of between 5.4 and 7.0 using an Na-phosphate buffer, 20 mM, pH 7.0. The fraction that elutes at pH 6.2 is harvested, concentrated and dialised against Tris-HCl buffer, 50 mM, pH 8.0, to a concentration of 100 U/ml and then freeze-dried. Total Total Specific activity proteins activity (Unit × (mg × (Unit × Recovery 10 3 ) 10 3 ) mg prot ) (%) Crude broth 250 250 1 100 Concentration and dialysis 237.5 118.8 2 95 DE-52 Whatman 212.5 2.2 97 85 CM-Sephadex C-50 Pharmacia 150 0.26 577 60 Concentration and dialysis 145 0.24 604 58 Freeze-drying 112.5 0.24 469 45 EXAMPLE 2 Preparation of PS from PC [0026] In a jacketed reactor fitted with a shaker and reflux condenser, 272 g of sodium acetate trihydrate and 59 gr of calcium hydrochloride trihydrate are dissolved in 10 lt of water. The pH is adjusted to 5.6 (acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6) and 5.0 kg of L-serine is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0027] Once solubilisation is complete, 1.5 kg of purified soybean lecithin with the following composition is added: PC 95%, PA 4%, lyso-PC 1%. Ten minutes later, 16,100 U of phopholipase D as in example 1 are added, and this is left to react for 24 hours at 45° C. [0028] On completion of the reaction, the reactor is unloaded by adding 10 lt of a mixture of n-hexane/ispropanol/water (60/80/15); the mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0029] The lower phase is harvested and the unreacted L-serine is recovered by cooling in a crystallizer. The upper phase is washed with 6,950 ml of HCl, 1 N and 1,113 ml of isopropanol at 5° C. [0030] The acid phase is counter-extracted with 10 lt of a mixture of hexane/isopropanol/water (60/80/15), after which the two organic phases are cascade-washed with a mixture of 7 lt of water and 6 lt of isopropanol. [0031] The organic phases are concentrated under vacuum and precipitated by slowly adding a solution of 450 ml of sodium acetate, 4.5 M, in water in 33.2 lt of ethanol. [0032] This is filtered and dried. [0033] 1.14 kg of phosphatidylserine with a titer of over 95%, a phosphatidic acid content of less than 5% and a peroxide index of less than 5 is obtained. [0034] After crystallisation and drying, 3.25 kg of L-serine is harvested. EXAMPLE 3 Preparation of PS from Egg Lecithin [0035] 180 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6, are placed n a jacketed reactor with a shaker and reflux condenser, after which 90 gr of L-serine is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0036] Once solubilisation is complete, 27 gr of purified egg lecithin is added (PC content≧95%); 10 minutes later, 290 U of phospholipase D as per example 1 is added and it is left to react for 24 hours at 45° C. [0037] Once the reaction is complete, the reactor is unloaded by adding 200 ml of a mixture of n-hexane/isopropanol/water (60/80/15) and the mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0038] The lower phase is discarded. [0039] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0040] The acid phase is counterextracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol [0041] The organic phases are concentrated under vacuum and precipitated by the slow addition of a solution of 8 ml of 4.5 M sodium acetate in water in 600 ml of ethanol. [0042] It is filtered and dried. [0043] This yields 20.8 g of phosphatidylserine with a titer of over 95% with a phosphatidic acid content of less than 5% and a peroxide index of less than 5. EXAMPLE 4 Preparation of Phosphatidylserine from Crude Soybean Lecithin [0044] 180 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser, after which 90 g of L-serine is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0045] Once solubilisation is complete, 27 g of crude soybean lecithin is added (total phospholipid content 75%, percentage composition PC 60.6/PE 29.5/PA 3.4/lyso-PC 2.5/other 3.9)); 10 minutes later, 290 U of phospholipase D as per example 1 is added and this is left to react for 24 hours at 45° C. [0046] Once the reaction is complete, the solution is unloaded by adding 200 ml of a mixture of n-hexane/isopropanol/water (60/80/15) into the reactor and the mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0047] The lower phase is discarded. [0048] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0049] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol [0050] The organic phases are concentrated under vacuum and precipitated by the slow addition of a solution of 8 ml of 4.5 M sodium acetate in water in 600 ml of ethanol. [0051] It is filtered and dried. [0052] This yields 19 g of phosphatidylserine with a titer of 83.5% (PA 7.7%, lyso-PS 2.3%, PE 1.9%, other 4.5%) and a peroxide index of less than 5. EXAMPLE 5 Preparation of Phosphatidyl-D-Serine [0053] 180 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser, after which 90 g of D-serine is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0054] Once solubilisation is complete, 27 g of purified soybean lecithin as per example 2 is added; 10 minutes later, 290 U of phospholipase D as per example 1 is added and it is left to react for 24 hours at 45° C. [0055] Once the reaction is complete, the reactor is unloaded by adding 200 ml of a mixture of n-hexane/isopropanol/water (60/80/15). The mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0056] The lower phase is discarded. [0057] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0058] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol [0059] The organic phases are concentrated under vacuum and precipitated by the slow addition of a solution of 8 ml of 4.5 M sodium acetate in water in 600 ml of ethanol. [0060] It is filtered and dried. [0061] This yields 18.7 g of phosphatidyl-D-serine with a titer of over 95% with a phosphatidic acid content of less than 5% and a peroxide index of less than 5. EXAMPLE 6 Preparation of Phosphatidylethanolamine (PE) from PC [0062] 200 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser. The entire process is conducted under nitrogen. [0063] 58 g of ethanolamine is added and the pH is adjusted to 5.6 with glacial acetic acid at a temperature setting of 30° C. [0064] At the end of the operation, it is heated to 45° C. and 30 g of purified soybean lecithin as per example 2 is added. After 10 minutes, 325 U of phospholipase D as per example 1 is added and this is left to react for 24 hours at 45° C. [0065] Once the reaction is complete, the reactor is unloaded by adding 400 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the shaking is stopped and the two phases are left to separate. [0066] The lower phase is discarded. [0067] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0068] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol, then with 100 ml of sodium acetate, 1 N, and 130 ml of isopropanol. [0069] The organic phases are concentrated under vacuum. [0070] It is purified by silica gel chromatography using an axial pressure chromatograph with a 1 lt column equilibrated with chloroform/methanol (80/20); gradient elution is performed till chloroform/methanol/water (70/30/3). [0071] The pure fractions are evaporated, dissolved in 250 ml of cyclohexane and freeze-dried, giving 24 g of a pale yellow, solid product, free from phosphatidic acid and lysoderivatives, and over 99% pure. EXAMPLE 7 Preparation of Phosphatidyl-Homoserine from PC [0072] 180 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser, after which 102 g of homoserine is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0073] Once solubilisation is complete, 27 g of purified soybean lecithin as per example 2 is added; 10 minutes later, 290 U of phospholipase D as per example 1 is added and it is left to react for 24 hours at 45° C. [0074] Once the reaction is complete, the reactor is unloaded by adding 200 ml of a mixture of n-hexane/isopropanol/water (60/80/15). The mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0075] The lower phase is discarded. [0076] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0077] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol [0078] The organic phases are concentrated under vacuum and precipitated by the slow addition of a solution of 8 ml of 4.5 M sodium acetate in water in 600 ml of ethanol. [0079] This is filtered and dried. [0080] 22.6 g of phosphatidyl-homoserine is obtained, with a titer of over 95%, a phosphatidic acid content of less than 5% and a peroxide index of less than 5. EXAMPLE 8 Preparation of Phosphatidyl-Hydroxyproline from PC [0081] 180 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser, after which 112 g of hydroxyproline is added and solubilised by heating to 45° C. The entire process is conducted under nitrogen. [0082] Once solubilisation is complete, 27 g of purified soybean lecithin as per example 2 is added; 10 minutes later, 290 U of phospholipase D as per example 1 is added and it is left to react for 24 hours at 45° C. [0083] Once the reaction is complete, the reactor is unloaded by adding 200 ml of a mixture of n-hexane/isopropanol/water (60/80/15) and the mass is dissolved by shaking, then the shaking is stopped and the two phases are left to separate. [0084] The lower phase is discarded. [0085] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0086] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol [0087] The organic phases are concentrated under vacuum and precipitated by the slow addition of a solution of 8 ml of 4.5 M sodium acetate in water in 600 ml of ethanol. [0088] It is filtered and dried. [0089] This yields 18.4 g of phosphatidyl-hydroxyproline with a titer of over 95%, a phosphatidic acid content of less than 5% and a peroxide index of less than 5. EXAMPLE 9 Preparation of Phosphatidylglycerol from PC [0090] 200 ml of acetate buffer, 0.2 M+calcium chloride, 0.04 M, pH 5.6 are placed in a jacketed reactor with a shaker and reflux condenser. The entire process is conducted under nitrogen. [0091] 80 g of glycerol is added; it is heated to 45° C., then 30 g of purified soybean lecithin as per example 2 is added; 10 minutes later, 325 U of phospholipase D as per example 1 is added and it is left to react for 24 hours at 45° C. [0092] Once the reaction is complete, the reactor is unloaded by adding 400 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the shaking is stopped and the two phases are left to separate. [0093] The lower phase is discarded. [0094] The upper phase is washed with 150 ml of 1 N HCl and 30 ml of isopropanol at 5° C. [0095] The acid phase is counter-extracted with 180 ml of a mixture of n-hexane/isopropanol/water (60/80/15), then the two organic phases are washed in a cascade with a mixture of 100 ml water and 130 ml of isopropanol, then with 100 ml of sodium acetate, 1 N, and 130 ml of isopropanol. [0096] The organic phases are concentrated under vacuum. [0097] Purification is performed by silica gel chromatography using an axial pressure chromatograph with a 1-lt column equilibrated with chloroform/methanol (80/20). Gradient elution is performed till chloroform/methanol/water (70/30/3). [0098] The pure fractions are evaporated, dissolved in 250 ml of cyclohexane and freeze-dried, giving 22.2 g of a white, solid product free from phosphatidic acid and lyso derivatives, with over 95% purity. [0099] This is filtered and dried. EXAMPLE 10 Harvesting and Recycling of L-Serine [0100] The mother waters from the first partitioning of the enzymatic reaction as per example 2 are kept at a temperature of 0° C. for 24 hours, then the crystallised product is filtered. It is washed with ethanol and dried, giving white needles of pure product identical to the original. [0101] The deficit in quantity (about 20%) is added and the product can be used as normal. EXAMPLE 11 Examples of Pharmaceutical Compositions [0102] [0102] (a) Each gelatinous capsule contains: phosphatidylserine 100.0 mg vegetal oil 270.0 mg soy lecithin 30.0 mg (b) Each injectable vial contains: phosphatidylserine 50.0 mg mannitol 100.0 mg soy lecithin (injectable grade) 7.5 mg phosphate buffer 2.2 mg water q.s.a. 2.0 ml EXAMPLE 12 Examples of Food and Dietary Supplements [0103] [0103] (a) Each gelatinous capsule contains: phosphatidylserine 100.0 mg vitamin E 5.0 mg vegetal oil 295.0 mg (b) Each sachet contains: phosphatidylserine 100.0 mg creatine 1.5 gr beta-carotene 0.6 mg vitamin E 5.0 mg vitamin C 30.0 mg vitamin B1 0.7 mg vitamin B6 1.0 mg vitamin B12 0.5 mcg folic acid 0.1 mg (c) Each chewable tablet contains: phosphatidylserine 75.0 mg vitamin E 5.0 mg vitamin C 30.0 mg vitamin B1 0.7 mg vitamin B6 1.0 mg vitamin B12 0.5 mcg folic acid 0.1 mg EXAMPLE 13 Examples of Cosmetic Compositions [0104] [0104] (a) Each Body Cream Tube contains: phosphatidylserine 4.0 gr macadamia ternifolia 2.0 gr sodium hyaluronate 10.0 mg cetearyloctanoate 8.0 gr caprylic/capric tryglyceride 7.0 gr sorbitol 5.0 gr cetearyl alcohol 4.0 gr polysorbate 20 1.0 gr carbomer 0.8 gr sodium dehydroacetate 0.4 gr disodium EDTA 0.3 gr antioxidant (tocopherol) 50.0 mg water q.s.a. 100.0 ml (b) Each Body Ointment Tube contains: phosphatidylserine 3.0 gr cholesterol 2.0 gr sodium hyaluronate 10.0 mg cetearyloctanoate 9.0 gr caprylic/capric tryglyceride 7.0 gr sorbitol 7.0 gr cetearyl alcohol 3.5 gr polysorbate 20 1.0 gr carbomer 0.6 gr sodium dehydroacetate 0.5 gr disodium EDTA 0.3 gr antioxidant (tocopherol) 50.0 mg water q.s.a. 100.0 [0105] The products described above in Examples 11 and 12 can be used in the treatment conditions of psycho-physical stress with attention, concentration and memory deficits, often associated with advancing age, and they can be prepared, for example in the form of capsules, tablets and granules. The tablets and capsules containing the phosphatides of the instant invention may be taken orally, typically 2-3 tablets or capsules per day. [0106] The cosmetic compositions and body ointments described in Example 13 may be applied directly to affected areas and are used in the treatment of skin with impaired physiological functions and as an aid in the therapy of dermatitis. [0107] Although the above pharmaceutical compositions have been described in particular physical forms with particular carriers, it will be recognized that the pharmaceutical compositions of the invention can be formulated in other standard physical forms combined with other known pharmaceutically acceptable carriers, excipients and diluents. [0108] The invention being thus described, it is clear that these methods can be modified in various ways. Such modifications are not to be considered as divergences from the spirit and purpose of the invention and any modification that would appear evident to an expert in the field comes within the scope of the following claims.

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